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Lefumide 20 mg
Each film-coated tablet contains Leflunomide 20 mg
Lefumide 10 mg
Each film-coated tablet contains Leflunomide 10 mg
Leflunomide is indicated in adults for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms and to retard structural damage as evidenced by X-ray erosions and joint space narrowing.
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.
ALT (SGPT) must be checked before initiation and at monthly or more frequent intervals during the first six months of treatment and every 8 weeks thereafter.
A complete blood cell count, including differential white blood cell count and platelets, must be performed before start of leflunomide treatment as well as every 2 weeks for the first 6 months of treatment and every 8 weeks thereafter.
It is recommended that leflunomide therapy be initiated with a loading dose of 100 mg tablet per day for 3 days.
Daily dosing of 20 mg is recommended for treatment of patients with RA.
Doses higher than 20 mg/day are not recommended. If dosing at 20 mg/day is not well tolerated clinically, the dose may be decreased to 10 mg daily.
Lefumide is contraindicated if you have any of the following conditions:
Leflunomide must not be used in patients with hypersensitivity to leflunomide (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) or to any of the excipients in the tablets.
Leflunomide is contraindicated in:
- Patients with impairment of liver function;
- Patients with severe immunodeficiency states, e.g. aids;
- Patients with significantly impaired bone marrow function or significan anaemia, leukopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid arthritis;
- Patients with serious infections;
- Patients with moderate to severe renal insufficieny;
- Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome;
- Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/l pregnancy must be excluded before start of treatment with leflunomide;
Women must not breast-feed while they are receiving leflunomide.
Male patients should be aware of the possible male-mediated foetal toxicity.
Reliable contraception during treatment with leflunomide should also be guaranteed.
Leflunomide is not recommended for use in patient under 18 years as its safety and efficacy have not been studied in this age group.
- Blister Pack of 10 tablets;