Folic Acid

Registered South African indications:

• Megaloblastic anaemia

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Folic acid should never be given alone or in conjunction with inadequate amounts of hydroxycobalamin for the treatment of megaloblastic or pernicious anaemia

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Long-term folate therapy is contraindicated in any patient with untreated cobalamin deficiency
  • This includes untreated pernicious anaemia or other causes of cobalamin deficiency, including lifelong vegetarians
• In elderly people, a cobalamin absorption test should be done before long-term folate therapy
• Folic acid should never be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states
  • This may precipitate the onset of subacute combined degeneration of the spinal cord
• Folic acid should not be used in malignant disease unless megaloblastic anaemia owing to folate deficiency is an important complication

• Elderly
• Pernicious anaemia
• Undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin (vitamin B12)
• Coronary stents
• Folate dependent tumours
• Haemodialysis
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption medicine

Forms avail. in SA and covered in this monograph: tab

South African registered indications and dosages

Treatment of megaloblastic anaemia

• Oral (tab): Initial: 10-20mg, dly for 14 days; Maintenance: 2.5-10mg, dly

The recommended daily dietary allowance of folate is 400µg

Prophylaxis of megaloblastic anaemia of pregnancy

• Oral (tab): 200-500µg, dly

Folic acid should never be given alone or in conjunction with inadequate amounts of hydroxycobalamin for the treatment of megaloblastic or pernicious anaemia

Forms avail. in SA and covered in this monograph: tab

South African registered indications and dosages

Treatment of megaloblastic anaemia

• Children: No specific recommendation provided
• Adolescents: See adult dosage

Pregnancy

• Safe
• 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

• Compatible
• Folic acid is excreted in breast milk. No adverse effects have been observed in breastfed infants whose mothers were receiving folic acid

• No dose adjustment recommended

• No dose adjustment recommended

South African recommendations

• Caution; no information available

Recommendations in other jurisdictions

• Caution; no dose adjustment recommended
  In elderly people, a cobalamin absorption test should be done before long-term folate therapy

Immune, Blood and Lymphatic System Disorders

• Allergic reactions

Gastrointestinal Disorders

• Abdominal distension
• Flatulence
• Anorexia 
• Nausea

• Sulfasalazine
• Cholestyramine 
• Antibiotics 
• Trimethoprim
• Sulfonamides
• Anticonvulsant drugs 
• Fluorouracil 
• Edible clay
• Antacids 
• Zinc

None routine

Folic acid, a biochemically inactive compound, is converted to tetrahydrofolic acid and methyltetrahydrofolate. These folic acid congeners are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can form methionine from homocysteine.

Folic Acid is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

Tablet 5mg

• Be-Tabs folic acid (Ranbaxy)
• Gulf Folic Acid (Gulf Drug)