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DRUGS & SUPPLEMENTS
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Calcium (Calcium HVP Chelate):
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)
The recommended initial dose of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.
- Starting dose is 2 capsules with each meal. (2)
- Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal. (2)
Capsule: 667 mg Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate capsule.
- Capsule: 667 mg Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate capsule. (3)
Patients with hypercalcemia.
- Hypercalcemia. (4)
- Treat mild hypercalcemia by reducing or interrupting Mega Multi Mineral Iron Free ) acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate. (5.1)
- Hypercalcemia may aggravate digitalis toxicity. (5.2)
Patients with end stage renal disease may develop hypercalcemia when treated with Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)), including Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate. Avoid the use of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) supplements, including Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) based nonprescription antacids, concurrently with Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate.
An overdose of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) levels twice weekly. Should hypercalcemia develop, reduce the Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia
More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate therapy.
Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.
Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate on the progression of vascular or soft tissue calcification has not been determined.
Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate; all cases resolved upon lowering the dose or discontinuing treatment.
Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.
Hypercalcemia may aggravate digitalis toxicity.
Hypercalcemia is discussed elsewhere [see Warnings and Precautions ].
- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. (6.1)
- In clinical studies, patients have occasionally experienced nausea during Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate therapy. (6)
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies, Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate has been generally well tolerated.
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
Preferred Term | Total adverse reactions reported for Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate N=167 N (%) | 3 month, open label study of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate N=98 N (%) | Double blind, placebo-controlled, cross-over study of liquid Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate N=69 | |
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate N (%) | Placebo N (%) | |||
Nausea | 6 (3.6) | 6 (6.1) | 0 (0) | 0 (0) |
Vomiting | 4 (2.4) | 4 (4.1) | 0 (0) | 0 (0) |
Hypercalcemia | 21 (12.6) | 16 (16.3) | 5 (7.2) | 0 (0) |
Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) concentration could reduce the incidence and severity of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate: dizziness, edema, and weakness.
The drug interaction of Mega Multi Mineral Iron Free ) acetate is characterized by the potential of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate and most concomitant drugs. When administering an oral medication with Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate.
- Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones. (7)
- When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate or consider monitoring blood levels of the drug. (7)
In a study of 15 healthy subjects, a co-administered single dose of 4 Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
Pregnancy Category C:
Mega Multi Mineral Iron Free ) acetate capsules contains Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate. Animal reproduction studies have not been conducted with Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate, and there are no adequate and well controlled studies of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate treatment, as recommended, is not expected to harm a fetus if maternal Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) levels are properly monitored during and following treatment.
The effects of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate on labor and delivery are unknown.
Mega Multi Mineral Iron Free ) Acetate Capsules contains Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate and is excreted in human milk. Human milk feeding by a mother receiving Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate is not expected to harm an infant, provided maternal serum Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) levels are appropriately monitored.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses 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.
Administration of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate acts as a phosphate binder. Its chemical name is Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:
Each white opaque/blue opaque capsule contains 667 mg of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)), polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.
Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Mega Multi Mineral Iron Free ) resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Orally administered Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
No carcinogenicity, mutagenicity, or fertility studies have been conducted with Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate.
Effectiveness of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate solid oral dosage form.
Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.
The patients received Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.
The data presented in Table 2 demonstrate the efficacy of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) levels are also presented.
* Ninety-one patients completed at least 6 weeks of the study. † ANOVA of difference in values at pre-study and study completion. ‡ Values expressed as mean ± SE. | |||||
Parameter | Pre-Study | Week 4* | Week 8 | Week 12 | p-value† |
Phosphorus (mg/dL)‡ | 7.4 ± 0.17 | 5.9 ± 0.16 | 5.6 ± 0.17 | 5.2 ± 0.17 | ≤0.01 |
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) (mg/dL)‡ | 8.9 ± 0.09 | 9.5 ± 0.10 | 9.7 ± 0.10 | 9.7 ± 0.10 | ≤0.01 |
There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) increased 9% during the study mostly in the first month of the study.
Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.
The phosphate binding effect of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate is shown in the Table 3.
* ANOVA of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM. | ||||
Parameter | Pre-Study | Post-Treatment | p-value* | |
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) Acetate | Placebo | |||
Phosphorus (mg/dL)† | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) (mg/dL)† | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
Overall, 2 weeks of treatment with Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) Acetate Capsules
667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body.
NDC 0615-2303-39: Blistercards of 30 Capsules
NDC 0615-2303-30: Unit-dose Boxes of 30 Capsules
STORAGE
Store at 20° to 25°C (68° to 77°F).
Inform patients to take Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].
Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Mega Multi Mineral Iron Free (Calcium (Calcium HVP Chelate)) acetate capsules.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003705/05
Revised April 2016
Iodine (Kelp):
Directions:
Topical Antiseptic
Use full Strength for superficial cuts, wounds, abrasions, insect bites and bruises on the skin of animals. Apply Mega Multi Mineral Iron Free (Iodine (Kelp)) with a swab.
If necessary, clip hair around the area being treated and clean with soap and water.
Apply Mega Multi Mineral Iron Free (Iodine (Kelp)) Tincture 7% only once daily. Dilute product 3 to 1 if repeating application.
Do not apply under bandage.
Irritation may occur if used on tender skin areas. If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian.
Storage:
Store at 2-30 degrees C (36-86 degrees F).
Keep container away from heat and out of sunlight. Rinse empty container thoroughly and discard.
DANGER - Poison
Caution:
If swallowed, give starch paste, milk, bread, egg white, or
activated charcoal. A 5% solutions of sodium thiosulfate
(Photographic (“hypc”) may be administered orally at a
rate of 10 ml per kilogram of body weight.
Eye irritant: Use only as directed. Avoid contact with eyes. In case of contact, flush eyes immediately with tepid water for at least 15 minutes. Consult a physician.
Avoid contamination of food.
Not for use on burns, deep cuts, or body cavities.
image description
Magnesium (Magnesium HVP Chelate):
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) Sulfate
Injection, USP
Ansyr Plastic Syringe
Rx only
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) Sulfate Injection, USP is a sterile solution of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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.
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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.
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) (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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)). While there are large stores of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) levels range from 1.5 to 2.5 mEq/liter.
As plasma Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)). Serum Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) concentrations in excess of 12 mEq/L may be fatal.
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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. Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) Sulfate Injection, USP is suitable for replacement therapy in Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) (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), Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.
Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.
FETAL HARM: Continuous administration of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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. Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) sulfate should be used during pregnancy only if clearly needed. If Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) intoxication. Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.
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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)), their dosage should be adjusted with caution because of additive CNS depressant effects of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)).
Because Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) should be given until they return. Serum Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) intoxication in eclampsia.
50% Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)), their dosage should be adjusted with caution because of additive CNS depressant effects of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)). CNS depression and peripheral transmission defects produced by Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) may be antagonized by calcium.
Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.
Cardiac Glycosides - Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) toxicity.
Pregnancy
Teratogenic Effects
Pregnancy Category D (See WARNINGS and PRECAUTIONS )
See WARNINGS and PRECAUTIONS .
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) sulfate for more than 5 to 7 days.1-10 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).
Labor and Delivery
Continuous administration of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) is distributed into milk during parenteral Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) should be monitored in such patients.
The adverse effects of parenterally administered Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) usually are the result of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) sulfate therapy for eclampsia has been reported.
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)).
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 of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) Deficiency
In the treatment of mild Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) sulfate is 20 grams/48 hours and frequent serum Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) concentrations must be obtained. Continuous use of Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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, Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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.
Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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).
Hospira, Inc., Lake Forest, IL 60045 USA
LAB-1024-1.0
April 2017
Hospira Logo
50% Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) Sulfate 5 g/10 mL (500 mg/mL)
Rx only
NDC 0409-1754-10
10 mL Single-dose syringe
50% Mega Multi Mineral Iron Free (Magnesium (Magnesium HVP Chelate)) 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 HVP Chelate):
Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 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 Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
None known.
Direct intramuscular or intravenous injection of Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 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 Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 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.
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.
Do not use unless solution is clear and seal is intact.
Mega Multi Mineral Iron Free ) 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.
Serum Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 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.
Long-term animal studies to evaluate the carcinogenic potential of Mega Multi Mineral Iron Free ) 0.1 mg/mL (Manganese Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
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 Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Animal reproduction studies have not been conducted with Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) chloride. It is also not known whether Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) chloride should be given to a pregnant woman only if clearly indicated.
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.
None known.
None known.
Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) toxicity in TPN patients has not been reported.
Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 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 Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 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 Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 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 .)
Mega Multi Mineral Iron Free (Manganese (Manganese HVP Chelate)) 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
Potassium (Potassium Chloride):
Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K
Rx Only
The Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride containing 1500 mg of microencapsulated Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride, USP equivalent to 20 mEq of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) in a tablet.
These formulations are intended to slow the release of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) so that the likelihood of a high localized concentration of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride within the gastrointestinal tract is reduced.
Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride, and the structural formula is KCl. Mega Multi Mineral Iron Free (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.
Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride.
Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose.
The Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) ion is the principal intracellular cation of most body tissues. Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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.
Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) is a normal dietary constituent and under steady-state conditions the amount of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) is 50 to 100 mEq per day.
Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) depletion will occur whenever the rate of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Mega Multi Mineral Iron Free (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. Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) in the form of high Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) food or Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride may be able to restore normal Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) levels.
In rare circumstances (eg, patients with renal tubular acidosis) Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) replacement should be accomplished with Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) salts other than the chloride, such as Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) bicarbonate, Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) citrate, Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) acetate, or Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) gluconate.
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) salts may be indicated.
Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).
All solid oral dosage forms of Mega Multi Mineral Iron Free (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.
Hyperkalemia (see OVERDOSAGE )
In patients with impaired mechanisms for excreting Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)), the administration of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) by the intravenous route but may also occur in patients given Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) salts in patients with chronic renal disease, or any other condition which impairs Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) excretion, requires particularly careful monitoring of the serum Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) concentration and appropriate dosage adjustment.
Interaction with Potassium-Sparing Diuretics
Hypokalemia should not be treated by the concomitant administration of Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) retention by inhibiting aldosterone production. Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) supplements should be given to patients receiving ACE inhibitors only with close monitoring.
Gastrointestinal Lesions
Solid oral dosage forms of Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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. Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride and thus to minimize the possibility of a high local concentration of Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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. Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) salt such as Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) bicarbonate, Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) citrate, Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) acetate, or Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) gluconate.
The diagnosis of Mega Multi Mineral Iron Free ) depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) depletion. In interpreting the serum Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) while acute acidosis per se can increase the serum Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) concentration into the normal range even in the presence of a reduced total body Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)). The treatment of Mega Multi Mineral Iron Free (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.
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:
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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Mega Multi Mineral Iron Free (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.
When blood is drawn for analysis of plasma Mega Multi Mineral Iron Free ) 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.
Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS ).
Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Mega Multi Mineral Iron Free ) is a normal dietary constituent.
Animal reproduction studies have not been conducted with Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.
The normal Mega Multi Mineral Iron Free ) ion content of human milk is about 13 mEq per liter. Since oral Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) becomes part of the body Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) pool, so long as body Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) is not excessive, the contribution of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride supplementation should have little or no effect on the level in human milk.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Mega Multi Mineral Iron Free (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.
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 Mega Multi Mineral Iron Free (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.
The administration of oral Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) salts to persons with normal excretory mechanisms for Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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:
In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum Mega Multi Mineral Iron Free (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.
The usual dietary intake of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) by the average adult is 50 to 100 mEq per day. Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (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 Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride.
Mega Multi Mineral Iron Free (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:
Aqueous suspension of Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) Chloride Extended Release Tablets USP, 20 mEq is not recommended.
Mega Multi Mineral Iron Free (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
Mega Multi Mineral Iron Free (Potassium (Potassium Chloride)) chloride 20 Meq
Selenium (Selenium HVP Chelate):
Rx Only
TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN).
Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism.
Prolonged TPN support in humans has resulted in Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)).
Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)). The conditions are endemic to geographical areas with low Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) soil content. Dietary supplementation with Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) salts has been reported to reduce the incidence of the conditions among affected children.
Normal blood levels of Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) in different human populations have been found to vary and depend on the Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) content of the food consumed. Results of surveys carried out in some countries are tabulated below:
COUNTRY | Number of Samples | Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) (mcg/100 mL) (a) | ||
Whole Blood | Blood Cells | Plasma/ Serum | ||
(a) Mean values with or without standard deviation in parentheses, all other ranges. | ||||
(b) Age group unknown. | ||||
(c) Three children recovered from Kwashiorkor and the other six under treatment for other diseases. | ||||
(d) Low selenium-content soil area. | ||||
(e) Well nourished children, three recovered from Kwashiorkor and the other six under treatment for other diseases. | ||||
(f) Mean values from seven subjects. | ||||
Canada | 254 Adults | (37.9 ± 7.8) | (23.6 ± 6.0) | (14.4 ± 2.9) |
England | 8 (b) | 26-37 (32) | -- | -- |
Guatemala & Southern USA | 10 Adults 9 Children (c) | 19-28 (22) (23 ± 5) | -- (36 ± 12) | -- (15 ± 5) |
New Zealand (d) | 113 Adults | (5.4 ± 0.1) | (6.6 ± 0.3) | (4.3 ± 0.1) |
Thailand | 3 Adults 9 Children (e) | 14.4-20.2 (12.0 ± 3.6) (f) | 17.8-35.8 (19.5 ± 8.2) | 8.1-12.5 (8.3 ± 2.2) |
USA | 210 Adults | 15.7-25.6 (20.6) | -- | -- |
Plasma Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) is eliminated primarily in urine. However, significant endogenous losses through feces also occur. The rate of excretion and the relative importance of two routes varies with the chemical form of Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) used in supplementation. Ancillary routes of elimination are lungs and skin.
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) in TPN solutions helps to maintain plasma Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) levels during TPN support and close medical supervision is recommended.
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection is a hypotonic solution and should be administered in admixtures only.
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.
As Mega Multi Mineral Iron Free ) is eliminated in urine and feces, Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) supplements may be adjusted, reduced or omitted in renal dysfunction and/or gastrointestinal malfunction. In patients receiving blood transfusions, contribution from such transfusions should also be considered. Frequent Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) plasma level determinations are suggested as a guideline.
In animals, Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium and arsenic.
Pregnancy Category C: Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however, no adequate and wellcontrolled studies in pregnant women. Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.
Presence of Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) in placenta and umbilical cord blood has been reported in humans.
The amount of Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) present in Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection is small. Symptoms of toxicity from Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) are unlikely to occur at the recommended dosage level.
Chronic toxicity in humans resulting from exposure to Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) has been reported in literature. Toxicity symptoms include hair loss, weakened nails, dermatitis, dental defects, gastrointestinal disorders, nervousness, mental depression, metallic taste, vomiting, and garlic odor of breath and sweat. Acute poisoning due to ingestion of large amounts of Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) compounds has resulted in death with histopathological changes including fulminating peripheral vascular collapse, internal vascular congestion, diffusely hemorrhagic, congested and edematus lungs, brick-red color gastric mucosa. The death was preceded by coma.
No effective antidote to Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) poisoning in humans is known. Animal studies have shown casein and linseed oil in feeds, reduced glutathione, arsenic, magnesium sulfate, and bromobenzene to afford limited protection.
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection provides 40 mcg selenium/mL. For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day.
In adults, Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) deficiency states resulting from long-term TPN support, Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity.
Aseptic addition of Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection to the TPN solution under laminar flow hood is recommended. Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) levels is suggested as a guideline for subsequent administration. The normal whole blood range for Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) is approximately 10 to 37 mcg/100 mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) 40 mcg/mL).
NDC 0517-6510-25 10 mL Single Dose Vial Packaged in boxes of 25
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
IN6510
Rev. 11/15
PRINCIPAL DISPLAY PANEL - Container
NDC 0517-6510-25
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) INJECTION
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) 400 mcg/10 mL
(40 mcg/mL)
10 mL
SINGLE DOSE VIAL
Trace Element Additive
FOR IV USE AFTER DILUTION
PRESERVATIVE FREE
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
PRINCIPAL DISPLAY PANEL - Carton
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) INJECTION
Mega Multi Mineral Iron Free (Selenium (Selenium HVP Chelate)) 400 mcg/10 mL
(40 mcg/mL)
Trace Element Additive
NDC 0517-6510-25
25 x 10 mL
SINGLE DOSE VIALS
FOR INTRAVENOUS USE AFTER DILUTION PRESERVATIVE FREE Rx Only
Each mL contains: Selenious Acid 65.4 mcg, Water for Injection q.s.
pH adjusted with Nitric Acid. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions
permitted to 15°-30°C (59°-86°F).
Directions for Use: See Package Insert.
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
Rev. 11/05
Container Carton
Zinc (Zinc HVP Chelate):
Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
None known.
Direct intramuscular or intravenous injection of Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) 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 Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) doses because these elements are primarily eliminated in the urine.
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.
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.
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 Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) from a bolus injection. Administration of Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) in the absence of copper may cause a decrease in serum copper levels.
Periodic determinations of serum copper as well as Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) are suggested as a guideline for subsequent Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) administration.
Long-term animal studies to evaluate the carcinogenic potential of Mega Multi Mineral Iron Free ) 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
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 Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.
Pregnancy Category C. Animal reproduction studies have not been conducted with Mega Multi Mineral Iron Free ) chloride. It is also not known whether Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) chloride should be given to a pregnant woman only if clearly needed.
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.
None known.
None known.
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 Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) 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 Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) concentration of 207 mcg/dl. Symptoms abated within three hours.
Hyperamylasemia may be a sign of impending Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) 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 Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) was delivered intravenously over the course of 60 hours to a 72 year old patient.
Symptoms of Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) level of 4184 mcg/dl.
Calcium supplements may confer a protective effect against Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) toxicity.
Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) 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 Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)).
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.
Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) 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 2004 EN-0488 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
10 mL Vial
Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate))
1 mg/mL
Mega Multi Mineral Iron Free (Zinc (Zinc HVP Chelate)) Chloride Inj., USP
Rx only
FOR I.V. USE ONLY AFTER DILUTION.
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
Depending on the reaction of the Mega Multi Mineral Iron Free after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mega Multi Mineral Iron Free 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 Mega Multi Mineral Iron Free 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.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology