Medicinal Products

ALLOPURINOL ZENTIVA 100 mg

Generic drug of Zyloric
Therapeutic class: Rheumatology
active ingredients: Allopurinol
laboratory: Sanofi-Aventis France

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Box of 28
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Indication

· Treatment of primary or secondary symptomatic hyperuricemia (haemopathies, nephropathies, iatrogenic hyperuricemia).

· Treatment of gout: tophaceous gout, relapsing gout, uterine arthropathy even when accompanied by hyperuraturia, uric lithiasis or renal failure.

· Treatment of hyperuricuries and hyperuraturia.

· Treatment and prevention of uric lithiasis.

· Prevention of recurrence of calcium lithiasis in hyperuricemic or hyperuricuric patients, in addition to usual dietary precautions, including the protein and calcium rations.

Dosage ALLOPURINOL ZENTIVA 100 mg Tablet Box of 28

Dosage

The usual dosage should be determined according to the serum uric acid which should be regularly checked.

In order to limit the risk of severe toxicosis, treatment should be started at an initial dose of 100 mg / day, which will be gradually increased every 1 to 2 months until the dose to maintain the serum uric acid below 420 μmol / l (70 mg / l).

In adults, the usual dosage varies from 2 to 10 mg / kg / day, ie 100 to 200 mg per day in mild cases, 300 to 600 mg per day in moderate cases or 700 to 900 mg per day in cases severe.

In children, the usual dosage varies from 10 to 20 mg / kg / day without exceeding the dose of 400 mg per day divided into 3 doses.

Renal insufficiency : It is recommended before the prescription to look for renal insufficiency, especially in the elderly.

The dosage should be adjusted according to the clearance of creatinine.

Clearance of creatinine

Maximum recommended dose

80 <Cl Cr <100 ml / min

300 mg / day

40 <Cl Cr <80 ml / min

200 mg / day

20 <Cl Cr <40 ml / min

100 mg / day

Cl Cr <20 ml / min

100 mg / 1 day out of 2

The dosage should be adjusted to maintain serum uric acid in the desired area.

Dialysis : In patients with renal failure on dialysis, the prescription of allopurinol is generally unnecessary because of the uric acid purification by dialysis. In exceptional cases where this treatment appears necessary, however, allopurinol may be given at the end of the hemodialysis sessions without exceeding the dose of 200 mg per session.

This specialty exists in the form of 200 and 300 mg doses that can be better adapted.

Administration mode

Oral way.

The tablets are swallowed as is with a large glass of water, after meals.

Against indications

This medicine is contraindicated:

· If hypersensitivity to allopurinol or any of the excipients,

· In children under 6 years of age (contraindication related to the pharmaceutical form),

· In case of breastfeeding.

Side effects Allopurinol Zentiva

The frequency of these adverse events has been established from postmarketing data.

The undesirable effects listed below are classified by organ system and frequency, according to the following convention:

Very common :

≥ 1/10 (≥ 10%)

Frequent

≥ 1/100 and <1/10 (≥ 1% and <10%)

Rare :

≥ 1/1000 and <1/100 (≥ 0.1% and <1%)

Rare:

≥ 1/10000 and <1/1000 (≥ 0.01% and <0.1%)

Very rare :

<1/10000 (<0.01%)

Blood and lymphatic system disorders

Rare: thrombocytopenia, agranulocytosis, leukopenia, anemia, pancytopenia.

Very rare: medullary aplasia.

These manifestations have been reported particularly in patients with renal insufficiency.

Immune system disorders

Uncommon: generalized hypersensitivity reactions.

The syndrome of generalized hypersensitivity associates with various degrees, fever, attacks of the general state, rash, polyadenopathy, liver injury, impaired renal function, hypereosinophilia. It is rare and can be fatal (see section Warnings and precautions for use ).

Anaphylactic shocks have been reported very rarely, most often in patients who have already developed an allergic reaction during an earlier dose of allopurinol.

Allopurinol must IMMEDIATELY AND DEFINITELY be stopped.

Very rare: angioimmunoblastic lymphadenopathy. They appear to be reversible upon discontinuation of treatment.

Nervous system disorders

Very rare: peripheral neuropathies, headache.

Affections of the ear and labyrinth

Very rare: vertigo.

Gastrointestinal disorders

Uncommon: epigastralgia, nausea, diarrhea, vomiting.

These disorders are very rarely important enough to stop treatment. They can be avoided by absorbing the drug after the meal.

Very rare: stomatitis.

Hepatobiliary disorders

Uncommon: asymptomatic elevation of hepatic enzymes, hepatitis (including hepatic necrosis and granulomatous hepatitis) sometimes outside any context of generalized hypersensitivity.

Skin and subcutaneous tissue disorders

Common: pruriginous, erythematous, papular, vesicular or bullous rash (see Warnings and Precautions ) section.

Rare: Stevens-Johnson syndrome, Lyell syndrome, DRESS or generalized hypersensitivity reaction.

The DRESS associates with various degrees, fever, attacks of the general state, rash, polyadenopathy, liver injury, impaired renal function, eosinophilia. It is rare and can be fatal (see section Warnings and precautions for use ). When such reactions occur, allopurinol should IMMEDIATELY and FINALLY be discontinued.

Retrospective pharmacogenetic studies in Chinese (Han ethnic), Japanese, Thai and European patients have shown a significant association between the carriage of the HLA B * 5801 allele and the risk of developing Stevens syndrome. -Johnson or Lyell. The portage of this allele is 20 to 30% in the Chinese population (ethnic "Han"), African and Indian. In people of European and Japanese origin, this portage is only 1 to 2%.

Given its low positive predictive value, performing genetic testing for the HLA B * 5801 allele prior to initiating allopurinol therapy can not be recommended.

Very rare: fixed pigmented erythema, alopecia.

Musculoskeletal disorders

The administration of allopurinol, like that of all hypo-uricemic agents, can cause, at the beginning of treatment, access to gout, hence the need to combine colchicine or a low-dose NSAID at the start of treatment. gouty patients (see section Warnings and precautions for use ).

Disorders of reproductive organs and breast

Very rare: gynecomastia.

General disorders and administration site conditions

Rare: fever. Fever has been reported outside any context of generalized hypersensitivity.

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