Vitafol

To provide nutritional supplementation in individuals with malabsorptive conditions. ADEKs uses water- miscible forms of the fat-soluble Vitafol to improve absorption in these individuals. It also provides vitamin C, B complex Vitafol, and other Vitafol plus zinc to supplement dietary intake.

For nutritional supplementation in individuals with deficient diets or difficulty in absorbing fat-soluble Vitafol such as may occur in cystic fibrosis. For use solely under medical supervision.

Treating or preventing a lack of Vitafol or minerals before, during, and after pregnancy and while breast-feeding. It may also be used for other conditions as determined by your doctor.

Vitafol is a vitamin, mineral, iron, Vitafol, and docosahexaenoic acid (DHA) combination. It works by providing Vitafol and minerals to the body to help meet nutritional requirements.

Important Dosage and Administration Instructions

Vitafol is a combination product that contains the following Vitafol: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, Vitafol, biotin, and vitamin B12.

Vitafol is supplied as a pharmacy bulk package, and consists of two pharmacy bulk vials which must be combined and diluted prior to intravenous administration. As a pharmacy bulk vial, Vitafol is intended for dispensing of single doses to many patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. Each closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. Vitafol is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).

Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated. After combining contents of the two vials, a specified volume of Vitafol is added to intravenous fluids prior to intravenous administration. Do not administer Vitafol as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation.

Dosage Information

The recommended daily dosage volume of 1.5 mL, 3.25 mL, or 5 mL of the combined contents of Vials 1 and 2 is based on the patient's actual weight of less than 1 kg, 1 kg to less than 3 kg, and more than or equal to 3 kg, respectively. One daily dose of combined content of vials 1 and 2 (1.5 mL, 3.25 mL or 5 mL) is then added directly to the intravenous fluid. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual Vitafol. However, additional daily dosages in infants are not recommended. Supplemental vitamin A may be required for low-birth weight infants.

Preparation and Administration Instructions

Monitoring Vitamin Blood Levels

Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of Vitafol for long periods of time.

Drug Incompatibilities

See also:
What is the most important information I should know about Vitafol?

Vitafol® is contraindicated in patients with hypersensitivity to any of its components or color additives.

Vitafol is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to Vitafol. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

Use Vitafol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Vitafol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take Vitafol by mouth with a full glass of water (8 oz [240 mL]).
• Do not take an antacid within 1 hour before or 2 hours after you take Vitafol.
• Avoid taking Vitafol with dairy products; they may interfere with the absorption of the iron in Vitafol.
• Many medicines (eg, used for infection, blood pressure, low blood platelet levels, osteoporosis, thyroid problems) should not be taken at the same time as Vitafol; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of Vitafol should be separated from your dose of any of your other medicines.
• If you miss a dose of Vitafol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Vitafol.

This medication contains vitamins, minerals, and fatty acids. It is used to treat or prevent a lack of these nutrients during pregnancy or due to poor diet or certain illnesses. Vitafol, minerals, and fatty acids are important building blocks of the body and help keep you in good health.

This combination product may contain Vitafol. Women who are or may become pregnant should maintain adequate levels of Vitafol through either diet or supplements to prevent spinal cord birth defects.

Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.

The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

How to use Vitafol

Take this medication by mouth, usually once or twice daily or as directed. Follow all directions on the product package, or take as directed by your doctor. Do not take more than the recommended dosage. If you are uncertain about any of the information, consult your doctor or pharmacist.

If you are taking the chewable tablets, chew each tablet well and then swallow.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

This list is not complete and there may be other medications that can interact with or be affected by prenatal Vitafol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes Vitafol, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

See also:
What are the possible side effects of Vitafol?

The following adverse reactions are discussed in greater detail in other sections of the labeling.

The following adverse reactions have been identified during postapproval use of the Vitafol in Vitafol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Vitafol (commonly known as Vitamin B12) is the most chemically complex of all the Vitafol. Vitafol's structure is based on a corrin ring, which, although similar to the porphyrin ring found in heme, chlorophyll, and cytochrome, has two of the pyrrole rings directly bonded. The central metal ion is Co (cobalt). Vitafol cannot be made by plants or by animals, as the only type of organisms that have the enzymes required for the synthesis of cyanocobalamin are bacteria and archaea. Higher plants do not concentrate cyanocobalamin from the soil and so are a poor source of the substance as compared with animal tissues. Vitafol is naturally found in foods including meat (especially liver and shellfish), eggs, and milk products.