Composition, form of production and packaging
Tablets coated with a forte of white or almost white color, round, biconvex, with a line of division on one side; On the fracture, a homogeneous nucleus of almost white color and a layer of a shell of white color.
1 tab.
atenolol 100 mg
chlorthalidone 25 mg
[PRING] corn starch - 148.5 mg, lactose - 92.5 mg, sodium lauryl sulfate - 2.5 mg, talc purified - 10 mg, povidone - 6 mg, silicon dioxide colloid - 8 mg, magnesium stearate 4 mg, hydroxypropyl methylcellulose 5 mg, titanium dioxide 3 mg, paraffin light liquid 0.5 mg, polyethylene glycol 400 mg 2 mg, beeswax white 0.166 mg, carnauba wax 0.333 mg.
10 pieces. - strips of aluminum foil (1) - packs of cardboard.
14 pcs. - blisters (2) - packs of cardboard.
The tablets covered with a cover of white or almost white color, round, biconcave, with a line of division on one party; On the fracture, a homogeneous nucleus of almost white color and a layer of a shell of white color.
1 tab.
atenolol 50 mg
Chlorthalidone 12.5 mg
[PRING] corn starch - 74.25 mg, lactose - 46.25 mg, sodium lauryl sulfate - 1.25 mg, talc refined - 5 mg, povidone - 3 mg, silicon dioxide colloid - 4 mg, magnesium stearate - 2 mg, hydroxypropyl methylcellulose 2.5 mg, titanium dioxide 1.5 mg, paraffin light liquid 0.25 mg, polyethylene glycol 400 mg 1 mg, beeswax white 0.083 mg, carnauba wax 0.1666 mg.
10 pieces. - strips of aluminum foil (1) - packs of cardboard.
14 pcs. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Combined antihypertensive drug, has a prolonged hypotensive effect. The effect is due to the action of two components - beta1-adrenoblocker (atenolol) and a diuretic (chlorthalidone).
- there may be a violation of glucose tolerance. Use with caution in patients with a known predisposition to diabetes mellitus;
- hyperuricemia may occur. An increase in serum uric acid, in some cases, may require the use of agents that promote the excretion of uric acid.
In the majority of patients with arterial hypertension, the use of one tablet of Fort 100 mg of "Tenorox" per day gives satisfactory results. With an increase in the dose of further reduction of blood pressure either does not occur, or it is insignificant, but, if necessary, another hypotensive agent may be additionally prescribed.
PHARMACOKINETICS
After ingestion, atenolol is absorbed from the digestive tract by 50%. C max in blood plasma is achieved 2-4 hours after ingestion. Atenolol is not exposed to severe hepatic metabolism and more than 90% of the absorbed drug is excreted unchanged. T 1/2 is 6-9 hours, but may increase in cases of severe renal failure, since the excretion of this drug occurs mainly through the kidneys. Binding to plasma proteins approximately - 6-16%. After ingestion, chlortalidone is absorbed from the digestive tract by 60%, C max in the blood plasma is noted approximately 12 hours after ingestion. T 1/2 is approximately 50 hours, and excretion occurs mainly through the kidneys. Chlortalidone binds to plasma proteins approximately 75%.
At the same time, the use of chlorthalidone and atenolol has little effect on the pharmacokinetics of each of them.
Tenorox is effective for at least 24 hours after a single intake of one daily dose.
INDICATIONS
Arterial hypertension.
DOSING MODE
For adults
Take inside, without chewing, 1 tablet a day.
With arterial hypertension, the initial dose is 50 mg of atenolol 1 time / day, with insufficient severity of the therapeutic effect, appoint "Tenorox" one tablet of forte containing 100 mg of atenolol per day.
For the elderly
For this age group, a lower dose of the drug (1/2 atenolol 50 mg tablet) is often required.
In case of impaired renal function
Caution should be exercised in the treatment of patients with impaired renal function. Abolition of the drug after prolonged treatment should be carried out, if possible, gradually.
SIDE EFFECT
Tenorox is usually well tolerated.
Laboratory indicators: hyperuricemia; hyponatremia (associated with chlorthalidone); hypokalemia: impaired glucose tolerance.
Side effects associated with its reception, appear rarely, in most cases is light and temporary.
Termination of treatment with beta-blockers should be carried out gradually.
There were reports of nausea and dizziness due to taking Chlortalidone and rarely reported such idiosyncrasy reactions to the drug as thrombocytopenia and leukopenia.
From the cardiovascular system: bradycardia; increased symptoms of heart failure; Orthostatic hypotension, which may be accompanied by syncope; coldness of the extremities. Possible occurrence of cardiac arrhythmias, including atrioventricular blockade; manifestation of the symptom of intermittent claudication, the onset of Raynaud's syndrome.
From the side of the central nervous system: confusion; dizziness; headache, emotional lability; acute psychosis, hallucinations; paresthesia; sleep disorders, fatigue, apathy; disorientation.
From the gastrointestinal tract: dry mouth; rarely - an increase in the level of "liver" transaminases in the blood serum, rarely - hepatotoxicity with the phenomena of intrahepatic cholestasis; nausea (associated with chlorthalidone), constipation, diarrhea, pancreatitis, anorexia.
Hematologic reactions: leukopenia; purpura; thrombocytopenia; agranulocytosis, eosinophilia.
From the skin: alopecia; psoriasis-like skin reactions; exacerbation of psoriasis, skin rash.
On the part of the respiratory system: bronchospasm may occur in patients suffering from bronchial asthma or having an anamnesis of bronchospasm.
From the senses: visual impairment.
Other: an increase in the number of antinuclear antibodies, although the clinical significance of this fact is not clear, a decrease in potency.
CONTRAINDICATIONS
- hypersensitivity to any of the components of the drug;
- pronounced bradycardia; cardiogenic shock; severe arterial hypotension, metabolic acidosis; expressed violations of peripheral blood circulation, atrioventricular blockade of II and III degree; syndrome of weakness of the sinus node; pheochromocytoma, acute heart failure; chronic heart failure, stenocardia Prinzmetal; bronchial asthma, obstructive bronchitis; diabetes mellitus, hypokalemia; gout; myasthenia gravis, acute hypotitis; acute renal insufficiency;
- Children under 18 years.
With caution appoint patients with atrioventricular blockade I degree, patients with bronchoobstructive syndrome, in the case of worsening of bronchial conductance due to the use of "Tenorox" prescribe therapy with beta-adrenomimetics (for example, salbutamol).
PREGNANCY AND LACTATION
The use of Tenorox during pregnancy and during lactation is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be exercised in the treatment of patients with impaired renal function. Abolition of the drug after prolonged treatment should be carried out, if possible, gradually.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 18 years.
APPLICATION IN ELDERLY PATIENTS
For the elderly, a lower dose of the drug (1/2 atenolol 50 mg tablet) is often required.
SPECIAL INSTRUCTIONS
Conditioned by the beta-blocker (atenolol), which is part of the "Tenorox":
- can mask the phenomenon of thyrotoxicosis and hypoglycemia;
- with the development of bradycardia (reduction of the heart rate to 50 cuts per minute) with clinical symptoms, the dose should be reduced or the drug should be withdrawn;
- Do not abruptly cancel "Tenoroks" in patients with IHD;
- in smokers, there may be a decrease in the therapeutic effect of the drug;
- special attention is needed in cases where surgical intervention is required under general anesthesia in patients taking atenolol. The drug should be discontinued 48 hours before surgery. As an anesthetic, the drug should be chosen with the possible minimum negative inotropic effect;
- may increase sensitivity to allergens and cause severe anaphylactic reactions, and therefore patients on desensitized therapy should take the drug with great care.These patients may not respond to conventional doses of epinephrine used to treat allergic reactions;
- with the use of atenolol, tear production can be reduced, which is of importance for patients using contact lenses.
Due to the action of chlorthalidone, which is a part of "Tenorox":
- hypokalemia may occur. It is necessary to regularly monitor the potassium level, especially in elderly patients, in patients taking cardiac glycosides for the treatment of heart failure, in patients with an unbalanced diet (low in potassium) or in patients with complaints of gastrointestinal dysfunction. In patients taking cardiac glycosides, hypokalemia may predispose to cardiac arrhythmias;
- caution should be exercised in appointing patients with severe renal failure.
Means for general anesthesia: increased hypotensive effect and summation of negative inotropic effect of both agents.
Insulin and oral antidiabetic agents: the effect of the latter can be intensified.
Signs of hypoglycemia: tachycardia, tremor, excessive sweating, general weakness, decreased tone of the eyeball. Regularly monitor blood glucose levels.
Tricyclic antidepressants, barbiturates, phenothiazines, diuretics, vasodilators and other antihypertensives, alcohol - it is possible to increase the antihypertensive effect of "Tenorox".
The use of beta-blockers in combination with calcium channel blockers, which have a negative inotropic effect, for example, verapomil, diltiazem, may lead to an increase in this effect, especially in patients with reduced myocardial contractility and / or with sinoarterial or atrioventricular conduction disorders. This can cause a marked decrease in blood pressure, severe bradycardia and heart failure. The calcium channel blocker should not be used iv for 48 hours after the abolition of the beta-blocker.
With the simultaneous appointment of "Tenorox" with reserpine, clonidine, guanfacin, there may be a pronounced bradycardia.
Impact on participation in road traffic
The use of the drug is unlikely to lead to any disruption in the ability of patients to drive a car or work with machinery. Nevertheless, one should take into account the fact that dizziness and increased fatigue may occur. This effect is enhanced by the simultaneous intake of alcohol.
OVERDOSE
Symptoms of overdose include: severe bradycardia, marked decrease in blood pressure, acute heart failure and bronchospasm, convulsions, increased drowsiness.
Treatment: Careful observation; treatment in the intensive care unit; gastric lavage, the use of activated charcoal and laxatives, in order to prevent the absorption of the drug still present in the gastrointestinal tract; application of plasma or plasma substitutes for the treatment of reduced blood pressure and shock. It is possible to use hemodialysis or hemoperfusion. Bronchospasm is usually stopped with the help of bronchodilators. With a significant diuresis - the introduction of fluid and electrolytes.
DRUG INTERACTION
Concomitant therapy with dihydropyridines, such as nifedipine, may increase the risk of a marked decrease in blood pressure in patients with latent heart failure, and signs of circulatory disorders may appear.
Cardiac glycosides in combination with beta-adrenoblockers can increase the time of atrioventricular conduction.
Beta-adrenoblockers can aggravate the "ricochet" hypertension, which can occur after the withdrawal of clonidine. If both drugs are prescribed, the beta-blocker should be withdrawn a few days before the stopping of clonidine. If you need to replace clonidine with a beta-blocker, the latter should be administered a few days after cessation of clonidine treatment. It is necessary to use caution in prescribing a beta-blocker in combination with anti-arrhythmic drugs of the first class, such as disopyramide (cardiodepressive effect can be summarized).
Concomitant use of sympathomimetic drugs, for example, epinephrine, norepinephrine can neutralize the effect of beta-blockers (a significant increase in blood pressure).
Salicylates and non-steroidal anti-inflammatory drugs (eg, ibuprofen, indomethacin), estrogens can reduce the hypotensive effect of beta-adrenoblockers, and with a high dosage of salicylates, there may be an increase in the toxic effect of salicylates on the CNS.
Preparations containing lithium should not be used with diuretics, since they can reduce its kidney clearance.
Care should be taken when using the means for general anesthesia in conjunction with "Tenorox". An anesthesiologist should be informed about the use of "Tenorox" and a general anesthetic should be chosen that has the least possible negative inotropic effect. The use of beta-blockers together with anesthesia can lead to an increased risk of hypotension. The use of funds for general anesthesia, which reduces the contractility of the myocardium, should be avoided. In addition, the effect of curaroid muscle relaxants is enhanced.
Do not use the drug with monoamine oxidase inhibitors (possibly increasing blood pressure).
Caution should be exercised when using the drug with angiotensin-converting enzyme (captopril, enalapril) inhibitors, because at the beginning of therapy, a sharp increase in the antihypertensive effect of "Tenorox" is possible. When combined with glucocorticoids, carbenoxolane, amphotericin B, furosemide, potassium excretion is possible.
Atenolol: cardioselective beta-1-adrenoblocker, acting primarily on beta-1-adrenoreceptors of the heart, selectivity decreases with increasing dose.
Atenolol has no internal sympathomimetic and membrane-stabilizing effects. Like other beta-blockers, it has a negative inotropic effect, reduces heart rate, and therefore it is not recommended for use in heart failure.
Chlortalidone: a non-azidic sulfonamide diuretic, increases the release of sodium and chlorine. Increases the secretion of potassium, magnesium and bicarbonate. The combination of atenolol with diuretics is possible and, as a rule, more effective than the use of each of the components.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
In dry, the dark place at a temperature below 25 В° C. The drug should be stored in places inaccessible to children.
Shelf life - 3 years. The drug should not be used after the expiry date indicated on the package.
