Product Description

 BRAND NAME:–  Leflunomide USP 20 mg

 GENERIC NAME:-   Leflunomide USP 20 mg .

COMPOSITION:- 

Each Film Coated Tablet Contains:

• Leflunomide USP…………… 20 mg

DOSAGE FORM:-  Tablet

 PACKAGING:- 30 x 1 HDPE Bottle

Following Information is for the use only of a Registered Medical Practitioner or Hospital or a Laboratory or Healthcare Personnel only.

INDICATIONS:-
Leflunomide is indicated for the treatment of adult patients with:
Active rheumatoid arthritis as a “disease-modifying antirheumatic drug” (DMARD),
active psoriatic arthritis.

Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, Therefore, The initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects.

Moreover, Switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

DOSAGE  AND  ADMINISTRATION:-

The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.

Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, Including a differential white blood cell count and a platelet count, Must be checked simultaneously and with the same frequency:

Before initiation of leflunomide, every two weeks during the first six months of treatment, and very 8 weeks thereafter.

DOSAGE:

In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days. Omission of the loading dose may decrease the risk of adverse events.
The recommended maintenance dose is leflunomide 10 mg to 20 mg once daily depending on the severity ( activity ) of the disease.
In psoriatic arthritis: Leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
The recommended maintenance dose is leflunomide 20 mg once daily.
The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
There is no dose adjustment recommended in patients with mild renal insufficiency.
No dose adjustment is required in patients above 65 years of age.

Paediatric population

Leflunomide is not recommended for us in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established.

Leflunomide of administration

Leflunomide tablet are for oral use. The tablet should be swallowed whole with sufficient amounts of liquid. The extent of Leflunomide absorption is not affected it is taken with food.