Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
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.
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 bodys metabolic demands and consequent tissue depletion of nutrients.
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 bodys normal resistance and repair processes.
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.
This product does not contain Vitamin K, which may have to be administered separately.
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.1 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 occurring.
The single-dose vial of CernevitTM (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, CernevitTM (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.5 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.
Adults and Children aged 11 years and above
Adults and children aged 11 years and above should receive the contents of one vial (5 mL) per day.
CernevitTM (multivitamins for infusion) is supplied in a single-dose amber glass vial as follows:
100 vials/case 2A6736 NDC 64371-869-60
Storage Store between 4° C (39° F) 25° C (77° F). Protect from light and heat. Do not freeze.
References
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 infusion).
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.
No information provided.
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
