Product image of Leflunomide Medac (Leflunomide) supplied by GNH India

Leflunomide Medac

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomide Medac (Leflunomide)

Leflunomide, the active ingredient in Leflunomide Medac, is an immunomodulator presented as an oral tablet for oral use. It is used to treat rheumatoid arthritis and psoriatic arthritis in adult patients.

GNH India supplies Leflunomide Medac as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

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Indications & Clinical Uses

Leflunomide is a disease-modifying antirheumatic drug (DMARD) that targets inflammatory pathways in autoimmune arthritis.

  • Rheumatoid arthritis: reduces joint inflammation and slows structural damage.
  • Psoriatic arthritis: improves skin lesions and joint symptoms.
  • Active disease in adults: provides disease control when other DMARDs are insufficient.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which blocks de novo pyrimidine synthesis. This limits the proliferation of activated lymphocytes, thereby reducing the immune‑mediated inflammation that drives rheumatoid and psoriatic arthritis.

Side Effects

Leflunomide may cause a range of adverse reactions, from mild to severe.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: loose stools, usually transient.
  • Hair loss: thinning of scalp hair.
  • Elevated liver enzymes: mild transaminase rise.
  • Rash: skin irritation or erythema.
  • Headache: occasional mild headache.

Serious or Rare Side Effects

  • Severe liver injury: potential for hepatitis or hepatic failure.
  • Aplastic anemia: profound bone‑marrow suppression.
  • Severe infections: increased susceptibility to opportunistic pathogens.
  • Pulmonary toxicity: interstitial lung disease or pneumonitis.
  • Stevens‑Johnson syndrome: severe skin reaction.
  • Teratogenicity: risk of fetal harm if exposure occurs during pregnancy.

Precautions & Warnings

Before initiating therapy, clinicians should assess baseline health and monitor patients regularly.

  • Monitor liver function: obtain baseline tests and repeat periodically.
  • Assess blood counts: watch for cytopenias, especially neutropenia.
  • Avoid in severe hepatic impairment: contraindicated in patients with existing liver disease.
  • Use effective contraception: teratogenic potential requires reliable birth control.
  • Discontinue before pregnancy: a wash‑out period of at least 8 weeks is recommended.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Leflunomide can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Teriflunomide: additive toxicity due to shared metabolic pathway.
  • Methotrexate: increased risk of hepatotoxicity.
  • Strong CYP1A2 inhibitors (e.g., fluvoxamine): may raise leflunomide plasma levels.

Moderate Interactions (Monitor Closely)

  • Warfarin: may enhance anticoagulant effect, monitor INR.
  • Live vaccines: reduced efficacy, consider timing.
  • Azathioprine: additive bone‑marrow suppression, monitor blood counts.
  • Statins: possible increased risk of muscle toxicity, observe for myalgia.

Frequently Asked Questions

Leflunomide Medac is prescribed for adult patients with rheumatoid arthritis and psoriatic arthritis. It helps to reduce joint inflammation, limit disease progression, and improve functional ability by modulating the immune response that drives these chronic autoimmune conditions.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for de novo synthesis of pyrimidine nucleotides. By limiting pyrimidine production, the drug reduces the proliferation of activated T‑lymphocytes, thereby dampening the inflammatory processes that cause joint damage in arthritis.

The dosage of Leflunomide Medac is determined by the prescribing physician based on the individual’s clinical condition, disease severity, and laboratory monitoring. Physicians typically start with a loading dose followed by a maintenance dose, but exact amounts should only be set by a qualified healthcare professional.

Leflunomide is classified as having unknown safety in pregnancy and is considered teratogenic. Women of child‑bearing potential must use effective contraception during treatment and for a defined wash‑out period after discontinuation. Breastfeeding is not recommended while taking leflunomide because of potential infant exposure.

To place an order, visit the product page on gnhindia.com, enter the required quantity, and submit the enquiry form. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain needs), and necessary import documentation.

Leflunomide is an oral synthetic DMARD, whereas the most common alternative, methotrexate, is also oral but works through folate antagonism. Biologic agents such as TNF‑α inhibitors target specific cytokines and are administered by injection. Leflunomide offers a convenient oral option with a distinct mechanism, but its safety profile—particularly liver and hematologic risks—differs from both methotrexate and biologics.

Leflunomide Medac tablets should be stored at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Keep the product out of reach of children and avoid storing in humid environments such as bathrooms.

Leflunomide Medac is taken orally, usually with a full glass of water. The tablets can be swallowed with or without food, but consistent administration with respect to meals helps maintain stable drug levels. Patients should follow the dosing schedule prescribed by their healthcare provider.

The most serious adverse events include severe liver injury, aplastic anemia, and life‑threatening infections. Patients should be educated to report symptoms such as persistent jaundice, unexplained fatigue, easy bruising, or signs of infection promptly, and regular laboratory monitoring is essential to detect early toxicity.

Leflunomide is contraindicated in patients with severe hepatic impairment, active serious infections, and in women who are pregnant or planning pregnancy without effective contraception. It should also be avoided in individuals with known hypersensitivity to leflunomide or its excipients.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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