Allopurinol-Egis 300 mg (30 tablets)
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The instruction for medical
of ALLOPURINOL-EGIS medicine
the Trade name
the International unlicensed
name Allopyrinolum Dosage Form
of the Tablet of 100 mg, 300 mg
One tablet contains
active agent: Allopyrinolum of 100 mg, 300 mg
lactoses monohydrate, potato starch, K-25 povidone, talc, magnesium stearate, sodium carboxymethylstarch (type A) (for a dosage of 100 mg)
cellulose microcrystalline, sodium carboxymethylstarch (type A), gelatin, silicon dioxide colloidal anhydrous, magnesium stearate (for a dosage of 300 mg)
Round flat tablets of white or grayish-white color, with a facet, with risky on one and with an engraving of the stylized letter E and number 351 on other party, without or almost flavourless (for a dosage of 100 mg)
Round flat tablets of white or grayish-white color, with a facet, with risky on one and with an engraving of the stylized letter E and number 352 on other party, without or almost flavourless (for a dosage of 300 mg)
Antigouty drugs. Inhibitors of synthesis of uric acid. Allopyrinolum.
The ATX M04AA01 code
Pharmacokinetics Allopyrinolum properties is active at oral administration. It is quickly soaked up from upper parts of digestive tract. Allopyrinolum is defined in blood plasma in 30-60 minutes after intake. The bioavailability of Allopyrinolum varies from 67% to 90%. The maximum concentration of Allopyrinolum and its metabolite of an oksipurinol are reached in blood plasma respectively in 1.5 and 35 h after reception. Then concentration of Allopyrinolum quickly decreases. 6 hours later after reception, in blood plasma only the trace concentration of drug is defined. Level of an oksipurinol in blood plasma decreases much more slowly.
Allopyrinolum almost does not contact proteins of blood plasma therefore changes of level of linking with proteins should not have considerable impact on clearance of drug. The seeming volume of distribution of Allopyrinolum is about 1.6 l/kg that speaks about rather significant absorption of drug fabrics. Allopyrinolum content in various body tissues is not studied, however it is very probable that Allopyrinolum and oksipurinol in the maximum concentration collect in a liver and a mucous membrane of intestines where the high activity of a xanthineoxidase is registered.
The main metabolite of Allopyrinolum is oksipurinol. Allopyrinolum riboside and an oksipurinol-7-riboside belong to other metabolites of Allopyrinolum.
About 20% of the accepted dose are removed with a stake in not changed look. Under the influence of a xanthineoxidase and aldehyde oxidase Allopyrinolum is metabolized with formation of an oksipurinol that is the main by Allopyrinolum removal. About 10% of a daily dose are excreted by the glomerular device of kidneys in the form of not changed Allopyrinolum. Elimination half-life of Allopyrinolum in plasma makes 0,5 1,5 hours.
Oksipurinol – not so powerful inhibitor of a xanthineoxidase, in comparison with Allopyrinolum, however its elimination half-life much more, from 13 to 30 hours. Thanks to these properties, after reception of a single daily dose of Allopyrinolum the effective suppression of activity of a xanthineoxidase is supported within 24 hours. At patients with normal function of kidneys the maintenance of an oksipurinol in blood plasma slowly increases up to achievement of equilibrium concentration. After intake of Allopyrinolum in a dose of 300 mg a day, concentration of Allopyrinolum in blood plasma as a rule makes 5-10 mg/l. Oksipurinol is brought by kidneys in not changed look, however in connection with a canalicular reabsorption it possesses long elimination half-life. Elimination half-life of Allopyrinolum makes 1-2 hours whereas elimination half-life of an oksipurinol varies from 13 to 30 hours. Such significant differences are probably connected with differences in structure of researches and/or clearance of creatinine at patients.
Special groups of patients
Patients with a renal failure
At patients with a renal failure the removal of Allopyrinolum and an oksipurinol can slow down considerably that at long therapy leads to growth of concentration of these connections in blood plasma. At patients with a renal failure and clearance of creatinine of 10-20 ml/min., after long-term therapy by Allopyrinolum in a dose of 300 mg a day the concentration of an oksipurinol in blood plasma made about 30 mg/l. Such concentration of an oksipurinol can decide at patients on normal function of kidneys against the background of therapy by Allopyrinolum in a dose of 600 mg a day. Therefore, at treatment of patients with a renal failure the dose of Allopyrinolum needs to be reduced.
Patients of advanced age
At patients of advanced age significant changes in pharmacokinetic properties of Allopyrinolum are improbable. The exception is made by patients with the accompanying pathology of kidneys.
Allopyrinolum is a structural analog of hypoxanthine. Allopyrinolum and also its main active metabolite – oksipurinol, inhibit a xanthineoxidase – the enzyme providing transformation of hypoxanthine to xanthine and xanthine in uric acid. Allopyrinolum reduces concentration of uric acid, both in blood serum, and in urine. Thereby it prevents adjournment of crystals of uric acid in fabrics and (or) promotes their dissolution. Besides suppression of catabolism of purines at some (but not at all) patients with a hyperuricemia, a large amount of xanthine and hypoxanthine becomes available to repeated formation of purine bases that leads to oppression of biosynthesis of de novo purines on the feedback mechanism mediated by enzyme oppression hypoxanthine-guanine phosphoribosyl-transferase. Other metabolites of Allopyrinolum Allopyrinolum riboside and oksipurinol-7 riboside.
Allopyrinolum is applied to suppression of formation of uric acid and its salts (urates) at the confirmed accumulation of these connections (for example, gout, skin tofusa, a nephrolithiasis) or at expected clinical risk of their accumulation (for example, treatment of malignant new growths can be complicated by development of a sharp urate nephropathy).
– the clinical states which are followed by accumulation of uric acid and its salts:
an urolithiasis (with formation of urates),
a sharp urate nephropathy,
tumoral diseases and myeloproliferative diseases with a high speed of updating of cell population when the hyperuricemia arises spontaneously or after performing cytotoxic therapy,
the certain enzymatic disturbances which are followed by hyperproduction of salts of uric acid, for example, insufficiency hypoxanthine-guanine-fosforiboziltransferazy (including Lesh-Nikhena’s syndrome), insufficiency of glyukozo-6-phosphatase (including glycogenoses), superactivity phosphoribosyl-pirofosfatsintetazy, superactivity of phosphoribosyl-pyrophosphate-amidotransferase, insufficiency adenine-fosforiboziltransferazy.
– treatment of the urolithiasis which is followed by formation of 2.8-digidroksiadeninovy (2.8-DGA) concrements in connection with hypoactivity adenine-fosforiboziltransferazy.
– prevention and treatment of the recurrent urolithiasis which is followed by formation of the mixed calcium-oxalic concrements against the background of a hyper uricosuria when the increased liquid consumption, the diet and other methods were inefficient.
The route of administration and doses
use Drug strictly on doctor’s orders!
Tablets for intake. Allopurinol-EGIS it is necessary to accept after a meal, washing down with a large amount of water. Allopyrinolum is usually well transferred, especially at reception after a meal. At the daily doses exceeding 300 mg the patients can have complaints from digestive tract therefore such doses need to be divided into several receptions.
For reduction of risk of development of side effects treatment it is necessary to begin with an initial dose 100 mg once a day.
If necessary, if the level of uric acid in blood serum decreases insufficiently, the initial dose is gradually increased by 100 mg before obtaining desirable effect. At increase in a dose of Allopurinol-EGIS each 1-3 weeks need to be defined concentration of uric acid in blood serum.
At selection of a dose of drug it is recommended to use the following modes of dosing:
– 100-200 mg a day at an easy course of the disease
– 300-600 mg a day at a medium-weight course
– 700-900 mg a day at a heavy course.
If when calculating a dose it is necessary to proceed from the body weight of the patient, then the dose of Allopurinol-EGIS has to make from 2 to 10 mg/kg/days.
Children and teenagers are younger than 15 years
Aged from 10 up to 15 years appoint 10-20 mg/kg/days. The maximum daily dose – 400 mg.
Allopyrinolum is applied in children’s therapy in malignant oncological diseases (especially leukemias) and some enzymatic disturbances (for example, Lesh-Naykhana’s syndrome).
Patients of advanced age
in the absence of specific data it is necessary to apply the minimal effective doses providing sufficient decrease in concentration of uric acid in blood serum. Special attention needs to be paid to recommendations about selection of a dose of drug for patients with impaired renal function and some other states.
As Allopyrinolum and its metabolites are brought out of an organism by kidneys, the renal failure can lead to a delay of drug and its metabolites in an organism with the subsequent lengthening of elimination half-life of these connections from blood plasma. In a heavy renal failure of Allopurinol-EGIS it is recommended to apply in the dose which is not exceeding 100 mg a day or to use single doses on 100 mg with an interval more than one day.
If there is an opportunity to control concentration of an oksipurinol in blood plasma, then the dose of Allopurinol-EGIS should be picked up so that the level of an oksipurinol in blood plasma was lower than 100 µmol/l (15.2 mg/l).
Allopyrinolum and its metabolites are removed from an organism at a hemodialysis. If sessions of a hemodialysis are held 2-3 times a week, then it is reasonable to define need of transition to the alternative mode of therapy reception of 300-400 mg of Allopurinol-EGIS right after completion of a session of a hemodialysis (between hemodialysis sessions the drug is not taken).
With renal failures the simultaneous use of Allopurinol-EGIS with thiazide diuretics demands extra care from patients. At the same time Allopyrinolum should be applied in the lowest effective dose at careful monitoring of function of kidneys.
Abnormal liver functions
In an abnormal liver function a dose of drug need to be lowered. At an early stage of therapy it is recommended to carry out monitoring of laboratory indicators of function of a liver.
The states which are followed by strengthening of exchange of salts of uric acid (for example, tumoral diseases, Lesh-Nikhena’s syndrome)
before therapy cytotoxic drugs recommend to execute correction of the existing hyperuricemia and (or) hyper uricosuria by means of Allopurinol-EGIS. The adequate hydration promoting maintenance of an optimum diuresis and also urine alkalization thanks to which the solubility of uric acid and its salts increases is of great importance. The dose of Allopurinol-EGIS has to be close to the lower bound of the recommended range of doses.
If the renal failure is caused by development of a sharp urate nephropathy or other renal pathology, then treatment should be continued according to the recommendations provided in the section of the Renal failure.
The described measures can reduce risk of accumulation of the xanthine and/or uric acid complicating the course of the disease.
The recommendation about monitoring
For establishment of an optimum dose of drug needs to estimate periodically concentration of salts of uric acid in blood serum and also the level of uric acid and urates to urine.
Are absent modern clinical data for determination of frequency of development of side effects. Their frequency can vary depending on a dose and from whether drug as monotherapy or in a combination with other drugs was appointed.
Often (from & gt, 1/100 to & lt, 1/10)
Infrequently (from & gt, 1/1000 to & lt, 1/100)
– reactions of hypersensitivity
– change of results of functional hepatic trials
– vomiting, nausea, diarrhea
Seldom (from & gt, 1/10000 to & lt, 1/1000)
– hepatitis (including necrotic and granulematozny forms)
– heavy reactions from skin (Stephens-Johnson’s syndrome (SJS) and the toxic epidermal necrolysis (TEN))
Is very rare (& lt, 1/10000)
– a furunculosis
– an agranulocytosis, aplastic anemia, thrombocytopenia, a granulocytosis, a leukopenia, a leukocytosis, the eosinophilia and an aplasia concerning only erythrocytes
– an angioimmunoblastny T-cellular lymphoma
– diabetes, a lipidemia
– a depression
– a coma, paralysis, an ataxy, peripheral neuropathy, paresthesias, drowsiness, a headache, a perversion of flavoring feelings
– a cataract, disorders of vision, macular changes
– dizziness (vertigo)
– stenocardia, bradycardia
– arterial hypertension
– a recurrent hematemesis, stomatitis, a steatorrhea, changes of frequency of defecation
– a Quincke’s disease, local medicamentous rash, an alopecia, discoloration of hair
– a hamaturia, uraemia
– male infertility, erectile dysfunction, a gynecomastia
– hypostasis, a general malaise, the general weakness, fever
Frequency is unknown (it is impossible to define proceeding from available data).
– an urolithiasis
– an abdominal pain
messages about thrombocytopenia, an agranulocytosis and aplastic anemia, in particular at persons with renal failures and/or a liver Very seldom arrived that emphasizes need of manifestation of extra care at these groups of patients.
Heavy reactions of hypersensitivity, including skin reactions with amotio of epidermis, fever, a lymphadenopathy, an arthralgia and (or) an eosinophilia (including Stephens-Johnson’s syndrome and a toxic epidermal necrolysis). The accompanying vasculitis or reactions from fabric can have various manifestations, including hepatitis, damage of kidneys an acute cholangitis, ksantinovy concrements and, seldom or never, spasms. Development of an acute anaphylaxis was very seldom observed. At development of heavy undesirable reactions the reception of Allopurinol-EGIS needs to stop and be not to resumed immediately.
At the delayed multiorgan hypersensitivity (known as a syndrome of medicinal hypersensitivity / DRESS/) the following symptoms in various combinations can develop: fever, skin rash, vasculitis, lymphadenopathy, pseudo-lymphoma, arthralgia, leukopenia, eosinophilia, gepato-splenomegaly, change of results of hepatic functional tests, syndrome of disappearing bile ducts (destruction or disappearance of intra hepatic bile ducts). There can be disturbances from other bodies (for example, a liver, lungs, kidneys, a pancreas, a myocardium and a large intestine). At development of such reactions during any period of treatment, reception of Allopurinol-EGIS it is necessary to cancel immediately and never to renew. Patients cannot appoint repeatedly the drug Allolpurinol-EGIS with a syndrome of hypersensitivity and SSD/TEN. Corticosteroids can be applied to treatment of skin reactions at hypersensitivity.
Generalized reactions of hypersensitivity developed at patients with impaired renal function and (or) a liver, in particular in cases with a lethal outcome.
The Angioimmunoblastny T-cellular lymphoma was very seldom diagnosed after a biopsy of lymph nodes concerning a generalized lymphadenopathy. The Angioimmunoblastny lymphadenopathy has reversible character and regresses after the therapy termination by Allopyrinolum.
In earlier conducted clinical trials observed nausea and vomiting, however later observations confirmed that these reactions are not clinically significant and they can be avoided, appointing Allopurinol-EGIS after a meal.
Abnormal liver functions can develop without strong indications of generalized hypersensitivity
At the patients accepting Allopyrinolum undesirable reactions from skin are most widespread. Against the background of therapy by drug these reactions can develop at any time. Skin reactions can be shown by an itching, makulopapulezny and scaly rashes. In other cases the purpura can develop. Exfoliative damage of skin (SSD/TEN) is in rare instances observed. At development of similar reactions the therapy by Allopyrinolum needs to be stopped immediately. If reaction from skin has easy temper, then after disappearance of these changes it is possible to resume intake of Allopyrinolum in a smaller dose (for example, 50 mg a day). Subsequently the dose can be increased gradually. When recuring skin reactions the therapy by Allopyrinolum needs to be stopped and not to renew any more as further administration of drug can lead to development of heavier reactions of hypersensitivity. If it is impossible to exclude SSD/TEN or other reactions of hypersensitivity, it is IMPOSSIBLE to resume treatment by Allopyrinolum owing to risk of development of heavy or fatal reactions. The clinical diagnosis of SSD/TEN is a basis for adoption of the correct decision. If such reactions arise at any time against the background of the carried-out treatment, Allopyrinolum should be cancelled immediately without a possibility of repeated purpose of treatment.
Against the background of therapy by Allopyrinolum fever developed as separately, and in combination with symptoms of generalized reaction of hypersensitivity
of the Contraindication
– hypersensitivity to active ingredients or any of components
6 Mercaptopurinum and Azathioprinum
Azathioprinum is metabolized with education 6 Mercaptopurinums which is inactivated by enzyme a xanthineoxidase. In cases when therapy by 6 Mercaptopurinum or Azathioprinum is combined with Allopyrinolum, the patients should appoint only one quarter of a usual dose 6 Mercaptopurinum or Azathioprinum as oppression of activity of a xanthineoxidase increases duration of action of these connections.
Vidarabin (adenine arabinozid)
At simultaneous use with Allopurinol-EGIS elimination half-life of a vidarabin increases. At simultaneous use of these drugs it is necessary to observe special caution concerning the enhanced toxic effects of therapy.
Salicylates and uricosuric means
the Main active metabolite of Allopyrinolum is oksipurinol which is removed by kidneys similar to salts of uric acid. Therefore, medicines with uricosuric activity, such as probenetsid or high doses of salicylates, can strengthen removal of an oksipurinol. In turn, the strengthened removal of an oksipurinol is followed by reduction of therapeutic activity of Allopyrinolum, however the importance of this type of interaction needs to be estimated individually in each case.
At simultaneous use of Allopyrinolum and chlorpropamide, at patients with impaired renal function increases risk of development of a long hypoglycemia as at a stage of canalicular excretion Allopyrinolum and chlorpropamide compete among themselves.
Anticoagulants derivative coumarin
At simultaneous use with Allopyrinolum strengthening of effects of warfarin and other anticoagulants of derivatives of coumarin was observed. In this regard, it is necessary to control carefully a condition of the patients receiving the accompanying therapy by these drugs.
Allopyrinolum is capable to suppress oxidation of Phenytoinum in a liver, however the clinical importance of this interaction is not established.
It is known that Allopyrinolum oppresses theophylline metabolism. Similar interaction can be explained with participation of a xanthineoxidase in the course of theophylline biotransformation in a human body. Concentration of theophylline in blood serum needs to be controlled at the beginning of the accompanying therapy by Allopyrinolum and also at increase in a dose of the last.
Ampicillin and amoxicillin
At the patients who were at the same time receiving ampicillin or amoxicillin and Allopyrinolum the increased frequency of development of reactions from skin was registered, in comparison with patients who did not receive the similar accompanying therapy. The reason of this type of medicinal interaction is not established yet. Nevertheless, the patients receiving Allopyrinolum instead of ampicillin and amoxicillin are recommended to appoint other antibacterial drugs.
Cyclophosphamide, doxorubicine, bleomycin, Procarbazinum, mekhloretamin
At patients with tumoral diseases (except leukemia) and receiving Allopyrinolum, the strengthened suppression of activity of marrow was observed by cyclophosphamide and other cytotoxic drugs. Nevertheless, according to results of controlled researches, with participation of the patients accepting cyclophosphamide, doxorubicine, bleomycin, Procarbazinum and (or) mekhloretamin (chlormethine a hydrochloride), the accompanying therapy by Allopyrinolum did not strengthen toxic influence of these cytotoxic drugs.
According to some messages, concentration of cyclosporine in blood plasma can increase against the background of the accompanying therapy by Allopyrinolum. At simultaneous use of these drugs it is necessary to consider a possibility of strengthening of toxicity of cyclosporine.
At the healthy volunteers and HIV-positive patients receiving didanozin against the background of the accompanying therapy Allopyrinolum (300 mg a day) observed increase in Cmax (the maximum concentration of drug in blood plasma) and AUC (the area under a curve concentration time) a didanozina approximately twice. Elimination half-life of a didanozin at the same time did not change. As a rule, simultaneous use of these medicines is not recommended. If the accompanying therapy is inevitable, the dose decline of a didanozin and careful observation of a condition of the patient can be required.
Simultaneous use of iAPF with Allopyrinolum is followed by the increased risk of development of a leukopenia, thus, these drugs should be combined with care.
It was reported about the interaction between Allopyrinolum and furosemide leading to increase in content of urates in serum of blood and a plasma oksipurinol.
There are messages about increase in risk of development of reactions of hypersensitivity at simultaneous use of Allopyrinolum with diuretics, especially from tiazida and for patients with a renal failure.
At therapy by the drug Allopurinol-EGIS it was reported about development of life-threatening reactions from skin, such as Stephens-Johnson’s syndrome (SJS) and toxic epidermal necrolysis (TEN). Patsiyentov it is necessary to inform on symptoms and signs of these states and to make careful observation in terms of development of reactions from skin. The likelihood of development of SSD and TEN is highest on the first weeks of treatment. At appearance of skin rash or other manifestations of reaction of hypersensitivity (the progressing skin rash which is often followed by blisters or damage of mucous) it is necessary to stop the Allopurinol-EGIS drug treatment immediately. Treatment of SSD and TEN is the most effective at their early diagnostics and immediate cancellation of the suspected medicines, fast cancellation of these drugs is followed by the best forecast. If at the patient SSD or TEN caused by administration of drug of Allopurinol-EGIS developed, then repeated purpose of the tablets Allopurinol-EGIS is forbidden.
The syndrome of hypersensitivity, SSD and TEN
the Demonstration of reactions of hypersensitivity to Allopyrinolum can be the most various, including a makulopapulezny dieback, a syndrome of medicinal hypersensitivity (DRESS) and SSD/TEN. These reactions are the clinical diagnosis and their clinical manifestations form a basis for adoption of the relevant decisions. Therapy by the drug Allopurinol-EGIS should be stopped immediately at appearance of skin rash or other manifestations of reaction of hypersensitivity. It is impossible to resume therapy at patients with a syndrome of hypersensitivity and SSD/TEN. Corticosteroids can be applied to treatment of skin reactions at hypersensitivity.
The chronic renal failure
the Patients with a chronic renal failure who are at the same time accepting diuretics, especially tiazida has bigger risk of development of the reactions of hypersensitivity connected with intake of Allopyrinolum including SSD/TEN.
It is necessary to monitor development of a syndrome of a giperchuvstivtelnost or SSD/TEN very carefully. Patsiyentov it is necessary to inform that at the first emergence of such symptoms, it is necessary to cancel treatment immediately and forever
the Allele of HLA-B*5801
It was established that presence allelya HLA-B*5801 is risk factor of development caused by SSD/TEN Allopyrinolum, (and, perhaps, other reactions of hypersensitivity) on what specify results of a retrospective pharmacogenetic case control research in population of Chinese Han, Taiwanese, Koreans, Japanese and Europeans presence Frequency allelya HLA-B*5801 can reach 20-30% in population of Chinese Han, and persons of the African and Indian origin while only at 1-2% of Japanese, northern Europeans and Americans of the European origin are carriers allelya HLA-B*5801. It is reasonable to weigh a possibility of use of genotyping on this an allele prior to treatment by Allopyrinolum. If it is known that the patient is the carrier allelya HLA-B*5801, then it is only necessary to appoint Allopyrinolum if there are no other methods of treatment and if the advantage of treatment exceeds possible risk. Patients, not being carriers alelya HLA-B*5801, nevertheless have a low risk of development of SSD/TEN. The clinical diagnosis of SSD/TEN and other reactions of hypersensitivity is a basis for adoption of the therapeutic decision. If such reactions develop at any time against the background of treatment, Allopyrinolum should be cancelled immediately without a possibility of resuming of therapy. Corticosteroids can be applied to treatment of skin reactions at hypersensitivity.
At treatment of patients with impaired renal function or a liver the dose of Allopyrinolum needs to be lowered. At the patients receiving treatment concerning arterial hypertension or heart failure (for example, the patients accepting diuretics or APF inhibitors), the accompanying renal failure can be observed therefore Allopyrinolum in this group of patients should be used with care.
The asymptomatic hyperuricemia
In itself is not the indication to use of Allopurinol-EGIS. In such cases the improvement of a condition of patients can be reached thanks to changes in a diet and intake of liquid along with elimination of a basic reason of a hyperuricemia.
The bad attack of gout
Allopyrinolum cannot be applied before full stopping of a bad attack of gout as these can provoke additional exacerbation of a disease.
Similar to therapy by uricosuric means, the initiation of treatment Allopyrinolum can provoke a bad attack of gouty arthritis. To avoid this complication, it is recommended to carry out preventive therapy by the corresponding anti-inflammatory drugs or colchicine within at least one month to prescribing of Allopyrinolum. Detailed data on the recommended doses, cautions and precautionary measures can be found in the corresponding literature.
If the bad attack of gout develops against the background of therapy by Allopyrinolum, then administration of drug should be continued in the same dose, and for treatment of an attack it is necessary to appoint suitable non-steroidal anti-inflammatory drug.
Deposits of xanthine
In cases when formation of urates is considerably strengthened (for example, a malignant tumor and the corresponding antineoplastic therapy, Lesh-Naykhana’s syndrome), absolute concentration of xanthine in urine only in rare instances can reach the levels promoting accumulation of xanthine in fabrics of uric ways. Probability of accumulation of xanthine in fabrics can be minimized thanks to adequate hydration which provides optimum cultivation of urine.
Vklineniye of concrements from uric acid.
Adequate therapy by Allopyrinolum can lead to dissolution of large concrements from uric acid and, therefore, to low probability a vklineniya of these concrements in ureters.
the Main effect of Allopyrinolum at treatment of gout consists in suppression of activity of enzyme of a xanthineoxidase. The xanthineoxidase can participate in reduction of maintenance and removal of the iron deposited in a liver. The researches showing safety of therapy by Allopyrinolum at patients with hemochromatosis no. To patients with hemochromatosis and also to their blood relatives it is necessary to appoint Allopyrinolum with care.
The drug Allopurinol-EGIS of a tablet of 100 mg contains lactose.
Each tablet Allopurinol-EGIS of 100 mg – contains 50 mg of lactose. Patients with rare hereditary diseases, such as intolerance of a galactose, deficiency of lactase or glyukozo-galaktozny malabsorption should not take this drug.
Pregnancy and the period of a lactation
of Data on safety of therapy by Allopyrinolum during pregnancy are not enough though this drug was widely used within long years without obvious adverse effects.
During pregnancy it is impossible to accept Allopurinol-EGIS unless there is no less dangerous alternative treatment and the disease makes bigger risk for mother and a fruit, than administration of drug.
According to the existing messages, Allopyrinolum and oksipurinol is emitted with breast milk. At the women accepting Allopyrinolum in a dose of 300 mg/days, concentration of Allopyrinolum and an oksipurinol in breast milk reached, respectively, 1.4 mg/l and 53.7 mg/l. Nevertheless, data on influence of Allopyrinolum and its metabolites on the babies staying on breastfeeding no. Thus, the drug Allopurinol-EGIS of a tablet is not recommended during breastfeeding.
Features of influence of medicine on ability of control of vehicles and potentially dangerous mechanisms
Against the background of therapy Allopyrinolum observed development of such undesirable reactions as drowsiness, dizziness (vertigo) and an ataxy which can affect ability of control of vehicles and potentially dangerous mechanisms. The patients taking the drug Allopurinol-EGIS should not run vehicles and mechanisms until they are not sure that Allopyrinolum has no adverse impact on these abilities.
Symptoms: nausea, vomiting, diarrhea, dizziness were observed at the patient who accepted 20 g of Allopyrinolum.
There is a message about reception of 22.5 g of Allopyrinolum without development of side effects. The heavy overdose can lead to considerable oppression of activity of a xanthineoxidase. This effect in itself should not be followed by undesirable reactions. The exception makes influence on the accompanying therapy, in particular on treatment by 6 Mercaptopurinum and (or) Azathioprinum.
Treatment: Specific antidote is unknown. The adequate hydration supporting an optimum diuresis promotes removal of Allopyrinolum and its derivatives with urine. In the presence of clinical indications the hemodialysis is shown.
Form of release and packing
On 30 (for a dosage of 300 mg) and 50 (for a dosage of 100 mg) tablets in a bottle from brown glass corked by a cover from polyethylene with control of the first opening and supplied with the shock-absorber accordion for glass bottles.
On 1 bottle in a cardboard pack together with the instruction for medical use in the state and Russian languages.
Not to use a period of storage of 5 years after an expiration date.
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