CALCIUM FOLINATE Tablet Ref.[7911] Active ingredients: Calcium folinate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

Therapeutic indications

Leucovorin (folinic acid) is the formyl derivative of tetrahydrofolic acid which is a metabolite and active form of folic acid.

Calcium Folinate is indicated in:

a) Neutralising the immediate toxic effects of folic acid antagonists, e.g. Methotrexate.

b) Calcium Folinate Rescue – a treatment technique using Calcium Folinate in conjunction with folic acid antagonists, e.g. methotrexate, to minimise systemic toxicity.

c) The treatment of megaloblastic anaemias due to sprue, nutritional deficiency, pregnancy, infancy, liver disease and malabsorption syndrome.

Posology and method of administration

To be given orally.

Although calcium folinate may also be available as a solution for injection, Calcium Folinate should not be administered intrathecally.

Adults and children

Calcium folinate rescue

Depending upon the dose of methotrexate administered, dosage regimens of calcium folinate vary. Up to 120 mg calcium folinate are generally given, usually in divided doses over 12-24 hours by intramuscular injection, bolus intravenous injection or intravenous infusion in normal saline. This is followed by 12-15 mg intramuscularly or 15 mg orally every 6 hours for 48 hours. Rescue therapy is usually started 24 hours after the commencement of methotrexate administration.

Neutralising the immediate toxic effects of folic acid antagonists

If overdosage of methotrexate is suspected, the dose of calcium folinate should be equal to or greater than the dose of methotrexate and should be administered within one hour of the methotrexate administration.

Megaloblastic anaemia (folate deficiency)

One tablet of calcium folinate per day.

Overdose

There is no specific antidote to calcium folinate overdose. In cases of overdosage patients should be given appropriate supportive care.

Should overdosage of the combination of 5-FU with Calcium Folinate occur, the overdosage instruction for 5-FU should be followed.

Shelf life

Product as packaged for sale: 3 years.

Special precautions for storage

Do not store above 25°C.

Keep container in outer carton.

Nature and contents of container

White polyethylene bottle with high density polyethylene screw closure containing 10 tablets.

Special precautions for disposal and other handling

Not applicable.

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