ATENOCARD [Atenolol] 50 mg Film-coated tablets
ATENOKARD
instructions for the medical use of a medicinal product
Tradename
Atenokard, Атенокард
International non-proprietary name or generic
name
Atenolol, Атенолол
Composition
Each
film-coated tablet contains:
Active substance: atenolol
50 mg.
Excipients: lactose, starch, primogel, talc,
magnesium stearate, PVP K-30.
Each
film-coated tablet contains:
Active substance: atenolol
100 mg.
Excipients: lactose, starch, primogel, talc,
magnesium stearate, PVP K-30.
Tablets.
Beta1-blocker.
Pharmacodynamics
Selective beta1 blocker with no
intrinsic sympathomimetic activity. Has hypotensive, antiarrhythmic,
antianginal action. In therapeutic doses, it does not affect the tone of the
peripheral arteries.
Reduces the effect of
catecholamines on the heart muscle, thereby reducing the heart rate, minute and
stroke volumes of blood within 24 hours.
Eliminates the effect of
arrhythmogenic factors: tachycardia, arterial hypertension, increased content
of cyclic adenosine monophosphate.
The antianginal effect is due to
a decrease in myocardial oxygen demand with prolonged diastole and improved
perfusion of the heart muscle.
After oral administration, it is absorbed in the
gastrointestinal tract in 50%. The half-life of atenolol is 6-9 hours. The
maximum concentration is reached in 2-4 hours. Atenolol binds to plasma
proteins up to 16%. Poorly penetrates the blood-brain barrier, crosses the
placenta. Partially metabolized in the liver, eliminated by the kidneys. During
hemodialysis, it is excreted from the blood plasma.
• arterial hypertension;
• prevention of angina attacks (except for
Prinzmetal's angina);
• heart rhythm disturbances;
• sinus tachycardia;
• prevention of supraventricular tachyarrhythmias,
ventricular premature beats.
Contraindications
• cardiogenic shock;
• AV blockade of II and III degree;
• severe bradycardia (heart rate less than 45-50 beats
/ min.);
• sick sinus syndrome;
• sinoauricular block;
• acute or chronic heart failure (in the stage of
decompensation);
• cardiomegaly without signs of heart failure;
• Prinzmetal's angina;
• arterial hypotension (if used for myocardial
infarction, systolic blood pressure less than 100 mm Hg);
• simultaneous intake of MAO inhibitors;
• age up to 18 years (efficacy and safety have not
been established);
• elderly age;
• hypersensitivity to the drug.
Method of administration
and dosage
Inside before eating, without
chewing, drinking a small amount of liquid.
Arterial hypertension. Treatment
begins with 50 mg of atenolol once a day. To achieve a stable hypotensive
effect, 1-2 weeks of admission are required. If the hypotensive effect is
insufficient, the dose is increased to 100 mg at a time. A further increase in
the dose is not recommended, since it is not accompanied by an increase in the
clinical effect.
With ischemic heart disease,
tachysystolic heart rhythm disturbances - 50 mg 1 time per day.
Angina pectoris. The starting dose
is 50 mg per day. If the optimal therapeutic effect is not achieved within a
week, the dose is increased to 100 mg per day.
Elderly patients and patients with
chronic renal failure need to adjust the dosage regimen. In elderly patients,
the initial single dose is 25 mg (can be increased under the control of blood
pressure, heart rate). In chronic renal failure, creatinine clearance is 15-35
ml per minute - 50 mg per day; with creatinine clearance less than 15 ml per
minute - 50 mg every other day.
An increase in the daily dose over
100 mg is not recommended, since the therapeutic effect does not increase, and
the likelihood of side effects increases.
Special instructions and
precautions
It is necessary to train the patient to control
heart rate and blood pressure, as well as to ensure monitoring of heart rate
and blood pressure (at the beginning of treatment - daily, then once every 3-4
months).
It should be used with caution in diabetes
mellitus, chronic lung diseases, incl. bronchial asthma, pulmonary emphysema,
metabolic acidosis, hypoglycemia, history of allergic reactions, chronic heart
failure (compensated), obliterating diseases of peripheral arteries
(intermittent claudication, Raynaud's syndrome), pheochromocytoma, liver
failure, chronic renal failure, myoxicosis, thyroid disease psoriasis, during
pregnancy, in elderly patients.
With the use of atenolol, it is possible to
reduce the production of tear fluid, which is important for patients using
contact lenses.
Cancellation of atenolol after a long course of
treatment should be carried out gradually under the supervision of a physician.
If it is necessary to conduct inhalation
anesthesia in patients receiving atenolol, several days before anesthesia, it
is necessary to stop taking atenolol or choose an anesthesia drug with a
minimal negative inotropic effect.
Influence on the ability to drive vehicles and mechanisms
During the
period of treatment, it is necessary to refrain from engaging in potentially
hazardous activities that require increased concentration of attention and
speed of psychomotor reactions.
Application during
pregnancy and during breastfeeding
Application during pregnancy is possible only in cases
where the intended benefit to the mother outweighs the potential risk to the
fetus.
If necessary, use during lactation should stop
breastfeeding.
Interaction with other
medicinal products
The
combined use of beta-blockers and calcium channel blockers with negative
inotropic effects, such as verapamil and diltiazem, can lead to an increase in
these effects, especially in patients with impaired ventricular function and /
or impaired sinoatrial or atrioventricular conduction. This can lead to severe
hypotension, bradycardia, and heart failure. Beta-blocker and calcium channel
blocker should not be administered intravenously within 48 hours after the
other is discontinued.
Concomitant
therapy with dihydropyridines such as nifedipine may increase the risk of
hypotension and heart failure in patients with latent heart failure.
Digitalis
glycosides in combination with beta-blockers can increase the time of
atrioventricular conduction.
Beta-blockers
can aggravate rebound hypertension that may occur after discontinuation of
clonidine. If two drugs are prescribed at the same time, the beta-blocker
should be withdrawn several days before the withdrawal of clonidine. When
replacing clonidine with beta-blocker therapy, the administration of
beta-blockers should be postponed for several days after discontinuation of
clonidine.
Side effect
From the side of the cardiovascular system: development (aggravation)
of symptoms of chronic heart failure (swelling of the ankles, feet, shortness
of breath), impaired atrioventricular conduction, arrhythmias, bradycardia,
marked decrease in blood pressure, palpitations, weakening of myocardial
contractility, orthostatic hypotension, chest pain.
From the digestive system: dry mouth, nausea,
vomiting, diarrhea, abdominal pain, constipation or diarrhea, change in taste.
From the nervous system: dizziness, headache, weakness, increased
fatigue, decreased ability to concentrate, decreased reaction speed, sleep
disturbances, depression, hallucinations, paresthesia in the extremities (in
patients with intermittent claudication and Raynaud's syndrome), muscle
weakness, convulsions ...
From the endocrine system: decreased potency,
hypoglycemic conditions in patients with diabetes mellitus.
From the respiratory system: the appearance of symptoms
of bronchial obstruction.
From the senses: visual impairment, decreased secretion of
lacrimal fluid, dry and sore eyes, nasal congestion.
From the side of the blood system: platelet purpura, anemia
(aplastic), thrombosis.
Allergic reactions: pruritus, urticaria, dermatitis.
Others: increased sweating, skin redness.
If any of the side effects
indicated in the instructions are aggravated, or you notice any other side
effects not listed in the instructions, inform your doctor.
Symptoms: severe bradycardia, AV block II-III degree,
an increase in symptoms of heart failure, an excessive decrease in blood
pressure, difficulty breathing, bronchospasm, dizziness, fainting, arrhythmia,
ventricular extrasystole, cyanosis of fingernails or palms, convulsions.
Treatment: gastric lavage and the appointment of
adsorbent drugs; in the event of bronchospasm, inhalation or intravenous
administration of the beta2-adrenergic agonist salbutamol is indicated. In case
of violation of AV conduction, bradycardia - intravenous administration of 1-2
mg of atropine, epinephrine or setting of a temporary pacemaker; with
ventricular premature beats - lidocaine (class 1A drugs are not used); with a
decrease in blood pressure - the patient should be in the Trendelenburg
position. If there are no signs of pulmonary edema - IV plasma-substituting
solutions, if ineffective - the introduction of epinephrine, dopamine,
dobutamine; with chronic heart failure - cardiac glycosides, diuretics,
glucagon; for convulsions - intravenous diazepam. Dialysis is possible.
Store in a dry and dark place, at a temperature not
exceeding 25°C.
Keep out of the reach of children!
Shelf life
2 years. Do not use after the expiration date printed
on the package.
Vacation conditions
Dispensed
by prescription.
Release form
10 tablets in an aluminum foil blister. 2 blisters together with instructions for use in a cardboard box.