Skip to main content Back to Top

12/1/2001

Injectable Multivitamin Product Containing Vitamin K Enters Market

Cheryl A. Thompson

Baxter Healthcare received approval to market Infuvite Adult, an injectable multivitamin product manufactured by the Canadian firm Sabex Inc. The product meets FDA's new requirement for the amount of thiamine, pyridoxine, ascorbic acid, and folic acid per dose and addition of vitamin K.

The two-vial product contains 13 vitamins in the following amounts:

  • Ascorbic acid 200 mg,   
  • Vitamin A 3300 IU,   
  • Vitamin D3 200 IU,   
  • Thiamine 6 mg,   
  • Riboflavin 3.6 mg,   
  • Pyridoxine 6 mg,   
  • Niacinamide 40 mg,   
  • Dexpanthenol 15 mg,   
  • Vitamin E 10 IU,   
  • Vitamin K 150 mcg,   
  • Folic acid 600 mcg,   
  • Biotin 60 mcg, and   
  • Vitamin B12 150 mcg.

Correction: In the list above, the amount of vitamin B12 should be 5 mcg.

Folic acid, biotin, and vitamin B12 are supplied in a solution of 30% propylene glycol in the container labeled Vial 2.

The multivitamin product is indicated as a daily supplement to parenteral nutrition administered to adults and children 11 years of age or older. Also, the product is indicated in clinical situations, such as surgery or the treatment of extensive burns, in which the i.v. administration of multivitamins is needed to counter immense changes in the patient's metabolic demands for nutrients.

Adult multivitamin injection is contraindicated in patients with hypervitaminosis or a known hypersensitivity to any of the product's ingredients. Allergic reactions have occurred after i.v. administration of thiamine and vitamin K.

The product is also contraindicated in patients suspected of having megaloblastic anemia, because folic acid and vitamin B12 can interfere with interpretation of the diagnostic blood test.

FDA's definition of an "effective parenteral multivitamin preparation" for adults officially changed in April 2000 when the agency finalized its adjustments to the 12-vitamin formulation that had been marketed for more than a decade. The adjustments were made in response to a 1985 workshop, sponsored by FDA and the American Medical Association, at which researchers presented data from clinical tests of the 12-vitamin formulation that had been based on a 1975 guideline by the physicians' organization.

FDA also changed the requirement for labeling on materials used in parenteral nutrition. By January 2003, the aluminum content must appear in the labeling for injectable multivitamins and other products used to make parenteral nutrient solutions.

Patients receiving warfarin and adult multivitamin injection should be monitored to ensure the appropriate dosage of the anticoagulant. The vitamin K in the multivitamin product may antagonize warfarin's effect.

The "Warnings" section of the product's labeling describes the possibility of aluminum toxicity in patients with impaired renal function who receive adult multivitamin injections for a prolonged period. This warning refers to the presence of aluminum in calcium- and phosphate-containing i.v. solutions, but the labeling does not specifically state the amount of aluminum present in the product's two vials.

The recommended daily dose of adult multivitamin injection is two 5-mL vials, added to at least 500 mL of dextrose injection, 0.9% sodium chloride injection, or a similar i.v. solution. This dosage may be increased for two or more days if the patient has multiple vitamin deficiencies or a greatly increased need for vitamins. The vitamin solution should not be administered undiluted, added directly to fat emulsion, or mixed with alkaline solutions or moderately alkaline drugs.

Infuvite Adult is supplied as boxes containing 2 or 10 vials—1 or 5 pairs, respectively, of vial 1 and vial 2. Until use, the vials are to be stored at 2–8 degrees C. Because riboflavin and vitamins A and D are light sensitive, the product's labeling suggests minimizing the diluted solution's exposure to light.

The Infuvite product line includes a formulation specifically for infants and children. This product, Infuvite Pediatric, differs in content from the adult formulation.