Folita 5mg Tab

Overview

Folita 5mg Tablet contains Calcium Folinate Hydrate, the calcium salt of folinic acid (also known as leucovorin or 5-formyl tetrahydrofolic acid). Folinic acid is an active, reduced form of folic acid that participates as an essential cofactor in one-carbon transfer reactions involved in the biosynthesis of purines and pyrimidines of nucleic acids. Unlike folic acid, folinic acid bypasses the dihydrofolate reductase enzyme and is therefore not affected by methotrexate-induced enzyme inhibition. It is used to counteract the toxic effects of folic acid antagonists, for folinic acid rescue therapy in high-dose methotrexate regimens, and in the treatment of megaloblastic anaemias due to folate deficiency.

Dosage and Administration

Folinic Acid Rescue (following high-dose methotrexate): Begin as soon as possible after inadvertent overdosage and within 24 hours of planned methotrexate administration when excretion is delayed. General dose: 15 mg (approximately 10 mg/m²) every 6 hours for 10 doses. Increase dose if plasma methotrexate levels remain elevated.

Neutralising toxic effects of folic acid antagonists (trimethoprim, pyrimethamine): 5–15 mg of folinic acid per day.

Megaloblastic Anaemia (folate deficiency — due to sprue, nutritional deficiency, pregnancy, infancy, liver disease, malabsorption): 5–15 mg of folinic acid per day. Duration is guided by clinical and haematological response.

Children and adolescents: Safety and efficacy have not been fully established; use only under specialist guidance.

Interaction

Folinic acid given in large amounts may counteract the antiepileptic effects of phenobarbitone, phenytoin, and primidone, potentially increasing seizure frequency in susceptible patients. Concurrent administration of folinic acid with fluoropyrimidines (e.g. 5-fluorouracil) has been associated with seizures and syncope — caution is required. Folinic acid does not inhibit the antibacterial activity of trimethoprim or pyrimethamine when co-administered with these agents.

Contraindications

Contraindicated in patients with known hypersensitivity to calcium folinate or any other components of the formulation. Contraindicated in pernicious anaemia or other megaloblastic anaemias where vitamin B12 deficiency is the causative factor, as masking of the neurological complications of B12 deficiency may occur. Patients with rare hereditary conditions of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption should not take this tablet formulation.

Side Effects

When used as a rescue agent with methotrexate or in combination with 5-fluorouracil, the most commonly reported side effects include mucositis, stomatitis, leukopenia, and diarrhoea, which may be dose-limiting. Allergic sensitisation including anaphylactoid reactions and urticaria have been reported after administration of folinic acid.

Pregnancy and Lactation

There are no adequate and well-controlled studies in pregnant women. Folinic acid should only be used during pregnancy if the potential benefit clearly justifies the potential risk to the fetus. It is not known whether folinic acid is excreted in human milk; caution should be exercised when administering to a nursing mother.

Precautions and Warnings

Folita should only be used with methotrexate or 5-fluorouracil under the direct supervision of a clinician experienced in cancer chemotherapy. In cases of inadvertent overdosage of a folic acid antagonist, folinic acid should be administered as soon as possible — if more than 4 hours have elapsed, treatment may be less effective. Folinic acid should not generally be given simultaneously with folic acid antagonists such as methotrexate, as this may nullify the therapeutic effect of the antagonist. Alkalinisation of urine (pH above 7) and adequate hydration (1800–2000 ml/m²/24 hours) are important components of methotrexate rescue therapy. Monitor plasma methotrexate levels, BUN, and creatinine on days 2, 3, and 4 of rescue; continue rescue until plasma methotrexate is below 10⁻⁷ molar.

Storage Conditions

Store below 30°C. Keep away from light. Keep out of reach of children.

Frequently Asked Questions

Q: What is the difference between Folinic Acid (Folita) and Folic Acid supplements?
A: Folinic acid (calcium folinate) is the active, reduced form of folic acid that does not require conversion by dihydrofolate reductase to become biologically active. This makes it particularly useful in situations where this enzyme is blocked — such as during methotrexate therapy — whereas standard folic acid supplements would be ineffective. Folinic acid is a prescription medicine used in specific medical conditions, not a general nutritional supplement.

Q: Can Folita 5mg be used to treat folate deficiency anaemia during pregnancy?
A: Folinic acid may be prescribed for megaloblastic anaemia resulting from folate deficiency (including during pregnancy) at doses of 5–15 mg/day. However, it must not be used if the anaemia is due to vitamin B12 deficiency. Only use during pregnancy on the explicit advice and prescription of your physician.