Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
LEFLUNOMIDE (UNII: G162GK9U4W) (LEFLUNOMIDE - UNII:G162GK9U4W)
Lupin Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide tablet is contraindicated in: - Pregnant women. Leflunomide tablets may cause fetal harm. If a woman becomes pregnant while taking this drug, stop leflunomide tablets, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1 and 5.3) and Use in Specific Populations (8.1)]. - Patients with severe hepatic impairment [see Warnings and Precautions (5.2)]. - Patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. Known reactions include anaphylaxis [see Adverse Reactions (6.1)]. - Patients being treated with teriflunomide [see Drug Interactions (7)]. Risk Summary Leflunomide tablet is contraindicated for use in pregnant women because of the potential for fetal harm. In animal reproduction studies, oral administration of leflunomi
How Supplied Leflunomide tablets USP; 10 mg and 20 mg Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Abbreviated New Drug Application
LEFLUNOMIDE - LEFLUNOMIDE TABLET, FILM COATED LUPIN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEFLUNOMIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEFLUNOMIDE TABLETS LEFLUNOMIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 INDICATIONS AND USAGE Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (1) DOSAGE AND ADMINISTRATION Loading dosage for patients at low risk for leflunomide tablets -associated hepatotoxicity and leflunomide tablets-associated myelosuppression: 100 mg daily for 3 days (2.1) Maintenance dosage: 20 mg daily. (2.1) Maximum recommended daily dosage: 20 mg once daily. (2.1) If 20 mg once daily is not tolerated, may decrease dosage to 10 mg once daily. (2.1) Screen patients for active and latent tuberculosis, pregnancy test (females), blood pressure, and laboratory tests before starting leflunomide tablets. (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 10 mg and 20 mg. (3) CONTRAINDICATIONS Pregnancy. (4, 5.1,8.1) Severe hepatic impairment. (4,5.2) Hypersensitivity to leflunomide tablets or any of its inactive components. (4) Current teriflunomide treatment. (4) WARNINGS AND PRECAUTIONS After stopping leflunomide tablets, it is recommended that an accelerated drug elimination procedure be used to reduce the plasma concentrations of the active metabolite, teriflunomide. (5.3) Severe infections (including sepsis), pancytopenia, agranulocytosis and thrombocytopenia: Stop leflunomide tablets and use accelerated elimination procedure. Do not start leflunomide tablets in patients with active infection. Monitor CBCs during treatment with leflunomide tablets (5.4) Stevens-Johnson syndrome and toxic epidermal necrolysis: Stop leflunomide tablets and use accelerated elimination procedure. (5.5) Peripheral neuropathy: If patient develops symptoms consistent with peripheral neuropathy, evaluate patient and consider disc Baca dokumen lengkap