Adelfan-Ezidreks

Adelfan-Ezidreks – the combined antihypertensive with arteriodilatiruyushchy, sympatholytic, diuretic action.

Form of release and structure

Dosage form – tablets: from almost white till white color, without cover, a round form, flat with slanted edges, with marking of "CIBA" on one party and dividing risky between the letters "A" and "F" – on another (on 10 pieces in the blister, in a cardboard pack of 1, 2, 3, 5 or 25 blisters).

Content of Adelfan-Ezidreksa active ingredients is 1 tablet:

• Digidralazina the sulfate hydrated –10,25 mg (on an anhydrous basis – 10 mg);
• Reserpinum – 0,1025 mg;
• Hydrochlorothiazide – 10 mg.

Auxiliary components: starch corn, attracts (Mannitolum), magnesium stearate (magnesium stearate), dinatrium эдетат, talc (magnesium hydroxysilicate).

Indications to use

Use of Adelfan-Ezidreksa is shown to patients with arterial hypertension.

Contraindications

• Age up to 18 years;
• Pulmonary heart or the isolated right ventricular insufficiency against the background of pulmonary hypertensia;
• Heart failure, the expressed tachycardia at high cordial emission (including a thyrotoxicosis);
• Heart failure because of obstruction in a left ventricle of the taking-out path (including chronic cardial compression, an aortal or mitral stenosis);
• The stratifying aortic aneurysm;
• Electroconvulsive therapy;
• Depression (including the anamnesis);
• Epilepsy;
• Parkinson's disease;
• System lupus erythematosus;
• Ulcer colitis;
• Period of an aggravation of a peptic ulcer of a stomach and duodenum;
• Heavy renal failure (the clearance of creatinine is less than 30 ml/min.), anury;
• Pheochromocytoma;
• The accompanying therapy by monoamine oxidase inhibitors (MAO) or their use in 14 days prior to purpose of drug;
• Pregnancy period;
• Hypersensitivity to related to Reserpinum to substances, gidrazinoftalazina, sulphonamide derivatives and components of drug.

Cannot appoint tablets the patients who had a myocardial infarction to a complete recovery of indicators of a hemodynamics.

With care it is recommended to appoint Adelfan-Ezidreks to patients at heart failure, coronary heart disease (or suspicion to it), a sinus bradycardia, disturbances of conductivity of heart, coronary and cerebral atherosclerosis, a peptic ulcer of a stomach and duodenum in the anamnesis, a liver failure, cholelithiasis, erosive gastritis, a diabetes mellitus, gout, bronchial asthma, disturbance of water and electrolytic balance, a porphyria, clinical manifestations of a hyperuricemia, in case of the accompanying therapy inhibitors of an angiotensin-converting enzyme (APF), blockers angiotensin II of receptors, renin inhibitors, the patient of advanced age, at planned surgery.

Route of administration and dosage

Pill is taken inside, washing down with water, daily in at one time days.

The dose is selected individually. Treatment should be begun with use of the minimum dose, depending on its therapeutic effect it is possible to raise gradually, but is not more often than once in 2-3 weeks.

The daily dose should not exceed 1-2 tablets (the maximum dose in 2 tablets is accepted in 2 receptions).

In the absence of adequate control of the arterial pressure (AP) treatment it is necessary to reconsider and appoint other drug.

Because of risk of excess accumulation of drug in an organism with care it is necessary to appoint Adelfan-Ezidreks at a renal failure and a liver, the dose and an interval between administration of drug should be established taking into account portability and ABP loudspeakers.

The special attention is required by correction of the mode of dosing at purpose of drug to elderly patients.

Side effects

As Adelfan-Ezidreks is the combined means, emergence of side effects can be caused by one of its active ingredients.

Digidralazina sulfate can become the reason of the undesirable phenomena:

• From cardiovascular system: often – heartbeat, tachycardia; sometimes – the expressed decrease in the ABP, rushes of blood to the person, stenocardia; seldom – heart failure, hypostases;
• From a liver: seldom – an abnormal liver function, jaundice, hepatitis;
• From digestive tract: sometimes – nausea, vomiting, the dispeptic phenomena, diarrhea;
• From a nervous system: often – a headache; sometimes – dizziness; seldom – anorexia, excitement, paresthesias, irritability, concern, peripheral neuritis, a condition of alarm (at purpose of a pyridoxine these side effects pass); separate cases – oppressed mood;
• Immunopathological and allergic reactions: seldom – a volchanochnopodobny syndrome;
• From system of a hemopoiesis: seldom – a leukopenia, anemia, thrombocytopenia;
• Others: sometimes – an arthralgia; seldom – fever, weakness, weight reduction of a body, a skin itch, rash.

Undesirable effects characteristic of Reserpinum:

• From cardiovascular system: sometimes – hypostases, a sinus bradycardia; seldom – pain behind a breast, arrhythmia (stenocardia symptoms), rushes of blood to the person, orthostatic hypotension; separate cases – disturbance of cerebral circulation, heart failure, a syncope;
• From digestive tract: sometimes – the increased salivation, dryness in a mouth, diarrhea, increase in secretion of a gastric juice; seldom – increase in appetite, nausea, vomiting, formation of ulcers; separate cases – gastrointestinal bleeding;
• From a respiratory organs: sometimes – an asthma, a rhinedema; separate cases – nasal bleeding;
• From urinogenital system: seldom – disturbance of an ejaculation and potentiality; separate cases – a glomerulonephritis, a dysuria;
• From sense bodys: sometimes – dacryagogue, a conjunctiva hyperemia, sight misting; separate cases – a hearing disorder;
• From a nervous system: sometimes – a depression, increased fatigue, dizziness, dreadful dreams, irritability; seldom – a headache, extrapyramidal disturbances (including parkinsonism), disturbance of concentration of attention, a condition of alarm, orientation disturbance, a stupor; separate cases – brain hypostasis;
• Metabolism and endocrine system: sometimes – increase in body weight; seldom – a gynecomastia, a galactorrhoea, increase in secretion of prolactin; separate cases – swelling of mammary glands;
• Others: seldom – an itch, eczema, decrease in a libido; separate cases – anemia, a purpura, thrombocytopenia.

Against the background of reception of a hydrochlorothiazide development of the following side effects is possible:

• From cardiovascular system: sometimes – orthostatic hypotension (which aggravation happens at simultaneous use of sedatives, anesthetics, alcohol intake); seldom – arrhythmia;
• Metabolism and water and electrolytic balance: often (generally against the background of reception of high doses) – increase in maintenance of lipids in blood, a hypopotassemia; sometimes – a hyperuricemia, a hyponatremia, a hypomagnesiemia; seldom – a glucosuria, a hypercalcemia, a hyperglycemia, at patients with a diabetes mellitus – strengthening of metabolic disturbances; separate cases – a gipokhloremichesky alkalosis;
• From the alimentary system: sometimes – nausea, vomiting, appetite loss; seldom – a lock, diarrhea, discomfort, jaundice, an intra hepatic cholestasia; separate cases – pancreatitis;
• Dermatological reactions: sometimes – skin rash, a small tortoiseshell; seldom – a photosensitization; separate cases – a toxic epidermal necrolysis, a necrotic vasculitis, manifestations on skin of a volchanochnopodobny syndrome, a lupus erythematosus aggravation;
• From system of a hemopoiesis: seldom – thrombocytopenia, sometimes with a purpura; separate cases – an agranulocytosis, hemolitic anemia, a leukopenia, oppression of a marrowy hemopoiesis;
• From sense bodys and nervous system: seldom – a vision disorder (especially in an initiation of treatment), sleep disorders, a headache, a depression, dizziness, paresthesias;
• Others: sometimes – impotence; separate cases – reactions of hypersensitivity, disturbance from respiratory system (including a pneumonitis, a fluid lungs).

Special instructions

Because of risk of suicide actions in case of symptoms of a depression administration of drug should be stopped. Provoked by Reserpinum (at high doses of Adelfan-Ezidreksa) the depression can proceed during the long period after drug withdrawal.

Presence of a digidralazin can cause a delay of water and sodium in an organism and to become the reason of hypostases, decrease in a diuresis.

Patients with abnormal liver functions need to provide systematic control of water and electrolytic balance as even its insignificant disturbances can lead to a hepatic coma, especially at cirrhosis.

The probability of development of a volchanochnopodobny syndrome is in direct dependence on a dose and the period of use of drug therefore the long maintenance therapy requires purpose of a minimal effective dose. A symptom of easy forms of a syndrome is the arthralgia which can be followed by skin rashes and fever. After drug withdrawal the condition of the patient is normalized independently. Signs of a clinical picture of a system lupus erythematosus are characteristic of hard cases.

Treatment digidralaziny should be accompanied with definition of an antinuclear factor regular (every 6 months) in a blood plasma, and in case of its detection to register credits and to watch their dynamics. In case of development of clinical manifestations of a volchanochnopodobny syndrome, immediate cancellation of Adelfan-Ezidreksa is required.

Because of existence of Reserpinum it is necessary to cancel drug before performing electroconvulsive therapy not later than in 7 days.

When carrying out planned surgery it is necessary to warn the anesthesiologist about administration of drug as preliminary cancellation of the combined means does not give a guarantee of stability of a hemodynamics during operation, perhaps expressed decrease in the ABP.

The hydrochlorothiazide causes development of a hypopotassemia, especially in patients with quickly developing diuresis, cirrhosis, deficit of intake of potassium with food, simultaneous therapy with glucocorticosteroids, stimulators of adrenocorticotropic hormone or beta adrenoceptors. The hypopotassemia can exponentiate response of heart to toxic influence of medicines of a foxglove and increase sensitivity of a myocardium. For timely definition of disturbances of electrolytic balance administration of drug should be accompanied with regular control of content of electrolytes in a blood plasma. At emergence of nausea, thirst, dryness in a mouth, weakness, concerns, drowsiness, muscular weakness, muscular pains and spasms, decrease in the ABP, tachycardia, an oliguria (nonspecific symptoms of disturbance of electrolytic balance) it is necessary to see a doctor.

Against the background of use of thiazide diuretics development of a hypercalcemia and hypophosphatemia is possible.

Use of thiazide diuretics can lead to a hypomagnesiemia as they promote the increased removal of magnesium with urine.

At high doses of a hydrochlorothiazide at the patient development of decrease in tolerance to glucose is possible that causes risk of increase in level of concentration in plasma of triglycerides, cholesterol, uric acid.

Reserpinum influences laboratory indicators in urine 17 of hydroxycorticosteroids and 17 ketosteroids a colorimetric method, underestimating their result.

Adelfan-Ezidreks exerts impact on the speed of psychomotor reactions, especially at the beginning of use. It is necessary to warn the patients managing vehicles and mechanisms about need of respect for care.

Medicinal interaction

Because of big risk of development of heavy side reactions during treatment by Adelfan-Ezidreksom the concomitant use of any medicines is recommended to be begun only after consultation of the doctor.

Terms and storage conditions

To protect from children.

To store in the place protected from moisture and light at a temperature up to 30 °C.

Period of validity – 4 years.