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Drug Details

REFOLINON Tablet

• Drug Class Description
  Folic acid derivatives.
• Generic Name
  Folinic acid [calcium folinate/ calcium leucovorin] - anaemia
• Presentation
  Uncoated tablet for oral use
• Description
  Leucovorin calcium equivalent to leucovorin (folinic acid) 15.0 mg
• Indications
  Leucovorin (folinic acid) is the formyl derivative of tetrahydrofolic acid and is an intermediate product of the metabolism of folic acid. Leucovorin is used in cytotoxic therapy as an antidote to folic acid antagonists such as methotrexate. Leucovorin is effective in the treatment of megaloblastic anaemia.
• Adult Dosage
  

  To be given orally.

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

  Adults and children:

  Leucovorin rescue: Depending upon the dose of methotrexate administered, dosage regimens of leucovorin calcium vary. Up to 120 mg leucovorin calcium 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.

  If overdosage of methotrexate is suspected, the dose of leucovorin calcium 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): 15 mg (one tablet) leucovorin per day.

• Contra Indications
  

  Leucovorin calcium should not be used in patients who have a known hypersensitivity to any of the constituents of the product.

  Calcium folinate should not be used for the treatment of pernicious anaemia or other megaloblastic anaemia where vitamin B₁₂ is deficient.

• Special Precautions
  

  Calcium folinate should only be used with methotrexate and 5-fluorouracil by clinicians experienced in the use of cancer chemotherapeutic agents.

  Patients with rare hereditary problems of galacatose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

• Interactions
  

  Leucovorin should not be given simultaneously with a folic acid antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified.

  Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin, as well as primidone and increase the frequency of seizures.

  Concurrent administration of chloramphenicol and folic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folic acid.

  Calcium folinate may enhance the toxicity of fluorouracil.

• Adverse Drug Reactions
  

  Adverse reactions to leucovorin calcium are rare, but following intravenous and intramuscular administration occasional pyrexial reactions have been reported.

  The most common dose-limiting adverse reaction occurring in patients receiving combination of calcium folinate and 5-fluorouracil are stomatitis and diarrhoea. In addition, haematological adverse reactions, such as leucocytopenia and thrombocytopenia, may occur. These adverse reactions are dose-dependent and their occurrence can usually be decreased by reducing the dosage of cytotoxic drugs. These adverse reactions can be controlled by close monitoring of haematological values, e.g. blood leucocyte and thrombocyte levels, and serum electrolyte (e.g. Na, K, Ca) and creatinine levels.

  Anaphylactoid and urticaria allergic reactions have also been reported with the use of leucovorin.