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 immunomodulatory agent presented as a tablet for oral use. It treats rheumatoid arthritis and psoriatic arthritis in adult patients, helping to reduce inflammation and slow disease progression.

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 that targets autoimmune joint disorders.

  • Rheumatoid arthritis: reduces joint inflammation, pain, and structural damage.
  • Psoriatic arthritis: improves skin lesions and joint symptoms.
  • Moderate to severe active disease refractory to other DMARDs: provides an alternative therapeutic option when first‑line agents are insufficient.

How It Works

  • Leflunomide inhibits dihydroorotate dehydrogenase, a key enzyme in de novo pyrimidine synthesis. By blocking this pathway, it limits the proliferation of activated lymphocytes, thereby reducing the autoimmune response that drives joint inflammation and tissue damage in rheumatoid and psoriatic arthritis.

Side Effects

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

Common Side Effects

  • Diarrhea: mild to moderate gastrointestinal upset.
  • Nausea: occasional feeling of queasiness.
  • Alopecia: reversible hair thinning.
  • Rash: skin irritation or erythema.
  • Elevated liver enzymes: mild hepatic transaminase rise.
  • Hypertension: increase in blood pressure readings.

Serious or Rare Side Effects

  • Severe liver injury: potential hepatic failure requiring monitoring.
  • Stevens‑Johnson syndrome: rare, life‑threatening skin reaction.
  • Bone marrow suppression: pancytopenia or severe neutropenia.
  • Pulmonary toxicity: interstitial lung disease.
  • Severe infections: opportunistic infections due to immunosuppression.
  • Teratogenicity: fetal harm if exposure occurs during pregnancy.

Precautions & Warnings

Before initiating therapy, clinicians should assess patient suitability and monitor key parameters.

  • Pregnancy contraindication: avoid use in pregnant women and those planning conception.
  • Liver function monitoring: perform baseline and periodic liver enzyme tests.
  • Blood pressure monitoring: check regularly, especially in hypertensive patients.
  • Hematologic monitoring: periodic complete blood counts to detect cytopenias.
  • Renal impairment caution: adjust use in severe renal dysfunction.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Leflunomide can interact with several medicines, altering efficacy or safety.

Major Interactions (Avoid)

  • Methotrexate: combined hepatotoxicity risk.
  • Warfarin: increased anticoagulant effect.
  • Live vaccines: reduced vaccine efficacy and potential infection.
  • Carbamazepine and other enzyme‑inducing anticonvulsants: lower leflofuno­mid exposure.
  • TNF‑α inhibitors: heightened immunosuppression.

Moderate Interactions (Monitor Closely)

  • NSAIDs: additive liver toxicity.
  • Statins: increased risk of myopathy.
  • ACE inhibitors: possible aggravation of hypertension.
  • Oral contraceptives: reduced effectiveness, advise alternative contraception.

Frequently Asked Questions

Leflunomide Medac is prescribed for adults with rheumatoid arthritis and psoriatic arthritis. It helps to lessen joint inflammation, reduce pain, and slow the structural damage associated with these chronic autoimmune diseases.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for making pyrimidine nucleotides. This inhibition limits the proliferation of activated lymphocytes, thereby dampening the immune response that drives joint inflammation in arthritis.

The specific dose and dosing schedule are determined by the prescribing physician based on the patient’s clinical condition, laboratory values, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Leflunomide is classified as pregnancy category X, meaning it is contraindicated in pregnancy due to a high risk of fetal harm. It is also not recommended during breastfeeding because it may be excreted in milk and affect the infant.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.

Leflunomide offers oral administration and a distinct mechanism—pyrimidine synthesis inhibition—compared with biologic DMARDs that target cytokines. It is often used when patients need an alternative to methotrexate or when biologics are not suitable, but safety monitoring differs.

Leflunomide tablets should be stored at temperatures below 25 °C, in the original packaging, and protected from moisture and direct sunlight. Do not store in a refrigerator or freezer unless otherwise directed by the manufacturer.

Leflunomide Medac is taken orally, usually as a whole tablet with or without food. The exact timing and whether it should be taken with meals are determined by the prescriber’s instructions.

The most serious risks include severe liver injury, life‑threatening skin reactions such as Stevens‑Johnson syndrome, bone‑marrow suppression leading to cytopenias, pulmonary toxicity, and teratogenic effects that can cause fetal malformations.

Leflunomide is contraindicated in pregnant women, women planning pregnancy, and patients with severe liver disease. Caution is also advised for those with significant renal impairment, uncontrolled hypertension, or a history of severe infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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