Generic Name

Composition

Therapeutic Category

Division

Folic Acid

Folic Acid 5mg Tablets

Supplement

COSMO

    BRAND COMPOSITION DESCRIPTION

    FOLVIN

    Each uncoated tablet contains:

    Folic Acid BP                 5mg

    Yellow colored, round, flat, uncoated tablet with breakline on one side.

     

    PATIENT INFORMATION

    Administration:

    • FOLVIN may be taken with or without food.
    • Alcohol decreases the ability to absorb B vitamins

    Pregnancy: Category A

    Nursing Mother: FOLVIN is actively excreted in human breast milk. No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.

    Storage: Store tablets at room temperature protected from direct light and heat; Keep out of reach of children.

    Missed dose: Take the missed dose as soon as you remember; Skip the missed dose if it is almost time for your next scheduled dose; Do not take extra medicine to make up the missed dose.

     

     

    PHARMACOLOGY

    Pharmacotherapeutic Group: Vitamin B9; Supplements

     Pharmacodynamic properties: FOLVIN (Folic acid) is a component of the B group of vitamins and is necessary for the normal production and maturation of red blood cells. It is essential in the synthesis and maintenance of nucleoprotein in erythropoesis. FOLVIN is needed to carry one-carbon groups for methylation reactions and nucleic acid synthesis. It also promotes WBC and platelet production in folate-deficiency anaemia. FOLVIN is also necessary for the production and maintenance of new cells, for DNA synthesis and RNA synthesis. It is especially important during periods of frequent cell division and growth, such as infancy and pregnancy.

     Pharmacokinetic properties:

    Absorption: Rapidly absorbed mainly from the duodenum and jejunum; Time to peak plasma concentrations: 0.5-1 hr.

    Distribution: Extensively bound to plasma protein. Principal site of storage is the liver. It is also concentrated in the CSF and enters the breast milk.

    Metabolism: Undergoes conversion in the plasma and liver to the metabolically active 5-methyltetrahydrofolate.

    Excretion: Via urine (as unchanged drug and metabolites).

     INDICATIONS

    Pregnancy and lactation; Anemia; Malnutrition and malabsorption; Antifolate induced deficiency

     DOSE

    Folate deficient megaloblastic anaemia and anti-folate drug induced deficiency: 5mg daily for 4 months; up to 15mg daily may be necessary for malabsorption states.

    Prophylaxis in chronic haemolytic states or in renal dialysis: 5mg every 1-7 days depending on underlying disease.

    Prophylaxis of neural tube defect in pregnancy: 5mg daily started before conception and continued throughout the first trimester.

    Pregnancy (In established folate deficiency): 5mg daily continued to term.

     CONTRAINDICATIONS

    Undiagnosed megaloblasticanaemia; Pernicious, aplastic or normocytic anaemias; Hypersensitivity; Untreated vitamin B12 deficiency; Malignant diseases.

     SPECIAL PRECAUTIONS

    Treatment resistance may occur in patients with depressed haematopoiesis, alcoholism, deficiencies of other vitamins; Folate depedent tumor; Neonates.

     ADVERSE DRUG REACTIONS

    GI disturbances, hypersensitivity reactions; bronchospasm.Rarely: Taking extremely high levels of folic acid may increase the risk of developing cancer of the colon or rectum.

     DRUG INTERACTIONS

    Antiepileptics, oral contraceptives, anti-TB drugs, alcohol, aminopterin, methotrexate, pyrimethamine, trimethoprim and sulphonamides may result to decrease in serum folate oncentration; Decreases serum phenytoin concentrations.

     PRESENTATION

    FOLVIN: Each box contains 20 blister packs of 10 tablets per strip.

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