Drug Information: Indications, Side Effects, Warnings
Category:Â Anti-inflammatories, Arthritis
Generic Arava is used for reducing signs and symptoms of rheumatoid arthritis. It is also used to improve physical function and to prevent the development of structural damage to the joints.
Brand(s): Cleft / Lefra
Manufacturer: Croslands / Torrent
Basic antirheumatic drug
Composition, structure and packing:
1. Tablets, film-coated white or almost white, round, marked “ZBN” on one side.
Basic ingredient: 10 mg leflunomide
Other ingredients: lactose monohydrate – 78 mg, corn starch – 50 mg, povidone K25 (polyvidone K25) – 3.5 mg, colloidal silicon dioxide – 500 mg, magnesium stearate – 500 mg, Valium – 7.5 mg.
The composition of the coating film: hypromellose (methylhydroxypropylcellulose 5 mPa.s) – 2.521 mg, macrogol 8000 – 160 mcg, titanium dioxide (E171) – 630 mcg, talc – 189 mcg.
- Tablets,film-coatedfroma pale yellowto palebrown, triangular, biconvex, marked”ZBO”on one side.
Basic ingredient: 20 mg leflunomide
Basic antirheumatic drug. Has antiproliferative, immunomodulatory (immunosuppressive) and anti-inflammatory effect.
Use of the drug should begin under the supervision of a physician experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
-diareya, abdominal pain, leukopenia, anemia, increase the functional state of the liver.
Cardio-vascular system: often – increased blood pressure.
From the digestive system: often – diarrhea, nausea, vomiting, anorexia, loss of the oral mucosa (eg, aphthous stomatitis, ulceration of the mucous membrane of the mouth), abdominal pain, increase in liver transaminases (ALT especially, at least – GGT and alkaline phosphatase ), hyperbilirubinemia; rarely – a violation of taste; rarely – hepatitis, jaundice / cholestasis; very rarely – pancreatitis, severe liver disease, such as liver failure, acute liver necrosis, which can be fatal.
The respiratory system: rarely – interstitial lung disease (including interstitial pneumonitis), which can be fatal.
From a metabolism: often – a slight increase in CPK, weight loss; rarely – hypokalemia, hyperlipidemia weak, insignificant hypophosphatemia; the frequency is unknown – a slight increase in the level of LDH, hypouricemia due urikozuricheskogo effect.
From the nervous system: often – headache, dizziness, paresthesia; infrequently – anxiety; very rarely – peripheral neuropathy.
On the part of the musculoskeletal system: the frequency is unknown – tenosynovitis and tendon rupture (causal relationship with the treatment with leflunomide has not been established).
Skin and subcutaneous tissue disorders: often – increased hair loss, eczema, pruritus, dry skin; very rarely – toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme, Stevens-Johnson syndrome (currently a causal relationship with treatment with leflunomide could not be determined, but it can not be excluded); the frequency is unknown – cutaneous lupus erythematosus, pustular psoriasis or worsening of psoriasis.
Allergic reactions: often – easy makulo-papular rash and other types of rash; rarely – urticaria; very rarely – severe anaphylactic / anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis (due to underlying disease causal relationship with treatment with leflunomide can not be installed).
Hematopoietic system: often – leukopenia (white blood cells> 2000 / l); rarely – anemia, a small thrombocytopenia (platelets <100,000 / mm); rarely – pancytopenia (probably due to the antiproliferative action), leukopenia (white blood cells <2,000 / mm), eosinophilia; very rarely – agranulocytosis. Newer concomitant or subsequent application of potentially myelotoxic agents may be associated with higher risk of hematological effects.
On the part of the reproductive system: the frequency is unknown – a slight decrease in sperm concentration, total sperm count and motility.
Infectious and parasitic diseases: rarely – the development of severe infections and sepsis, which can be fatal.
Indications for use:
– As a reference drug for the treatment of adult patients with active rheumatoid arthritis.
– To reduce symptoms and the delay of progression of structural damage of joints;
– The active form of psoriatic arthritis.
– Abnormal liver function;
– Severe immunodeficiency (including AIDS);
– The expressed disturbances of bone marrow hematopoiesis, or severe anemia, leukopenia, thrombocytopenia due to other causes (except for rheumatoid arthritis and psoriatic arthritis);
– Severe, uncontrolled infection;
– Renal failure secondary to severe (because of the small clinical experience);
– Severe hypoproteinemia (including with nephrotic syndrome);
– Lactation (breastfeeding);
– Hypersensitivity to the drug.
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