Generics: Calcium Folinate
Dosage Form: Tablet
- To diminish the toxicity and counteract the effect of impaired Methotrexate elimination.
- To treat the Megaloblastic anemia due to folate deficiency, as in sprue, nutritional deficiency.
- To treat the Megaloblastic anemia of pregnancy and infancy.
Folinic acid is a 5-formyl derivative of tetrahydrofolic acid. It is readily converted to other reduced folic acid derivatives (e.g., tetrahydrofolate), and thus has vitamin activity equivalent to that of folic acid. Since it does not require the action of dihydrofolate reductase for its conversion, its function as a vitamin is unaffected by the inhibition of this enzyme by drugs such as methotrexate. This is the classical view of folinic acid rescue therapy. In the 1980s, however, folinic acid was found to reactivate the dihydrofolate reductase itself even when methotrexate exists. Although the mechanism is not very clear, the polyglutamylation of methotrexate and dihydrofolate in malignant cells is considered to play an important role in the selective reactivation of dihydrofolate reductase by folinic acid in normal cells. Folinic acid, therefore, allows for some purine/pyrimidine synthesis to occur in the presence of dihydrofolate reductase inhibition, so some normal DNA replication processes can proceed.
Four times in daily.
- Reduction of harmful effects of folic acid antagonists such as Methotrexate, Trimethoprim etc: The dose is usually one 5-15mg tablet every 6 hours for 2 to 3 days.
- Megaloblastic anemia: In the treatment of Megaloblastic anemia, the dose is one 5-15 mg tablet daily. Or, as directed by the registered physician.
Route of administration: Orally.
Calcium Folinate therapy is contraindicated for the following:
- Known hypersensitivity to Calcium Folinate, or to any components of the product formulation.
- Pernicious anemia or other Megaloblastic anemia where Vitamin B12 is deficient.
- Allergic reaction: one may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing).
- Fits and fainting.
Pregnancy & Lactation:
There are no adequate and well-controlled clinical studies conducted in pregnant or breastfeeding women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcium Folinate is administered to a nursing mother.
Precautions & Warnings:
- Calcium Folinate treatment may mask pernicious anemia and other Megaloblastic anemia resulting from Vitamin B12 deficiency.
- Calcium Folinate should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
- Many cytotoxic medicinal products- direct or indirect DNA synthesis inhibitors- lead to macrocytosis (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Such macrocytosis should not be treated with Folinic acid.
- In epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides, there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drug.
Supportive Care Therapy.
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
Manufactured by: Incepta Pharmaceuticals Ltd.