Actifol 15 Tablet: Each tablet contains Calcium Folinate Hydrate BP 18.746 mg equivalent to Folinic Acid 15 mg.
Actifol ® is the preparation of Calcium Folinate Hydrate which is calcium salt of folinic acid (5-formyl derivative of tetrahydrofolic acid). It is a metabolite and active form of folic acid that is involved as a cofactor for 1-carbon transfer reactions in the biosynthesis of purine and pyrimidines of nucleic acids. Impairment of thymidylate synthesis in patients with folic acid deficiency is thought to account for the defective DNA synthesis that leads to megaloblast formation and megaloblastic and macrocytic anemias. Because of its ready conversion to other tetrahydrofolic acid derivatives, Folinate is a potent antidote for both hematopoietic and reticuloendothelia toxic effects of folic acid antagonists, (e.g. methotrexate, pyrimethamine, trimethoprim). It is postulated that in some cancers, folinate enters and "rescues" normal cells from the toxic effects of folic add antagonists, in preference to tumour cells, because of a difference in membrane transport mechanisms; this principle is the basis of high-dose methotrexate therapy with "Folinate rescue".
Route: Oral
Adults & Children:
High-dose folinate counteracts the antineoplastic effect of methotrexate; enhances toxicity of 5-fluorouracil; decreases plasma concentrations of antiepileptic drugs (phenobarbital, phenytoin, primidone) increasing seizure risk.
It is contraindicated to patients with known hypersensitivity to calcium folinate or any other components of this product. It is also contraindicated in pernicious anemia or other megaloblastic anemia where vitamin B12 is deficient. Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take calcium folinate tablets.
Common: Mucositis, stomatitis, leukopenia, diarrhea.
Overdose
There have been no reported sequelae in patients who have received significantly more calcium folinate than the recommended dosage. However, excessive amounts of calcium folinate may nullity the chemotherapeutic effect of folic acid antagonists. There is no specific antidote to calcium folinate overdose. In cases of overdosage patients should be given appropriate supportive care.
Category C. No adequate and well-controlled studies in pregnant women; use only if potential benefit justifies potential fetal risk. Lactation: Excretion in human milk unknown; caution should be exercised in nursing mothers.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.