Leucofolate

Uses

Calcium Folinate is used-

- 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

Leucofolate dosage

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

Precaution

- 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.

Pregnancy & Breastfeeding use

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.

Contraindication

Calcium Folinate therapy is contraindicated in known hypersensitivity to Calcium Folinate, or to any components of the product formulation. Pernicious anemia or other Megaloblastic anemia where Vitamin B12 is deficient

Acute 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.

Innovators Monograph

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