Allopurinol-Egis, 30 pcs., 300 mg, tablets

Nosological classification (ICD-10)

• C80 Malignant neoplasm without specification of localization
• D47.1 Chronic myeloproliferative disease
• E74.0 Glycogen storage diseases
• E79 Disorders of purine and pyrimidine metabolism
• E79.0 Hyperuricemia without signs of inflammatory arthritis and gouty nodes
• E79.1 Lesch-Nychen syndrome
• M10 Gout
• M10.0 Idiopathic gout
• N20 Kidney and ureteral stones
• N20.0 Kidney stones
• N20.9 Urinary stones, unspecified
• N22.8 Urinary tract stones in other diseases classified elsewhere
• Z51.0 Radiotherapy course
• Z51.1 Chemotherapy for neoplasm

Allopurinol-Egis

There are no current clinical data to determine the incidence of side effects. Their frequency may vary depending on the dose and whether the drug was prescribed as monotherapy or in combination with other drugs.

The classification of the frequency of side effects is based on an approximate estimate; for most side effects there is no data to determine the frequency of their development.

The classification of adverse reactions depending on the frequency of occurrence is as follows:

very common (≥1/10),

frequent (from ≥1/100 to <1/10),

uncommon (from ≥1/1000 to <1/100),

rare (from ≥1/10000 to <1/1000),

very rare (< 1/10000),

frequency unknown (cannot be determined from available data).

Adverse reactions associated with allopurinol therapy observed in the post-marketing period are rare or very rare. In the general patient population, most cases are mild. The incidence of adverse events increases with impaired renal and (or) liver function.

Infections and parasitic diseases : very rare:

furunculosis.

Blood and lymphatic system disorders:

very rare:

agranulocytosis, aplastic anemia, thrombocytopenia, granulocytosis, leukopenia, leukocytosis, eosinophilia and red blood cell only aplasia.

Thrombocytopenia, agranulocytosis and aplastic anemia have been reported very rarely, particularly in persons with impaired renal and/or hepatic function, highlighting the need for special caution in these patient groups.

Immune system disorders:

infrequent:

hypersensitivity reactions;
rare:
severe hypersensitivity reactions, including skin reactions with epidermal detachment, fever, lymphadenopathy, arthralgia and/or eosinophilia (including Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section "Skin and subcutaneous tissue disorders") .
Associated vasculitis or tissue reactions may have a variety of manifestations, including hepatitis, renal involvement, acute cholangitis, xanthine stones, and, in very rare cases, seizures. In addition, the development of anaphylactic shock was very rarely observed. If severe adverse reactions develop, allopurinol therapy should be stopped immediately and not restarted.
In delayed multiorgan hypersensitivity (known as drug hypersensitivity syndrome /DRESS), the following symptoms may develop in various combinations: fever, skin rash, vasculitis, lymphadenopathy, pseudolymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, changes in liver function tests, syndrome disappearing bile ducts (destruction or disappearance of intrahepatic bile ducts).
If such reactions develop during any period of treatment, Allopurinol-EGIS should be immediately discontinued and never restarted. Generalized hypersensitivity reactions developed in patients with impaired renal and (or) liver function. Such cases were sometimes fatal; very rare:
angioimmunoblastic lymphadenopathy. Angioimmunoblastic lymphadenopathy has very rarely been diagnosed after lymph node biopsy for generalized lymphadenopathy. Angioimmunoblastic lymphadenopathy is reversible and regresses after cessation of allopurinol therapy.

Metabolic and nutritional disorders:

very rare:

diabetes mellitus, hyperlipidemia

Mental disorders:

very rare:

depression

Nervous system disorders:

very rare:

coma, paralysis, ataxia, neuropathy, paresthesia, drowsiness, headache, taste disturbance

Visual disorders:

very rare:

cataracts, visual impairment, macular changes

Hearing and labyrinth disorders:

very rare:

dizziness (vertigo)

Heart disorders:

very rare:

angina, bradycardia.

Vascular disorders:

very rare:

increased blood pressure

Gastrointestinal disorders: uncommon:

vomiting, nausea, diarrhea;

Nausea and vomiting were observed in earlier clinical studies, but more recent observations have confirmed that these reactions are not a clinically significant problem and can be avoided by administering allopurinol after meals.

very rare:

recurrent hematemesis, steatorrhea, stomatitis, changes in bowel movements

Frequency unknown

: abdominal pain

Disorders of the liver and biliary tract:

infrequent:

asymptomatic increase in the concentration of liver enzymes (increased levels of alkaline phosphatase and transaminases in the blood serum)
rare:
hepatitis (including necrotizing and granulomatous forms).

Liver dysfunction may develop without obvious signs of generalized hypersensitivity

Skin and subcutaneous tissue disorders:

frequent:

rash;
rare:
severe skin reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN),
very rare:
angioedema, local drug rash, alopecia, hair bleaching.

Skin adverse reactions are the most common in patients taking allopurinol. During drug therapy, these reactions can develop at any time. Skin reactions may include itching, maculopapular and scaly rashes. In other cases, purpura may develop. In rare cases, exfoliative skin lesions (SSD/TEN) are observed. If such reactions develop, allopurinol therapy should be discontinued immediately. If the skin reaction is mild, then allopurinol can be resumed at a lower dose (for example, 50 mg per day) after these changes have resolved. Subsequently, the dose can be gradually increased. If skin reactions recur, allopurinol therapy should be stopped and not restarted, since further use of the drug may lead to the development of more severe hypersensitivity reactions (see “Immune system disorders”).

According to existing information, during therapy with allopurinol, angioedema developed in isolation, as well as in combination with symptoms of a generalized hypersensitivity reaction.

Musculoskeletal and connective tissue disorders:

very rare

: myalgia.

Nocturnal and urinary tract disorders:

very rare:

hematuria, renal failure, uremia,
frequency unknown:
urolithiasis.

Reproductive system and breast disorders:

very rare:

male infertility, erectile dysfunction, gynecomastia.

General disorders and disorders at the injection site:

very rare:

swelling, general malaise, general weakness, fever.

According to existing information, during therapy with allopurinol, fever developed both in isolation and in combination with symptoms of a generalized hypersensitivity reaction (see “Immune system disorders”)

Reports of possible adverse reactions

If adverse reactions occur, including those not listed in this instruction, you should stop using the drug.

In the post-registration period, any information about possible adverse reactions is important, since these reports help to continuously monitor the safety of the drug. Healthcare professionals are required to report any suspected adverse reactions to local pharmacovigilance authorities.

Compound

Allopurinol-Egis tablets 100 mg 50 pcs.

There are no current clinical data to determine the incidence of side effects. Their frequency may vary depending on the dose and whether the drug was prescribed as monotherapy or in combination with other drugs. The classification of the frequency of side effects is based on an approximate estimate; for most side effects there is no data to determine the frequency of their development. The classification of adverse reactions depending on the frequency of occurrence is as follows: very common (?1/10), common (from?1/100 to <1/10), uncommon (from?1/1000 to <1/100), rare (from ?1/10,000 to <1/1000), very rare (<1/10,000), frequency unknown (cannot be determined from available data). Adverse reactions associated with allopurinol therapy observed in the post-marketing period are rare or very rare. In the general patient population, most cases are mild. The incidence of adverse events increases with impaired renal and (or) liver function. Infections and parasitic diseases: very rare: furunculosis. Disorders of the blood and lymphatic system: very rare - agranulocytosis, aplastic anemia, thrombocytopenia, granulocytosis, leukopenia, leukocytosis, eosinophilia and aplasia affecting only red blood cells; There have been very rare reports of thrombocytopenia, agranulocytosis and aplastic anemia, particularly in persons with impaired renal and/or hepatic function, highlighting the need for special caution in these patient groups. Immune system disorders: uncommon - hypersensitivity reactions; rare - severe hypersensitivity reactions, including skin reactions with epidermal detachment, fever, lymphadenopathy, arthralgia and (or) eosinophilia (including Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section "Skin and subcutaneous tissue disorders" "). Associated vasculitis or tissue reactions may have a variety of manifestations, including hepatitis, renal involvement, acute cholangitis, xanthine stones, and, in very rare cases, seizures. In addition, the development of anaphylactic shock was very rarely observed. If severe adverse reactions develop, allopurinol therapy should be stopped immediately and not restarted. In delayed multiorgan hypersensitivity (known as drug hypersensitivity syndrome /DRESS), the following symptoms may develop in various combinations: fever, skin rash, vasculitis, lymphadenopathy, pseudolymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, changes in liver function tests, syndrome disappearing bile ducts (destruction or disappearance of intrahepatic bile ducts). If such reactions develop during any period of treatment, Allopurinol-Egis should be immediately discontinued and never resumed. Generalized hypersensitivity reactions developed in patients with impaired renal and (or) liver function. Such cases were sometimes fatal; very rare - angioimmunoblastic lymphadenopathy. Angioimmunoblastic lymphadenopathy has very rarely been diagnosed after lymph node biopsy for generalized lymphadenopathy. Angioimmunoblastic lymphadenopathy is reversible and regresses after cessation of allopurinol therapy. Metabolic and nutritional disorders: very rare - diabetes mellitus, hyperlipidemia. Mental disorders: very rare - depression. Nervous system disorders: very rare - coma, paralysis, ataxia, neuropathy, paresthesia, drowsiness, headache, distortion of taste. Visual disorders: very rare - cataracts, visual impairment, macular changes. Hearing disorders and labyrinthine disorders: very rare - dizziness (vertigo). Cardiac disorders: very rare - angina, bradycardia. Vascular disorders: very rare - increased blood pressure. Gastrointestinal disorders: uncommon - vomiting, nausea, diarrhea. Nausea and vomiting were observed in earlier clinical studies, but more recent observations have confirmed that these reactions are not a clinically significant problem and can be avoided by administering allopurinol after meals; very rare - recurrent hematemesis, steatorrhea, stomatitis, changes in frequency of bowel movements; frequency unknown - abdominal pain. Disorders of the liver and biliary tract: infrequent - asymptomatic increase in the concentration of liver enzymes (increased levels of alkaline phosphatase and transaminases in the blood serum); rare - hepatitis (including necrotizing and granulomatous forms). Liver dysfunction may develop without obvious signs of generalized hypersensitivity. Disorders of the skin and subcutaneous tissues: frequent - rash; rare - severe skin reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN); very rare - angioedema, local drug rash, alopecia, hair bleaching. Skin adverse reactions are the most common in patients taking allopurinol. During drug therapy, these reactions can develop at any time. Skin reactions may include itching, maculopapular and scaly rashes. In other cases, purpura may develop. In rare cases, exfoliative skin lesions (SSD/TEN) are observed. If such reactions develop, allopurinol therapy should be discontinued immediately. If the skin reaction is mild, then after these changes disappear, you can resume taking allopurinol at a lower dose (for example, 50 mg / day). Subsequently, the dose can be gradually increased. If skin reactions recur, allopurinol therapy should be stopped and not restarted, since further use of the drug may lead to the development of more severe hypersensitivity reactions. According to existing information, during therapy with allopurinol, angioedema developed in isolation, as well as in combination with symptoms of a generalized hypersensitivity reaction. Musculoskeletal and connective tissue disorders: very rare - myalgia. Renal and urinary tract disorders: very rare - hematuria, renal failure, uremia; frequency unknown - urolithiasis. Reproductive system and breast disorders: very rare - male infertility, erectile dysfunction, gynecomastia. General disorders and disorders at the injection site: very rare - swelling, general malaise, general weakness, fever. According to existing information, during therapy with allopurinol, fever developed both in isolation and in combination with symptoms of a generalized hypersensitivity reaction. Reports of possible adverse reactions. In case of adverse reactions, incl. not specified in this instruction, you should stop using the drug. In the post-registration period, any information about possible adverse reactions is important, since these reports help to continuously monitor the safety of the drug. Healthcare professionals are required to report any suspected adverse reactions to local pharmacovigilance authorities.

Directions for use and doses

Inside. The drug should be taken once a day after meals with plenty of water.

If the daily dose exceeds 300 mg or symptoms of gastrointestinal intolerance are observed, the dose must be divided into several doses.

Adult patients. In order to reduce the risk of side effects, it is recommended to use allopurinol at an initial dose of 100 mg 1 time per day. If this dose is not sufficient to adequately reduce serum uric acid levels, the daily dose of the drug can be gradually increased until the desired effect is achieved. Particular caution should be exercised if renal function is impaired. When increasing the dose of allopurinol, it is necessary to determine the concentration of uric acid in the blood serum every 1–3 weeks.

When selecting the dose of the drug, it is recommended to use the dosage regimens indicated below (depending on the selected dosage regimen, tablets of 100 or 300 mg are recommended).

The recommended dose of the drug is 100–200 mg/day for mild disease, 300–600 mg/day for moderate disease, and 700–900 mg/day for severe disease.

If, when calculating the dose, we proceed from the patient’s body weight, then the dose of allopurinol should be from 2 to 10 mg/kg/day.

Children and teenagers under 15 years of age. The recommended dose for children from 3 to 10 years is 5–10 mg/kg/day. For low doses, 100 mg tablets are used, which can be divided into two equal doses of 50 mg using a score. The recommended dose for children from 10 to 15 years is 10–20 mg/kg/day. The daily dose of the drug should not exceed 400 mg. Allopurinol is rarely used for pediatric therapy. The exceptions are malignant oncological diseases (especially leukemia) and some enzymatic disorders (for example, Lesch-Nyhan syndrome).

Elderly patients. Since there are no specific data on the use of allopurinol in the elderly population, for the treatment of such patients the drug should be used in the minimum dose that provides a sufficient reduction in the concentration of uric acid in the blood serum. Particular attention should be paid to recommendations for selecting the dose of the drug for patients with impaired renal function.

Renal dysfunction. Since allopurinol and its metabolites are excreted from the body by the kidneys, impaired renal function may lead to retention of the drug and its metabolites in the body with a subsequent prolongation of T1/2 of these compounds from the blood plasma. In severe renal failure, it is recommended to use allopurinol in a dose not exceeding 100 mg/day, or to use single doses of 100 mg at intervals of more than one day.

If conditions allow the concentration of oxypurinol in the blood plasma to be controlled, then the dose of allopurinol should be adjusted so that the level of oxypurinol in the blood plasma is below 100 µmol/L (15.2 mg/L).

Allopurinol and its derivatives are removed from the body by hemodialysis. If hemodialysis sessions are performed 2-3 times a week, then it is advisable to determine the need to switch to an alternative therapy regimen - taking 300-400 mg of allopurinol immediately after completion of the hemodialysis session (the drug is not taken between hemodialysis sessions).

In patients with impaired renal function, the combination of allopurinol with thiazide diuretics should be done with extreme caution. Allopurinol should be administered at the lowest effective dose with close monitoring of renal function.

Liver dysfunction. If liver function is impaired, the dose of the drug must be reduced. At an early stage of therapy, it is recommended to monitor laboratory parameters of liver function.

Conditions accompanied by increased metabolism of uric acid salts (for example, tumor diseases, Lesch-Nyhan syndrome). Before starting therapy with cytotoxic drugs, it is recommended to correct existing hyperuricemia and (or) hyperuricosuria with allopurinol. Adequate hydration, which helps maintain optimal diuresis, as well as alkalinization of urine, which increases the solubility of uric acid and its salts, is of great importance. The dose of allopurinol should be close to the lower end of the recommended dosage range.

If renal dysfunction is caused by the development of acute uric acid nephropathy or other renal pathology, then treatment should be continued in accordance with the recommendations presented in the section Renal dysfunction.

The measures described can reduce the risk of xanthine and uric acid accumulation, which complicates the course of the disease.

Monitoring recommendations. To adjust the dose of the drug, it is necessary to evaluate the concentration of uric acid salts in the blood serum, as well as the level of uric acid and urate in the urine, at optimal intervals.

Instructions for use ALLOPURINOL

The use of the drug by patients with renal failure, as well as with hematopoietic disorders, should be under constant medical supervision.

Skin reactions are the most common reactions and can occur at any time during treatment; if they occur, allopurinol should be discontinued immediately. After symptoms have reduced, the drug can be prescribed in low doses (for example, 50 mg / day), gradually increasing the dose if necessary. If the skin rash recurs, the drug should be discontinued permanently, as severe generalized hypersensitivity reactions may occur.

There have been reports of life-threatening skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) with the use of allopurinol. Patients should be informed of the signs and symptoms of skin reactions and monitored closely. The highest risk of developing Stevens-Johnson syndrome and toxic epidermal necrolysis is during the first weeks of treatment.

If signs or symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis occur (eg, progressive skin rash, often with blisters, or mucosal lesions), Allopurinol 100 mg tablets should be discontinued immediately.

The best results in the treatment of Stevens-Johnson syndrome or toxic epidermal necrolysis have been obtained with early diagnosis and immediate discontinuation of the suspected drug. Early discontinuation of Allopurinol 100 mg tablets is associated with a better prognosis.

If a patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Allopurinol, 100 mg tablets, the use of Allopurinol, 100 mg tablets should not be resumed.

Vasculitis and tissue reactions associated with hypersensitivity reactions can have various manifestations, incl. hepatitis, kidney damage (interstitial nephritis) and, very rarely, seizures. These reactions can occur at any time during treatment; if they occur, the drug should be discontinued immediately.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

During the period of use of Allopurinol, it is necessary to refrain from driving vehicles and other mechanisms due to the possibility of dizziness or drowsiness.