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Dopegit 250 mg No. 50 tablet.

Instructions for medical use of the drug DOPEGITâ Trade name Dopegitâ International nonproprietary name Methyldopa Dosage form Tablets 250 mg Composition One tablet contains the active substance - methyldopa anhydrous 250 mg (equivalent to methyldopa sesquihydrate 282 mg), excipients: corn starch, ethylcellulose, talc, sodium starch glycolate (type A), stearic acid, magnesium stearate. Description White or grayish-white round flat tablets with a bevel, smooth on one side, engraved with DOPEGYT on the other side, odorless or almost odorless. Pharmacotherapeutic group Antihypertensive drugs. Central agonists. Methyldopa (levorotatory). ATC code C02A B01 Pharmacological properties Pharmacokinetics Absorption of methyldopa from the gastrointestinal tract is variable. After oral administration, bioavailability is 25%. Maximum plasma concentration is achieved after 2-3 hours. Binding to plasma proteins is less than 20%. The site of the main and intensive metabolism of methyldopa is the liver. The drug's active metabolite, alpha-methylnorepinephrine, originates from central adrenergic neurons. In addition, many other metabolites are known to be excreted in urine. Approximately 2/3 of methyldopa is excreted in the urine as methyldopa or sulfate conjugate, and the remaining amount is excreted unchanged in the feces. Removal is biphasic. With normal renal function, the half-life is 1.8 ± 0.2 hours. The active component of the drug is completely eliminated from the body within 36 hours. Methyldopa is eliminated during hemodialysis. Six-hour hemodialysis can remove 60% of the absorbed dose of methyldopa from the circulating blood, and peritoneal dialysis within 20-30 hours removes approximately 22-39%. Methyldopa crosses the placental barrier and is excreted into breast milk. The maximum reduction in blood pressure occurs 4 - 6 hours after taking one dose orally and lasts 12 - 24 hours. After repeated administration, the maximum hypotensive effect develops within 2 to 3 days. After discontinuation of the drug, blood pressure returns to its original level within 1 to 2 days. In renal failure, the elimination of methyldopa slows down in accordance with the degree of decline in renal function. In severe cases (without hemodialysis), the half-life of methyldopa is extended by 10 times. Pharmacodynamics The active substance of the drug, methyldopa, is a centrally acting antihypertensive agent. The mechanism of its action is currently still completely unknown. The active metabolite (α-methylnorepinephrine) formed in the central nervous system stimulates central inhibitory presynaptic α2-adrenoreceptors, reducing sympathetic tone; replaces endogenous dopamine in dopaminergic nerve endings as a false neurotransmitter; reduces plasma renin activity and reduces peripheral vascular resistance; inhibits the enzyme dopa decarboxylase, thereby reducing the synthesis of norepinephrine, dopamine, serotonin and the concentration of norepinephrine and adrenaline in tissues. Dopegit has no direct effect on cardiac function, does not reduce cardiac output, does not cause reflex tachycardia, and does not reduce glomerular filtration rate, renal blood flow, or filtered fraction. In some cases, the heart rate decreases. The drug reduces blood pressure when the patient is lying down or standing and only in rare cases causes orthostatic hypotension. Indications for use: arterial hypertension. Method of administration and dosage: Tablets for oral administration. The tablets can be taken before or after meals. The recommended starting dose is 250 mg 2-3 times a day for the first two days. The daily dose may then be increased or decreased, depending on the degree of blood pressure reduction, at two-day intervals. To reduce the severity of sedation, which is possible at the beginning of the course of treatment and when increasing the dose, first increase the evening dose. Maintenance dose - 500-2000 mg 2-4 times a day. If the drug is insufficiently effective at a dose of 2 g/day, it is recommended to use a combination with other antihypertensive drugs. After 1 to 3 months of treatment, tolerance may develop. Effective blood pressure control can be restored by adding a diuretic or increasing the dose of methyldopa. After discontinuation of Dopegyt, blood pressure returns to the initial level after 48 hours without the phenomenon of reverse effects. Dopegit can also be used in patients who are already taking other antihypertensive drugs, gradually withdrawing the previous drug. In such cases, the recommended starting dose is 500 mg per day. To achieve the desired therapeutic effect, the dose can be increased at intervals of at least two days. If Dopegit is used as an addition to existing antihypertensive therapy, it may be necessary to change the dose of the antihypertensive drug so that the transition to combination therapy occurs without complications. In elderly patients, the initial dose should be lower and not exceed 500 mg/day. If necessary, the dose can be gradually increased every 2 days to a maximum dose of 2 g/day, which cannot be exceeded. Syncope (loss of consciousness), which is more often observed in elderly patients, probably associated with the increased sensitivity of elderly patients and with a pronounced narrowing of the lumen of blood vessels, can be avoided by using lower doses. If renal function is impaired, reduced doses should be used. In case of mild renal failure (glomerular filtration rate GFR > 50 ml/min), an interval of 8 hours should be maintained between doses, in case of moderate renal failure (GFR = 10-50 ml/min) with an interval of 8-12 hours, and in case of severe renal failure (GFR < 10 ml/min) 12-24 hours. Since methyldopa is removed by hemodialysis, the patient should be given an additional dose of 250 mg after this procedure to avoid an increase in blood pressure. Children and adolescents under 18 years of age The recommended initial dose in children is 10 mg/kg body weight per day in 2 to 4 doses. If necessary, the daily dose can be gradually increased (up to 65 mg/kg body weight) at intervals of at least two days. The daily dose should not exceed 3000 mg. The dose of the drug and duration of treatment are determined by the doctor individually depending on the clinical condition of the patient. Side effects Very common (≥ 1/10) - positive Coombs test Rare (≥ 1/10,000 and <1/1000) - hemolytic anemia, leukopenia, granulocytopenia, thrombocytopenia Very rare (<1/10,000) - myocarditis, pericarditis - parkinsonism - increased angina - pancreatitis - hepatitis, liver necrosis Not known (frequency cannot be estimated from available data) - bone marrow suppression, positive test for antinuclear antibodies, LE cells, rheumatoid factor - hyperprolactinemia, gynecomastia, galactorrhea, amenorrhea - nightmares, usually unexpressed, transient psychosis or depression, decreased libido - peripheral paresis of the facial nerve, lethargy, involuntary choreoathetotic movements, symptoms of cerebrovascular insufficiency (possibly associated with hypotension), headache, sedation (usually transient), apathy, weakness, dizziness, paresthesia - congestive heart failure, sinus bradycardia, edema, weight gain. Edema and weight gain usually respond well to diuretics. If edema becomes more pronounced, as well as when symptoms of heart failure appear, treatment with the drug should be discontinued - increased sensitivity of the carotid sinus, orthostatic hypotension (a dose reduction is recommended) - nasal congestion - colitis, vomiting, inflammation of the salivary glands, soreness or blackening of the tongue, nausea , constipation, flatulence, dry mouth - cholestasis, jaundice, liver function test disorders - toxic epidermal necrolysis, eczema, lichenoid eruptions - impotence, ejaculation disorders - increased residual blood nitrogen Contraindications - hypersensitivity to the active or other components of the drug - liver dysfunction associated with previous use of methyldopa - active stage of liver disease (active hepatitis or active cirrhosis) - concomitant therapy with monoamine oxidase inhibitors - depression - pheochromocytoma - children under 18 years of age. Drug interactions Dopegit should not be used simultaneously with monoamine oxidase inhibitors. Concomitant use with the following drugs requires special caution: Drugs that reduce the hypotensive effect of Dopegit: - sympathomimetics - tricyclic antidepressants - phenothiazines (at the same time, an additive hypotensive effect is possible) - oral iron preparations (ferrous sulfate and gluconate/II) (may reduce the bioavailability of methyldopa) - non-steroidal anti-inflammatory drugs - estrogen drugs · Drugs that enhance the hypotensive effect of the drug Dopegit: - other antihypertensive drugs (summation of hypotensive effects is possible) - anesthetics Dopegit and the following drugs can change the effects of each other: - lithium preparations (possible development of lithium intoxication ) - levodopa (reduced antiparkinsonian effect and increased undesirable effect on the central nervous system) - ethanol and other drugs that depress the central nervous system (increased depression of the central nervous system) - anticoagulants (increased anticoagulant effect, risk of bleeding) - bromocriptine (possibly undesirable effect on concentration of prolactin) - haloperidol (possible impairment of cognitive functions - disorientation and confusion). Special instructions During treatment with drugs containing methyldopa, hemolytic anemia may develop in rare cases. If symptoms indicating hemolytic anemia develop, it is necessary to determine the hematocrit and hemoglobin level. If anemia is confirmed, further studies should be performed to confirm hemolysis. If hemolytic anemia is confirmed, methyldopa should be discontinued immediately. After discontinuation of the drug, hemolytic anemia quickly resolves without or with the help of corticosteroid treatment. In rare cases, fatalities have been observed. If hemolytic anemia is caused by taking methyldopa, the patient should not continue to receive this drug. In some patients, with long-term use of Dopegyt, a positive Coombs test may be observed. A positive Coombs test, according to the literature, can occur in 10 - 20% of patients receiving this drug. A positive Coombs test is rarely observed during the first 6 months of treatment. If it does not develop within 12 months, then its development is unlikely with further use of this drug. A positive Coombs test is dose-dependent and is unlikely to develop at doses less than 1 g/day. A positive Coombs test that developed during treatment with Dopegyt may become negative only a few weeks or months after discontinuation of the drug. Before starting the course of treatment, as well as at 6 and 12 months of treatment with Dopegyt, the number of blood cells should be examined and a direct Coombs test should be performed. The mere presence of a previous positive Coombs test or its occurrence in a patient during treatment is not a contraindication to Dopegyt therapy. If the Coombs test becomes positive during treatment with Dopegyt, the presence of hemolytic anemia and the degree of clinical significance of a positive Coombs test should be checked. Information about the presence of a positive Coombs test helps in the evaluation of cross-blood compatibility testing. If a blood transfusion is necessary in a patient receiving Dopegyt, direct and indirect Coombs tests should be performed. In the absence of hemolytic anemia, only the direct Coombs test is usually positive. The direct Coombs test itself does not affect blood typing or crossmatching. If the indirect Coombs test is also positive, consultation with a hematologist or transfusiologist is necessary. During treatment, rare cases of leukopenia, granulocytopenia and thrombocytopenia are possible. Typically, the granulocyte count normalizes after discontinuation of methyldopa. Thrombocytopenia is also reversible. In some cases, fever may occur, accompanied by eosinophilia and liver dysfunction. Jaundice may also develop with or without fever. These symptoms usually develop in the 2nd – 3rd month of treatment. In some cases, the symptoms were found to be due to cholestasis. Biopsies were taken from some patients with liver dysfunction. Histological examination revealed focal necrosis, characteristic of a hypersensitivity reaction. Before starting treatment with Dopegyt and during the first 6–12 weeks of treatment, as well as at any time with the development of fever of unknown etiology, tests to determine liver function, as well as qualitative and quantitative blood tests are recommended. Therefore, if fever, changes in the activity of liver enzymes or jaundice occur, the course of treatment with Dopegyt should be stopped immediately. If this condition is caused by a hypersensitivity reaction, the increase in temperature and changes in laboratory parameters disappear after discontinuation of the drug. Such patients should not be prescribed Dopegit in the future. This drug should be given with extreme caution to patients with a history of liver disease or impairment. Patients receiving Dopegyt may require reduced doses of anesthetics. If hypotension occurs during anesthesia, vasoconstrictor drugs can be administered to correct it. Adrenergic receptors remain sensitive when using methyldopa. Some patients may experience swelling or weight gain while taking Dopegyt; in these conditions, diuretics should be prescribed. Treatment with Dopegyt should not be continued if edema increases or symptoms of heart failure develop. Methyldopa is eliminated by dialysis. Therefore, after this procedure, blood pressure in patients on hemodialysis may increase. In rare cases, involuntary choreoathetotic movements may occur in patients with severe bilateral cerebral vascular disease. In this case, treatment should be discontinued. Extreme caution is required when prescribing Dopegyt to patients with hepatic porphyria or their close relatives. Dopegit can change the results of the analysis of uric acid in urine using the phosphotungstic acid method, the determination of serum creatinine by the alkaline picrate method, and the colorimetric determination of the AST enzyme. To date, there is no evidence that methyldopa changed the results of spectrophotometric determination of AST. Since methyldopa fluoresces at the same wavelength as catecholamines, the use of Dopegyt may give pseudo-positive results; high concentrations of catecholamines may be detected in the urine, which interferes with the diagnosis of pheochromocytoma. However, methyldopa does not affect the results of measurements of VMA (vanillyl mandelic acid) in urine. Drinking alcohol is not recommended during treatment. Pregnancy and lactation For arterial hypertension in pregnant women, the drug should be prescribed after careful medical supervision. Available data showed no evidence of harm to the fetus or newborn. The drug can be prescribed to pregnant women, women planning pregnancy and women who have the possibility of pregnancy, only in cases where the expected benefit of treatment outweighs the possible risk. Methyldopa passes through the placenta and is detected in the blood of the umbilical cord and in breast milk. Dopegit can be prescribed to nursing mothers only after careful comparison of the expected benefits of treatment and the possible risks. Features of the effect of the drug on the ability to drive a vehicle and potentially dangerous mechanisms Dopegit may have a sedative effect, which is usually transient and can be observed either at the beginning of treatment or when the dose is increased. If patients develop symptoms indicating the development of sedation, they are prohibited from driving a vehicle or performing work that requires concentration. Overdose Symptoms: severe arterial hypotension, bradycardia, drowsiness, weakness, dizziness, nausea, vomiting, intestinal atony, flatulence, constipation, diarrhea. Treatment: symptomatic treatment - gastric lavage, stimulation of vomiting (if the drug has been taken recently). After absorption of the drug, its excretion through the kidneys can be stimulated by administering fluids. Monitoring of heart rate, cardiac output and blood volume, electrolyte balance, bowel and renal function, and brain function is required. According to indications, sympathomimetics (for example, adrenaline) are prescribed. If a chronic overdose is suspected, the drug Dopegit should be discontinued. Release form and packaging 50 tablets are placed in brown glass bottles with polyethylene caps, with first-opening control and equipped with an accordion shock absorber. One bottle each along with instructions for medical use in the state and Russian languages in a cardboard pack. Storage conditions Store at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life: 5 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription 1106 BUDAPEST, st. Keresturi, 30-38 Hungary Phone: (36-1) 803-5555, fax: (36-1) 803-5529 Registration certificate owner JSC "EGIS Pharmaceutical Plant", Hungary Address of the organization accepting claims from consumers on the territory of the Republic of Kazakhstan quality of products (goods) Representative office in the Republic of Kazakhstan CJSC "EGIS Pharmaceutical Plant" 050060, Almaty, st. Zharokova 286 G tel: +, +, fax: + 7 (727) 247 61 41 e-mail