DRUGS & SUPPLEMENTS

Super-O-Ligo

Name: Super-O-Ligo drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Super-O-Ligo uses

Super-O-Ligo consists of Copper (Copper Proteinate), Copper (Copper Sulfate), Magnesium (Magnesium Hydroxide), Magnesium (Magnesium Proteinate), Manganese (Manganese Proteinate), Manganese (Manganese Sulfate), Potassium (Potassium Chloride), Potassium (Potassium Proteinate), Zinc (Zinc Oxide).

Copper (Copper Proteinate):

Indications:
General directions:
Active ingredient:
Inactive ingredients:
Caution:
Storage:
Net contents:
Super-O-Ligo (Copper (Copper Proteinate)) reviews

Water-Resistant Protection Without Bandaging

Recommended as an Aid in Treating Horses and Ponies With Thrush Due to Organisms Susceptible to Super-O-Ligo (Copper (Copper Proteinate)) Naphthenate.

For Animal Use Only.

INDICATIONS:

ThrushTox® is indicated in the treatment of thrush in horses and ponies.

GENERAL DIRECTIONS:

Clean the hoof thoroughly, removing debris and necrotic material prior to application of Super-O-Ligo (Copper (Copper Proteinate))^®. Apply daily to affected hoofs with a narrow paint brush (about 1”) until fully healed. Caution: Do not allow runoff of excess Super-O-Ligo (Copper (Copper Proteinate))^® onto hair since contact with Super-O-Ligo (Copper (Copper Proteinate))^® may cause some hair loss. Do not contaminate feed.

NOTE: Super-O-Ligo (Copper (Copper Proteinate))^® is easily removed from hands, clothing and surfaces with light grade fuel oil or any type of lighter fluid.

CONTAINS FOIL SEAL – REMOVE BEFORE USE.

SHAKE WELL BEFORE USE.

To report suspected adverse reactions or to obtain technical assistance, call 1-800-650-4899.

ACTIVE INGREDIENT:

Super-O-Ligo (Copper (Copper Proteinate)) Naphthenate...37.5% w/w

INACTIVE INGREDIENTS:

Inert Ingredients...62.5% w/w

Total... 100.0%

CAUTION:

Do not use in horses intended for human consumption.

CAUTION: COMBUSTIBLE MIXTURE.

Use in a well-ventilated place. Avoid fire, flame, sparks or heaters.

If swallowed, do not induce vomiting, call physician immediately. Avoid breathing vapor. Avoid contact with skin and eyes.

KEEP OUT OF REACH OF CHILDREN AND PETS.

STORAGE:

Store at controlled room temperature 15º to 30ºC (59º to 86ºF). Keep container tightly closed when not in use.

Manufactured for:

Aspen Veterinary Resources,^® Ltd.

Liberty, MO 64068, USA

FC163FP 11/13

Manufactured by:

First Priority, Inc.

Elgin, IL 60123-1146, USA

NET CONTENTS:

16 OZ (473 mL)

ANADA 200-304, Approved by FDA

Image of 473 mL bottle/case label

Copper (Copper Sulfate):

Indications:
General directions:
Active ingredient:
Inactive ingredients:
Caution:
Storage:
Net contents:
Super-O-Ligo (Copper (Copper Sulfate)) reviews

Water-Resistant Protection Without Bandaging

Recommended as an Aid in Treating Horses and Ponies With Thrush Due to Organisms Susceptible to Super-O-Ligo (Copper (Copper Sulfate)) Naphthenate.

For Animal Use Only.

INDICATIONS:

ThrushTox® is indicated in the treatment of thrush in horses and ponies.

GENERAL DIRECTIONS:

Clean the hoof thoroughly, removing debris and necrotic material prior to application of Super-O-Ligo (Copper (Copper Sulfate))^®. Apply daily to affected hoofs with a narrow paint brush (about 1”) until fully healed. Caution: Do not allow runoff of excess Super-O-Ligo (Copper (Copper Sulfate))^® onto hair since contact with Super-O-Ligo (Copper (Copper Sulfate))^® may cause some hair loss. Do not contaminate feed.

NOTE: Super-O-Ligo (Copper (Copper Sulfate))^® is easily removed from hands, clothing and surfaces with light grade fuel oil or any type of lighter fluid.

CONTAINS FOIL SEAL – REMOVE BEFORE USE.

SHAKE WELL BEFORE USE.

To report suspected adverse reactions or to obtain technical assistance, call 1-800-650-4899.

ACTIVE INGREDIENT:

Super-O-Ligo (Copper (Copper Sulfate)) Naphthenate...37.5% w/w

INACTIVE INGREDIENTS:

Inert Ingredients...62.5% w/w

Total... 100.0%

CAUTION:

Do not use in horses intended for human consumption.

CAUTION: COMBUSTIBLE MIXTURE.

Use in a well-ventilated place. Avoid fire, flame, sparks or heaters.

If swallowed, do not induce vomiting, call physician immediately. Avoid breathing vapor. Avoid contact with skin and eyes.

KEEP OUT OF REACH OF CHILDREN AND PETS.

STORAGE:

Store at controlled room temperature 15º to 30ºC (59º to 86ºF). Keep container tightly closed when not in use.

Manufactured for:

Aspen Veterinary Resources,^® Ltd.

Liberty, MO 64068, USA

FC163FP 11/13

Manufactured by:

First Priority, Inc.

Elgin, IL 60123-1146, USA

NET CONTENTS:

16 OZ (473 mL)

ANADA 200-304, Approved by FDA

Image of 473 mL bottle/case label

Magnesium (Magnesium Hydroxide):

Description
Clinical pharmacology
Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
References
Super-O-Ligo (Magnesium (Magnesium Hydroxide)) reviews

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate

Injection, USP

Ansyr Plastic Syringe

Rx only

Hospira Logo

DESCRIPTION

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate Injection, USP is a sterile solution of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate heptahydrate in Water for Injection, USP administered by the intravenous or intramuscular routes as an electrolyte replenisher or anticonvulsant. Must be diluted before intravenous use. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 5.5 to 7.0. The 50% concentration has an osmolarity of 4.06 mOsmol/mL (calc.).

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded with the entire unit.

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate, USP heptahydrate is chemically designated MgSO₄ - 7H₂O with molecular weight of 246.48 and occurs as colorless crystals or white powder freely soluble in water.

The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

CLINICAL PHARMACOLOGY

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) (Mg⁺⁺) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

As a nutritional adjunct in hyperalimentation, the precise mechanism of action for Super-O-Ligo (Magnesium (Magnesium Hydroxide)) is uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/liter) may develop as early as three to four days or within weeks.

Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of Super-O-Ligo (Magnesium (Magnesium Hydroxide)). While there are large stores of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Super-O-Ligo (Magnesium (Magnesium Hydroxide)) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Super-O-Ligo (Magnesium (Magnesium Hydroxide)) is said to have a depressant effect on the central nervous system (CNS), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Normal plasma Super-O-Ligo (Magnesium (Magnesium Hydroxide)) levels range from 1.5 to 2.5 mEq/liter.

As plasma Super-O-Ligo (Magnesium (Magnesium Hydroxide)) rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/liter. At this level respiratory paralysis may occur. Heart block also may occur at this or lower plasma levels of Super-O-Ligo (Magnesium (Magnesium Hydroxide)). Serum Super-O-Ligo (Magnesium (Magnesium Hydroxide)) concentrations in excess of 12 mEq/L may be fatal.

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral effects of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) poisoning are antagonized to some extent by intravenous administration of calcium.

Pharmacokinetics

With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter. Super-O-Ligo (Magnesium (Magnesium Hydroxide)) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

INDICATIONS AND USAGE

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate Injection, USP is suitable for replacement therapy in Super-O-Ligo (Magnesium (Magnesium Hydroxide)) deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum Super-O-Ligo (Magnesium (Magnesium Hydroxide)) (Mg⁺⁺) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca⁺⁺) level is normal (4.3 to 5.3 mEq/liter) or elevated.

In total parenteral nutrition (TPN), Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.

CONTRAINDICATIONS

Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

WARNINGS

FETAL HARM: Continuous administration of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate should be used during pregnancy only if clearly needed. If Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate beyond 5 to 7 days may cause fetal abnormalities.

ALUMINUM TOXICITY: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Parenteral use in the presence of renal insufficiency may lead to Super-O-Ligo (Magnesium (Magnesium Hydroxide)) intoxication. Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.

PRECAUTIONS

General

Administer with caution if flushing and sweating occurs. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with Super-O-Ligo (Magnesium (Magnesium Hydroxide)), their dosage should be adjusted with caution because of additive CNS depressant effects of Super-O-Ligo (Magnesium (Magnesium Hydroxide)).

Because Super-O-Ligo (Magnesium (Magnesium Hydroxide)) is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL or more during the four hours preceding each dose. Monitoring serum Super-O-Ligo (Magnesium (Magnesium Hydroxide)) levels and the patient's clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). When repeated doses of the drug are given parenterally, knee jerk reflexes should be tested before each dose and if they are absent, no additional Super-O-Ligo (Magnesium (Magnesium Hydroxide)) should be given until they return. Serum Super-O-Ligo (Magnesium (Magnesium Hydroxide)) levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). The strength of the deep tendon reflexes begins to diminish when Super-O-Ligo (Magnesium (Magnesium Hydroxide)) levels exceed 4 mEq/liter. Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) intoxication in eclampsia.

50% Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate Injection, USP must be diluted to a concentration of 20% or less prior to intravenous infusion. Rate of administration should be slow and cautious, to avoid producing hypermagnesemia. The 50% solution also should be diluted to 20% or less for intramuscular injection in infants and children.

Laboratory Tests

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) is monitored. The normal serum level is 1.5 to 2.5 mEq/L.

Drug Interactions

CNS Depressants - When barbiturates, narcotics or other hypnotics (or systemic anesthetics), or other CNS depressants are to be given in conjunction with Super-O-Ligo (Magnesium (Magnesium Hydroxide)), their dosage should be adjusted with caution because of additive CNS depressant effects of Super-O-Ligo (Magnesium (Magnesium Hydroxide)). CNS depression and peripheral transmission defects produced by Super-O-Ligo (Magnesium (Magnesium Hydroxide)) may be antagonized by calcium.

Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.

Cardiac Glycosides - Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate should be administered with extreme caution in digitalized patients, because serious changes in cardiac conduction which can result in heart block may occur if administration of calcium is required to treat Super-O-Ligo (Magnesium (Magnesium Hydroxide)) toxicity.

Pregnancy

Teratogenic Effects

Pregnancy Category D (See WARNINGS and PRECAUTIONS )

See WARNINGS and PRECAUTIONS .

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate can cause fetal abnormalities when administered beyond 5 to 7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization, osteopenia and other skeletal abnormalities with continuous maternal administration of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate for more than 5 to 7 days.^1-10 Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate injection should be used during pregnancy only if clearly needed. If this drug is used during pregnancy, the woman should be apprised of the potential harm to the fetus.

Nonteratogenic Effects

When administered by continuous intravenous infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).

Labor and Delivery

Continuous administration of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Nursing Mothers

Since Super-O-Ligo (Magnesium (Magnesium Hydroxide)) is distributed into milk during parenteral Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate administration, the drug should be used with caution in nursing women.

Geriatrics

Geriatric patients often require reduced dosage because of impaired renal function. In patients with severe impairment, dosage should not exceed 20 grams in 48 hours. Serum Super-O-Ligo (Magnesium (Magnesium Hydroxide)) should be monitored in such patients.

ADVERSE REACTIONS

The adverse effects of parenterally administered Super-O-Ligo (Magnesium (Magnesium Hydroxide)) usually are the result of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate therapy for eclampsia has been reported.

OVERDOSAGE

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of Super-O-Ligo (Magnesium (Magnesium Hydroxide)).

For Treatment of Overdose

Artificial respiration is often required. Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.

Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

DOSAGE AND ADMINISTRATION

Dosage of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained.

Both intravenous and intramuscular administration are appropriate. Intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas intravenous doses will provide a therapeutic level almost immediately. The rate of intravenous injection should generally not exceed 150 mg/minute (1.5 mL of a 10% concentration or its equivalent), except in severe eclampsia with seizures. Continuous maternal administration of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Solutions for intravenous infusion must be diluted to a concentration of 20% or less prior to administration. The diluents commonly used are 5% Dextrose Injection, USP and 0.9% Sodium Chloride Injection, USP. Deep intramuscular injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children.

In Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Deficiency

In the treatment of mild Super-O-Ligo (Magnesium (Magnesium Hydroxide)) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) per 24 hours). For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given intramuscularly within a period of four hours if necessary. Alternatively, 5 grams, (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow intravenous infusion over a three-hour period. In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

In Hyperalimentation

In total parenteral nutrition, maintenance requirements for Super-O-Ligo (Magnesium (Magnesium Hydroxide)) are not precisely known. The maintenance dose used in adults ranges from 8 to 24 mEq (1 gram to 3 grams) daily; for infants, the range is 2 to 10 mEq (0.25 gram to 1.25 grams) daily.

In Pre-eclampsia or Eclampsia

In severe pre-eclampsia or eclampsia, the total initial dose is 10 grams to 14 grams of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate. Intravenously, a dose of 4 grams to 5 grams in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Simultaneously, intramuscular doses of up to 10 grams (5 grams or 10 mL of the undiluted 50% solution in each buttock) are given. Alternatively, the initial intravenous dose of 4 grams may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected intravenously over a period of three to four minutes. Subsequently, 4 grams to 5 grams (8 to 10 mL of the 50% solution) are injected intramuscularly into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. Alternatively, after the initial intravenous dose, some clinicians administer 1 gram to 2 grams/hour by constant intravenous infusion. Therapy should continue until paroxysms cease. A serum Super-O-Ligo (Magnesium (Magnesium Hydroxide)) level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 grams to 40 grams should not be exceeded. In the presence of severe renal insufficiency, the maximum dosage of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate is 20 grams/48 hours and frequent serum Super-O-Ligo (Magnesium (Magnesium Hydroxide)) concentrations must be obtained. Continuous use of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Other Uses

In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate is 1 gram to 2 grams given intravenously.

For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 gram administered intramuscularly or intravenously.

In paroxysmal atrial tachycardia, Super-O-Ligo (Magnesium (Magnesium Hydroxide)) should be used only if simpler measures have failed and there is no evidence of myocardial damage. The usual dose is 3 grams to 4 grams (30 to 40 mL of a 10% solution) administered intravenously over 30 seconds with extreme caution.

For reduction of cerebral edema, 2.5 grams (25 mL of a 10% solution) is given intravenously.

Incompatibilities

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate in solution may result in a precipitate formation when mixed with solutions containing:

Alcohol (in high Heavy Metals

concentrations) Hydrocortisone sodium

Alkali carbonates and succinate

bicarbonates Phosphates

Alkali hydroxides Polymixin B sulfate

Arsenates Procaine hydrochloride

Barium Salicylates

Calcium Strontium

Clindamycin phosphate Tartrates

The potential incompatibility will often be influenced by the changes in the concentration of reactants and the pH of the solutions.

It has been reported that Super-O-Ligo (Magnesium (Magnesium Hydroxide)) may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate Injection, USP is supplied in single-dose containers as follows:

NDC No.

Container

Total

Amount

Concentration

mEq

Mg⁺⁺/mL

0409-1754-10

Ansyr

Plastic Syringe

5 g/10 mL

50%

4 mEq/mL

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Store at 20 to 25°C (68 to 77°F).

REFERENCES

Yokoyama K, Takahashi N, Yada Y. Prolonged maternal Super-O-Ligo (Magnesium (Magnesium Hydroxide)) administration and bone metabolism in neonates. Early Hum Dev. 2010;86(3):187-91. Epub 2010 Mar 12.
Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal Super-O-Ligo (Magnesium (Magnesium Hydroxide)) toxicity. J. Perinatol. 2006; 26(6):371-4.
Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
Matsuda Y, Maeda Y, Ito M, et al. Effect of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997;44(2):82-8.
Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997;43(4):236-41.
Santi MD, Henry GW, Douglas GL. Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthrop. 1994;14(2):249-53.
Holcomb WL, Shackelford GD, Petrie RH. Super-O-Ligo (Magnesium (Magnesium Hydroxide)) tocolysis and neonatal bone abnormalities; a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980; 56(5): 595-600.
Riaz M, Porat R, Brodsky NL, et al. The effects of maternal Super-O-Ligo (Magnesium (Magnesium Hydroxide)) sulfate treatment on newborns: a prospective controlled study. J. Perinatol. 1998;18(6 pt 1):449-54.

Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1024-1.0

April 2017

Hospira Logo

50% Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate 5 g/10 mL (500 mg/mL)

Rx only

NDC 0409-1754-10

10 mL Single-dose syringe

50% Super-O-Ligo (Magnesium (Magnesium Hydroxide)) Sulfate Injection, USP

5 g/10 mL (500 mg/mL) (4 mEq Mg++/mL)

MUST BE DILUTED FOR INTRAVENOUS USE.

For Intravenous or Intramuscular Use. Sterile. 4.06 mOsmol/mL (calc.).

Contains no more than 75 mcg/L of aluminum.

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

RL-6891

Magnesium (Magnesium Proteinate):

Description
Clinical pharmacology
Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
References
Super-O-Ligo (Magnesium (Magnesium Proteinate)) reviews

Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate

Injection, USP

Ansyr Plastic Syringe

Rx only

Hospira Logo

DESCRIPTION

Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate Injection, USP is a sterile solution of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate heptahydrate in Water for Injection, USP administered by the intravenous or intramuscular routes as an electrolyte replenisher or anticonvulsant. Must be diluted before intravenous use. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 5.5 to 7.0. The 50% concentration has an osmolarity of 4.06 mOsmol/mL (calc.).

Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate, USP heptahydrate is chemically designated MgSO₄ - 7H₂O with molecular weight of 246.48 and occurs as colorless crystals or white powder freely soluble in water.

CLINICAL PHARMACOLOGY

Super-O-Ligo (Magnesium (Magnesium Proteinate)) (Mg⁺⁺) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

As a nutritional adjunct in hyperalimentation, the precise mechanism of action for Super-O-Ligo (Magnesium (Magnesium Proteinate)) is uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/liter) may develop as early as three to four days or within weeks.

Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of Super-O-Ligo (Magnesium (Magnesium Proteinate)). While there are large stores of Super-O-Ligo (Magnesium (Magnesium Proteinate)) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Super-O-Ligo (Magnesium (Magnesium Proteinate)) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.

Super-O-Ligo (Magnesium (Magnesium Proteinate)) prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Super-O-Ligo (Magnesium (Magnesium Proteinate)) is said to have a depressant effect on the central nervous system (CNS), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Normal plasma Super-O-Ligo (Magnesium (Magnesium Proteinate)) levels range from 1.5 to 2.5 mEq/liter.

As plasma Super-O-Ligo (Magnesium (Magnesium Proteinate)) rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/liter. At this level respiratory paralysis may occur. Heart block also may occur at this or lower plasma levels of Super-O-Ligo (Magnesium (Magnesium Proteinate)). Serum Super-O-Ligo (Magnesium (Magnesium Proteinate)) concentrations in excess of 12 mEq/L may be fatal.

Super-O-Ligo (Magnesium (Magnesium Proteinate)) acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral effects of Super-O-Ligo (Magnesium (Magnesium Proteinate)) poisoning are antagonized to some extent by intravenous administration of calcium.

Pharmacokinetics

With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter. Super-O-Ligo (Magnesium (Magnesium Proteinate)) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

INDICATIONS AND USAGE

Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate Injection, USP is suitable for replacement therapy in Super-O-Ligo (Magnesium (Magnesium Proteinate)) deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum Super-O-Ligo (Magnesium (Magnesium Proteinate)) (Mg⁺⁺) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca⁺⁺) level is normal (4.3 to 5.3 mEq/liter) or elevated.

In total parenteral nutrition (TPN), Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.

Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.

CONTRAINDICATIONS

Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

WARNINGS

FETAL HARM: Continuous administration of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate should be used during pregnancy only if clearly needed. If Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate beyond 5 to 7 days may cause fetal abnormalities.

Parenteral use in the presence of renal insufficiency may lead to Super-O-Ligo (Magnesium (Magnesium Proteinate)) intoxication. Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.

PRECAUTIONS

General

Administer with caution if flushing and sweating occurs. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with Super-O-Ligo (Magnesium (Magnesium Proteinate)), their dosage should be adjusted with caution because of additive CNS depressant effects of Super-O-Ligo (Magnesium (Magnesium Proteinate)).

Because Super-O-Ligo (Magnesium (Magnesium Proteinate)) is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL or more during the four hours preceding each dose. Monitoring serum Super-O-Ligo (Magnesium (Magnesium Proteinate)) levels and the patient's clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). When repeated doses of the drug are given parenterally, knee jerk reflexes should be tested before each dose and if they are absent, no additional Super-O-Ligo (Magnesium (Magnesium Proteinate)) should be given until they return. Serum Super-O-Ligo (Magnesium (Magnesium Proteinate)) levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). The strength of the deep tendon reflexes begins to diminish when Super-O-Ligo (Magnesium (Magnesium Proteinate)) levels exceed 4 mEq/liter. Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of Super-O-Ligo (Magnesium (Magnesium Proteinate)) intoxication in eclampsia.

50% Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate Injection, USP must be diluted to a concentration of 20% or less prior to intravenous infusion. Rate of administration should be slow and cautious, to avoid producing hypermagnesemia. The 50% solution also should be diluted to 20% or less for intramuscular injection in infants and children.

Laboratory Tests

Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Super-O-Ligo (Magnesium (Magnesium Proteinate)) is monitored. The normal serum level is 1.5 to 2.5 mEq/L.

Drug Interactions

CNS Depressants - When barbiturates, narcotics or other hypnotics (or systemic anesthetics), or other CNS depressants are to be given in conjunction with Super-O-Ligo (Magnesium (Magnesium Proteinate)), their dosage should be adjusted with caution because of additive CNS depressant effects of Super-O-Ligo (Magnesium (Magnesium Proteinate)). CNS depression and peripheral transmission defects produced by Super-O-Ligo (Magnesium (Magnesium Proteinate)) may be antagonized by calcium.

Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.

Cardiac Glycosides - Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate should be administered with extreme caution in digitalized patients, because serious changes in cardiac conduction which can result in heart block may occur if administration of calcium is required to treat Super-O-Ligo (Magnesium (Magnesium Proteinate)) toxicity.

Pregnancy

Teratogenic Effects

Pregnancy Category D (See WARNINGS and PRECAUTIONS )

See WARNINGS and PRECAUTIONS .

Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate can cause fetal abnormalities when administered beyond 5 to 7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization, osteopenia and other skeletal abnormalities with continuous maternal administration of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate for more than 5 to 7 days.^1-10 Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate injection should be used during pregnancy only if clearly needed. If this drug is used during pregnancy, the woman should be apprised of the potential harm to the fetus.

Nonteratogenic Effects

When administered by continuous intravenous infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of Super-O-Ligo (Magnesium (Magnesium Proteinate)) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).

Labor and Delivery

Continuous administration of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Nursing Mothers

Since Super-O-Ligo (Magnesium (Magnesium Proteinate)) is distributed into milk during parenteral Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate administration, the drug should be used with caution in nursing women.

Geriatrics

ADVERSE REACTIONS

The adverse effects of parenterally administered Super-O-Ligo (Magnesium (Magnesium Proteinate)) usually are the result of Super-O-Ligo (Magnesium (Magnesium Proteinate)) intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate therapy for eclampsia has been reported.

OVERDOSAGE

Super-O-Ligo (Magnesium (Magnesium Proteinate)) intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of Super-O-Ligo (Magnesium (Magnesium Proteinate)) intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of Super-O-Ligo (Magnesium (Magnesium Proteinate)).

For Treatment of Overdose

Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

DOSAGE AND ADMINISTRATION

Dosage of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained.

Both intravenous and intramuscular administration are appropriate. Intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas intravenous doses will provide a therapeutic level almost immediately. The rate of intravenous injection should generally not exceed 150 mg/minute (1.5 mL of a 10% concentration or its equivalent), except in severe eclampsia with seizures. Continuous maternal administration of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

In Super-O-Ligo (Magnesium (Magnesium Proteinate)) Deficiency

In the treatment of mild Super-O-Ligo (Magnesium (Magnesium Proteinate)) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Super-O-Ligo (Magnesium (Magnesium Proteinate)) (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of Super-O-Ligo (Magnesium (Magnesium Proteinate)) per 24 hours). For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given intramuscularly within a period of four hours if necessary. Alternatively, 5 grams, (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow intravenous infusion over a three-hour period. In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

In Hyperalimentation

In total parenteral nutrition, maintenance requirements for Super-O-Ligo (Magnesium (Magnesium Proteinate)) are not precisely known. The maintenance dose used in adults ranges from 8 to 24 mEq (1 gram to 3 grams) daily; for infants, the range is 2 to 10 mEq (0.25 gram to 1.25 grams) daily.

In Pre-eclampsia or Eclampsia

In severe pre-eclampsia or eclampsia, the total initial dose is 10 grams to 14 grams of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate. Intravenously, a dose of 4 grams to 5 grams in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Simultaneously, intramuscular doses of up to 10 grams (5 grams or 10 mL of the undiluted 50% solution in each buttock) are given. Alternatively, the initial intravenous dose of 4 grams may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected intravenously over a period of three to four minutes. Subsequently, 4 grams to 5 grams (8 to 10 mL of the 50% solution) are injected intramuscularly into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. Alternatively, after the initial intravenous dose, some clinicians administer 1 gram to 2 grams/hour by constant intravenous infusion. Therapy should continue until paroxysms cease. A serum Super-O-Ligo (Magnesium (Magnesium Proteinate)) level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 grams to 40 grams should not be exceeded. In the presence of severe renal insufficiency, the maximum dosage of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate is 20 grams/48 hours and frequent serum Super-O-Ligo (Magnesium (Magnesium Proteinate)) concentrations must be obtained. Continuous use of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Other Uses

In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate is 1 gram to 2 grams given intravenously.

For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 gram administered intramuscularly or intravenously.

In paroxysmal atrial tachycardia, Super-O-Ligo (Magnesium (Magnesium Proteinate)) should be used only if simpler measures have failed and there is no evidence of myocardial damage. The usual dose is 3 grams to 4 grams (30 to 40 mL of a 10% solution) administered intravenously over 30 seconds with extreme caution.

For reduction of cerebral edema, 2.5 grams (25 mL of a 10% solution) is given intravenously.

Incompatibilities

Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate in solution may result in a precipitate formation when mixed with solutions containing:

Alcohol (in high Heavy Metals

concentrations) Hydrocortisone sodium

Alkali carbonates and succinate

bicarbonates Phosphates

Alkali hydroxides Polymixin B sulfate

Arsenates Procaine hydrochloride

Barium Salicylates

Calcium Strontium

Clindamycin phosphate Tartrates

The potential incompatibility will often be influenced by the changes in the concentration of reactants and the pH of the solutions.

It has been reported that Super-O-Ligo (Magnesium (Magnesium Proteinate)) may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate Injection, USP is supplied in single-dose containers as follows:

NDC No.

Container

Total

Amount

Concentration

mEq

Mg⁺⁺/mL

0409-1754-10

Ansyr

Plastic Syringe

5 g/10 mL

50%

4 mEq/mL

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Store at 20 to 25°C (68 to 77°F).

REFERENCES

Yokoyama K, Takahashi N, Yada Y. Prolonged maternal Super-O-Ligo (Magnesium (Magnesium Proteinate)) administration and bone metabolism in neonates. Early Hum Dev. 2010;86(3):187-91. Epub 2010 Mar 12.
Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal Super-O-Ligo (Magnesium (Magnesium Proteinate)) toxicity. J. Perinatol. 2006; 26(6):371-4.
Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
Matsuda Y, Maeda Y, Ito M, et al. Effect of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997;44(2):82-8.
Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997;43(4):236-41.
Santi MD, Henry GW, Douglas GL. Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthrop. 1994;14(2):249-53.
Holcomb WL, Shackelford GD, Petrie RH. Super-O-Ligo (Magnesium (Magnesium Proteinate)) tocolysis and neonatal bone abnormalities; a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980; 56(5): 595-600.
Riaz M, Porat R, Brodsky NL, et al. The effects of maternal Super-O-Ligo (Magnesium (Magnesium Proteinate)) sulfate treatment on newborns: a prospective controlled study. J. Perinatol. 1998;18(6 pt 1):449-54.

Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1024-1.0

April 2017

Hospira Logo

50% Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate 5 g/10 mL (500 mg/mL)

Rx only

NDC 0409-1754-10

10 mL Single-dose syringe

50% Super-O-Ligo (Magnesium (Magnesium Proteinate)) Sulfate Injection, USP

5 g/10 mL (500 mg/mL) (4 mEq Mg++/mL)

MUST BE DILUTED FOR INTRAVENOUS USE.

For Intravenous or Intramuscular Use. Sterile. 4.06 mOsmol/mL (calc.).

Contains no more than 75 mcg/L of aluminum.

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

RL-6891

Manganese (Manganese Proteinate):

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Drug abuse and dependence
Overdosage
Dosage and administration
How supplied
Rl-0104
Super-O-Ligo (Manganese (Manganese Proteinate)) reviews

INDICATIONS AND USAGE

Super-O-Ligo (Manganese (Manganese Proteinate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN).

Administration helps to maintain Super-O-Ligo (Manganese (Manganese Proteinate)) serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Super-O-Ligo (Manganese (Manganese Proteinate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is contraindicated as the acidic pH of the solution (pH 2.0) may cause considerable tissue irritation.

Liver and/or biliary tract dysfunction may require omission or reduction of copper and Super-O-Ligo (Manganese (Manganese Proteinate)) doses because these elements are primarily eliminated in the bile.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

PRECAUTIONS

General

Do not use unless solution is clear and seal is intact.

Super-O-Ligo ) 0.1 mg/mL (Manganese Chloride Injection, USP) should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Laboratory Tests

Serum Super-O-Ligo (Manganese (Manganese Proteinate)) levels can be measured periodically at the discretion of the investigator. Because of the low serum concentration normally present, samples will usually be analyzed by a reference laboratory.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Super-O-Ligo ) 0.1 mg/mL (Manganese Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Super-O-Ligo (Manganese (Manganese Proteinate)) 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Super-O-Ligo (Manganese (Manganese Proteinate)) chloride. It is also not known whether Super-O-Ligo (Manganese (Manganese Proteinate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Super-O-Ligo (Manganese (Manganese Proteinate)) chloride should be given to a pregnant woman only if clearly indicated.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Super-O-Ligo (Manganese (Manganese Proteinate)) toxicity in TPN patients has not been reported.

DOSAGE AND ADMINISTRATION

Super-O-Ligo (Manganese (Manganese Proteinate)) 0.1 mg/mL (Manganese Chloride Injection, USP) contains 0.1 mg manganese/mL and is administered intravenously only after dilution. The additive should be administered in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage for Super-O-Ligo (Manganese (Manganese Proteinate)) is 0.15 to 0.8 mg/day (1.5 to 8 mL/day). For pediatric patients, a dosage of 2 to 10 mcg manganese/kg/day (0.02 to 0.1 mL/kg/day) is recommended.

Periodic monitoring of Super-O-Ligo (Manganese (Manganese Proteinate)) plasma levels is suggested as a guideline for subsequent administration.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)

HOW SUPPLIED

Super-O-Ligo (Manganese (Manganese Proteinate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Plastic Vials (NDC No. 0409-4091-01).

Store at 20 to 25°C (68 to 77°F)

Revised: November, 2009

Printed in USA EN-2320

Hospira, Inc., Lake Forest, IL 60045 USA

RL-0104

Manganese (Manganese Sulfate):

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Drug abuse and dependence
Overdosage
Dosage and administration
How supplied
Rl-0104
Super-O-Ligo (Manganese (Manganese Sulfate)) reviews

INDICATIONS AND USAGE

Super-O-Ligo (Manganese (Manganese Sulfate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN).

Administration helps to maintain Super-O-Ligo (Manganese (Manganese Sulfate)) serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Super-O-Ligo (Manganese (Manganese Sulfate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is contraindicated as the acidic pH of the solution (pH 2.0) may cause considerable tissue irritation.

Liver and/or biliary tract dysfunction may require omission or reduction of copper and Super-O-Ligo (Manganese (Manganese Sulfate)) doses because these elements are primarily eliminated in the bile.

PRECAUTIONS

General

Do not use unless solution is clear and seal is intact.

Laboratory Tests

Serum Super-O-Ligo (Manganese (Manganese Sulfate)) levels can be measured periodically at the discretion of the investigator. Because of the low serum concentration normally present, samples will usually be analyzed by a reference laboratory.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Super-O-Ligo (Manganese (Manganese Sulfate)) 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Super-O-Ligo (Manganese (Manganese Sulfate)) chloride. It is also not known whether Super-O-Ligo (Manganese (Manganese Sulfate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Super-O-Ligo (Manganese (Manganese Sulfate)) chloride should be given to a pregnant woman only if clearly indicated.

Geriatric Use

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Super-O-Ligo (Manganese (Manganese Sulfate)) toxicity in TPN patients has not been reported.

DOSAGE AND ADMINISTRATION

Super-O-Ligo (Manganese (Manganese Sulfate)) 0.1 mg/mL (Manganese Chloride Injection, USP) contains 0.1 mg manganese/mL and is administered intravenously only after dilution. The additive should be administered in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage for Super-O-Ligo (Manganese (Manganese Sulfate)) is 0.15 to 0.8 mg/day (1.5 to 8 mL/day). For pediatric patients, a dosage of 2 to 10 mcg manganese/kg/day (0.02 to 0.1 mL/kg/day) is recommended.

Periodic monitoring of Super-O-Ligo (Manganese (Manganese Sulfate)) plasma levels is suggested as a guideline for subsequent administration.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)

HOW SUPPLIED

Super-O-Ligo (Manganese (Manganese Sulfate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Plastic Vials (NDC No. 0409-4091-01).

Store at 20 to 25°C (68 to 77°F)

Revised: November, 2009

Printed in USA EN-2320

Hospira, Inc., Lake Forest, IL 60045 USA

RL-0104

Potassium (Potassium Chloride):

Description
Clinical pharmacology
Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
Super-O-Ligo (Potassium (Potassium Chloride)) reviews

Super-O-Ligo (Potassium (Potassium Chloride)) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

The Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Super-O-Ligo (Potassium (Potassium Chloride)) chloride containing 1500 mg of microencapsulated Super-O-Ligo (Potassium (Potassium Chloride)) chloride, USP equivalent to 20 mEq of Super-O-Ligo (Potassium (Potassium Chloride)) in a tablet.

These formulations are intended to slow the release of Super-O-Ligo (Potassium (Potassium Chloride)) so that the likelihood of a high localized concentration of Super-O-Ligo (Potassium (Potassium Chloride)) chloride within the gastrointestinal tract is reduced.

Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Super-O-Ligo (Potassium (Potassium Chloride)) chloride, and the structural formula is KCl. Super-O-Ligo (Potassium (Potassium Chloride)) chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Super-O-Ligo (Potassium (Potassium Chloride)) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of Super-O-Ligo (Potassium (Potassium Chloride)) chloride.

Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose.

CLINICAL PHARMACOLOGY

The Super-O-Ligo (Potassium (Potassium Chloride)) ion is the principal intracellular cation of most body tissues. Super-O-Ligo (Potassium (Potassium Chloride)) ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.

The intracellular concentration of Super-O-Ligo (Potassium (Potassium Chloride)) is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.

Super-O-Ligo (Potassium (Potassium Chloride)) is a normal dietary constituent and under steady-state conditions the amount of Super-O-Ligo (Potassium (Potassium Chloride)) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Super-O-Ligo (Potassium (Potassium Chloride)) is 50 to 100 mEq per day.

Super-O-Ligo (Potassium (Potassium Chloride)) depletion will occur whenever the rate of Super-O-Ligo (Potassium (Potassium Chloride)) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Super-O-Ligo (Potassium (Potassium Chloride)) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of Super-O-Ligo (Potassium (Potassium Chloride)) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Super-O-Ligo (Potassium (Potassium Chloride)) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Super-O-Ligo (Potassium (Potassium Chloride)) depletion may produce weakness, fatigue, disturbances or cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

If Super-O-Ligo (Potassium (Potassium Chloride)) depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, eg, where the patient requires long-term diuretic therapy, supplemental Super-O-Ligo (Potassium (Potassium Chloride)) in the form of high Super-O-Ligo (Potassium (Potassium Chloride)) food or Super-O-Ligo (Potassium (Potassium Chloride)) chloride may be able to restore normal Super-O-Ligo (Potassium (Potassium Chloride)) levels.

In rare circumstances (eg, patients with renal tubular acidosis) Super-O-Ligo (Potassium (Potassium Chloride)) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Super-O-Ligo (Potassium (Potassium Chloride)) replacement should be accomplished with Super-O-Ligo (Potassium (Potassium Chloride)) salts other than the chloride, such as Super-O-Ligo (Potassium (Potassium Chloride)) bicarbonate, Super-O-Ligo (Potassium (Potassium Chloride)) citrate, Super-O-Ligo (Potassium (Potassium Chloride)) acetate, or Super-O-Ligo (Potassium (Potassium Chloride)) gluconate.

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Super-O-Ligo (Potassium (Potassium Chloride)) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Super-O-Ligo (Potassium (Potassium Chloride)) PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.

2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias.

The use of Super-O-Ligo (Potassium (Potassium Chloride)) salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum Super-O-Ligo (Potassium (Potassium Chloride)) should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with Super-O-Ligo (Potassium (Potassium Chloride)) salts may be indicated.

CONTRAINDICATIONS

Super-O-Ligo (Potassium (Potassium Chloride)) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Super-O-Ligo (Potassium (Potassium Chloride)) concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis, such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

Controlled-release formulations of Super-O-Ligo (Potassium (Potassium Chloride)) chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Super-O-Ligo (Potassium (Potassium Chloride)) supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Super-O-Ligo (Potassium (Potassium Chloride)) Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).

All solid oral dosage forms of Super-O-Ligo (Potassium (Potassium Chloride)) chloride are contraindicated in any patient in whom there is structural, pathological (eg, diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

WARNINGS

Hyperkalemia (see OVERDOSAGE )

In patients with impaired mechanisms for excreting Super-O-Ligo (Potassium (Potassium Chloride)), the administration of Super-O-Ligo (Potassium (Potassium Chloride)) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Super-O-Ligo (Potassium (Potassium Chloride)) by the intravenous route but may also occur in patients given Super-O-Ligo (Potassium (Potassium Chloride)) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Super-O-Ligo (Potassium (Potassium Chloride)) salts in patients with chronic renal disease, or any other condition which impairs Super-O-Ligo (Potassium (Potassium Chloride)) excretion, requires particularly careful monitoring of the serum Super-O-Ligo (Potassium (Potassium Chloride)) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of Super-O-Ligo (Potassium (Potassium Chloride)) salts and a potassium-sparing diuretic (eg, spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin-Converting Enzyme Inhibitors

Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril, enalapril) will produce some Super-O-Ligo (Potassium (Potassium Chloride)) retention by inhibiting aldosterone production. Super-O-Ligo (Potassium (Potassium Chloride)) supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of Super-O-Ligo (Potassium (Potassium Chloride)) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Super-O-Ligo (Potassium (Potassium Chloride)) chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to sustained release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Super-O-Ligo (Potassium (Potassium Chloride)) chloride and thus to minimize the possibility of a high local concentration of Super-O-Ligo (Potassium (Potassium Chloride)) near the gastrointestinal wall.

Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral Super-O-Ligo (Potassium (Potassium Chloride)) chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (ie, 96 mEq per day in divided doses of Super-O-Ligo (Potassium (Potassium Chloride)) chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing). The relevance of these findings to the usual conditions (ie, non-fasting, no anticholinergic agent, smaller doses) under which controlled-release Super-O-Ligo (Potassium (Potassium Chloride)) chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq should be discontinued immediately and the possibility of ulceration, obstruction, or perforation should be considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs.

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing Super-O-Ligo (Potassium (Potassium Chloride)) salt such as Super-O-Ligo (Potassium (Potassium Chloride)) bicarbonate, Super-O-Ligo (Potassium (Potassium Chloride)) citrate, Super-O-Ligo (Potassium (Potassium Chloride)) acetate, or Super-O-Ligo (Potassium (Potassium Chloride)) gluconate.

PRECAUTIONS

General

The diagnosis of Super-O-Ligo ) depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Super-O-Ligo (Potassium (Potassium Chloride)) depletion. In interpreting the serum Super-O-Ligo (Potassium (Potassium Chloride)) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body Super-O-Ligo (Potassium (Potassium Chloride)) while acute acidosis per se can increase the serum Super-O-Ligo (Potassium (Potassium Chloride)) concentration into the normal range even in the presence of a reduced total body Super-O-Ligo (Potassium (Potassium Chloride)). The treatment of Super-O-Ligo (Potassium (Potassium Chloride)) depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

Information for Patients

Physicians should consider reminding the patient of the following: To take each dose with meals and with a full glass of water or other liquid. To take each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration:

Break the tablet in half, and take each half separately with a glass of water.
Prepare an aqueous (water) suspension as follows:
1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
2. Allow approximately 2 minutes for the tablet(s) to disintegrate.
3. Stir for about half a minute after the tablet(s) has disintegrated.
4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
5. Add another 1 fluid ounce of water, swirl, and consume immediately.
6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of Super-O-Ligo (Potassium (Potassium Chloride)) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.

To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Laboratory Tests

When blood is drawn for analysis of plasma Super-O-Ligo ) it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Drug Interactions

Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS ).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Super-O-Ligo ) is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Super-O-Ligo (Potassium (Potassium Chloride)) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal Super-O-Ligo ) ion content of human milk is about 13 mEq per liter. Since oral Super-O-Ligo (Potassium (Potassium Chloride)) becomes part of the body Super-O-Ligo (Potassium (Potassium Chloride)) pool, so long as body Super-O-Ligo (Potassium (Potassium Chloride)) is not excessive, the contribution of Super-O-Ligo (Potassium (Potassium Chloride)) chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Super-O-Ligo (Potassium (Potassium Chloride)) Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection; and it may be useful to monitor renal function.

ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS , and OVERDOSAGE ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ). The most common adverse reactions to oral Super-O-Ligo (Potassium (Potassium Chloride)) salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.

OVERDOSAGE

The administration of oral Super-O-Ligo (Potassium (Potassium Chloride)) salts to persons with normal excretory mechanisms for Super-O-Ligo (Potassium (Potassium Chloride)) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Super-O-Ligo (Potassium (Potassium Chloride)) is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS ). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum Super-O-Ligo (Potassium (Potassium Chloride)) concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Treatment measures for hyperkalemia include the following:

Patients should be closely monitored for arrhythmias and electrolyte changes.
Elimination of foods and medications containing Super-O-Ligo (Potassium (Potassium Chloride)) and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
Intravenous calcium gluconate if the patient is at no risk of developing digitalis toxicity.
Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
Correction of acidosis, if present, with intravenous sodium bicarbonate.
Use of exchange resins, hemodialysis, or peritoneal dialysis.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum Super-O-Ligo (Potassium (Potassium Chloride)) concentration can produce digitalis toxicity.

The extended release feature means that absorption and toxic effects may be delayed for hours.

Consider standard measures to remove any unabsorbed drug.

DOSAGE AND ADMINISTRATION

The usual dietary intake of Super-O-Ligo (Potassium (Potassium Chloride)) by the average adult is 50 to 100 mEq per day. Super-O-Ligo (Potassium (Potassium Chloride)) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Super-O-Ligo (Potassium (Potassium Chloride)) from the total body store.

Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of Super-O-Ligo (Potassium (Potassium Chloride)) depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

Each Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Super-O-Ligo (Potassium (Potassium Chloride)) chloride.

Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS ).

Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:

Break the tablet in half, and take each half separately with a glass of water.
Prepare an aqueous (water) suspension as follows:
- Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
- Allow approximately 2 minutes for the tablet(s) to disintegrate.
- Stir for about half a minute after the tablet(s) has disintegrated.
- Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
- Add another 1 fluid ounce of water, swirl, and consume immediately.
- Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

HOW SUPPLIED

Super-O-Ligo (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.

Storage Conditions

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by:

Eurand, Inc.

Vandalia, OH 45377 USA

Distributed by:

Watson Pharma, Inc.

Rev. Date (01/09) 173714

Super-O-Ligo (Potassium (Potassium Chloride)) chloride 20 Meq

Potassium (Potassium Proteinate):

Description
Clinical pharmacology
Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
Super-O-Ligo (Potassium (Potassium Proteinate)) reviews

Super-O-Ligo (Potassium (Potassium Proteinate)) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

The Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride containing 1500 mg of microencapsulated Super-O-Ligo (Potassium (Potassium Proteinate)) chloride, USP equivalent to 20 mEq of Super-O-Ligo (Potassium (Potassium Proteinate)) in a tablet.

These formulations are intended to slow the release of Super-O-Ligo (Potassium (Potassium Proteinate)) so that the likelihood of a high localized concentration of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride within the gastrointestinal tract is reduced.

Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Super-O-Ligo (Potassium (Potassium Proteinate)) chloride, and the structural formula is KCl. Super-O-Ligo (Potassium (Potassium Proteinate)) chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Super-O-Ligo (Potassium (Potassium Proteinate)) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride.

Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose.

CLINICAL PHARMACOLOGY

The Super-O-Ligo (Potassium (Potassium Proteinate)) ion is the principal intracellular cation of most body tissues. Super-O-Ligo (Potassium (Potassium Proteinate)) ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.

The intracellular concentration of Super-O-Ligo (Potassium (Potassium Proteinate)) is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.

Super-O-Ligo (Potassium (Potassium Proteinate)) is a normal dietary constituent and under steady-state conditions the amount of Super-O-Ligo (Potassium (Potassium Proteinate)) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Super-O-Ligo (Potassium (Potassium Proteinate)) is 50 to 100 mEq per day.

Super-O-Ligo (Potassium (Potassium Proteinate)) depletion will occur whenever the rate of Super-O-Ligo (Potassium (Potassium Proteinate)) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Super-O-Ligo (Potassium (Potassium Proteinate)) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of Super-O-Ligo (Potassium (Potassium Proteinate)) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Super-O-Ligo (Potassium (Potassium Proteinate)) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Super-O-Ligo (Potassium (Potassium Proteinate)) depletion may produce weakness, fatigue, disturbances or cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

If Super-O-Ligo (Potassium (Potassium Proteinate)) depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, eg, where the patient requires long-term diuretic therapy, supplemental Super-O-Ligo (Potassium (Potassium Proteinate)) in the form of high Super-O-Ligo (Potassium (Potassium Proteinate)) food or Super-O-Ligo (Potassium (Potassium Proteinate)) chloride may be able to restore normal Super-O-Ligo (Potassium (Potassium Proteinate)) levels.

In rare circumstances (eg, patients with renal tubular acidosis) Super-O-Ligo (Potassium (Potassium Proteinate)) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Super-O-Ligo (Potassium (Potassium Proteinate)) replacement should be accomplished with Super-O-Ligo (Potassium (Potassium Proteinate)) salts other than the chloride, such as Super-O-Ligo (Potassium (Potassium Proteinate)) bicarbonate, Super-O-Ligo (Potassium (Potassium Proteinate)) citrate, Super-O-Ligo (Potassium (Potassium Proteinate)) acetate, or Super-O-Ligo (Potassium (Potassium Proteinate)) gluconate.

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Super-O-Ligo (Potassium (Potassium Proteinate)) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Super-O-Ligo (Potassium (Potassium Proteinate)) PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias.

The use of Super-O-Ligo (Potassium (Potassium Proteinate)) salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum Super-O-Ligo (Potassium (Potassium Proteinate)) should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with Super-O-Ligo (Potassium (Potassium Proteinate)) salts may be indicated.

CONTRAINDICATIONS

Super-O-Ligo (Potassium (Potassium Proteinate)) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Super-O-Ligo (Potassium (Potassium Proteinate)) concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis, such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

Controlled-release formulations of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Super-O-Ligo (Potassium (Potassium Proteinate)) supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).

All solid oral dosage forms of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride are contraindicated in any patient in whom there is structural, pathological (eg, diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

WARNINGS

Hyperkalemia (see OVERDOSAGE )

In patients with impaired mechanisms for excreting Super-O-Ligo (Potassium (Potassium Proteinate)), the administration of Super-O-Ligo (Potassium (Potassium Proteinate)) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Super-O-Ligo (Potassium (Potassium Proteinate)) by the intravenous route but may also occur in patients given Super-O-Ligo (Potassium (Potassium Proteinate)) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Super-O-Ligo (Potassium (Potassium Proteinate)) salts in patients with chronic renal disease, or any other condition which impairs Super-O-Ligo (Potassium (Potassium Proteinate)) excretion, requires particularly careful monitoring of the serum Super-O-Ligo (Potassium (Potassium Proteinate)) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of Super-O-Ligo (Potassium (Potassium Proteinate)) salts and a potassium-sparing diuretic (eg, spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin-Converting Enzyme Inhibitors

Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril, enalapril) will produce some Super-O-Ligo (Potassium (Potassium Proteinate)) retention by inhibiting aldosterone production. Super-O-Ligo (Potassium (Potassium Proteinate)) supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to sustained release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Super-O-Ligo (Potassium (Potassium Proteinate)) chloride and thus to minimize the possibility of a high local concentration of Super-O-Ligo (Potassium (Potassium Proteinate)) near the gastrointestinal wall.

Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral Super-O-Ligo (Potassium (Potassium Proteinate)) chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (ie, 96 mEq per day in divided doses of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing). The relevance of these findings to the usual conditions (ie, non-fasting, no anticholinergic agent, smaller doses) under which controlled-release Super-O-Ligo (Potassium (Potassium Proteinate)) chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq should be discontinued immediately and the possibility of ulceration, obstruction, or perforation should be considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs.

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing Super-O-Ligo (Potassium (Potassium Proteinate)) salt such as Super-O-Ligo (Potassium (Potassium Proteinate)) bicarbonate, Super-O-Ligo (Potassium (Potassium Proteinate)) citrate, Super-O-Ligo (Potassium (Potassium Proteinate)) acetate, or Super-O-Ligo (Potassium (Potassium Proteinate)) gluconate.

PRECAUTIONS

General

The diagnosis of Super-O-Ligo ) depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Super-O-Ligo (Potassium (Potassium Proteinate)) depletion. In interpreting the serum Super-O-Ligo (Potassium (Potassium Proteinate)) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body Super-O-Ligo (Potassium (Potassium Proteinate)) while acute acidosis per se can increase the serum Super-O-Ligo (Potassium (Potassium Proteinate)) concentration into the normal range even in the presence of a reduced total body Super-O-Ligo (Potassium (Potassium Proteinate)). The treatment of Super-O-Ligo (Potassium (Potassium Proteinate)) depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

Information for Patients

Break the tablet in half, and take each half separately with a glass of water.
Prepare an aqueous (water) suspension as follows:
1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
2. Allow approximately 2 minutes for the tablet(s) to disintegrate.
3. Stir for about half a minute after the tablet(s) has disintegrated.
4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
5. Add another 1 fluid ounce of water, swirl, and consume immediately.
6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.

To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Laboratory Tests

Drug Interactions

Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS ).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Super-O-Ligo ) is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Super-O-Ligo (Potassium (Potassium Proteinate)) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal Super-O-Ligo ) ion content of human milk is about 13 mEq per liter. Since oral Super-O-Ligo (Potassium (Potassium Proteinate)) becomes part of the body Super-O-Ligo (Potassium (Potassium Proteinate)) pool, so long as body Super-O-Ligo (Potassium (Potassium Proteinate)) is not excessive, the contribution of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS , and OVERDOSAGE ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ). The most common adverse reactions to oral Super-O-Ligo (Potassium (Potassium Proteinate)) salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.

OVERDOSAGE

The administration of oral Super-O-Ligo (Potassium (Potassium Proteinate)) salts to persons with normal excretory mechanisms for Super-O-Ligo (Potassium (Potassium Proteinate)) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Super-O-Ligo (Potassium (Potassium Proteinate)) is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS ). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum Super-O-Ligo (Potassium (Potassium Proteinate)) concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Treatment measures for hyperkalemia include the following:

Patients should be closely monitored for arrhythmias and electrolyte changes.
Elimination of foods and medications containing Super-O-Ligo (Potassium (Potassium Proteinate)) and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
Intravenous calcium gluconate if the patient is at no risk of developing digitalis toxicity.
Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
Correction of acidosis, if present, with intravenous sodium bicarbonate.
Use of exchange resins, hemodialysis, or peritoneal dialysis.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum Super-O-Ligo (Potassium (Potassium Proteinate)) concentration can produce digitalis toxicity.

The extended release feature means that absorption and toxic effects may be delayed for hours.

Consider standard measures to remove any unabsorbed drug.

DOSAGE AND ADMINISTRATION

The usual dietary intake of Super-O-Ligo (Potassium (Potassium Proteinate)) by the average adult is 50 to 100 mEq per day. Super-O-Ligo (Potassium (Potassium Proteinate)) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Super-O-Ligo (Potassium (Potassium Proteinate)) from the total body store.

Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of Super-O-Ligo (Potassium (Potassium Proteinate)) depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

Each Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Super-O-Ligo (Potassium (Potassium Proteinate)) chloride.

Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS ).

Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:

Break the tablet in half, and take each half separately with a glass of water.
Prepare an aqueous (water) suspension as follows:
- Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
- Allow approximately 2 minutes for the tablet(s) to disintegrate.
- Stir for about half a minute after the tablet(s) has disintegrated.
- Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
- Add another 1 fluid ounce of water, swirl, and consume immediately.
- Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

HOW SUPPLIED

Super-O-Ligo (Potassium (Potassium Proteinate)) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.

Storage Conditions

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by:

Eurand, Inc.

Vandalia, OH 45377 USA

Distributed by:

Watson Pharma, Inc.

Rev. Date (01/09) 173714

Super-O-Ligo (Potassium (Potassium Proteinate)) chloride 20 Meq

Zinc (Zinc Oxide):

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Drug abuse and dependence
Overdosage
Dosage and administration
How supplied
Super-O-Ligo (Zinc (Zinc Oxide)) reviews

INDICATIONS AND USAGE

Super-O-Ligo (Zinc (Zinc Oxide)) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Super-O-Ligo (Zinc (Zinc Oxide)) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Super-O-Ligo (Zinc (Zinc Oxide)) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Super-O-Ligo (Zinc (Zinc Oxide)) doses because these elements are primarily eliminated in the urine.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Super-O-Ligo (Zinc (Zinc Oxide)) from a bolus injection. Administration of Super-O-Ligo (Zinc (Zinc Oxide)) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Super-O-Ligo (Zinc (Zinc Oxide)) are suggested as a guideline for subsequent Super-O-Ligo (Zinc (Zinc Oxide)) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Super-O-Ligo ) 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Super-O-Ligo (Zinc (Zinc Oxide)) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Super-O-Ligo ) chloride. It is also not known whether Super-O-Ligo (Zinc (Zinc Oxide)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Super-O-Ligo (Zinc (Zinc Oxide)) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Super-O-Ligo (Zinc (Zinc Oxide)) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Super-O-Ligo (Zinc (Zinc Oxide)) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Super-O-Ligo (Zinc (Zinc Oxide)) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Super-O-Ligo (Zinc (Zinc Oxide)) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Super-O-Ligo (Zinc (Zinc Oxide)) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Super-O-Ligo (Zinc (Zinc Oxide)) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Super-O-Ligo (Zinc (Zinc Oxide)) toxicity.

DOSAGE AND ADMINISTRATION

Super-O-Ligo (Zinc (Zinc Oxide)) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Super-O-Ligo (Zinc (Zinc Oxide)) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Super-O-Ligo (Zinc (Zinc Oxide)).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Super-O-Ligo (Zinc (Zinc Oxide)) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Super-O-Ligo (Zinc (Zinc Oxide))

1 mg/mL

Super-O-Ligo (Zinc (Zinc Oxide)) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Super-O-Ligo pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.

Super-O-Ligo available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.

Capsules; Oral; Copper (Copper Proteinate), Copper (Copper Sulfate) 1.05 mg; Magnesium (Magnesium Hydroxide), Magnesium (Magnesium Proteinate) 50 mg; Manganese (Manganese Proteinate), Manganese (Manganese Sulfate) 4.71 mg; Potassium (Potassium Chloride),

Super-O-Ligo destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.

Human:
Mineral supplements
Minerals

Super-O-Ligo Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.

A12CX - Other mineral products

Super-O-Ligo pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.

Clinique Lafontaine

References

Dailymed."COPPER: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"Potassium". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"Zinc". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Super-O-Ligo?

Depending on the reaction of the Super-O-Ligo after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Super-O-Ligo not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Super-O-Ligo addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Super-O-Ligo, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Super-O-Ligo consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.