“The Recommended Treatment of Megaloblastic Anemia due to Folic Acid Deficiency”

FORMULATION: Each tablet contains: Folic Acid ………………………………… 5 mg

PRODUCT DESCRIPTION: Folic Acid (Olilc) 5 mg Tablet is a yellow, coloured round shaped. biconvex. break line on one side uncoated tablets.

DOSAGE AND ADMINISTRATION:
Adults
In folate deficient megaloblastic anaemia: 5mg daily for 4 months Up to 15 mg daily may be necessary for malabsorption states
For prophylaxis In chronic haemolytic states or In renal dialysis: 5mg every 1-7 days depending on diet and underlying disease.
In drug Induced folate deficiency: 5mg daily
Prevention of recurrence of neural tube defects: 5mg daily starting before conception and continuing throughout the first trimester of pregnancy is recommended.

Children
Over l year: As adult dose
Up to l year: 500 μg/kg daily

INDICATIONS: Indicated for the treatment of megaloblastic anaemia due to folic acid deficiency. It is also used for prophylaxis in chronic haemolytic states. in renal dialysis. and in drug induced folate deficiency. Folic acid is used for the prevention of recurrence of neural tube defects.

CONTRAINDICATIONS:

Hypersensitivity to the active substance orto any of the excipients.
Patients with malignant disease. unless megaloblastic anaemia due to folic acid deficiency.

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 translated to the tissues.

Felic acid is readily absorbed following oral dosage, and is extensively bound to plasma proteins.

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 hove not been reported following ingestion of folic acid.
Lactation
Folic acid is excreted in breast milk. No adverse effects have been observed in breast-fed infants whose mothers were receiving folic acid.

Absorption of folic acid may be reduced by sulfasalazine.
Concurrent administration with cholestyramine may interfere with folic acid absorption. Patients on prolonged cholestyramine therapy should take folic acid l hour before or 4 to 6 hours after receiving cholestyramine. Antibiotics may interfere with the microbiological assay for serum and erythrocyte folic acid concentrations and may cause falsely low results.
Trimethoprim or sulfonamides. alone or in combination as co-trimoxazole. may reduce the effect of folic acid and this may be serious in patients with megaloblastic anemia.
Serum levels of anticonvulsant drugs (phenytoin. phenobarbital. primidone) may be reduced by administration of folate and therefore patients should be carefully monitored by the physician and the anticonvulsant drug dose adjusted as necessary.
Fluorouracil toxicity may occur in patients taking folic acid and this combination should be avoided.
Edible clay or antacids containing aluminum or magnesium may reduce folic acid absorption.
Patients should be advised to take antacids at least two hours after administration of folic acid.
Folic acid may reduce intestinal absorption of zinc (of particular importance in pregnancy).

Folic acid is generally well tolerated although the following side effects have been reported:
Blood and lymphatic system disorders: Felic acid may worsen the symptoms of co-existing vitamin B 12 deficiency and should never be used to treat anemia without a full investigation of the cause.
Immune system disorders: Rare: Allergic reactions. comprising erythema, rash. pruritus. urticaria!. dyspnoea, and anaphylactic reactions (including shock).
Gastrointestinal disorder: Abdominal distension. flatulence, anorexia and nausea.

For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph

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 antidotes are likely to be needed.

Store at temperatures not exceeding 30°C.

Dosage form: Tablet
Packaging available: Alu/ Alu blister pack x l O’s ( Box of l OO’s )

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

Folic acid should not be administered for treatment of pernicious anaemia or undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin {vitamin B 12) as folic acid alone will not prevent and may precipitate development of subacute combined degeneration of the spinal cord. Therefore a full clinical diagnosis should be made before initiating treatment.
Folate should not be routinely used in patients receiving coronary stents. Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.
Folic acid is removed by haemodialysis.
Patients with rare hereditary problems of galactose intolerance. the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.