Adelfan-Ezidreks - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Adelfan-Ezidrex

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Adelfan-Ezidrex is a combined antihypertensive agent with arteriodilating, sympatholytic, diuretic action.

Release form and composition

Dosage form - tablets: from almost white to white, without a shell, round, flat with beveled edges, marked "CIBA" on one side and a dividing line between the letters "A" and "F" - on the other (10 pcs.. in a blister, in a cardboard box 1, 2, 3, 5 or 25 blisters).

Content of active ingredients of Adelfan-Ezidreks in 1 tablet:

Dihydralazine sulfate hydrated –10.25 mg (on an anhydrous basis - 10 mg);
Reserpine - 0.1025 mg;
Hydrochlorothiazide - 10 mg

Auxiliary components: corn starch, beckons (mannitol), magnesium stearate (magnesium stearic acid), disodium edetate, talc (magnesium hydroxysilicate).

Indications for use

The use of Adelfan-Ezidreks is indicated for patients with arterial hypertension.

Contraindications

Age under 18;
Cor pulmonale or isolated right ventricular failure on the background of pulmonary hypertension;
Heart failure, severe tachycardia with high cardiac output (including thyrotoxicosis);
Heart failure due to obstruction in the left ventricle of the outflow tract (including constrictive pericarditis, aortic or mitral stenosis);
Aortic dissecting aneurysm;
Electroconvulsive therapy;
Depression (including history);
Epilepsy;
Parkinson's disease;
Systemic lupus erythematosus;
Ulcerative colitis;
The period of exacerbation of gastric ulcer and duodenal ulcer;
Severe renal failure (creatinine clearance less than 30 ml / min), anuria;
Pheochromocytoma;
Concomitant therapy with monoamine oxidase (MAO) inhibitors or their use 14 days before prescribing the drug;
Pregnancy period;
Hypersensitivity to reserpine-related substances, hydrazinophthalazines, sulfonamide derivatives and drug components.

It is impossible to prescribe pills to patients who have had myocardial infarction until the hemodynamic parameters are completely restored.

It is recommended to prescribe Adelfan-Ezidrex with caution to patients with heart failure, coronary heart disease (or suspicion of it), sinus bradycardia, cardiac conduction disorders, coronary and cerebral atherosclerosis, gastric ulcer and duodenal ulcer in history, cholelithiasis gastritis, diabetes mellitus, gout, bronchial asthma, imbalance in water and electrolyte balance, porphyria, clinical manifestations of hyperuricemia, in case of concomitant therapy with angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, renin inhibitors, elderly patients, with planned surgery.

Method of administration and dosage

The tablets are taken orally with water, every day at one time of the day.

The dose is selected individually. Treatment should begin with a minimum dose, depending on the therapeutic effect, it can be gradually increased, but not more often than once every 2-3 weeks.

The daily dose should not exceed 1-2 tablets (the maximum dose of 2 tablets is taken in 2 divided doses).

In the absence of adequate control of blood pressure (BP), treatment should be reviewed and another drug prescribed.

Due to the risk of excessive accumulation of the drug in the body, Adelfan-Ezidrex should be prescribed with caution in case of impaired renal and liver function, the dose and the interval between taking the drug should be set taking into account the tolerance and dynamics of blood pressure.

Correction of the dosage regimen when prescribing the drug to elderly patients requires special attention.

Side effects

Since Adelfan-Ezidrex is a combined agent, the appearance of side effects can be caused by one of its active ingredients.

Dihydralazine sulfate can cause undesirable effects:

From the side of the cardiovascular system: often - palpitations, tachycardia; sometimes - a pronounced decrease in blood pressure, flushing of the face, angina pectoris; rarely - heart failure, edema;
From the liver: rarely - abnormal liver function, jaundice, hepatitis;
From the gastrointestinal tract: sometimes - nausea, vomiting, dyspeptic symptoms, diarrhea;
From the nervous system: often - headache; sometimes dizziness; rarely - anorexia, agitation, paresthesia, irritability, anxiety, peripheral neuritis, anxiety (when pyridoxine is prescribed, these side effects disappear); isolated cases - depressed mood;
Immunopathological and allergic reactions: rarely - lupus-like syndrome;
From the hematopoietic system: rarely - leukopenia, anemia, thrombocytopenia;
Others: sometimes - arthralgia; rarely - fever, weakness, weight loss, pruritus, rash.

Side effects specific to reserpine:

From the side of the cardiovascular system: sometimes - edema, sinus bradycardia; rarely - chest pain, arrhythmia (symptoms of angina pectoris), flushing of the face, orthostatic hypotension; some cases - cerebrovascular accident, heart failure, fainting;
From the gastrointestinal tract: sometimes - increased salivation, dry mouth, diarrhea, increased secretion of gastric juice; rarely - increased appetite, nausea, vomiting, ulceration; isolated cases - gastrointestinal bleeding;
From the respiratory system: sometimes - shortness of breath, swelling of the nasal mucosa; isolated cases - nosebleeds;
From the genitourinary system: rarely - violation of ejaculation and potency; isolated cases - glomerulonephritis, dysuria;
From the senses: sometimes - lacrimation, conjunctival hyperemia, blurred vision; isolated cases - hearing impairment;
From the nervous system: sometimes - depression, increased fatigue, dizziness, nightmares, irritability; rarely - headache, extrapyramidal disorders (including parkinsonism), impaired concentration, anxiety, disorientation, stupor; isolated cases - cerebral edema;
Metabolism and endocrine system: sometimes - an increase in body weight; rarely - gynecomastia, galactorrhea, increased prolactin secretion; isolated cases - swelling of the mammary glands;
Others: rarely - itching, eczema, decreased libido; isolated cases - anemia, purpura, thrombocytopenia.

While taking hydrochlorothiazide, the following side effects may develop:

On the part of the cardiovascular system: sometimes - orthostatic hypotension (which is aggravated by the simultaneous use of sedatives, anesthetics, alcohol); rarely - arrhythmia;
Metabolism and water-electrolyte balance: often (mainly against the background of high doses) - increased blood lipids, hypokalemia; sometimes - hyperuricemia, hyponatremia, hypomagnesemia; rarely - glucosuria, hypercalcemia, hyperglycemia, in patients with diabetes mellitus - increased metabolic disorders; isolated cases - hypochloremic alkalosis;
From the digestive system: sometimes - nausea, vomiting, loss of appetite; rarely - constipation, diarrhea, discomfort, jaundice, intrahepatic cholestasis; isolated cases - pancreatitis;
Dermatological reactions: sometimes - skin rash, urticaria; rarely - photosensitivity; isolated cases - toxic epidermal necrolysis, necrotizing vasculitis, skin manifestations of lupus-like syndrome, exacerbation of lupus erythematosus;
From the hematopoietic system: rarely - thrombocytopenia, sometimes with purpura; isolated cases - agranulocytosis, hemolytic anemia, leukopenia, inhibition of bone marrow hematopoiesis;
From the senses and the nervous system: rarely - visual impairment (especially at the beginning of treatment), sleep disturbances, headache, depression, dizziness, paresthesia;
Others: sometimes - impotence; isolated cases - hypersensitivity reactions, disorders of the respiratory system (including pneumonitis, pulmonary edema).

special instructions

Due to the risk of suicidal action, if symptoms of depression appear, the drug should be discontinued. A depression provoked by reserpine (at high doses of Adelfan-Ezidrex) can continue for a long period after the drug is discontinued.

The presence of dihydralazine can cause water and sodium retention in the body, and cause edema, decreased urine output.

Patients with impaired liver function need to ensure systematic monitoring of the water-electrolyte balance, since even minor violations can lead to hepatic coma, especially in liver cirrhosis.

The likelihood of developing lupus-like syndrome is in direct proportion to the dose and period of use of the drug, therefore, for long-term maintenance therapy, the appointment of a minimum effective dose is required. The symptom of mild forms of the syndrome is arthralgia, which can be accompanied by skin rashes and fever. After discontinuation of the drug, the patient's condition normalizes on its own. For severe cases, signs of the clinical picture of systemic lupus erythematosus are characteristic.

Treatment with dihydralazine should be accompanied by regular (every 6 months) determination of antinuclear factor in blood plasma, and if it is detected, titers should be recorded and their dynamics monitored. In the case of the development of clinical manifestations of lupus-like syndrome, immediate cancellation of Adelfan-Ezidrex is required.

Due to the presence of reserpine, the drug should be discontinued before electroconvulsive therapy no later than 7 days.

When conducting a planned surgical operation, it is necessary to warn the anesthesiologist about taking the drug, since the very preliminary cancellation of the combined agent does not guarantee the stability of hemodynamics during the operation, a pronounced decrease in blood pressure is possible.

Hydrochlorothiazide causes the development of hypokalemia, especially in patients with rapidly developing diuresis, cirrhosis of the liver, deficiency of potassium intake with food, simultaneous therapy with glucocorticosteroids, adrenocorticotropic hormone stimulants or beta-adrenergic receptors. Hypokalemia can potentiate the heart's response to the toxic effects of digitalis drugs and increase myocardial sensitivity. For the timely determination of electrolyte imbalance, taking the drug should be accompanied by regular monitoring of the electrolyte content in the blood plasma. If you experience nausea, thirst, dry mouth, weakness, anxiety, drowsiness, muscle weakness, muscle pain and cramps, decreased blood pressure, tachycardia, oliguria (nonspecific symptoms of electrolyte imbalance), you should consult a doctor.

With the use of thiazide diuretics, hypercalcemia and hypophosphatemia may develop.

The use of thiazide diuretics can lead to hypomagnesemia, since they increase the excretion of magnesium in the urine.

At high doses of hydrochlorothiazide, the patient may develop a decrease in glucose tolerance, which causes the risk of an increase in the plasma concentration of triglycerides, cholesterol, and uric acid.

Reserpine affects laboratory parameters in the urine of 17-hydroxycorticosteroids and 17-ketosteroids by the colorimetric method, underestimating their result.

Adelfan-Ezidrex affects the speed of psychomotor reactions, especially at the beginning of use. Patients who drive vehicles and mechanisms should be warned about the need for caution.

Drug interactions

Due to the high risk of developing severe adverse reactions during treatment with Adelfan-Ezidrex, it is recommended to start taking any medications at the same time only after consulting a doctor.

Analogs

Analogues of Adelfan-Ezidreks are: Kristepin, Normatens.

Terms and conditions of storage

Keep out of the reach of children.

Store in a place protected from moisture and light at temperatures up to 30 ° C.

Shelf life is 4 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!