"On April 3, 2015, the U.S. District Court for the District of Massachusetts on behalf of the U.S. Food and Drug Administration has filed a consent decree of permanent injunction against Michael P. Ferry Inc., a dairy operation located in Westport"...
(Generic versions may still be available.)
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.
Carcinogenicity, mutagenicity and fertility studies have not been performed with Cernevit†-12 (multivitamins for infusion).
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.
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.
Safety and efficacy of Cernevit†-12 (multivitamins for infusion) administration to children <11 years of age has not been established. Cernevit†-12 (multivitamins for infusion) is not recommended for use in children <11 years of age because it lacks Vitamin K and contains an inadequate amount of Vitamin D compared to that recommended by the Nutrition Advisory Group (NAG) of the Department of Food and Nutrition, American Medical Association (AMA) for children in this age group receiving total parenteral nutrition.6
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Cernevit Information
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