Composition, form of production and packaging
The tablets covered with a cover of white color, round, biconcave; On a break - white or white with a grayish shade of color.
1 tab.
atenolol 50 mg
Chlorthalidone 12.5 mg
[PRING] lactose, corn starch, sodium lauryl sulfate, polyvinylpyrrolidone, talc purified, silicon dioxide colloid, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide, paraffin liquid light, polyethylene glycol-400.
7 pcs. - blisters (1) - packs of cardboard.
7 pcs. - blisters (2) - packs of cardboard.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
14 pcs. - blisters (1) - packs of cardboard.
14 pcs. - blisters (2) - packs of cardboard.
The tablets covered with a cover of white color, round, biconcave; On a break - white or white with a grayish shade of color.
1 tab.
atenolol 100 mg
chlorthalidone 25 mg
[PRING] lactose, corn starch, sodium lauryl sulfate, polyvinylpyrrolidone, talc purified, silicon dioxide colloid, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide, paraffin liquid light, polyethylene glycol-400.
7 pcs. - blisters (1) - packs of cardboard.
7 pcs. - blisters (2) - packs of cardboard.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
14 pcs. - blisters (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 2008.
PHARMACHOLOGIC EFFECT
Combined antihypertensive drug. The effect is due to the action of the constituents of the preparation.
Atenolol - cardioselective beta 1 -adrenoblocker, acting mainly on? 1- adrenoreceptors of the heart. Selectivity decreases with increasing dose. Reduces the automatism of the sinus node, reduces heart rate, slows down AV-conductivity, reduces myocardial contractility and excitability, reduces myocardial oxygen demand. Atenolol has no internal sympathomimetic and membrane-stabilizing effects.
Chlortalidone is a non-iodide sulfonamide diuretic, enhances the excretion of sodium and chlorine. Increases the excretion of potassium, magnesium and bicarbonate.
The combination of atenolol with chlorthalidone is possible and usually more effective than the use of each of the components.
The antihypertensive effect of Tenonorm persists for 24 hours after a single oral intake of one daily dose.
PHARMACOKINETICS
The simultaneous use of chlorthalidone and atenolol has little effect on the pharmacokinetics of each of them.
Atenolol
Suction
After taking the drug inside, atenolol is absorbed from the digestive tract by 50%. C max in blood plasma is achieved in 2-4 hours after taking the drug.
Distribution
It binds to plasma proteins approximately 6-16%.
Metabolism and excretion
Not exposed to severe hepatic metabolism.
More than 90% of the absorbed atenolol is excreted unchanged, mainly with urine. T 1/2 is 6-9 hours.
Pharmacokinetics in special clinical cases
T 1/2 may increase in cases of severe renal failure.
Chlorthalidone
Suction
After taking the drug inside chlorthalidone absorbed from the gastrointestinal tract by 60%, Cmax in the blood plasma was noted approximately 12 hours after taking the drug.
Distribution
It binds to plasma proteins approximately 75%.
Excretion
T 1/2 is approximately 50 hours. It is excreted mainly in the urine.
INDICATIONS
- arterial hypertension.
DOSING MODE
With arterial hypertension, at the beginning of therapy, Tenonorm is prescribed 1 tablet each containing 50 mg of atenolol, 1 time / day. If the therapeutic effect is inadequate, Tenonorm is prescribed for 1 tablet containing 100 mg of atenolol, 1 time / day. Further increase in the dose is not shown (because with increasing doses of further decrease in blood pressure either does not occur, or it is insignificant). If necessary, another antihypertensive drug may be additionally prescribed.
Cancellation of the drug after prolonged treatment should be carried out gradually.
Elderly patients often require a lower dose of the drug (1/2 tab., Containing 50 mg of atenolol).
Patients with impaired renal function Tenonorm should be administered with caution.
SIDE EFFECT
From the cardiovascular system: bradycardia, increased symptoms of heart failure, cold extremities, orthostatic hypotension, which may be accompanied by syncope;possibly the appearance of cardiac arrhythmias (including AV-blockade), the manifestation of a symptom of intermittent claudication, the emergence of Raynaud's syndrome.
From the side of the central nervous system and peripheral nervous system: confusion, dizziness, headache, emotional lability, acute psychosis, hallucinations, paresthesia, sleep disturbance, fatigue, apathy, disorientation, visual impairment.
On the part of the digestive system: dry mouth; rarely - increased levels of hepatic transaminases in the serum, hepatotoxicity with intrahepatic cholestasis, nausea (associated with chlorthalidone intake), constipation, diarrhea, pancreatitis, anorexia.
On the part of the hematopoiesis system: leukopenia, purpura, thrombocytopenia, agranulocytosis, eosinophilia.
Dermatological reactions: 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.
On the part of metabolism: hyperuricemia, hyponatremia (associated with the administration of chlorthalidone), hypokalemia, impaired glucose tolerance.
Other: a decrease in potency, an increase in the number of antinuclear antibodies, although the clinical significance of this fact is not clear.
CONTRAINDICATIONS
- pronounced bradycardia;
- cardiogenic shock;
- severe arterial hypotension;
metabolic acidosis;
- severe peripheral circulatory disturbances;
- AV blockade II and III degree;
- SSSU;
- pheochromocytoma;
- acute heart failure;
- Chronic heart failure;
- Prinzmetal angina;
- bronchial asthma;
- obstructive bronchitis;
- diabetes;
- hypokalemia;
- gout;
- Myasthenia gravis;
acute hepatitis;
acute renal failure;
- Pregnancy;
- the period of lactation (breastfeeding);
- children and adolescents under 18 years of age (efficacy and safety not established);
- Hypersensitivity to any of the components of the drug.
With caution appoint Tenonorm to patients with AV-blockade I degree, patients with bronchoobstructive syndrome. In the case of worsening of bronchial patency due to the use of Tenonorm therapy is prescribed beta-adrenomimetics (for example, salbutamol).
PREGNANCY AND LACTATION
The use of Tenonom during pregnancy and lactation (breastfeeding) is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with impaired renal function Tenonorm should be administered with caution.
Contraindicated in acute renal failure.
SPECIAL INSTRUCTIONS
Atenolol, which is part of Tenonorm, can mask the phenomenon of thyrotoxicosis.
When developing a bradycardia with the Tenonorm therapy (heart rate reduction to 50 bpm) with clinical symptoms, the dose should be reduced or the drug should be withdrawn. Do not sharply cancel Tenonorm in patients with IHD.
In cases where surgery is required under general anesthesia, the drug should be discontinued 48 hours before surgery, as an anesthetic should be chosen with the possible minimum negative inotropic effect.
Atenolol, which is part of Tenonorm, can increase sensitivity to allergens and cause severe anaphylactic reactions, so patients on desensitizing 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 important for patients using contact lenses.
Smokers may experience a decrease in the therapeutic effect of the drug.
Chlortalidone, which is part of Tenonorm, can cause hypokalemia (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 unbalanced diet / low potassium) or in patients with complaints on violations of the function of the digestive tract). In patients taking cardiac glycosides, hypokalemia may predispose to arrhythmias.
Caution should be exercised in appointing Tenonorm to patients with severe renal failure.
With caution, Tenonorm should be prescribed to patients with a known predisposition to diabetes mellitus, because they are not susceptible to diabetes. the use of atenolol can mask the symptoms of hypoglycemia, and the use of chlorthalidone can cause impaired glucose tolerance. Regularly monitor blood glucose levels.
Against the background of Tenonorm, hyperuricemia may occur, which in some cases may require the use of agents that promote the excretion of uric acid.
Use in Pediatrics
The effectiveness and safety of Tenonorm in children and adolescents have not been established, so do not prescribe the drug to patients of this age group.
Impact on the ability to drive vehicles and manage mechanisms
The use of Tenonoma as a rule does not affect the ability to drive vehicles and control mechanisms. Nevertheless, the question of the possibility of driving a vehicle should be addressed after assessing the individual tolerability of the drug.
OVERDOSE
Symptoms: pronounced bradycardia, marked decrease in blood pressure, acute heart failure and bronchospasm, convulsions, increased drowsiness.
Treatment: gastric lavage, the use of activated carbon and laxatives to prevent absorption of the drug; careful observation, the use of plasma or plasma substitutes for the treatment of low 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
With the simultaneous use of atenolol with dihydropyridine derivatives (for example, nifedipine), the risk of a significant decrease in blood pressure may increase; In patients with latent cardiac insufficiency, signs of circulatory disturbance may appear. Cardiac glycosides in combination with atenolol may slow AV conduction.
Against the background of taking atenolol, hypertension that occurs after the withdrawal of clonidine may increase. If both drugs are prescribed, take atenolol should be discarded a few days before the stopping of clonidine. If you need to replace clonidine with atenolol, the latter should be administered a few days after cessation of treatment with clonidine.
With the use of atenolol in combination with anti-arrhythmic drugs of the first class, such as disopyramide, cardiodepressive effect can be summarized.
The concomitant use of sympathomimetic drugs (eg, epinephrine, norepinephrine) can neutralize the effect of atenolol.
Salicylates and NSAIDs (ibuprofen, indomethacin), estrogens can reduce the hypotensive effect of atenolol.
Preparations containing lithium should not be used with diuretics (because they can reduce renal clearance of lithium).
When using Tenonorm with MAO inhibitors, it is possible to increase blood pressure.
At the beginning of the combination therapy with ACE inhibitors (captopril, enalapril), a sharp increase in the antihypertensive effect of Tenonorm is possible.
With the combined use of Tenonomorm with GCS, carbenoxolone, amphotericin B, furosemide, potassium excretion is possible.
With the simultaneous use of funds for general anesthesia and Tenonorm, the hypotensive effect is amplified and the negative inotropic effect of both agents is summarized.
With the simultaneous use of Tenonorm insulin and oral hypoglycemic agents, the effect of the latter can be enhanced. There may be signs of hypoglycemia (tachycardia, tremor, excessive sweating, general weakness, decreased tone of the eyeball).
With the simultaneous use of tricyclic antidepressants, barbiturates, phenothiazines, diuretics, vasodilators and other antihypertensive agents, as well as alcohol, an increase in the antihypertensive effect of Tenonorm is possible.
The use of beta-blockers in combination with slow calcium channel blockers, which have a negative inotropic effect (verapamil, diltiazem), may lead to an increase in this effect, especially in patients with reduced myocardial contractility and / or with a violation of sinoatrial or AV-conduction. This can cause a marked decrease in blood pressure, severe bradycardia and heart failure. The slow calcium channel blockers should not be used IV for 48 hours after the atenolol withdrawal.
With the simultaneous appointment of Tenonorm with reserpine, clonidine, guanfacin, a pronounced bradycardia may occur.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
