FOLUS®
Folic Acid

COMPOSITION:
Folus® Tablet: Each tablet contains Folic Acid BP 5mg.

PHARMACOLOGICAL INFORMATION:
Pharmacological Action
Folic acid is a B-complex vitamin needed to form healthy cells, especially red blood cells.FolicAcid is a complex organic compound present in liver, yeast and other substances, and which may be prepared synthetically. In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells, and platelets in persons suffering from certain megaloblastic anemia.

Mechanism of Action
Folic acid is necessary for formation of a number of coenzymes in many metabolic systems, particularly for purine and pyrimidine synthesis; required for nucleoprotein synthesis and maintenance in erythropoiesis; stimulates WBC and platelet production in folate deficiency anemia.

CLINICAL INFORMATION:
Therapeutic Indications
Folus® (Folic Acid) As prophylaxis: Folic acid is effective in the treatment of megaloblastic anemia due to a deficiency of folic acid as may be seen in tropical or non-tropical sprue, in anemia's of nutritional origin, pregnancy, infancy, or childhood. Chronic hemolytic states, Prevention of neural tube defects, Myelofibrosis, Prematurity and Renal dialysis. In megaloblastic anemia due to: Nutritional deficiency, Pregnancy, Coeliac disease, Haemolytic anaemia, Chronic myelofibrosis, Extensive exfoliative skin disorder such as psoriasis, Tropical sprue, Anticonvulsant drug therapy, Sideroblastic anaemia, Scurvy, Antimalarial therapy with pyrimethamine & Methotrexate (folate antagonist) therapy. Oral Administration: Folic acid is well absorbed and may be administered orally with satisfactory results except in severe instances of intestinal malabsorption.

Dosage and Administration:
Usual Therapeutic Dosage: Adults and children regardless of age, up to 1.0 mg daily. Resistant cases may require larger doses.
Maintenance Level: When clinical symptoms have subsided and the blood picture has become normal, a maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under four years of age, 0.4 mg for adults and children four or more years of age, and 0.8 mg for pregnant and lactating women, per day, but never less than 0.1 mg per day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.In the presence of alcoholism hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

CONTRAINDICATION:
Folus® is contraindicated in patients with prior history of hypersensitivity to Folic Acid.

USE IN HEPATIC IMPAIREMENT:
No information provided.

DOSAGE IN RENAL IMPAIRMENT:
No information provided.

DRUG INTERACTION:
Decreased effect:
In folate-deficient patients, folic acid therapy (>15 mg/day) may increase phenytoin metabolism. Phenytoin, primidone, para-aminosalicylic acid, and sulfasalazine may decrease serum folate concentrations and cause deficiency. Concurrent administration of chloramphenicol and folic acid may result in antagonism of the haematopoietic response to folic acid; dihydrofolate reductase inhibitors (eg, methotrexate, trimethoprim) may interfere with folic acid utilization.

USE IN PREGNANCY AND LACTATION:
Folus® (Folic Acid) is used for the production of DNA and red blood cells, making it essential during pregnancy for normal fetal development.

UNDESIRABLE EFFECTS:
Folic acid usually has little side effects. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, drowsiness, trouble breathing.

PHARMACEUTICAL INFORMATION:
Storage & Conditions
Store in cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Folus® Tablet: Each box Containing: 10x10 tablets in Alu-PVC blister pack.