Lederfoline 5 mg - Calcium Folinate - Box of 30 Tablets

Description

This medicine is a derivative of a vitamin from the B vitamin group. It is used with the following medicines: trimethoprim, salazopyrine, pyrimethamine, trimetrexate and methotrexate.

Directions for use

Correction of haematotoxicity induced by treatment with trimethoprim or salazopyrine:

In adults, a daily dose of 5 mg of folinic acid (dl) during the period of administration of the agent responsible for the haematotoxicity is usually sufficient.

In children, the dosage is 5 mg of folinic acid (dl) every 2 to 4 days.

Prevention and correction of hematotoxicity induced by long-term or high-dose pyrimethamine: Dosage regimens depend on the doses of pyrimethamine administered.

In adults:

- in the case of high doses of pyrimethamine, the dose of folinic acid (dl) to be administered is usually between 10 and 25 mg/day, more rarely 50 mg/day; in the case of low doses of pyrimethamine administered over the long term, the dose of folinic acid (dl) to be administered is between 30 and 75 mg as a cumulative weekly dose.

In children: the dosage of folinic acid (dl) is 5 to 10 mg every 2 to 4 days.

Prevention and correction of toxic accidents caused by trimetrexate in the treatment of moderate to severe Pneumocystis carinii pneumonia in patients with acquired immunodeficiency syndrome.

Folnic acid (dl) should be administered daily during treatment with trimetrexate and for 72 hours after the last dose of trimetrexate in four equally spaced doses (see table below). The recommended duration of treatment is 21 days of trimetrexate and 24 days of folinic acid (dl).

Precautions for use

In elderly patients or patients with impaired renal function, the benefit/risk ratio of methotrexate administration should be reassessed regularly. Monitoring of methotrexate elimination using pharmacokinetic parameters is essential.

As part of the prevention of toxic accidents caused by methotrexate, vomiting must be followed by rehydration and parenteral administration of folinic acid.

As this medicine is a methotrexate antagonist, it must not be administered at the same time except in specific protocols.

Composition

· The active substance is: Calcium folinate*

Amount corresponding to folinic acid...................................................................... 5,000 mg Per tablet *

The amount of calcium folinate must be adjusted according to the folinic acid content of the raw material.

· The other ingredients are: lactose**, magnesium stearate, pregelatinised maize starch (STARCH RX 1500), sodium carboxymethyl starch (PRIMOGEL), microcrystalline cellulose (AVICEL PH 101).

**The total amount of calcium folinate and lactose must be 53.4 mg.