Multi Vitamin Infusion Adult

Hospira Worldwide, Inc.

M.V.I. ADULT™

FULL PRESCRIBING INFORMATION: CONTENTS*

• MULTI VITAMIN INFUSION ADULT DESCRIPTION
• MULTI VITAMIN INFUSION ADULT INDICATIONS AND USAGE
• MULTI VITAMIN INFUSION ADULT CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Drug-Drug Interactions
  • Drug-Laboratory Test Interactions
  • Carcinogenesis, Mutagenesis, and Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
• MULTI VITAMIN INFUSION ADULT ADVERSE REACTIONS
• OVERDOSAGE
• MULTI VITAMIN INFUSION ADULT DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• CA-2073

FULL PRESCRIBING INFORMATION

(Multi-Vitamin Infusion)

For dilution in intravenous infusions only.

Rx only

MULTI VITAMIN INFUSION ADULT DESCRIPTION

M.V.I. Adult^TM is available as a sterile product consisting of two vials labeled Vial 1 (50 mL) and Vial 2 (50 mL). A single 10 mL dose consists of 5 mL from Vial 1 and 5 mL from Vial 2.

Adult Formulation (intended for ages 11 and older)

“Aqueous” multivitamin formula for intravenous infusion: M.V.I. Adult (Multi-Vitamin Infusion) makes available a combination of important fat-soluble and water-soluble vitamins in an aqueous solution, formulated specially for incorporation into intravenous infusions. Through special processing techniques, the liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.

MULTI VITAMIN INFUSION ADULT INDICATIONS AND USAGE

Adults and Children Aged 11 and Above: This formulation is indicated as daily multivitamin maintenance dosage for adults and children aged 11 years and above receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients. M.V.I. Adult (administered in intravenous fluids under proper dilution) contributes toward the intake of these vitamins that are necessary toward maintaining the body’s normal resistance and repair processes.

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days as indicated by the clinical status. Clinical testing indicates that some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the sole source of vitamins.

MULTI VITAMIN INFUSION ADULT CONTRAINDICATIONS

Known hypersensitivity to any of the vitamins in this product or a pre-existing hypervitaminosis. Allergic reaction has been known to occur following intravenous administration of thiamine and vitamin K. This formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.

WARNINGS

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

Caution should be exercised when administering this multivitamin formulation to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypopro-thrombinemic response to anticoagulant drugs, therefore requiring dosage adjustment of the warfarin sodium-type anticoagulant therapy. Periodic monitoring of prothrombin time is essential in determining the appropriate dosage of anticoagulant therapy.

Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with M.V.I. Adult.

Where long-standing specific vitamin deficiencies exist, it may be necessary to add therapeutic amounts of specific vitamins to supplement the maintenance vitamins provided in M.V.I. Adult.

In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing.

M.V.I. Adult should be aseptically transferred to the infusion fluid.

Drug-Drug Interactions

Physical Incompatibilities

M.V.I. Adult (Multi-Vitamin Infusion) is not physically compatible with DIAMOX^® (acetazolamide) 500 mg, DIURIL^® Intravenous Sodium (chlorothiazide sodium) 500 mg, or aminophylline 125 mg, ampicillin 500 mg or moderately alkaline solutions. ACHROMYCIN^® (tetracycline HCl) 500 mg may not be physically compatible with M.V.I. Adult. It has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Some of the vitamins in M.V.I. Adult may react with vitamin K bisulfite. Direct addition of M.V.I. Adult to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.

Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin.

Some of the vitamins in M.V.I. Adult may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies.

Clinical Interactions

A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions.

Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient's response to methotrexate therapy.

Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.

In patients with pernicious anemia, the hematologic response to vitamin B₁₂ therapy may be inhibited by concomitant administration of chloramphenicol.

Vitamin K may antagonize the hypopro-thrombinemic effect of oral anticoagulants (see bolded statement above).

Consult appropriate references for additional specific vitamin-drug interactions.

Drug-Laboratory Test Interactions

Ascorbic acid in the urine may cause false negative urine glucose determinations.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenicity studies have not been performed.

Pregnancy

Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women.

Nursing Mothers

Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonlactating women.

Pediatric Use

Safety and effectiveness in children below the age of 11 years have not been established.

MULTI VITAMIN INFUSION ADULT ADVERSE REACTIONS

There have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine. The risk, however, is negligible if thiamine is co-administered with other vitamins in the B group. There have been no reports of fatal anaphylactoid reactions associated with M.V.I. Adult.

There have been rare reports of the following types of reactions:

Dermatologic — rash, erythema, pruritus

CNS — headache, dizziness, agitation, anxiety

Ophthalmic — diplopia

Allergic — urticaria, periorbital and digital edema

OVERDOSAGE

The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution.

MULTI VITAMIN INFUSION ADULT DOSAGE AND ADMINISTRATION

M.V.I. Adult is ready for immediate use in adults and children aged 11 years and above when added to intravenous infusion fluids.

Directions: Prepare the dose by aseptically transferring 5 mL from Vial 1 and 5 mL from Vial 2. Mix the solution gently. The mixed solution is ready for dilution in not less than 500 mL of infusion fluid. The mixed solution will provide a single 10 mL dose. Utilize a suitable sterile transfer device or dispensing set, which allows measured distribution of the contents.

The withdrawal of container contents should be accomplished without delay. The solution should be administered within 4 hours after dilution.

Use of this product is restricted to a suitable work area, such as a laminar flow hood.

M.V.I. Adult should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.

For intravenous feeding, one daily dose of M.V.I. Adult (5 mL from Vial 1 plus 5 mL from Vial 2) added directly to not less than 500 mL, preferably 1,000 mL, of intravenous dextrose, saline or similar infusion solutions.

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

After M.V.I. Adult is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A and D and riboflavin, are light sensitive, and exposure to light should be minimized.

Store at 2 to 8°C (36 to 46°F).

HOW SUPPLIED

M.V.I. Adult (PHARMACY BULK PACKAGE) — NDC 61703-422-83. 2 boxes of 10 vials (5 vial 1 and 5 vial 2), 50 mL each. Contents provide for ten single 10 mL doses.

Created: February, 2009

Printed in USA                                                                         EN-2047

Hospira, Inc. Lake Forest, IL 60045 USA

CA-2073