Folimax 5 mg (Tablet)

Indications

• Neutralising the immediate toxic effects of folic acid antagonists, e.g. methotrexate
• Calcium folinate rescue- a treatment technique using calcium folinate in conjunction with folic acid antagonists, e.g. methotrexate, to minimise systemic toxicity
• The treatment of megaloblastic anaemias due to sprue, nutritional deficiency, pregnancy, infancy, liver disease and malabsorption syndrome

Composition

• 6.249 mg Calcium Folinate Hydrate BP equivalent to 5 mg Folinic Acid
• 18.746 mg Calcium Folinate Hydrate BP equivalent to 15 mg Folinic Acid

Pharmacology

• Calcium Folinate Hydrate is calcium salt of folinic acid, a metabolite and active form of folic acid involved as a cofactor for 1-carbon transfer reactions in the biosynthesis of purine and pyrimidines of nucleic acids
• Used as a potent antidote for hematopoietic and reticuloendothelial toxic effects of folic acid antagonists like methotrexate, pyrimethamine, trimethoprim
• Acts as a rescuer for normal cells from the toxic effects of folic acid antagonists, in preference to tumor cells

Dosage & Administration

• Calcium folinate rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion
• Recommended dose of Folinic Acid to counteract hematologic toxicity from folic acid antagonists with less affinity is 5 mg to 15 mg per day
• No established safety and efficacy in children and adolescents

Interaction

• Folinates may counteract the antiepileptic effect of phenobarbitone, phenytoin and primidone and increase the frequency of seizures in susceptible patients
• Caution required during concurrent administration of calcium folinate with fluoropyrimidine as this has been associated with seizures and syncope

Contraindications

• Known hypersensitivity to calcium folinate or any other components of this product
• 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

Side Effects

• Mucositis
• Stomatitis
• Leukopenia
• Diarrhea

Pregnancy & Lactation

• No adequate and well-controlled clinical studies conducted in pregnant women
• Use in pregnant women only if potential benefit justifies potential risk to the fetus
• Caution should be exercised when administered to a nursing mother

Precautions & Warnings

• Should only be used with methotrexate or 5-FU under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents
• Should not be given simultaneously with folic acid antagonists, e.g. methotrexate, to abort clinical toxicity as the therapeutic effect of the antagonist may be nullified
• Measures to ensure the prompt excretion of methotrexate are important as part of Calcium Folinate Rescue Therapy

Overdose Effects

• No reported sequelae in patients who have received significantly more calcium folinate than the recommended dosage
• Excessive amounts may nullity the chemotherapeutic effect of folic acid antagonists
• No specific antidote to calcium folinate overdose

Therapeutic Class

• Supportive Care Therapy

Storage Conditions

• Do not store above 30°C
• Keep away from light and out of the reach of children

Related Brands

• Nuvifol 5 mg (Tablet) - nuvista-pharma-ltd
• Folidel 15 mg (Tablet) - delta-pharma-ltd
• Folidel 5 mg (Tablet) - delta-pharma-ltd
• Actifol 15 mg (Tablet) - aci-limited
• Actifol 5 mg (Tablet) - aci-limited