INFORMATION FOR HEALTH PROFESSIONALS
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APO-FOLIC 0.8mg tablets are yellow, round, 5.5mm in diameter, biconvex tablets, engraved “F” over “0.8” one side and “APO” on the other side. Each tablet contains 0.8mg of folic acid and typically weighs 85mg.
APO-FOLIC 5mg tablets are yellow, round, 6.5 mm in diameter, flat with bevelled edges and engraved “F5” on one side and “APO” on the other side. Each tablet contains 5mg of folic acid and typically weighs 82mg.
Folic acid is a member of the vitamin B group and is the substrate for the production of tetrahydrofolate by enzymatic reduction in vivo. Tetrahydrofolate is a coenzyme for various metabolic pathways including purine and pyrimidine nucleotide synthesis, and ultimately DNA synthesis. It is also involved in some amino acid conversions, and in the formation and utilisation of formate. It is involved in the maturation of all rapidly proliferating tissues particularly those of bone marrow and gastrointestinal tract. Folic acid deficiency develops from inadequate dietary intake through malnutrition or malabsorption, or may result from increased utilisation in pregnancy or conditions such as haemolytic anaemia. Folate deficiency is also an adverse side effect of chemotherapeutic agents that function as folate antagonists by interfering with folate metabolism.
Conclusive evidence that folic acid therapy when taken as a supplement by women during the periconceptional period significantly reduces the incidence of foetal neural tube defects was established by a multinational, multicentre, controlled clinical study organised by the Medical Research Council in the United Kingdom. In the final report of this study published in 1991, investigators concluded that a daily supplement of folic acid would be beneficial to all women planning a pregnancy. A later randomised controlled clinical study conducted in Hungary established that a daily dose of 0.8 mg folic acid was effective for reducing the incidence of neural tube defects.
Orally administered folic acid is rapidly absorbed mainly from the wall of the proximal small intestine as the 5-methyltetrahydrofolate metabolite. This metabolite is extensively bound to plasma proteins in the portal circulation. Folic acid is rapidly absorbed from normal diets and is widely distributed in body tissues with the liver as the principal storage site. Folate is also distributed in breast milk.
There is an enterohepatic circulation for folate; approximately 4 to 5 micrograms is excreted in the urine daily. Urinary levels of excreted folate are a function of dose.
APO-FOLIC 5 mg tablets
Folate-deficient megaloblastic anaemia: Adults: An initial dosage of 10-20mg folic acid daily for 14 days is recommended or until a haematopoietic response has been obtained. The daily maintenance dose is 2.5-10mg.
Children: 5-15mg daily according to the severity of the deficiency.
Prophylaxis of folate deficiency: 1 tablet (5 mg) taken daily or weekly may be necessary in chronic haemolytic cases such as thalassaemia major or sickle-cell anaemia, depending on the diet and rate of haemolysis.
Expected pregnancy: 5 mg taken daily for 4 weeks before conception and during the first trimester of pregnancy for women who are at risk of having a pregnancy affected by neural tube defects.
Paediatric use: APO-FOLIC 5 mg tablets are not suitable for administration to infants aged under 12 months.
APO-FOLIC 0.8 mg tablets
Prophylaxis of neural tube defects: 1 tablet (0.8 mg) taken daily for 4 weeks before conception and during the first trimester of pregnancy. It may be advantageous to the patient to continue this dosing schedule throughout the full term of pregnancy and during lactation for general prophylaxis of folate deficiency. APO-FOLIC 0.8 mg tablets are intended as a supplement for women of childbearing potential only.
Folic acid should never be administered for the treatment of undiagnosed megaloblastic anaemia without first excluding vitamin B12 deficiency as the cause. The haematopoietic response to folic acid therapy may be misinterpreted as an improvement in the condition of vitamin B12 deficient patients, but irreversible neurological lesions may develop as a consequence of masking the true deficiency state.
Patients receiving concurrent administration of diphenylhydantoin and folic acid should be monitored for possible loss of seizure control.
Folic acid does not correct folate deficiency due to dihydrofolate reductase inhibitors, such as methotrexate. Folinic acid should be used for this purpose.
Folic acid should not be added to multivitamin preparations as it may lower the concentration of vitamin B12 in the blood.
Category A
Folic acid crosses the placenta, however adequate and well controlled studies in humans have shown that therapeutically acceptable doses of folic acid may be safely administered to pregnant women.
Folic acid is excreted in breast milk, but problems in humans have not been documented with intake of normal daily requirements.
Folic acid is generally well tolerated.
Although uncommon, nausea diarrhoea, flatulence and gastro-intestinal disturbances have been associated with folic acid therapy.
Hypersensitivity reactions such as bronchospasm, erythema, fever rash or itching have been reported rarely.
Folic acid may interact with antacids which contain aluminium or magnesium, antibiotics and cholestyramine, sulphonamides including sulphasalazine and zinc supplements.
Folate depletion is a side effect of folate antagonists such as 5-fluorouracil, methotrexate, trimethoprim, pyrimethamine and sulphonamides. Potentially severe deficiencies may be treated with calcium folinate therapy.
The requirements for folic acid may be increased in patients receiving analgesics, anticonvulsant particularly hydantoin and carbamaepine, oestogens and oral contraceptives.
Chronic alcoholism decreases the absorption of folic acid. Abstinence from alcohol will partially reverse this effect.
No reports of overdosage have been reported.
Folic acid has a low acute and chronic toxicity profile. Adults receiving a daily dose of 400 mg for 5 months followed by a daily dose of 10 mg for 5 years did not present any adverse side effects.
Store below 30°C.
Protect from heat, light and moisture.
Keep container tightly closed.
Pharmacy only medicine.
APO-FOLIC tablets 0.8 mg:
Bottles of 100 and 120 tablets.
APO-FOLIC tablets 5 mg:
Bottles of 500 tablets.
Tablets contain lactose and wheat starch.
Approximately 400 micrograms/day of folic acid is considered a suitable average intake. Body stores of folate in healthy people have been reported between 5-10mg, but could be much higher.
Folate is present, mostly combined with several L(+)-glutamic acid moieties, in many foods, but in particular, liver, kidney, yeast, nuts and leafy green vegetables. Folic acid is readily oxidised to unavailable forms and is easily destroyed during cooking.
APOTEX NZ LTD
32 Hillside Road
Glenfield,
Auckland
Private Bag 102995
North Shore Mail Centre
Tel: (09) 444 2073
Fax: (09) 444 2951
01 February 2007