Medicinal Products

ALLOPURINOL PHR LAB 200 mg

Generic drug of Zyloric
Therapeutic class: Rheumatology
active ingredients: Allopurinol
laboratory: Phr Lab

Compressed
box of 28
All forms

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 PHR LAB 200 mg tablet box of 28

· 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.

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 Phr Lab

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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