LEFLUNOMIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Golden State Medical Supply, Inc.

INN (International Name):

LEFLUNOMIDE

Sammensetning:

LEFLUNOMIDE 10 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LEFLUNOMIDE- LEFLUNOMIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
LEFLUNOMIDE TABLETS, 10 MG AND 20 MG
CONTRAINDICATIONS AND WARNINGS
PREGNANCY
PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH
LEFLUNOMIDE. LEFLUNOMIDE IS CONTRAINDICATED IN PREGNANT WOMEN,
OR WOMWN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE
CONTACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS). PREGNANCY
MUST BE AVOIDED DURING LEFLUNOMIDE TREATMENT OR PRIOR TO THE
COMPLETION OF THE DRUG ELIMINAT PROCEDURE AFTER LEFLUNOMIDE
TREATMENT.
HEPATOTOXICITY
SEVERE LIVER INJURY, INCLUDING FATAL LIVER FAILURE, HAS BEEN
REPORTED IN SOME PATIENTS TREATED WITH LEFLUNOMIDE. PATIENTS
WITH PRE-EXISTING ACUTE OR CHRONIC LIVER DISEASE, OR THOSE WITH
SERUM ALANINE AMINOTRANSFERADE (ALT) >2XULN BEFORE INITIATING
TREATMENT, SHOULD NOT BE TREATED WITH LEFLUNOMIDE. USE CAUTION
WHEN LEFLUNOMIDE IS GIVEN WITH OTHER POTENTIALLY HEPATOTOXIC
DRUGS.
MONITORING OF ALT LEVELS IS RECOMMENDED AT LEAST MONTHLY FOR
SIX MONTHS AFTER STARTING LEFLUNOMIDE, AND THEREAFTER EVERY SIX
TO EIGHT WEEKS. IF ALTELEVATION > 3 FOLD ULN OCCURS, INTERRUPT
LEFLUNOMIDE THERAPY WHILE INVESTIGATING THE PROBABLE CAUSE OF
THE ALT ELEVATION BY CLOSE OBSERVATION AND ADDITIONAL TESTS. IF
LIKELY LEFLUNOMIDE-INDUCED, START CHOLESTYRAMINE WASHOUT AND
MONITOR LIVER TESTS WEEKLY UNTIL NORMALIZED. IF LEFLUNOMIDE-
INDUCED LIVER INJURY IS UNLIKELY BECAUSE SOME OTHER PROBABLE
CAUSE HAS BEEN FOUND, RESUMPTION OF LEFLUNOMIDE THERAPY MAY BE
CONSIDERED. (SEE WARNINGS –HEPATOTOXICITY).
DESCRIPTION
Leflunomide is a pyrimidine synthesis inhibitor. The chemical name for
leflunomide is N-(4'-
trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an
empirical formula C
H F N O , a
molecular weight of 270.2 and the following structural formula:
Leflunomide is available for oral administration as tablets containing
10 or 20 mg of active drug. Each
Leflunomide Tablet, USP contains anhydrous lactose, colloidal silicon
dioxide, crospovidone, and
12
9
3
2
2
magnesium stearate.
CLINICAL PHAR