Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc

Calcium (Calcium Carbonate):

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Overdosage
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) reviews

1 INDICATIONS AND USAGE

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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)

2 DOSAGE AND ADMINISTRATION

The recommended initial dose of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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)

3 DOSAGE FORMS AND STRENGTHS

Capsule: 667 mg Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate capsule.

- Capsule: 667 mg Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate capsule. (3)

4 CONTRAINDICATIONS

Patients with hypercalcemia.

- Hypercalcemia. (4)

5 WARNINGS AND PRECAUTIONS

- Treat mild hypercalcemia by reducing or interrupting Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc ) acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate. (5.1)

- Hypercalcemia may aggravate digitalis toxicity. (5.2)

5.1 Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)), including Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate. Avoid the use of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) supplements, including Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) based nonprescription antacids, concurrently with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate.

An overdose of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) levels twice weekly. Should hypercalcemia develop, reduce the Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg²/dL².

5.2 Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

6 ADVERSE REACTIONS

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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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

6.1 Clinical Trial Experience

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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate has been generally well tolerated.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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.

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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) concentration could reduce the incidence and severity of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.

6.2 Postmarketing Experience

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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate: dizziness, edema, and weakness.

7 DRUG INTERACTIONS

The drug interaction of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc ) acetate is characterized by the potential of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate and most concomitant drugs. When administering an oral medication with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate or consider monitoring blood levels of the drug. (7)

7.1 Ciprofloxacin

In a study of 15 healthy subjects, a co-administered single dose of 4 Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C:

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc ) acetate capsules contains Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate. Animal reproduction studies have not been conducted with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate, and there are no adequate and well controlled studies of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate treatment, as recommended, is not expected to harm a fetus if maternal Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) levels are properly monitored during and following treatment.

8.2 Labor and Delivery

The effects of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate on labor and delivery are unknown.

8.3 Nursing Mothers

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc ) Acetate Capsules contains Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate and is excreted in human milk. Human milk feeding by a mother receiving Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate is not expected to harm an infant, provided maternal serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) levels are appropriately monitored.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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.

10 OVERDOSAGE

Administration of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

11 DESCRIPTION

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate acts as a phosphate binder. Its chemical name is Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate USP (anhydrous; Ca(CH₃COO)₂; MW=158.17 grams) equal to 169 mg (8.45 mEq) Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)), 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

Chemical Structure

12 CLINICAL PHARMACOLOGY

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc ) resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.

12.1 Mechanism of Action

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

12.2 Pharmacodynamics

Orally administered Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate.

14 CLINICAL STUDIES

Effectiveness of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) levels are also presented.

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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate is shown in the Table 3.

Overall, 2 weeks of treatment with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

16 HOW SUPPLIED/STORAGE AND HANDLING

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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).

17 PATIENT COUNSELING INFORMATION

Inform patients to take Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Calcium (Calcium Carbonate)) acetate capsules.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003705/05

Revised April 2016

Folic Acid:

• Indications and usage
• Contraindications
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• Storage
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Folic Acid) reviews

INDICATIONS AND USAGE

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Folic Acid)^® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

PRECAUTIONS

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Folic Acid) acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Folic Acid) acid.

DOSAGE AND ADMINISTRATION

One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.

HOW SUPPLIED

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Folic Acid)^® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)

KEEP OUT OF REACH OF CHILDREN.

STORAGE

Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container to protect from light and moisture.

To report SUSPECTED ADVERSE REACTIONS contact Meda Pharmaceuticals Inc. at 1-888-349-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch

Distributed by:

Meda Pharmaceuticals Inc.

Somerset New Jersey 08873-4120

© 2014 Meda Pharmaceuticals Inc.

U.S. Patent Nos. 7,585,527 and 8,080,520

Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Folic Acid) and the BIFERA logo are registered trademarks and the Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Folic Acid) logo is a trademark of Alaven Pharmaceutical LLC, used under license by Meda Pharmaceuticals Inc.

MEDA PHARMACEUTICALS mark and logo are trademarks of Meda AB.

IN-6885-02 Rev 6/2014

Magnesium (Magnesium Carbonate):

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• References
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) reviews

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) Sulfate

Injection, USP

Ansyr Plastic Syringe

Rx only

Hospira Logo

DESCRIPTION

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) Sulfate Injection, USP is a sterile solution of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) Sulfate, USP heptahydrate is chemically designated MgSO₄ - 7H₂O with molecular weight of 246.48 and occurs as colorless crystals or white powder freely soluble in water.

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

CLINICAL PHARMACOLOGY

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) (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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)). While there are large stores of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) levels range from 1.5 to 2.5 mEq/liter.

As plasma Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)). Serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) concentrations in excess of 12 mEq/L may be fatal.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

INDICATIONS AND USAGE

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) Sulfate Injection, USP is suitable for replacement therapy in Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) (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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.

CONTRAINDICATIONS

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

WARNINGS

FETAL HARM: Continuous administration of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) sulfate should be used during pregnancy only if clearly needed. If Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) intoxication. Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.

PRECAUTIONS

General

Administer with caution if flushing and sweating occurs. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)), their dosage should be adjusted with caution because of additive CNS depressant effects of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)).

Because Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) should be given until they return. Serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) intoxication in eclampsia.

50% Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)), their dosage should be adjusted with caution because of additive CNS depressant effects of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)). CNS depression and peripheral transmission defects produced by Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) may be antagonized by calcium.

Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.

Cardiac Glycosides - Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) toxicity.

Pregnancy

Teratogenic Effects

Pregnancy Category D (See WARNINGS and PRECAUTIONS )

See WARNINGS and PRECAUTIONS .

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) sulfate for more than 5 to 7 days.^1-10 Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).

Labor and Delivery

Continuous administration of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) is distributed into milk during parenteral Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) should be monitored in such patients.

ADVERSE REACTIONS

The adverse effects of parenterally administered Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) usually are the result of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) sulfate therapy for eclampsia has been reported.

OVERDOSAGE

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)).

For Treatment of Overdose

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

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

DOSAGE AND ADMINISTRATION

Dosage of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) Deficiency

In the treatment of mild Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) sulfate is 20 grams/48 hours and frequent serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) concentrations must be obtained. Continuous use of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together.

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

HOW SUPPLIED

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) Sulfate Injection, USP is supplied in single-dose containers as follows:

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

Store at 20 to 25°C (68 to 77°F).

REFERENCES

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

Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1024-1.0

April 2017

Hospira Logo

50% Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) Sulfate 5 g/10 mL (500 mg/mL)

Rx only

NDC 0409-1754-10

10 mL Single-dose syringe

50% Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Magnesium (Magnesium Carbonate)) 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

Vitamin B12:

• Pharmacological action
• Pharmacokinetics
• Why is Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc prescribed?
• Dosage and administration
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) side effects, adverse reactions
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc contraindications
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc using during pregnancy and breastfeeding
• Special instructions
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) drug interactions
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) reviews

Pharmacological action

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc refers to a group of water-soluble vitamins. It has high biological activity. Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) is necessary for normal hematopoiesis (promotes maturation of erythrocytes). Involved in the processes of transmethylation, hydrogen transport, synthesis of methionine, nucleic acids, choline, creatine. Contributes to the accumulation in erythrocytes of compounds containing sulfhydryl groups. Has a beneficial effect on liver function and the nervous system. Activates the coagulation of blood in high doses causes an increase in the activity of thromboplastin and prothrombin.

Pharmacokinetics

After oral administration Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) absorbed from the gastrointestinal tract. Metabolized in the tissues, becoming a co-enzyme form - adenosylcobalamin which is the active form of cyanocobalamin. Excreted in bile and urine.

Why is Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc prescribed?

Anemia due to B12-deficiency conditions; in the complex therapy for iron and posthemorrhagic anemia; aplastic anemia caused by toxic substances and drugs; liver disease (hepatitis, cirrhosis); funicular myelosis; polyneuritis, radiculitis, neuralgia, amyotrophic lateral sclerosis; children cerebral palsy, Down syndrome, peripheral nerve injury; skin diseases (psoriasis, photodermatosis, herpetiformis dermatitis, neurodermatitis); to prevent and treat symptoms of deficiency of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) (including the application of biguanide, PASA, vitamin C in high doses); radiation sickness.

Dosage and administration

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc is used as injections SC, IV, IM, intralumbar, and also oral. With anemia associated with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) deficiency is introduced on 100-200 mcg in 2 days. In anemia with symptoms of funicular myelosis and megalocytic anemia with diseases of the nervous system - 400-500 micrograms in the first 7 days daily, then 1 time every 5-7 days. In the period of remission in the absence of events funicular myelosis maintenance dose - 100 mcg 2 times a month, in the presence of neurological symptoms - at 200-400 mcg 2-4 times a month. In acute post-hemorrhagic anemia and iron anemia by 30-100 mcg 2-3 times a week. When aplastic anemia (especially in children) - 100 micrograms before clinical improvement. When nutritional anemia in infants and preterm - 30 mcg / day during 15 days.

In diseases of the central and peripheral nervous system and neurological diseases with a pain syndrome is administered in increasing doses - 200-500 mcg, with the improvement in the state - 100 mcg / day. The course of treatment with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) is 2 weeks. In traumatic lesions of peripheral nervous system - at 200-400 mcg every other day for 40-45 days.

When hepatitis and cirrhosis - 30-60 mcg / day or 100 mg every other day for 25-40 days.

Dystrophy in young children, Down syndrome and cerebral palsy - by 15-30 mcg every other day.

When funicular myelosis, amyotrophic lateral sclerosis can be introduced into the spinal canal at 15-30 mcg, gradually increasing the dose of 200-250 micrograms.

In radiation sickness, diabetic neuropathy, sprue - by 60-100 mcg daily for 20-30 days.

When deficiency of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) to prevent - IV or IM for 1 mg 1 time a month; for treatment - IV or IM for 1 mg daily for 1-2 weeks, the maintenance dose is 1-2 mg IV or IM from 1 per week, up to 1 per month. Duration of treatment is determined individually.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) side effects, adverse reactions

CNS: rarely - a state of arousal.

Cardiovascular system: rarely - pain in the heart, tachycardia.

Allergic reactions: rarely - urticaria.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc contraindications

Thromboembolism, erythremia, erythrocytosis, increased sensitivity to cyanocobalamin.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc using during pregnancy and breastfeeding

Cyanocobalamin can be used in pregnancy according to prescriptions.

Special instructions

When stenocardia should be used with caution in a single dose of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc 100 mcg. During treatment should regularly monitor the blood picture and coagulation. It is unacceptable to enter in the same syringe with cyanocobalamin solutions of thiamine and pyridoxine.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) drug interactions

In an application of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) with hormonal contraceptives for oral administration may decrease the concentration of cyanocobalamin in plasma.

In an application with anticonvulsant drugs decreased cyanocobalamin absorption from the gut.

In an Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin B12) application with neomycin, aminosalicylic acid, colchicine, cimetidine, ranitidine, drugs potassium decreased cyanocobalamin absorption from the gut.

Cyanocobalamin may exacerbate allergic reactions caused by thiamine.

When parenteral application of chloramphenicol may decrease the hematopoietic effects of cyanocobalamin with anemia.

Pharmaceutical incompatibility

Contained in the molecule of cyanocobalamin cobalt ion contributes to the destruction of ascorbic acid, thiamine bromide, riboflavin in one solution.

Vitamin C:

• Pharmacological action
• Pharmacokinetics
• Why is Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc prescribed?
• Dosage and administration
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) side effects, adverse reactions
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc drug interactions
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc in case of emergency / overdose
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) reviews

Pharmacological action

Ascorbic acid is essential for the formation of intracellular collagen, is required to strengthen the structure of teeth, bones, and the capillary walls. Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) participates in redox reactions, the metabolism of tyrosine, converting folic acid into folinic acid, metabolism of carbohydrates, the synthesis of lipids and proteins, iron metabolism, processes of cellular respiration. Reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid, enhances the body's resistance to infections; enhances iron absorption, contributing to its sequestration in reduced form. Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) has antioxidant properties.

With intravaginal application of ascorbic acid lowers the vaginal pH, inhibiting the growth of bacteria and helps to restore and maintain normal pH and vaginal flora (Lactobacillus acidophilus, Lactobacillus gasseri).

Pharmacokinetics

After oral administration ascorbic acid is completely absorbed from the gastrointestinal tract. Widely distributed in body tissues.

The concentration of ascorbic acid in blood plasma in normal amounts to approximately 10-20 mg / ml.

The concentration of ascorbic acid in white blood cells and platelets is higher than in erythrocytes and plasma. When deficient state of concentration in leucocytes is reduced later and more slowly and is regarded as the best criterion for evaluating the deficit than the concentration in plasma.

Plasma protein binding is about 25%.

Ascorbic acid is reversibly oxidized to form dehydroascorbic acid, is metabolized with the formation of ascorbate-2-sulphate which is inactive and oxalic acid which is excreted in the urine.

Ascorbic acid taken in excessive quantities is rapidly excreted unchanged in urine, it usually happens when exceeding a daily dose is 200 mg.

Why is Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc prescribed?

For systemic use of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) Kimia Farma: prevention and treatment of hypo- and avitaminosis of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C); providing increased need for Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Dosage and administration

This medication administered orally, IM, IV, intravaginally.

For the prevention of deficiency conditions Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc dose is 25-75 mg / day, for the treatment - 250 mg / day or more in divided doses.

For intravaginal used ascorbic acid drugs in appropriate dosage forms.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) side effects, adverse reactions

CNS: headache, fatigue, insomnia.

Digestive system: stomach cramps, nausea and vomiting.

Allergic reaction: describes a few cases of skin reactions and manifestations of the respiratory system.

Urinary system: when used in high doses - hyperoxaluria and the formation of kidney stones of calcium oxalate.

Local reactions: with intravaginal application - a burning or itching in the vagina, increased mucous discharge, redness, swelling of the vulva. Other: sensation of heat.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc contraindications

Increased sensitivity to ascorbic acid.

Using during pregnancy and breastfeeding

The minimum daily requirement of ascorbic acid in the II and III trimester of pregnancy is about 60 mg.

Ascorbic acid crosses the placental barrier. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid, which takes a pregnant woman, and then a newborn baby may develop the ascorbic disease as the reaction of cancel. Therefore, during pregnancy should not to take ascorbic acid in high doses, except in cases where the expected benefit outweighs the potential risk.

The minimum daily requirement during lactation is 80 mg. Ascorbic acid is excreted in breast milk. A mother's diet that contains adequate amounts of ascorbic acid, is sufficient to prevent deficiency in an infant. It is unknown whether dangerous to the child's mother use of ascorbic acid in high doses. Theoretically it is possible. Therefore, it is recommended not to exceed the maximum daily nursing mother needs to ascorbic acid, except when the expected benefit outweighs the potential risk.

Special instructions

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because ascorbic acid increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.

Patients with high content body iron should apply ascorbic acid in minimal doses.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.

The use of ascorbic acid in high doses can cause exacerbation of sickle cell anemia.

Data on the diabetogenic action of ascorbic acid are contradictory. However, prolonged use of ascorbic acid should periodically monitor your blood glucose levels.

It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in ascorbic acid in patients with advanced cancer.

Absorption of ascorbic acid decreased while use of fresh fruit or vegetable juices, alkaline drinking.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc drug interactions

In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.

With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.

In an application of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.

Ascorbic acid in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

With the simultaneous use of aspirin reduces the absorption of ascorbic acid by about a third.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin C) in an application with warfarin may decrease effects of warfarin.

With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.

In an application with tetracycline is increased excretion of ascorbic acid in the urine.

There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with ascorbic acid 500 mg 2 times / day.

May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc in case of emergency / overdose

Symptoms: long-term use of large doses (more than 1 g) - headache, increased CNS excitability, insomnia, nausea, vomiting, diarrhea, gastritis giperatsidnyh, ultseratsiya gastrointestinal mucosa, inhibition of the function insular apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis (calcium oxalate), damage to the glomerular apparatus of the kidneys, moderate thamuria (when receiving a dose of 600 mg / day).

Decrease capillary permeability (possibly deteriorating trophic tissues, increased blood pressure, hypercoagulability, the development of microangiopathy).

When IV administration in high doses - the threat of termination of pregnancy (due to estrogenemia), hemolysis of red blood cells.

Vitamin E (D-Alpha Tocopherol Acetate):

• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) reviews

Indication: Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)), known for its antioxidant activities, is protective against cardiovascular disease and some forms of cancer and has also demonstrated immune-enhancing effects. It may be of limited benefit in some with asthma and rheumatoid arthritis. It may be helpful in some neurological diseases including Alzheimer's, some eye disorders including cataracts, and diabetes and premenstrual syndrome. It may also help protect skin from ultraviolet irradiation although claims that it reverses skin aging, enhances male fertility and exercise performance are poorly supported. It may help relieve some muscle cramps.

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) is a fat-soluble vitamin and is an important antioxidant. It acts to protect cells against the effects of free radicals, which are potentially damaging by-products of the body's metabolism. Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) is often used in skin creams and lotions because it is believed to play a role in encouraging skin healing and reducing scarring after injuries such as burns. There are three specific situations when a Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) deficiency is likely to occur. It is seen in persons who cannot absorb dietary fat, has been found in premature, very low birth weight infants (birth weights less than 1500 grams, or 3½ pounds), and is seen in individuals with rare disorders of fat metabolism. A Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) deficiency is usually characterized by neurological problems due to poor nerve conduction. Symptoms may include infertility, neuromuscular impairment, menstrual problems, miscarriage and uterine degradation. Preliminary research has led to a widely held belief that Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) may help prevent or delay coronary heart disease. Antioxidants such as Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) help protect against the damaging effects of free radicals, which may contribute to the development of chronic diseases such as cancer. It also protects other fat-soluble vitamins (A and B group vitamins) from destruction by oxygen. Low levels of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Vitamin E (D-Alpha Tocopherol Acetate)) have been linked to increased incidence of breast and colon cancer.

Zinc (Zinc Gluconate):

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) reviews

INDICATIONS AND USAGE

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) 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.

PRECAUTIONS

General

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

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

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) from a bolus injection. Administration of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) are suggested as a guideline for subsequent Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc ) 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc ) chloride. It is also not known whether Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

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

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) toxicity.

DOSAGE AND ADMINISTRATION

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)).

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

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

HOW SUPPLIED

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) 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 Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate))

1 mg/mL

Mega Stress Vite with Vitamin E, Cal, Mag, and Zinc (Zinc (Zinc Gluconate)) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA