Medicinal Products

ALLOPURINOL TEVA 100 mg

Generic drug of Zyloric
Therapeutic class: Rheumatology
active ingredients: Allopurinol
laboratory: Teva Sante

Compressed
Box of 28
All forms

Indication

adults

· Hyperuricemia not controlled by a dietary regime, including secondary hyperuricemia of different etiologies and clinical complications of hyperuricemic states, especially recurrent gout, uric nephropathies.

· Treatment and prevention of uric lithiasis.

· Prevention of recurrence of calcium lithiasis in hyperuricemic patients after failure of water, diet and other usual measures.

Children and adolescents

· Secondary hyperuricemia of different etiologies,

· Uric nephropathy when treating leukemia,

· Hereditary enzymatic deficiency, Lesch-Nyhan syndrome (partial or total deficiency of hypoxanthine-guanine phosphoribosyltransferase) and adenine phosphoribosyltransferase deficiency.

Dosage ALLOPURINOL TEVA 100 mg Tablet Box of 28

Oral way.

Administration mode :

Allopurinol Teva can be taken orally once a day.

To improve gastrointestinal tolerance, Allopurinol Teva should be taken after a meal. If the daily dose exceeds 300 mg and gastrointestinal intolerance develops, fractionation of the dose may be appropriate.

Adults:

The usual dosage ranges from 2 to 10 mg / kg / day, ie 100 to 200 mg daily in mild cases, 300 to 600 mg daily in moderate cases or 700 to 900 mg daily in severe cases.

Treatment with Allopurinol Teva should be initiated at low doses, eg 100 mg / day, to reduce the risk of adverse effects; an increase in the dose should only be considered if the serum uric acid is not reduced satisfactorily. Special caution should be exercised in case of impaired renal function (see Renal impairment).

Children (up to 15 years old)

The usual dosage ranges from 10 to 20 mg / kg / day without exceeding the maximum dose of 400 mg per day, divided into 3 doses.

Allopurinol is rarely indicated in children except in cases of malignancy, particularly in leukemia and certain enzymatic disorders, eg Lesch-Nyhan syndrome.

Elderly

There is no specific dosage recommendation with the exception of the use of the lowest dose ensuring a satisfactory decrease in serum uricemia. See "Renal Insufficiency" recommendations (see also Warnings and Precautions ).

Renal failure :

Due to the excretion of allopurinol and its metabolites by the kidney, impaired renal function may result in the retention of the molecule and / or its metabolites. Plasma half-lives can then be prolonged. The dosage should be adjusted according to the clearance of creatinine according to the following scheme:

Clearance of creatinine

Dosage

> 20 ml / min

Usual dosage

10-20 ml / min

100-200 mg daily

<10 ml / min

100 mg / day or increase the interval between 2 shots

In cases of renal impairment, care should be taken to use the maximum dose of 100 mg / day when initiating therapy. An increase in the dose should only be considered if uricemia or uraturia is not satisfactorily reduced. In cases of severe renal impairment, it may be preferable to use less than 100 mg / day or to space 100 mg doses longer than one day.

If it is possible to monitor the plasma concentration of oxipurinol, the dosage should be adjusted to maintain oxipurinol plasma levels below 100 μmol / liter (15.2 μg / ml).

Hemodialysis:

Allopurinol and its metabolites are eliminated during hemodialysis. If the dialysis frequency is two to three sessions per week, an alternative dosing regimen should be used by administering 300 to 400 mg of allopurinol immediately after each dialysis, without further administration between sessions.

Hepatic insufficiency :

The dosage should be reduced in patients with hepatic impairment. Periodic monitoring of liver function is recommended, especially at the beginning of treatment.

Neoplasms, Lesch-Nyhan syndrome:

It is recommended to correct the existing hyperuricemia and / or hyperuraturia with allopurinol before initiation of cytotoxic therapy. It is important to ensure proper hydration to maintain optimum diuresis and thereby increase the solubility of uric acid by alkalinization of the urine. The dosage of allopurinol should be as low as possible.

In case of uric nephropathy or other pathology affecting renal function, follow the dosage recommendations in the section "Renal impairment".

These recommendations will reduce the risk of deposition of xanthine and / or oxipurinol that may complicate the clinical picture. (See sections Interactions with other medicinal products and other forms of interaction and side effects ).

Advice for monitoring: The dosage should be adapted according to the uricemia and uraturia which must be regularly checked.

Against indications

Hypersensitivity to allopurinol or to any of the excipients.

Adverse effects Allopurinol Teva

There are no recent clinical data to accurately determine the frequency of adverse events related to allopurinol.

The incidence of adverse reactions may vary depending on the dose of allopurinol administered and the combination with other drugs.

The frequency of adverse events listed below represents estimated rates: for most adverse events, there are no appropriate data to calculate incidence. The frequencies of adverse events established from post marketing data are defined as rare and very rare. The undesirable effects listed below are classified by organ system and frequency, according to the following convention:

Very common> 1/10,

Frequent> 1/100 and <1/10,

Uncommon> 1/1000 and <1/100,

Rare> 1/10000 and <1/1000,

Very rare <1/10000, unknown (can not be estimated from the available data).

The incidence of side effects increases with impaired renal and / or hepatic function.

Infections and infestations

Very rare: furunculosis.

Blood and lymphatic system disorders

Very rare: agranulocytosis, polynucleosis, medullary aplasia, thrombocytopenia, leukopenia, leucocytosis, eosinophilia, chronic acquired erythroblastopenia.

Very rare cases of thrombocytopenia, agranulocytosis and medullary aplasia, especially in people with renal and / or hepatic insufficiency, have been reported. Special monitoring for this group of patients should be initiated.

Immune system disorders

Few Frequent: hypersensitivity syndrome.

Very rare: angioimmunoblastic lymphadenopathy.

Serious hypersensitivity reactions, such as skin reactions associated with exfoliation, fever, lymphadenopathy, arthralgia and / or eosinophilia, including Stevens-Johnson Syndrome and Lyell's syndrome (toxic epidermal necrolysis) occur. rarely (see also "skin and tissue disorders").

Adverse reactions associating vasculitis and tissue reaction can manifest themselves in various ways: hepatitis, renal failure, acute cholangitis, xanthine stones and, very rarely, epilepsy. Very rare cases of anaphylactic shock have been reported. If these reactions occur, allopurinol should be discontinued immediately, irrespective of the stage of treatment .

Corticosteroids can help to control skin reactions of hypersensitivity. At the onset of generalized hypersensitivity reactions, impaired renal and / or hepatic function was usually observed, particularly in those cases with fatal outcome.

Angioimmunoblastic lymphadenopathy has been described, very rarely, after biopsy of generalized lymphadenopathy. It seems reversible when stopping allopurinol.

Metabolism and nutrition disorders

Very rare : diabetes mellitus, hyperlipidemia.

Psychiatric disorders

Very rare : depression.

Nervous system disorders

Very rare : coma, paralysis, ataxia, neuropathy, paresthesia, somnolence, headache, taste alteration.

Eye disorders

Very rare: cataracts, visual disturbances, macular disorders.

Affections of the ear and labyrinth

Very rare: vertigo.

Heart conditions

Very rare: angina pectoris, bradycardia.

Vascular disorders

Very rare: hypertension.

Gastrointestinal disorders

Uncommon: vomiting, nausea, diarrhea

Very rare: recurrent haematemesis, steatorrhea, stomatitis, change in intestinal transit.

In previous clinical studies, nausea and vomiting have been reported. Gastrointestinal tolerance is improved by administering allopurinol after meals.

Hepatobiliary disorders

Uncommon: asymptomatic increases in liver enzyme levels.

Rare: hepatitis (including hepatic necrosis and granulomatous hepatitis).

Cases of liver function impairment have been reported without any other noticeable sign of a more generalized hypersensitivity reaction.

Skin and subcutaneous tissue disorders

Frequent: eruption.

Very rare: angioedema, fixed drug eruption, alopecia, hair discoloration.

Skin reactions are the most common and can occur at any time during treatment. They may be pruritus or maculopapular exanthema with occasional peeling and itching or, more rarely, exfoliation. In these cases, treatment with allopurinol should be discontinued immediately. In the case of a mild reaction, allopurinol can be reinstituted, if necessary after complete cure, at a low dosage (eg 50 mg per day), and increased gradually. If skin conditions recur, discontinue use of allopurinol, as there is a risk of serious hypersensitivity reactions (see "Immune system disorders").

Angioedema has been reported with and without signs and symptoms of generalized hypersensitivity reaction.

Musculoskeletal and connective tissue disorders

Very rare: muscle pain.

Renal and urinary disorders

Rare: urolithiasis.

Very rare: hematuria, uricemia.

Disorders of the reproductive system and breasts

Very rare: infertility in humans, erectile dysfunction, gynecomastia.

General disorders and administration site reaction

Very rare: edema, general malaise, asthenia, fever.

Fever occurring with or without symptoms of a generalized hypersensitivity reaction following allopurinol treatment have been reported (see Immune system disorders).

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