Presentation
Biofol 15 mg: Each tablet contains Calcium Folinate BP eq. to Folinic Acid 15 mg.
Descriptions
Calcium Folinate is a Calcium salt of Folinic acid (citrovorum factor), is a mixture of the diastereoisomers of the 5-formyl derivative of Tetrahydrofolic acid. It is a metabolite of Folic acid and an essential coenzyme for nucleic acid synthesis used in cytotoxic therapy.
Indications
Biofol is indicated-
- 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
Dosage & Administration
a) Reduction of harmful effects of folic acid antagonists such as. Methotrexate, Trimethoprime etc.:
The dose is usually one 15 mg tablet every 6 hours for 2 to 3 days.
b)Megaloblastic anemia
In the treatment of Megaloblastic anemia, the dose is one 15 mg tablet daily
Side Effects
- 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
Precautions
- 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.
Contraindications
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
Use in 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.
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 nullify the chemotherapeutic effect of folic acid antagonists.
Commercial Packaging
Biofol 15 mg: Each box contains 3 blister strips of 10 Tablets.
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