LEFLUNOMIDE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Dispensing Solutions, Inc.

INN (इंटरनेशनल नाम):

LEFLUNOMIDE

रचना:

LEFLUNOMIDE 20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Leflunomide tablets are indicated in adults for the treatment of active rheumatoid arthritis (RA): - to reduce signs and symptoms - to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing - to improve physical function (see CLINICAL STUDIES). Aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with leflunomide tablets (see PRECAUTIONS - Drug Interactions – NSAIDs). The combined use of leflunomide tablets with antimalarials, intramuscular or oral gold, D penicillamine, azathioprine, or methotrexate has not been adequately studied. (See WARNINGS - Immunosuppression Potential/Bone Marrow Suppression). Leflunomide tablets are contraindicated in patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. Leflunomide tablets can cause fetal harm when administered to a pregnant woman. Leflunomide, when administered orally to rats during organogenesis at a dose of 15 mg/kg, was ter

उत्पाद समीक्षा:

Leflunomide Tablets, USP in 10 and 20 mg strengths are packaged in bottles. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Rx only Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

LEFLUNOMIDE- LEFLUNOMIDE TABLET
DISPENSING SOLUTIONS, INC.
----------
LEFLUNOMIDE TABLETS, USP 10 MG AND 20 MG
RX ONLY
CONTRAINDICATIONS AND WARNINGS
PREGNANCY
PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH
LEFLUNOMIDE TABLETS. LEFLUNOMIDE TABLETS ARE 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 TABLET
TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION
PROCEDURE AFTER LEFLUNOMIDE TABLET 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) >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 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 a
molecular formula C
H F N O , a
molecular weight of 270.2 and the following structural formula:
12
9
3
2
2
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,
croscarm