Product image of Fedolen (Calcium Folinate) supplied by GNH India

Fedolen

Active Ingredient:
Calcium Folinate
Origin:
EU

Fedolen (Calcium Folinate)

Calcium folinate, the active ingredient in Fedolen, is a folate analog presented as a 5mg/10ml injection for intravenous use. It is primarily used to counteract the effects of folic acid antagonists and support cellular function and DNA synthesis. GNH India supplies Fedolen as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals and oncology centers worldwide.

Fedolen is essential in managing methotrexate toxicity and folate deficiency, ensuring effective rescue therapy in critical care settings. Its formulation adheres to stringent quality standards, making it a reliable choice for healthcare professionals.

Manufacturer / TM Owner

Viofar Ltd

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Indications & Clinical Uses

Fedolen acts on the folate pathway, crucial for cellular function and DNA synthesis. It is used to:

  • Methotrexate toxicity rescue: Mitigates the toxic effects of methotrexate by providing a reduced form of folic acid.
  • Folate deficiency: Treats folate deficiency when oral administration is not feasible, such as in cases of malabsorption or parenteral nutrition.
  • Combination therapy: Enhances the effectiveness of 5-fluorouracil in cancer treatment by stabilizing its complex with thymidylate synthase.

How It Works

  • Calcium folinate provides a reduced form of folic acid that bypasses dihydrofolate reductase inhibition. This action restores nucleotide synthesis and mitigates folate deficiency or methotrexate toxicity by supplying the necessary folate coenzymes for cellular processes. It competes with methotrexate for cellular transport, promoting its efflux and reducing its toxic effects.

Side Effects

Fedolen may cause several side effects, ranging from common to serious. Common Side Effects:

  • Nausea and vomiting
  • Diarrhea
  • Stomatitis (inflammation of the mouth)
  • Rash
  • Allergic reactions

Serious or Rare Side Effects

  • Severe allergic reactions, including anaphylaxis
  • Increased ammonia levels in the blood
  • Bone marrow suppression
  • Severe diarrhea leading to dehydration
  • Skin reactions such as hand-foot syndrome

Precautions & Warnings

Fedolen should be used with caution and under medical supervision. Precautions include:

  • Allergies: Avoid use in patients with known hypersensitivity to calcium folinate or folic acid.
  • Renal impairment: Monitor closely in patients with kidney dysfunction.
  • Pregnancy: Use only if clearly needed, as safety during pregnancy is not established.
  • Breastfeeding: Consult a healthcare provider before use.
  • Store below 25°C: Keep in the original pack, protect from moisture.

Avoid Interactions

Fedolen may interact with other medications, requiring careful monitoring. Major Interactions (Avoid):

  • Antifolate drugs: Avoid concurrent use with methotrexate without proper rescue therapy.
  • Fluorouracil: Adjust dosing when used in combination to prevent excessive toxicity.

Moderate Interactions (Monitor Closely)

  • Phenobarbital: May reduce the effectiveness of calcium folinate.
  • Phenytoin: Monitor for altered drug levels when used together.
  • Trimethoprim: May require dosage adjustments to avoid folate deficiency.

Frequently Asked Questions

Fedolen is used primarily to counteract the toxic effects of methotrexate and to treat folate deficiency. It provides a reduced form of folic acid that helps restore nucleotide synthesis and mitigate the adverse effects of folic acid antagonists. This makes it crucial in managing methotrexate toxicity and ensuring effective rescue therapy in critical care settings.

Calcium folinate works by providing a reduced form of folic acid that bypasses the inhibition of dihydrofolate reductase. This action restores nucleotide synthesis and mitigates folate deficiency or methotrexate toxicity. It competes with methotrexate for cellular transport, promoting its efflux and reducing its toxic effects, thereby protecting cells from the harmful effects of methotrexate.

The usual dose of Fedolen is determined by a healthcare provider based on the specific condition being treated, the patient's response, and other clinical factors. It is crucial to follow the prescribed dosage and administration instructions provided by the healthcare professional to ensure safe and effective treatment.

The safety of Fedolen during pregnancy or breastfeeding has not been fully established. It should be used during pregnancy only if clearly needed and under the supervision of a healthcare provider. Similarly, breastfeeding mothers should consult their healthcare provider before using Fedolen to ensure the safety of the infant.

To order Fedolen from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets. The team will ask you to confirm your trade or institutional credentials and will then provide pricing, availability, shipping details, and the necessary import paperwork.

Fedolen is specifically designed to counteract the effects of folic acid antagonists and provide rescue therapy in cases of methotrexate toxicity. Unlike general folate supplements, it provides a reduced form of folic acid that can bypass the inhibition of dihydrofolate reductase, making it more effective in specific clinical scenarios where folate deficiency or toxicity is a concern.

Fedolen should be stored below 25°C, kept in the original pack, and protected from moisture. It is essential to follow the storage instructions provided to maintain the efficacy and safety of the medication. Always handle the medication with care and follow the administration guidelines provided by the healthcare professional.

Fedolen is administered intravenously, typically in a clinical setting under the supervision of a healthcare provider. The dosage and administration schedule are determined based on the specific condition being treated and the patient's response. It is crucial to follow the prescribed administration instructions to ensure safe and effective treatment.

The most serious risks associated with Fedolen include severe allergic reactions, increased ammonia levels in the blood, bone marrow suppression, and severe diarrhea leading to dehydration. Patients should be closely monitored for these adverse effects, and any signs of serious reactions should be reported to a healthcare provider immediately.

Fedolen should not be used by patients with known hypersensitivity to calcium folinate or folic acid. It should be used with caution in patients with renal impairment and only if clearly needed during pregnancy. Always consult a healthcare provider before using Fedolen to ensure it is appropriate for your specific medical condition.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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