LEFLUNOMIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

LEFLUNOMIDE (UNII: G162GK9U4W) (LEFLUNOMIDE - UNII:G162GK9U4W)

Beszerezhető a:

REMEDYREPACK INC.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide Tablets are 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 tablets are contraindicated for use in pregnant women because of the potential for fetal harm. In animal reproduction studies, oral administ

Termék összefoglaló:

Leflunomide Tablets Yellow, triangular, film coated, biconvex tables debossed with “V56” on one side, and plain on the other side NDC: 70518-3240-00 NDC: 70518-3240-01 PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LEFLUNOMIDE- LEFLUNOMIDE TABLET
REMEDYREPACK INC.
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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
WARNING: EMBRYO-FETAL TOXICITY AND HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EMBRYO-FETAL TOXICITY
TERATOGENICITY AND EMBRYO-LETHALITY OCCURRED IN ANIMALS ADMINISTERED
LEFLUNOMIDE.
(5.1, 8.1)
EXCLUDE PREGNANCY PRIOR TO INITIATING LEFLUNOMIDE TABLETS THERAPY.
(5.1, 8.3)
ADVISE USE OF EFFECTIVE CONTRACEPTION IN FEMALES OF REPRODUCTIVE
POTENTIAL DURING
TREATMENT AND DURING A DRUG ELIMINATION PROCEDURE. (5.1, 5.3, 8.3)
STOP LEFLUNOMIDE TABLETS AND USE AN ACCELERATED DRUG ELIMINATION
PROCEDURE IF THE
PATIENT BECOMES PREGNANT. (5.1, 5.3, 8.1)
HEPATOTOXICITY
SEVERE LIVER INJURY AND FATAL LIVER FAILURE HAVE BEEN REPORTED. (5.2)
AVOID LEFLUNOMIDE TABLETS USE IN PATIENTS WITH PRE-EXISTING LIVER
DISEASE, OR THOSE
WITH SERUM ALANINE AMINOTRANSFERASE (ALT) >2XULN. (5.2, 8.6)
USE CAUTION WHEN LEFLUNOMIDE TABLETS ARE GIVEN WITH OTHER POTENTIALLY
HEPATOTOXIC
DRUGS. (5.2)
MONITOR ALT LEVELS. INTERRUPT LEFLUNOMIDE TABLETS TREATMENT IF ALT
ELEVATION > 3 FOLD
ULN. IF LIKELY LEFLUNOMIDE-INDUCED, START ACCELERATED DRUG ELIMINATION
PROCEDURE AND
MONITOR LIVER TESTS WEEKLY UNTIL NORMALIZED. (5.2, 5.3)
INDICATIONS AND USAGE
Leflunomide tablets are a pyrimidine synthesis inhibitor indicated for
the treatment of adults with active
rheumatoid arthritis. (1) (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) (2)
Screen patients for active and latent tuber