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 an oral dosage form for oral use. It is indicated for the treatment of 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 that targets inflammatory pathways in autoimmune joint disease.

  • Rheumatoid arthritis: reduces joint inflammation and slows structural damage.
  • Psoriatic arthritis: improves skin lesions and joint symptoms.
  • Active adult disease: helps control overall disease activity and functional impairment.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which blocks de novo pyrimidine synthesis. This limits the proliferation of activated T‑lymphocytes and B‑cells, thereby reducing the autoimmune inflammatory response that drives joint damage in rheumatoid and psoriatic arthritis.

Side Effects

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

Common Side Effects

  • Diarrhoea: loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may be transient.
  • Alopecia: thinning or loss of hair.
  • Rash: skin redness or itching.
  • Elevated liver enzymes: mild transaminase rise.
  • Hypertension: increased blood pressure readings.

Serious or Rare Side Effects

  • Severe liver injury: jaundice, hepatic failure.
  • Stevens‑Johnson syndrome: severe skin blistering.
  • Bone marrow suppression: low blood counts, risk of infection.
  • Interstitial lung disease: breathing difficulty, cough.
  • Severe infections: opportunistic bacterial or viral infections.
  • Teratogenicity: risk of fetal malformations if exposure occurs during pregnancy.

Precautions & Warnings

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

  • Liver monitoring: check transaminases before start and periodically thereafter.
  • Blood pressure: measure regularly and manage hypertension if present.
  • Pregnancy avoidance: contraindicated in pregnancy; effective contraception required.
  • Infection risk: assess for active infections and vaccinate appropriately.
  • Discontinue if serious adverse events occur: stop therapy and provide supportive care.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Leflunomide can alter the activity of several concomitant medicines; careful review is essential.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect, may cause bleeding.
  • Methotrexate: additive hepatotoxicity, heightened liver risk.
  • Bupropion: increased plasma levels, risk of seizures.

Moderate Interactions (Monitor Closely)

  • Statins: potential for increased muscle toxicity.
  • Azathioprine: combined immunosuppression, monitor blood counts.
  • Live vaccines: reduced efficacy, consider timing or avoidance.

Frequently Asked Questions

Leflunomide Medac is prescribed for adult patients with rheumatoid arthritis and psoriatic arthritis. In both conditions it helps reduce joint inflammation, slows disease progression, and improves functional ability and skin symptoms in psoriatic disease.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for making pyrimidine nucleotides. By limiting pyrimidine synthesis, it reduces the proliferation of activated lymphocytes, thereby dampening the autoimmune inflammation that drives joint damage.

The dose of Leflunomide Medac is determined by the prescribing clinician based on the individual’s disease severity, laboratory results, and overall health. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Leflunomide is classified as pregnancy category X because it can cause fetal malformations. It is contraindicated in pregnancy, and women of child‑bearing potential must use reliable contraception. Breastfeeding is not recommended while taking leflunomide.

To 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 and any necessary import documentation.

Leflunomide differs from biologic DMARDs in that it is a small‑molecule oral agent that inhibits pyrimidine synthesis, whereas biologics target specific cytokines or cell surface receptors. Both classes can control disease activity, but leflunomide offers oral convenience and a distinct safety profile.

Leflunomide Medac should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture and direct sunlight to maintain stability throughout its shelf life.

Leflunomide Medac is taken orally, usually as a tablet swallowed with water. The exact timing (e.g., with or without food) should follow the prescriber’s guidance, and the medication should be taken consistently each day.

The most serious risks include severe liver injury, life‑threatening skin reactions such as Stevens‑Johnson syndrome, bone‑marrow suppression leading to low blood counts, interstitial lung disease, and teratogenic effects if exposure occurs during pregnancy.

Leflunomide should not be used by pregnant women, women planning pregnancy, or those who cannot use effective contraception. It is also contraindicated in patients with severe liver disease, uncontrolled hypertension, or known hypersensitivity to leflunomide.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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