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DRUGS & SUPPLEMENTS
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Calcium (Durapatite):
Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate capsule.
- Capsule: 667 mg Super Cal-Mag (Calcium (Durapatite)) acetate capsule. (3)
Patients with hypercalcemia.
- Hypercalcemia. (4)
- Treat mild hypercalcemia by reducing or interrupting Super Cal-Mag ) acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Super Cal-Mag (Calcium (Durapatite)) acetate. (5.1)
- Hypercalcemia may aggravate digitalis toxicity. (5.2)
Patients with end stage renal disease may develop hypercalcemia when treated with Super Cal-Mag (Calcium (Durapatite)), including Super Cal-Mag (Calcium (Durapatite)) acetate. Avoid the use of Super Cal-Mag (Calcium (Durapatite)) supplements, including Super Cal-Mag (Calcium (Durapatite)) based nonprescription antacids, concurrently with Super Cal-Mag (Calcium (Durapatite)) acetate.
An overdose of Super Cal-Mag (Calcium (Durapatite)) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Super Cal-Mag (Calcium (Durapatite)) levels twice weekly. Should hypercalcemia develop, reduce the Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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, Super Cal-Mag (Calcium (Durapatite)) acetate has been generally well tolerated.
Super Cal-Mag (Calcium (Durapatite)) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate N=167 N (%) | 3 month, open label study of Super Cal-Mag (Calcium (Durapatite)) acetate N=98 N (%) | Double blind, placebo-controlled, cross-over study of liquid Super Cal-Mag (Calcium (Durapatite)) acetate N=69 | |
Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) concentration could reduce the incidence and severity of Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate: dizziness, edema, and weakness.
The drug interaction of Super Cal-Mag ) acetate is characterized by the potential of Super Cal-Mag (Calcium (Durapatite)) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Super Cal-Mag (Calcium (Durapatite)) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Super Cal-Mag (Calcium (Durapatite)) acetate and most concomitant drugs. When administering an oral medication with Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate or consider monitoring blood levels of the drug. (7)
In a study of 15 healthy subjects, a co-administered single dose of 4 Super Cal-Mag (Calcium (Durapatite)) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
Pregnancy Category C:
Super Cal-Mag ) acetate capsules contains Super Cal-Mag (Calcium (Durapatite)) acetate. Animal reproduction studies have not been conducted with Super Cal-Mag (Calcium (Durapatite)) acetate, and there are no adequate and well controlled studies of Super Cal-Mag (Calcium (Durapatite)) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Super Cal-Mag (Calcium (Durapatite)) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Super Cal-Mag (Calcium (Durapatite)) 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. Super Cal-Mag (Calcium (Durapatite)) acetate treatment, as recommended, is not expected to harm a fetus if maternal Super Cal-Mag (Calcium (Durapatite)) levels are properly monitored during and following treatment.
The effects of Super Cal-Mag (Calcium (Durapatite)) acetate on labor and delivery are unknown.
Super Cal-Mag ) Acetate Capsules contains Super Cal-Mag (Calcium (Durapatite)) acetate and is excreted in human milk. Human milk feeding by a mother receiving Super Cal-Mag (Calcium (Durapatite)) acetate is not expected to harm an infant, provided maternal serum Super Cal-Mag (Calcium (Durapatite)) levels are appropriately monitored.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
Super Cal-Mag (Calcium (Durapatite)) acetate acts as a phosphate binder. Its chemical name is Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Super Cal-Mag (Calcium (Durapatite)), 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.
Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag ) resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
Super Cal-Mag (Calcium (Durapatite)) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Super Cal-Mag (Calcium (Durapatite)) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Orally administered Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate.
Effectiveness of Super Cal-Mag (Calcium (Durapatite)) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Super Cal-Mag (Calcium (Durapatite)) 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 |
Super Cal-Mag (Calcium (Durapatite)) (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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate is shown in the Table 3.
* ANOVA of Super Cal-Mag (Calcium (Durapatite)) acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM. | ||||
Parameter | Pre-Study | Post-Treatment | p-value* | |
Super Cal-Mag (Calcium (Durapatite)) Acetate | Placebo | |||
Phosphorus (mg/dL)† | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
Super Cal-Mag (Calcium (Durapatite)) (mg/dL)† | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
Overall, 2 weeks of treatment with Super Cal-Mag (Calcium (Durapatite)) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Super Cal-Mag (Calcium (Durapatite)) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Super Cal-Mag (Calcium (Durapatite)) 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 Super Cal-Mag (Calcium (Durapatite)) acetate capsules.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003705/05
Revised April 2016
Magnesium (Magnesium Proteinate):
Super Cal-Mag (Magnesium (Magnesium Proteinate)) Sulfate
Injection, USP
Ansyr Plastic Syringe
Rx only
Super Cal-Mag (Magnesium (Magnesium Proteinate)) Sulfate Injection, USP is a sterile solution of Super Cal-Mag (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.).
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 Cal-Mag (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.
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.
Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)). While there are large stores of Super Cal-Mag (Magnesium (Magnesium Proteinate)) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Super Cal-Mag (Magnesium (Magnesium Proteinate)) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.
Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) levels range from 1.5 to 2.5 mEq/liter.
As plasma Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)). Serum Super Cal-Mag (Magnesium (Magnesium Proteinate)) concentrations in excess of 12 mEq/L may be fatal.
Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.
Super Cal-Mag (Magnesium (Magnesium Proteinate)) Sulfate Injection, USP is suitable for replacement therapy in Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) 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 Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) sulfate should be used during pregnancy only if clearly needed. If Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) 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 Cal-Mag (Magnesium (Magnesium Proteinate)) 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 Super Cal-Mag (Magnesium (Magnesium Proteinate)), their dosage should be adjusted with caution because of additive CNS depressant effects of Super Cal-Mag (Magnesium (Magnesium Proteinate)).
Because Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) should be given until they return. Serum Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) intoxication in eclampsia.
50% Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)), their dosage should be adjusted with caution because of additive CNS depressant effects of Super Cal-Mag (Magnesium (Magnesium Proteinate)). CNS depression and peripheral transmission defects produced by Super Cal-Mag (Magnesium (Magnesium Proteinate)) may be antagonized by calcium.
Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Super Cal-Mag (Magnesium (Magnesium Proteinate)) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.
Cardiac Glycosides - Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) toxicity.
Pregnancy
Teratogenic Effects
Pregnancy Category D (See WARNINGS and PRECAUTIONS )
See WARNINGS and PRECAUTIONS .
Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) sulfate for more than 5 to 7 days.1-10 Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).
Labor and Delivery
Continuous administration of Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) is distributed into milk during parenteral Super Cal-Mag (Magnesium (Magnesium Proteinate)) 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 Cal-Mag (Magnesium (Magnesium Proteinate)) should be monitored in such patients.
The adverse effects of parenterally administered Super Cal-Mag (Magnesium (Magnesium Proteinate)) usually are the result of Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) sulfate therapy for eclampsia has been reported.
Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)).
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 Super Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) 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 Cal-Mag (Magnesium (Magnesium Proteinate)) Deficiency
In the treatment of mild Super Cal-Mag (Magnesium (Magnesium Proteinate)) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (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 Cal-Mag (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 Cal-Mag (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 Cal-Mag (Magnesium (Magnesium Proteinate)) sulfate is 20 grams/48 hours and frequent serum Super Cal-Mag (Magnesium (Magnesium Proteinate)) concentrations must be obtained. Continuous use of Super Cal-Mag (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 Cal-Mag (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 Cal-Mag (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 Cal-Mag (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 Cal-Mag (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.
Super Cal-Mag (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).
Hospira, Inc., Lake Forest, IL 60045 USA
LAB-1024-1.0
April 2017
Hospira Logo
50% Super Cal-Mag (Magnesium (Magnesium Proteinate)) Sulfate 5 g/10 mL (500 mg/mL)
Rx only
NDC 0409-1754-10
10 mL Single-dose syringe
50% Super Cal-Mag (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 Citrate):
Super Cal-Mag (Manganese (Manganese Citrate)) 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 Cal-Mag (Manganese (Manganese Citrate)) serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
None known.
Direct intramuscular or intravenous injection of Super Cal-Mag (Manganese (Manganese Citrate)) 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 Cal-Mag (Manganese (Manganese Citrate)) 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.
Super Cal-Mag ) 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 Super Cal-Mag (Manganese (Manganese Citrate)) 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 Super Cal-Mag ) 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 Super Cal-Mag (Manganese (Manganese Citrate)) 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 Super Cal-Mag (Manganese (Manganese Citrate)) chloride. It is also not known whether Super Cal-Mag (Manganese (Manganese Citrate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Super Cal-Mag (Manganese (Manganese Citrate)) 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.
Super Cal-Mag (Manganese (Manganese Citrate)) toxicity in TPN patients has not been reported.
Super Cal-Mag (Manganese (Manganese Citrate)) 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 Cal-Mag (Manganese (Manganese Citrate)) 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 Cal-Mag (Manganese (Manganese Citrate)) 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 .)
Super Cal-Mag (Manganese (Manganese Citrate)) 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
Depending on the reaction of the Super Cal-Mag after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Super Cal-Mag 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 Cal-Mag 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