Instruction for use: Atehexal compositum

Active substance Atenolol + Chlortalidone

ATX Code C07BB03 Atenolol in combination with tiazidami

Pharmacotherapeutic group:

Beta-blockers in combination

The nosological classification (ICD-10)

I10 Essential (primary) hypertension

Hypertension, Arterial hypertension, Arterial hypertension crisis course, Essential Hypertension

Primary hypertension, Arterial hypertension, complications of diabetes, hypertension, The sudden increase in blood pressure, Hypertensive disorders of blood circulation, hypertensive condition, hypertensive crises, hypertension, arterial Hypertension, malignant Hypertension, Hypertonic disease, Hypertensive crisis, Hypertension, accelerated hypertension, malignant hypertension, The aggravation of hypertensive disease, Transient hypertension, Isolated systolic hypertension

I15 Secondary hypertension

Arterial hypertension, complications of diabetes, hypertension, The sudden rise in blood pressure, Hypertensive disorders of blood circulation, hypertensive condition, hypertensive crises, hypertension, arterial hypertension, malignant hypertension, Hypertensive crisis, Hypertension, accelerated hypertension, malignant hypertension, hypertensive crisis, The aggravation of hypertensive disease, Transient hypertension, hypertension, Arterial hypertension, Arterial hypertension crisis course, renovascular hypertension, symptomatic hypertension, renal hypertension, Renovascular hypertension, Symptomatic hypertension

Structure and Composition

Tablets, film-coated Table 1.

atenolol 50 mg

chlorthalidone 12.5 mg

Excipients: corn starch; magnesium carbonate; sodium lauryl sulfate; giproloza; sodium carboxymethyl starch; magnesium stearate

shell: lactose monohydrate; Valium; macrogol 4000; titanium dioxide

in blisters of 10 pcs .; in a stack of cardboard 3 packaging.

Tablets, film-coated Table 1.

Atenolol 100 mg

chlorthalidone 25 mg

Excipients: corn starch; magnesium carbonate; sodium lauryl sulfate; giproloza; sodium carboxymethyl starch; magnesium stearate

shell: lactose monohydrate; Valium; macrogol 4000; titanium dioxide

in blisters of 10 pcs .; in a stack of cardboard 3 packaging.

The drug forms

White, round, biconvex film-coated tablets, scored on one side.

Characteristic

Combined antihypertensive medication.

pharmachologic effect

antianginal, diuretic, hypotensive, an antiarrhythmic, cardioprotective.

pharmacodynamics

The effect is caused by the action of two components - a beta-blocker (atenolol) and a diuretic (chlorthalidone).

Atenolol: hydrophilic cardioselective beta1-blocker.

It makes no intrinsic sympathomimetic activity, has no membrane stabilizing activity.

Reduces heart rate (negative chronotropic effect); slows AV conduction (negative dromotropic action); reduces the excitability of the myocardium (batmotroponoe negative effect); reduced myocardial contractile capacity (negative inotropic effect); It lowers blood pressure by these mechanisms, as well as by inhibiting renin secretion; reducing pressure in the portal venous system by reducing the mesenteric and hepatic blood flow. The main pharmacological effects: antiadrenergic, antianginal, antiarrhythmic, antihypertensive, cardioprotective.

Chlorthalidone: netiazidny sulfanilamide diuretic drug long-acting (48-72 hours after a single oral administration).

Chlorthalidone violates the reabsorption of sodium, chlorine, and equivalent amounts of water in the distal tubules of the nephron; increased excretion of potassium ions, magnesium bicarbonate; delaying the excretion of uric acid, and calcium ions; reduces the sensitivity of the vascular wall to vasoconstrictor influences. The main pharmacological effects: a diuretic and antihypertensive. The drug has a prolonged antihypertensive action, including providing morning defense. It prevents repeated heart attacks and strokes.

It refers to the average efficiency of diuretics and is characterized by an extremely low toxicity.

Pharmacokinetics

Atenolol

Following oral administration about 50% is absorbed from the gastrointestinal tract, Cmax in plasma achieved in 2-4 hours.

Bioavailability - 50%. Protein binding - about 3%. It is metabolized very little. About 90% of the systemic availability of atenolol excreted by the kidneys unchanged. T1 / 2 - 6-10. H In chronic renal insufficiency T1 / 2 can be up to 140 hours.

chlorthalidone

The relatively slowly absorbed from the gastrointestinal tract. System availability - (64 ± 10)%. Binding to plasma proteins - 75%. Chlorthalidone excreted mainly by the kidneys, for the most part unchanged. T1 / 2 - about 50 hours.

Indications

Essential hypertension (prevention and treatment).

In cases where the individual active substance therapy to normalize blood pressure or insufficient for easier prescribing doses were chosen in separate therapy.

Contraindications

Hypersensitivity to any component of the medication, acute and chronic heart failure, sick sinus syndrome, bradycardia, AV block II and III degree, marked hypotension, disorders of peripheral blood circulation, simultaneous reception of MAO inhibitors (except MAO inhibitors type B) , bronchial asthma, severe chronic obstructive bronchitis, hypokalemia, hyponatremia, hypercalcemia, gout, pregnancy, lactation, children's age.

Pregnancy and breast-feeding

Contraindicated during pregnancy. At the time of treatment should stop breastfeeding.

Side effects

Ategeksal kompozitum generally well tolerated. In rare cases there may be a manifestation of the following side effects:

on the part of the cardiovascular system: bradycardia, heart failure, cold extremities. Perhaps the appearance of AV block, increasing incidence of intermittent claudication syndrome, the occurrence of Raynaud's syndrome;

CNS: dizziness, insomnia, fatigue;

Gastrointestinal: diarrhea disorders;

on the part of the hemopoietic system: rarely - thrombocytopenia, leukopenia;

Dermatological reactions: skin rash, exacerbation of psoriasis;

From the water-electrolyte imbalance: hyponatremia (related to chlorthalidone), hypokalemia;

on the part of the respiratory system: in patients with bronchial asthma or having in the anamnesis on bronchospasm bronchospasm may occur;

Other: hyperuricemia, impaired glucose tolerance, reduced potency (with prolonged use).

Interaction

Insulin and oral antidiabetic agents: potentiation of (symptoms of hypoglycemia: tachycardia and tremor). Regularly check your blood sugar levels.

Tricyclic antidepressants, barbiturates, phenothiazines, diuretics, vasodilators, and other antihypertensive agents: the antihypertensive effect may be increased.

ACE inhibitors (captopril, enalapril): at the beginning of therapy, possibly a sharp increase in the antihypertensive effect Ategeksal compositum.

BPC: type of nifedipine - may increase the antihypertensive effect; such as verapamil or diltiazem disopyramide and - perhaps a sharp increase in the antihypertensive effect of the development of bradycardia and other cardiac arrhythmias. Should be avoided in / in the introduction of these agents in patients receiving the drug Ategeksal compositum

Antiarrhythmic agents: cardiodepressivny stacking.

Cardiac glycosides: because of the possible occurrence of potassium deficiency and / or magnesium in connection with the admission Ategeksal kompozitum may increase sensitivity of the cardiac muscle to cardiac glycosides, and, accordingly, increase the frequency of side effects.

Clonidine: abrupt withdrawal of clonidine may lead to increased blood pressure, so it should be done gradually and only a few days after receiving the cancellation Ategeksal compositum.

Norepinephrine, epinephrine: may substantially increase blood pressure.

MAO inhibitors: may increase blood pressure.

Salicylates and other NSAIDs (eg, indomethacin): may reduce the antihypertensive effect, but at a high dosage of salicylates increase in the toxic effects of salicylates on the central nervous system.

Anaesthetic agents, including alcohol: increased antihypertensive effect and the summation of negative inotropic effect.

Muscle relaxants (tubocurarine) may be increased, or the weakening of neuromuscular blockade. Anesthesiologist must be made aware of the reception Ategeksal compositum.

Glucocorticoids, carbenoxolone, amphotericin B, furosemide: may increase potassium excretion.

Lithium: Lithium elimination reduction and increased cardiovascular and neurotoxic effects of lithium.

Dosing and Administration

Inside, before breakfast without chewing and drinking plenty of fluids, the initial dose - 1 tab. (50 mg + 12,5 mg) per day. If necessary, increase the dose to 1 tab. (50 mg + 12.5 mg), 2 times a day, or up to Table 1. (100 mg + 25 mg) per day.

In patients with impaired renal function the dose should be reduced.

Abolition of the drug after long-term treatment should be carried out, as far as possible, gradually.

Overdose

Symptoms: Nausea, vomiting, loss of appetite, tremor, anxiety, palpitations, headache, pain in the chest.

Treatment: bradycardia development enter in / 1.2 mg atropine, if necessary - 10 mg of glucagon / in bolus. In the absence or ineffectiveness of glucagon possible I / dobutamine (2.5 g / min / kg) and 10-25 mcg isoprenaline / drip at a rate not exceeding 5 g / min.

special instructions

With care prescribed in severe violation of liver and kidney function (glomerular filtration below 30 ml / min), labile diabetes mellitus type 1, of hormone of the adrenal tumor during therapy, digitalis glycosides, glucocorticoids, or taking laxatives, AV block of I degree.

Patients with psoriasis have a family history prescriptions containing beta-adrenergic receptors, only possible with careful weighing of risks and benefits.

Beta-adrenoceptor blockers may increase the sensitivity to allergens and cause anaphylactic reactions, and therefore, patients undergoing desensitizing therapy, the drug should be taken with great caution.

Against the background of treatment requires systematic monitoring of the level of potassium in the blood, especially in elderly patients, patients receiving cardiac glycosides, in patients with impaired gastrointestinal function.

In connection with the development of individual reactions to the drug, caution is necessary when activities that require quick response (involved in road traffic, car maintenance and other.). This effect increases with the simultaneous reception of alcohol.

Storage conditions

The temperature is not above 25 ° C.

Keep out of the reach of children.

Shelf-life

5 years.

Do not use beyond the expiration date printed on the package.