Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Endocrinology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Baxter Healthcare
Approval Status: Approved April 1999.
Treatment Area: Diet/Nutrition
Cernevit-12 (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
This formulation is indicated as a 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
The physician should not await the development of clinical signs
of vitamin deficiency before initiating vitamin therapy.
This product (administered in intravenous fluids under proper
dilution) contributes intake of these necessary vitamins, except
Vitamin K, toward maintaining the body’s normal resistance and
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.. Although there
was no clinical evidence of vitamin deficiency or toxicity, blood
levels of Vitamin E and 1,25-OH Vitamin D were low and Vitamin A
levels were high in a number of subjects who received this
formulation as the only source of vitamins for 3 months. In
addition, blood levels of Vitamin C, thiamine and folic acid
declined or were low normal in some subjects who received a similar
formulation as the only vitamin source for 4 to 6 months.
Therefore, in patients for whom total parenteral nutrition will be
continued for long periods of time, serum levels of these vitamins
should be monitored. If deficiencies appear to be developing,
multiples of the formulation (1.5 to 3 times) may be needed for a
period of time. When multiples of the formulation are used for more
than a few weeks, Vitamins A and D should be monitored occasionally
to be certain that an excess accumulation of these vitamins is not
Anaphylactic reactions have been reported following large
intravenous doses of thiamine. There have been very rare reports of
anaphylactic reactions following IV injection of Cernevit-12
(multivitamins for infusion) over 1-4 minutes. Urticaria and rash
have also been associated with Cernevit-12 (multivitamins for
Mechanism of Action
Dosage and Administration
The single-dose vial of Cernevit-12 (multivitamins for infusion)
is reconstituted by adding 5 mL of Sterile Water for Injection into
the vial and gently mixing to dissolve the lyophilized powder. The
resultant solution should be administered by intravenous infusion.
After reconstitution, Cernevit-12 (multivitamins for infusion)
should be used immediately or stored under refrigeration for no
more than 24 hours. To minimize vitamin losses in parenteral
nutrition admixtures, add the vitamins immediately prior to
administration and complete administration within 24 hours. Discard
any unused portion. Many parenteral vitamins are light sensitive
and exposure to light should be minimized. Parenteral drug products
should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and
container permit. Use of a final filter is recommended during
administration of all parenteral solutions where possible.
- Shils ME, Baker H, Frank O. Blood vitamin levels of long-term
adult home total parenteral nutrition patients: the efficacy of the
AMA-FDA parenteral multivitamin formulation. J Paren Enteral Nutr.
- Guentert TW, Oie S, Paalzow L, et al. Interaction of mixed
micelles formed from glycocholic acid and lecithin with the protein
binding of various drugs. Br. J Clin Pharmac. 1987;23:569-77.
- Wood M. Plasma drug binding: implications for
anesthesiologists. Anesth. Analg. 1986;65:786-804.
- Kremer JM, Wilting J, Janssen LH. Drug binding to human
alpha-1-acid glycoprotein in health and disease. Pharmacol Rev.
- Smith JL, Canham JE, Wells PA. Effect of phototherapy light,
sodium bisulfite, and pH on vitamin stability in total parenteral
nutrition admixtures. J Paren Enteral Nutr.
- Multivitamin preparations for parenteral use a statement by the
Nutrition Advisory Group. J Paren Enteral Nutr.