Folee

A light yellow to yellow, 8 mm round, biconvex tablet, plain on both sides.
Each tablet contains: Folic Acid, USP 5 mg.

Vitamin/Hematinic.
Pharmacology: Pharmacodynamics: Folic acid is a water-soluble B-complex vitamin found in foods such as liver, kidney, yeast, and green leafy vegetables. Also known as folate or vitamin B₉, folic acid is a member of the vitamin B group which is reduced in the body to tetrahydrofolate, a co-enzyme active in several metabolic processes and produces a haemopoietic response in nutritional megaloblastic anemias. Folic acid is an essential co-factor for enzymes involved in DNA and RNA synthesis. Folic acid is particularly important during phases of rapid cell division, such as infancy, pregnancy, and erythropoiesis, and plays a protective factor in the development of cancer. As humans are unable to synthesize folic acid endogenously, diet and supplementation is necessary to prevent deficiencies.
Pharmacokinetics: Folic acid is rapidly absorbed from the gastrointestinal tract, mainly from the proximal part of the small intestine. Dietary folates are stated to have about half-life the bioavailability of crystalline folic acid. The naturally occurring folate polyglutamates are largely deconjugated and reduced by dihydrofolate reductase in the intestine to form 5-methyltetrahydrofolate (5MTHF). Folic acid given therapeutically enters the portal circulation largely unchanged, since it is a poor substrate for reduction by dihydrofolate reductases. The principal storage site of folate is the liver; it is also actively concentrated in the CSF. Folate metabolites are eliminated in the urine and folate in excess of body requirements is excreted unchanged in the urine.

It is used in the treatment and prevention of folate deficiency state. Also used in women of child-bearing potential and pregnant women to protect against neural tube defects in their offspring. It is also indicated for the treatment of megaloblastic anemia.

The medicine should be taken orally. (See Tables 1 and 2.)

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No special procedures or antidote are likely to be needed.

Contraindicated to patients with folic acid hypersensitivity.
Folate deficiency due to dihydrofolate reductase inhibitors, pernicious, aplastic or normocytic anemia.

Should not be given alone or with inadequate vitamin B₁₂ for the treatment of pernicious anemia or undiagnosed megaloblastic anemia and in patients with folate-dependent tumors.
Large and continuous dosage folic acid may lower the blood concentration of vitamin B₁₂. Folic acid does not correct folate deficiency due to dihydrofolate reductase inhibitors.
The availability of folates may be inhibited by gastric acidity and the presence of ascorbate in the gastrointestinal tract. Metformin reduces intestinal absorption of folic acid and phenytoin may cause folate depletion.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.

Pregnancy: Category A. (ref. US FDA/MIMS) Controlled studies in women fail to demonstrate a risk to fetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm remains remote.

Folic acid is generally well-tolerated. Gastrointestinal disturbance may occur. Allergic reactions have been reported rarely. Instruction to the patient to seek medical attention immediately at the first sign of adverse drug reaction.

Folate deficiency states may be produced by drugs such as antiepileptics, oral contraceptives, anti-tuberculosis drugs, alcohol, and folic acid antagonists such as methotrexate, pyrimethamine, triamterene, trimethoprim and sulfonamides. In some instances, such as during methotrexate or antiepileptics therapy, replacement therapy with folic acid may become necessary in order to prevent megaloblastic anemia developing; folate supplementation has reportedly decreased serum-phenytoin concentrations in few cases and there is a possibility that such an effect could also occur with barbiturate-antiepileptics. Cholestyramine and folic acid when administered together, there may be reduction or delay in folic acid absorption. If concomitant therapy is required, folic acid should be administered at least 1 hour before or 4 hours after cholestyramine.

Store at temperatures not exceeding 30°C.

Vitamins & Minerals (Pre & Post Natal) / Antianemics

B03BB01 - folic acid ; Belongs to the class of folic acid and derivatives. Used in the treatment of anemia.

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