Dopegit

Dopegit – drug with hypotensive action.

Form of release and structure

Dopegit release in the form of tablets: grayish-white or white color, round, flat, with a facet and a text of "DOPEGYT" on one of the parties, without or almost inodorous (on 50 pieces in brown glass bottles, on 1 bottle in a cardboard pack).

Is a part of 1 tablet:

• Active agent: Methyldopum – 250 mg (in shape sexivihydrat Methyldopums – 282 mg);
• Auxiliary components: talc – 6 mg; stearic acid – 3 mg; corn starch – 45,7 mg; sodium carboxymethylstarch – 3,5 mg; ethyl cellulose – 8,8 mg; magnesium stearate – 1 mg.

Indications to use

Dopegit appoint at arterial hypertension.

Contraindications

• Hemolitic anemia;
• Depression;
• Pheochromocytoma;
• Acute myocardial infarction;
• Cirrhosis, acute hepatitis;
• Liver diseases in the anamnesis (at reception Methyldopums);
• The accompanying therapy by monoamine oxidase inhibitors;
• Age up to 3 years;
• Hypersensitivity to drug components.

The feeding and pregnant women of Dopegit can accept only after ratio assessment "advantage/risk" for health of mother and the child.

Dopegit it is necessary to take with caution to children of 3 years, to patients of advanced age, and also patients with a renal failure (dose adjustment is necessary) and a diencephalic syndrome.

Route of administration and dosage

Dopegit it is necessary to accept inside, administration of drug to or after food is possible.

The doctor sets the dosing mode individually.

Adult patients in the first 2 days of treatment of Dopegit are recommended to accept 2-3 times a day on 0,25 g (1 tablet). Further depending on degree of a lowering of arterial pressure the dose can be reduced or increased gradually. Duration of breaks between increase/reduction of a dose should not be less than 2 days.

Because within several days after an initiation of treatment, and also at increase in a dose, there can be collateral sedative influence of drug, it is recommended to increase the dose accepted in the evening at first.

The standard supporting daily dose of Dopegit makes 0,5-2 g (as much as possible – 3 g) which is accepted in 2-4 receptions. If at administration of drug in a daily dose of 2 g insufficiently effective lowering of the level of arterial pressure is noted, Dopegit is recommended to be accepted along with other anti-hypertensive medicines. In 2-3 months of treatment to active agent of drug (Methyldopum) tolerance can be developed. Effective lowering of the level of arterial pressure can be reached by increase in a dose of Dopegit or the accompanying use of diuretics. After the treatment termination arterial pressure, as a rule, is returned to initial level in 48 hours without development of "effect of a ricochet".

Dopegit patients who already accept other anti-hypertensive medicines, on condition of their gradual cancellation can apply. In this case the initial daily dose of Dopegit should not be more than 0,5 g. As required with breaks not less than 2 days it is possible to increase a dose. For implementation of smooth transition correction of doses of hypotensive drugs can be required.

The elderly patient Dopegit it is appointed in the minimum daily dose which is not exceeding 0,25 g. If necessary the dose is gradually increased. The maximum daily dose – 2 g.

At this group of patients faints are more often observed that can be connected with the raised susceptibility to Dopegit's action and the expressed atherosclerotic defeat of vessels. To avoid developing of faints, decrease in a dose of drug can be required.

To children of 3 years Dopegit appoint 0,010 g/kg of body weight which is divided into 2-4 receptions in an initial daily dose. In case of need, the desirable effect will not be reached yet, the dose is gradually increased. The maximum daily dose – 0,065 g/kg of body weight, but is no more than 3 g in day.

Patients with a slight renal failure (at a glomerular filtration rate – 60-89 ml/min. / 1,73 sq.m.) a break between administrations of drug need to increase till 8 o'clock, with average weight (at a glomerular filtration rate – 30-59 ml/min. / 1,73 sq.m.) – till 8-12 o'clock, with a heavy renal failure (at a glomerular filtration rate – less than 30 ml/min. / 1,73 sq.m.) – till 12-24 o'clock.

After the hemodialysis session for prevention of increase in level of arterial pressure it is recommended to accept an additional dose of Dopegit (0,25 g).

Side effects

In an initiation of treatment, and also at increase in a dose of Dopegit the headache, passing sedations, increased fatigue and the general weakness can be observed.

Also at use of drug development of disturbances from some systems of an organism which are shown with various frequency is possible:

• Central nervous system: very seldom – parkinsonism; in some cases – paralysis Bella (a flaccid paralysis of a facial nerve), an involuntary horeoatetotichesky physical activity, decrease in intelligence, decrease in a libido, frustration of mentality, (including dreadful dreams, a depression and slight psychosis), paresthesias, symptoms of insufficiency of cerebral circulation, a headache, dizziness, sedation, increased fatigue or the general weakness;
• Cardiovascular system: very seldom – a pericardis, myocarditis, progressing of stenocardia; in some cases – long hypersensitivity of a carotid sine, congestive heart failure, orthostatic hypotension (decrease in a dose of Dopegit is recommended), increase in body weight, peripheral hypostases, a sinus bradycardia (as a rule, increase in body weight and peripheral hypostases regress against the background of therapy by diuretics. At emergence of symptoms of heart failure or at increase of hypostases administration of drug needs to be stopped);
• Alimentary system: very seldom – pancreatitis; in some cases – vomiting, colitis, an inflammation of sialadens, diarrhea, a lock, nausea, abdominal distention, a xerostomia, a meteorism, necrotic hepatitis, hepatitis, jaundice, a cholestasia, dark coloring of language or pain;
• Respiratory system: in some cases – a nose congestion;
• Endocrine system: in some cases – a gynecomastia, a giperprolaktinemiya, an amenorrhea, a galactorrhoea;
• Musculoskeletal system: in some cases – a mialgiya, an easy joint pain with hypostasis or without it;
• Immune system: in some cases – a lupoid syndrome, a vasculitis, an eosinophilia, medicamentous fever;
• Integuments: in some cases – the rash reminding deprive, a toxic epidermal necrolysis or eczema;
• Laboratory indicators: very often – positive test of Koombs; seldom – a leukopenia, hemolitic anemia, thrombocytopenia, a granulocytopenia; in some cases – increase in activity of hepatic transaminases, oppression of function of marrow, a LE cell and a rhematoid factor, the increased concentration of urea in blood, positive takes of tests for antinuclear antibodies;
• Others: in some cases – disturbances of an ejaculation, impotence.

Special instructions

In some cases during therapy hemolitic anemia can develop. At emergence of symptoms of a disease it is necessary to define a hematocrit and concentration of hemoglobin. At confirmation of the diagnosis it is necessary to estimate extent of hemolysis in addition. At development of hemolitic anemia Dopegit's reception is stopped.

At long therapy positive test of Koombs can be defined. If this phenomenon did not arise for the first year of reception of Dopegit, further his identification is improbable. Most less often this disturbance is observed at the patients accepting drug in a daily dose it is less than 1 g. At identification of positive direct test of Koombs against the background of administration of drug, it is necessary to exclude existence at the patient of hemolitic anemia and to define the clinical importance of this phenomenon.

In rare instances at Dopegit's use it can be observed emergence of a reversible leukopenia and granulocytopenia. As a rule, after the treatment termination the quantity of granulocytes is returned to norm.

At some patients during the first 21 day of therapy fever which in rare instances is followed by an eosinophilia or increase in activity of hepatic transaminases develops. Besides, Dopegit's use can be followed by development of jaundice which develops within the first 2-3 months of therapy. Development of a cholestasia and fatal necrotic hepatitis is in certain cases possible. When developing inexplicable fever it is recommended to define activity of hepatic transaminases and the general blood test with a leukocytic formula.

At development of jaundice, fever or at increase in activity of hepatic transaminases therapy needs to be stopped immediately. If emergence of these symptoms is connected with hypersensitivity to active agent of drug, then after Dopegit's cancellation fever disappears, and functional hepatic trials are returned to normal values. Such patients are not recommended to resume therapy. Patients with liver pathology in the anamnesis need to accept Dopegit with extra care.

At some patients during therapy peripheral hypostases and increase in body weight are observed. Such by-effects easily are eliminated by means of diuretics. At emergence of symptoms of heart failure and increase of hypostases therapy should be stopped.

Decrease in doses of anesthetics can be required by the patients accepting Dopegit. At development of hypotonia during the general anesthesia it is necessary to use therapy by vazopressor.

At bilateral defeat of vessels of a brain (a cerebrovascular disease) Dopegit's reception can be followed by the involuntary horeoatetotichesky movements. In this case therapy is stopped.

Drug should be used carefully at therapy of patients with a hepatic porphyria and their close relatives.

Dopegit can influence results of measurement of concentration of uric acid, creatinine and aspartate aminotransferase in blood serum. Obtaining false positive results of determination of content of catecholamines in urine by a fluorescent method is also possible that can complicate diagnosis of a pheochromocytoma.

During therapy it is not necessary to take alcoholic beverages.

Dopegit's reception can be followed by sedations which, as a rule, have passing character and develop at the beginning of therapy or at increase in the accepted dose. In this case patients should not perform works which require special attention, for example, to manage motor transport or mechanisms.

Medicinal interaction

Extra care is demanded by simultaneous use of Dopegit with the following medicines:

• Sympathomimetics, tricyclic antidepressants, fenotiazina, iron preparations for intake, oestrogenic medicines, non-steroidal anti-inflammatory drugs: decrease in anti-hypertensive effect of Dopegit;
• Other antihypertensives, the general anesthetics, anxiolytic medicines, beta adrenoblockers, levodopa from karbidopy: strengthening of anti-hypertensive effect of Dopegit;
• Levodopa, lithium, anticoagulants, ethanol and other drugs, the oppressing central nervous system, a haloperidol, Bromocriptinum: change of effects of these drugs and Dopegit.

It is impossible to apply at the same time Dopegit with monoamine oxidase inhibitors.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 15-25 °C.

Period of validity – 5 years.