LEFLUNOMIDE tablet film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

leflunomide (UNII: G162GK9U4W) (leflunomide - UNII:G162GK9U4W)

Pieejams no:

Prasco LLC

SNN (starptautisko nepatentēto nosaukumu):

leflunomide

Kompozīcija:

leflunomide 10 mg

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

New Drug Application Authorized Generic

Produkta apraksts

LEFLUNOMIDE- LEFLUNOMIDE TABLET, FILM COATED
PRASCO LLC
----------
LEFLUNOMIDE TABLETS
10 MG, 20 MG
CONTRAINDICATIONS AND WARNINGS
PREGNANCY
PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH
LEFLUNOMIDE. LEFLUNOMIDE IS
CONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL
WHO ARE NOT USING
RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.)
PREGNANCY MUST
BE AVOIDED DURING LEFLUNOMIDE TREATMENT OR PRIOR TO THE COMPLETION OF
THE DRUG ELIMINATION
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 AMINOTRANSFERASE (ALT) >2×ULN 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 6-8 WEEKS. IF ALT ELEVATION > 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.
Combined with leflunomide are the following inactive ingredients:
colloidal silicon dioxide,
crospovidone, hypromellose, lactose monohydrate, magnesium stearate,
p