Each uncoated tablet contains: Folic Acid 5 mg.
Pharmacology: Pharmacodynamics: The mucosa of the duodenum and upper part of the jejunum are rich in dihydrofolate reductase, where folates and folic acid are absorbed. Once absorbed, folic acid is rapidly reduced and then methylated to form tetrahydrofolic acid derivatives which are rapidly transported to the tissues.
Pharmacokinetics: Folic acid is rapidly absorbed from the gastrointestinal tract, mainly from the duodenum and jejunum. Dietary folates are stated to have about half the bioavailability of crystalline folic acid. The naturally occurring folate polyglutamates are largely deconjugated and then reduced by dihydrofolate reductase in the intestines to form 5-methyltetrahydrofolate, which appears in the portal circulation, where it is extensively bound to plasma proteins. Folic acid given therapeutically enters the portal circulation largely unchanged, since it is a poor substrate for reduction by dihydrofolate reductase. It is converted to the metabolically active form 5-methyltetrahydrofolate in the plasma and liver.
The primary storage site of folate is the liver; it is also actively concentrated in the CSF.
Folate undergoes enterohepatic circulation. Folate metabolites are eliminated in the urine and folate in excess of body requirements is excreted unchanged in the urine. Folate is distributed into breast milk. Folic acid is removed by haemodialysis.
Folic acid is used in the treatment and prevention of the folate deficiency state. It does not correct folate deficiency due to dihydrofolate reductase inhibitors. Folic acid is also used in women of childbearing potential and pregnant women to protect against neural tube defects in their offspring. It is also used for the treatment of folate-deficient megaloblastic anaemia, chronic heamolytic states such as thalassaemia major or sickle-cell anaemia.
Folate-deficient megaloblastic anaemia: 5 mg daily for 4 mos. Up to 15 mg daily may be necessary in malabsorption states.
Chronic haemolytic states such as thalassaemia major or sickle-cell anaemia: 5 mg every 1 to 7 days.
Prophylaxis of folate deficiency in children on dialysis in children more than 12 years old: 5 to 10 mg daily.
For women of child-bearing potential at high risk of having pregnancy affected by neural tube defect, the dose of folic acid is 4 or 5 mg daily starting before pregnancy and continued through the first trimester. Or as prescribed by the physician.
No cases of acute overdosage appear to have been reported, but even extremely high doses are unlikely to cause harm to patients. No special procedures or antidote are likely to be needed.
Folic Acid is contraindicated in patients with known hypersensitivity to it or any of its excipients.
Folic acid should never be given alone or with inadequate amounts of vitamin B12 for the treatment of undiagnosed megaloblastic anaemia, since folic acid may produce a haematopoietic response in patients with a megaloblastic anaemia due to vitamin B12 deficiency without preventing aggravation of neurological symptoms
Pregnancy: Folic acid deficiency during pregnancy may lead to the appearance of foetal malformations. Imbalance in folate requiring trophoblast cells may also lead to detachment of the placenta.
Very high doses of folic acid have been shown to cause foetal abnormalities in rats; however, harmful effects in the human foetus, mother or the pregnancy have not been reported following ingestion of folic acid.
Breastfeeding: Folic acid is excreted in breast milk.
No adverse effects have been observed in breast-fed infants whose mothers were receiving folic acid.
Folic acid is usually well tolerated.
Folate deficiency states may be produced by drugs such as antiepileptics, oral contraceptives, antituberculous drugs, alcohol, and folic acid antagonists such as methotrexate, pyrimethamine, triamterene, trimethoprim, and sulfonamides. In some instances, such as during methotrexate or antiepileptic therapy, replacement therapy with folinic acid or folic acid may become necessary in order to prevent megaloblastic anaemia 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.
Store at temperatures not exceeding 30°C.
B03BB01 - folic acid ; Belongs to the class of folic acid and derivatives. Used in the treatment of anemia.
Vitfolix FC tab 5 mg
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