Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

DESCRIPTION For dilution in infusions only CernevitTM (multivitamins for infusion) is a lyophilized, sterile powder containing both water soluble and fat soluble vitamins (except Vitamin K) combined with mixed micelles (glycocholic acid and lecithin) in a single-dose amber glass vial intended for intravenous infusion following reconstitution and further dilution. Each single-dose vial of CernevitTM (multivitamins for infusion) provides: Retinol palmitate corresponding to Retinol (Vitamin A) 3500 IU Cholecalciferol (Vitamin D3 ) 200 IU DL a-tocopherol 10.2 mg corresponding to a-tocopherol (Vitamin E) 11.2 IU Ascorbic Acid (Vitamin C) 125 mg Nicotinamide (Vitamin B3 ) 46 mg Dexpanthenol 16.15 mg corresponding to pantothenic acid (Vitamin B5) 17.25 mg Pyridoxine hydrochloride 5.5 mg corresponding to pyridoxine (Vitamin B6) 4.53 mg Riboflavin sodium phosphate 5.67 mg corresponding to riboflavin (Vitamin B2) 4.14 mg Cocarboxylase tetrahydrate 5.8 mg corresponding to thiamine (Vitamin B1) 3.51 mg Folic Acid 414 mcg D-Biotin 60 mcg Cyanocobalamin (Vitamin B12) 5.5 mcg Other Ingredients Glycine 250 mg Glycocholic acid 140 mg Soybean lecithin 112.5 mg Sodium hydroxide and/or Hydrochloric acid added to adjust pH to 5.9 CernevitTM (multivitamins for infusion) makes available a combination of important water soluble and fat soluble vitamins in a physiologic micellar system specially formulated for incorporation into intravenous infusions. Glycocholic acid and lecithin, both possessing emulsifying properties, are combined to form mixed micelles allowing the water soluble and fat soluble vitamins to solubilize in one container. The lyophilization of CernevitTM (multivitamins for infusion) produces a sterile dry powder intended for reconstitution, providing an aqueous solution. Glycine is incorporated for rapid reconstitution.

PATIENT INFORMATION See CONTRAINDICATIONS

OVERDOSE No informatoin provided. CONTRAINDICATIONS Known hypersensitivity to any of the vitamins in this product or a pre-existing hypervitaminosis.

WARNINGS No information provided. PRECAUTIONS Folic acid may obscure pernicious anemia. Drug Interactions The dosage of drugs known to be influenced by folic acid and pyridoxine, for example phenytoin and phenobarbital, must be carefully monitored. Pyridoxine can reduce the effect of levodopa. Several drugs are known to influence the serum concentration of vitamins. An in vitro study 2 using therapeutic concentrations of glycocholic acid (0.177 mg glycocholate/mL human serum) demonstrated a 50-80% increase in the unbound (free) fraction of drugs known to bind a 1-acid glycoprotein (e.g., disopyramide, propranolol, quinidine, and prazosin). Although the in vivo response has not been determined, physicians should closely monitor patients for the possibility of an increase in the therapeutic response to drugs binding to a1-acid glycoprotein. Consult appropriate references for drugs that bind to a1-acid glycoprotein3,4 and for listings of specific drug-vitamin interactions. Folic acid has been reported to be unstable in the presence of calcium gluconate. Bisulfites have been reported to affect the stability of Vitamin A, thiamine, and ascorbic acid.5 The pH of the parenteral nutrition admixture may affect the stability of Vitamin C and thiamine.5 Bleomycin can be inactivated by ascorbic acid and riboflavin. Several vitamins have been reported to decrease the activity of certain antibiotics. Admixture or Y-site administration of alkaline drugs through a vitamin infusion should be avoided. Cernevit†-12 (multivitamins for infusion) should not be admixed directly into a lipid emulsion. Cernevit†-12 (multivitamins for infusion) may be combined with parenteral nutrition containing a lipid emulsion. The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to additions of divalent cations (Ca++ and Mg++) which have been shown to cause emulsion instability. Consult the current literature for physical compatibility of drugs with parenteral nutrition. Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity, mutagenicity and fertility studies have not been performed with Cernevit†-12 (multivitamins for infusion). Pregnancy Pregnancy Category C: The use of Cernevit†-12 (multivitamins for infusion) has not been studied in human pregnancy. Animal reproduction studies have not been conducted with Cernevit†-12 (multivitamins for infusion). It is also not known whether Cernevit†-12 (multivitamins for infusion) should be given to a pregnant woman or can affect reproduction capacity. Cernevit†-12 (multivitamins for infusion) should be given to a pregnant woman only if clearly needed. 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. 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 Cernevit†-12 (multivitamins for infusion) is administered to a nursing mother. Pediatric use Safety and efficacy of Cernevit†-12 (multivitamins for infusion) administration to children