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DRUGS & SUPPLEMENTS
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Calcium:
Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate capsule.
- Capsule: 667 mg Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate capsule. (3)
Patients with hypercalcemia.
- Hypercalcemia. (4)
- Treat mild hypercalcemia by reducing or interrupting Vita-Cal Mag with Zinc and Vitamin D acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate. (5.1)
- Hypercalcemia may aggravate digitalis toxicity. (5.2)
Patients with end stage renal disease may develop hypercalcemia when treated with Vita-Cal Mag with Zinc and Vitamin D (Calcium), including Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate. Avoid the use of Vita-Cal Mag with Zinc and Vitamin D (Calcium) supplements, including Vita-Cal Mag with Zinc and Vitamin D (Calcium) based nonprescription antacids, concurrently with Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate.
An overdose of Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Vita-Cal Mag with Zinc and Vitamin D (Calcium) levels twice weekly. Should hypercalcemia develop, reduce the Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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, Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate has been generally well tolerated.
Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate N=167 N (%) | 3 month, open label study of Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate N=98 N (%) | Double blind, placebo-controlled, cross-over study of liquid Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate N=69 | |
Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) concentration could reduce the incidence and severity of Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate: dizziness, edema, and weakness.
The drug interaction of Vita-Cal Mag with Zinc and Vitamin D acetate is characterized by the potential of Vita-Cal Mag with Zinc and Vitamin D (Calcium) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate and most concomitant drugs. When administering an oral medication with Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate or consider monitoring blood levels of the drug. (7)
In a study of 15 healthy subjects, a co-administered single dose of 4 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
Pregnancy Category C:
Vita-Cal Mag with Zinc and Vitamin D acetate capsules contains Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate. Animal reproduction studies have not been conducted with Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate, and there are no adequate and well controlled studies of Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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. Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate treatment, as recommended, is not expected to harm a fetus if maternal Vita-Cal Mag with Zinc and Vitamin D (Calcium) levels are properly monitored during and following treatment.
The effects of Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate on labor and delivery are unknown.
Vita-Cal Mag with Zinc and Vitamin D Acetate Capsules contains Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate and is excreted in human milk. Human milk feeding by a mother receiving Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate is not expected to harm an infant, provided maternal serum Vita-Cal Mag with Zinc and Vitamin D (Calcium) levels are appropriately monitored.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate acts as a phosphate binder. Its chemical name is Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Vita-Cal Mag with Zinc and Vitamin D (Calcium), 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.
Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Vita-Cal Mag with Zinc and Vitamin D (Calcium) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Orally administered Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate.
Effectiveness of Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 |
Vita-Cal Mag with Zinc and Vitamin D (Calcium) (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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate is shown in the Table 3.
* ANOVA of Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM. | ||||
Parameter | Pre-Study | Post-Treatment | p-value* | |
Vita-Cal Mag with Zinc and Vitamin D (Calcium) Acetate | Placebo | |||
Phosphorus (mg/dL)† | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
Vita-Cal Mag with Zinc and Vitamin D (Calcium) (mg/dL)† | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
Overall, 2 weeks of treatment with Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Vita-Cal Mag with Zinc and Vitamin D (Calcium) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Vita-Cal Mag with Zinc and Vitamin D (Calcium) 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 Vita-Cal Mag with Zinc and Vitamin D (Calcium) acetate capsules.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003705/05
Revised April 2016
Magnesium:
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) Sulfate
Injection, USP
Ansyr Plastic Syringe
Rx only
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) Sulfate Injection, USP is a sterile solution of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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.
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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.
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) (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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium). While there are large stores of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Vita-Cal Mag with Zinc and Vitamin D (Magnesium) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) levels range from 1.5 to 2.5 mEq/liter.
As plasma Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium). Serum Vita-Cal Mag with Zinc and Vitamin D (Magnesium) concentrations in excess of 12 mEq/L may be fatal.
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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. Vita-Cal Mag with Zinc and Vitamin D (Magnesium) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) Sulfate Injection, USP is suitable for replacement therapy in Vita-Cal Mag with Zinc and Vitamin D (Magnesium) deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum Vita-Cal Mag with Zinc and Vitamin D (Magnesium) (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), Vita-Cal Mag with Zinc and Vitamin D (Magnesium) sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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. Vita-Cal Mag with Zinc and Vitamin D (Magnesium) sulfate should be used during pregnancy only if clearly needed. If Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium), their dosage should be adjusted with caution because of additive CNS depressant effects of Vita-Cal Mag with Zinc and Vitamin D (Magnesium).
Because Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) should be given until they return. Serum Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) intoxication in eclampsia.
50% Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium), their dosage should be adjusted with caution because of additive CNS depressant effects of Vita-Cal Mag with Zinc and Vitamin D (Magnesium). CNS depression and peripheral transmission defects produced by Vita-Cal Mag with Zinc and Vitamin D (Magnesium) may be antagonized by calcium.
Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Vita-Cal Mag with Zinc and Vitamin D (Magnesium) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.
Cardiac Glycosides - Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) toxicity.
Pregnancy
Teratogenic Effects
Pregnancy Category D (See WARNINGS and PRECAUTIONS )
See WARNINGS and PRECAUTIONS .
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) sulfate for more than 5 to 7 days.1-10 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).
Labor and Delivery
Continuous administration of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) is distributed into milk during parenteral Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) should be monitored in such patients.
The adverse effects of parenterally administered Vita-Cal Mag with Zinc and Vitamin D (Magnesium) usually are the result of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) sulfate therapy for eclampsia has been reported.
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of Vita-Cal Mag with Zinc and Vitamin D (Magnesium).
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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) Deficiency
In the treatment of mild Vita-Cal Mag with Zinc and Vitamin D (Magnesium) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) sulfate is 20 grams/48 hours and frequent serum Vita-Cal Mag with Zinc and Vitamin D (Magnesium) concentrations must be obtained. Continuous use of Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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, Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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 Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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.
Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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% Vita-Cal Mag with Zinc and Vitamin D (Magnesium) Sulfate 5 g/10 mL (500 mg/mL)
Rx only
NDC 0409-1754-10
10 mL Single-dose syringe
50% Vita-Cal Mag with Zinc and Vitamin D (Magnesium) 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
Zinc:
Vita-Cal Mag with Zinc and Vitamin D (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Vita-Cal Mag with Zinc and Vitamin D (Zinc) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
None known.
Direct intramuscular or intravenous injection of Vita-Cal Mag with Zinc and Vitamin D (Zinc) 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 Vita-Cal Mag with Zinc and Vitamin D (Zinc) 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 Vita-Cal Mag with Zinc and Vitamin D (Zinc) from a bolus injection. Administration of Vita-Cal Mag with Zinc and Vitamin D (Zinc) in the absence of copper may cause a decrease in serum copper levels.
Periodic determinations of serum copper as well as Vita-Cal Mag with Zinc and Vitamin D (Zinc) are suggested as a guideline for subsequent Vita-Cal Mag with Zinc and Vitamin D (Zinc) administration.
Long-term animal studies to evaluate the carcinogenic potential of Vita-Cal Mag with Zinc and Vitamin D 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 Vita-Cal Mag with Zinc and Vitamin D (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.
Pregnancy Category C. Animal reproduction studies have not been conducted with Vita-Cal Mag with Zinc and Vitamin D chloride. It is also not known whether Vita-Cal Mag with Zinc and Vitamin D (Zinc) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vita-Cal Mag with Zinc and Vitamin D (Zinc) 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 Vita-Cal Mag with Zinc and Vitamin D (Zinc) 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 Vita-Cal Mag with Zinc and Vitamin D (Zinc) concentration of 207 mcg/dl. Symptoms abated within three hours.
Hyperamylasemia may be a sign of impending Vita-Cal Mag with Zinc and Vitamin D (Zinc) 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 Vita-Cal Mag with Zinc and Vitamin D (Zinc) was delivered intravenously over the course of 60 hours to a 72 year old patient.
Symptoms of Vita-Cal Mag with Zinc and Vitamin D (Zinc) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Vita-Cal Mag with Zinc and Vitamin D (Zinc) level of 4184 mcg/dl.
Calcium supplements may confer a protective effect against Vita-Cal Mag with Zinc and Vitamin D (Zinc) toxicity.
Vita-Cal Mag with Zinc and Vitamin D (Zinc) 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 Vita-Cal Mag with Zinc and Vitamin D (Zinc) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Vita-Cal Mag with Zinc and Vitamin D (Zinc).
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.
Vita-Cal Mag with Zinc and Vitamin D (Zinc) 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
Vita-Cal Mag with Zinc and Vitamin D (Zinc)
1 mg/mL
Vita-Cal Mag with Zinc and Vitamin D (Zinc) 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 Vita-Cal Mag with Zinc and Vitamin D after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Vita-Cal Mag with Zinc and Vitamin D 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 Vita-Cal Mag with Zinc and Vitamin D 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