M.V.I. Adult (Page 2 of 3)

5.3 Risk of Low Vitamin A Levels

Vitamin A may adhere to plastic, resulting in lower vitamin A concentrations after administration of M.V.I.-Adult™. Therefore, blood vitamin concentrations should be periodically monitored and the administration of additional therapeutic doses of Vitamin A may be required.

5.4 Allergic Reactions to Thiamine

Allergic reactions such as urticaria, periorbital and digital edema, have been reported following intravenous administration of thiamine, which is found in M.V.I.-Adult™. There have been rare reports of anaphylaxis following intravenous doses of thiamine. No fatal anaphylaxis reactions associated with M.V.I. Adult™ have been reported.

5.5 Hypervitaminosis A

Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision, has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. Therefore, supplementation of renal failure patients and patients with liver diseases with vitamin A, an ingredient found in M.V.I.-Adult™, should be undertaken with caution [see Use in Specific Populations (8.6, 8.7)]. Blood levels of Vitamin A should be monitored periodically.

5.6 Interference with Diagnosis of Megaloblastic Anemia

M.V.I-Adult contains folic acid and cyanocobalamin which can mask serum deficits of folic acid and cyanocobalamin in patients with megaloblastic anemia. Avoid the use of M.V.I.-Adult™ in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.

5.7 Potential to Develop Vitamin Deficiencies or Excesses

In patients receiving parenteral multivitamins, such as with M.V.I.-Adult™, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. M.V.I.-Adult™ may not correct long-standing specific vitamin deficiencies. The administration of additional doses of specific vitamins may be required [see Dosage and Administration (2.2) ].

5.8 Interference with Urine Glucose Testing

M.V.I.-Adult™ contains Vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose determinations.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other section of the labeling.

Allergic reactions to thiamine [see Warnings and Precautions (5.4) ].
Hypervitaminosis A [see Warnings and Precautions (5.5) ].

The following adverse reactions have been identified during post approval use of M.V.I.-Adult™. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: rash, erythema, pruritus
CNS: headache, dizziness, agitation, anxiety
Ophthalmic: diplopia

7 DRUG INTERACTIONS

A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions:

7.1 Effect of M.V.I.-Adult on Other Drugs

Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity.

Methotrexate: Folic acid may decrease a patient’s response to methotrexate therapy.

Levodopa: Pyridoxine may increase the metabolism of levodopa (decrease blood level of levodopa) and decrease its efficacy.

Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.

Bleomycin: Ascorbic acid and riboflavin inactivate bleomycin in vitro , thus the activity of bleomycin may be reduced.

7.2 Effect of Other Drugs on M.V.I.-Adult

Hydralazine or Isoniazid:

Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.

Chloramphenicol:

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

Phenytoin:

Phenytoin may decrease serum folic acid concentrations.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

M.V.I.-Adult™ has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant women. Animal reproduction studies have not been conducted with M.V.I-Adult (Multi-Vitamin Injection) administered by intravenous infusion.

8.3 Nursing Mothers

M.V.I.-Adult™ has not been studied in lactating women. Lactating women may have vitamin requirements that exceed those of nonlactating woman. Caution should be exercised when M.V.I.-Adult™ is administered to a nursing woman.

8.4 Pediatric Use

M.V.I.-Adult™ has not been studied in children below the age of 11 years.

8.6 Renal Impairment

M.V.I.-Adult™ has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment [see Warnings and Precautions (5.2, 5.5)].

8.7 Hepatic Impairment

M.V.I.-Adult™ has not been studied in patients with hepatic impairment. Monitor vitamin A level in patients with liver disease, high alcohol consumption [see Warnings and Precautions (5.5) ].

10 OVERDOSAGE

Signs and symptoms of acute or chronic overdosage may be those of individual M.V.I.-Adult™ component toxicity. There is no clinical experience with M.V.I.-Adult™ overdosage.

11 DESCRIPTION

M.V.I.-Adult™ (Multi-Vitamin Injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution:

M.V.I.-Adult™ supplied as single dose

(a) Vial 1 (5 mL)
(b) Vial 2 (5 mL).

The mixed solution will provide a single 10 mL dose.

M.V.I.-Adult™ supplied as pharmacy bulk package

(a) Vial 1 (50 mL) (b) Vial 2 (50 mL).

The mixed solution will provide ten single doses of 10 mL each.

Each 5 mL of Vial 1 contains 10 vitamins and each 5 mL of Vial 2 contains 3 vitamins (see Table 1).

Table 1: ADULT FORMULATION (INTENDED FOR AGES 11 AND OLDER)

Vial 1*

Fat Soluble Vitamins**

Ingredient

Amount per Unit Dose

Vitamin A (retinol)

1 mga

Vitamin D (ergocalciferol)

5 mcgb

Vitamin E (dl-alpha-tocopheryl acetate)

10 mgc

Vitamin K (phytonadione)

150 mcg

Water Soluble Vitamins

Vitamin C (ascorbic acid)

200 mg

Niacinamide

40 mg

Vitamin B2 (as riboflavin 5-phosphate sodium)

3.6 mg

Vitamin B1 (thiamine)

6 mg

Vitamin B6 (pyridoxine HCl)

6 mg

Dexpanthenol (d-pantothenyl alcohol)

15 mg

* With 30% propylene glycol and 2% gentisic acid ethanolamide as stabilizers and preservatives; sodium hydroxide for pH adjustment; 1.6% polysorbate 80; 0.028% polysorbate 20; 0.002% butylated hydroxytoluene; 0.0005% butylated hydroxyanisole.** Fat soluble vitamins A, D, E and K are water solubilized with polysorbate 80.(a) 1 mg vitamin A equals 3,300 USP units.(b) 5 mcg ergocalciferol equals 200 USP units.(c) 10 mg vitamin E equals 10 USP units.

Vial 2*

Biotin

60 mcg

Folic acid

600 mcg

B12 (cyanocobalamin)

5 mcg

* With 30% propylene glycol; and citric acid, sodium citrate, and sodium hydroxide for pH adjustment.

Multiple vitamin preparation for intravenous infusion:

M.V.I.-Adult™ (Multi-Vitamin Injection) makes available a combination of fat-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous infusions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.

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