Active substanceAtenolol + ChlortalidoneAtenolol + Chlortalidone
Similar drugsTo uncover
  • Sandoz d.     Slovenia
  • Tenonorm®
    pills inwards 
  • Tenoretic®
    pills inwards 
    AstraZeneca UK Ltd     United Kingdom
  • Tenorik®
    pills inwards 
  • Tenorox
    pills inwards 
  • Dosage form: & nbspcoated tablets
    Composition:

    1 tablet contains:

    Active substances: atenolol 100.0 mg, chlorthalidone 25.0 mg;

    Excipients: corn starch 79.4 mg, magnesium carbonate 190.0 mg, gelatin 4.0 mg, sodium lauryl sulfate 6.6 mg, magnesium stearate 10.0 mg;

    Film membrane (approximate composition): hypromellose 6.3 mg, glycerol (glycerol) 1.2 mg, titanium dioxide 1.2 mg.

    Description:

    Round biconvex tablets, coated with a white film shell, engraved TENORETIC on one side and risk on the other side.

    Pharmacotherapeutic group:antihypertensive combination drug (beta 1-blocker selective + diuretic)
    ATX: & nbsp

    C.07.C.B   Selective beta-1 blockers in combination with other diuretics

    Pharmacodynamics:

    Tenoretik® is a combined preparation whose antihypertensive effect is due to the action of two active components included in its composition, a beta1-adrenoblocker (atenolol) and a diuretic (chlorthalidone) (additive effect).

    Atenolol

    Atenolol is a selective beta 1-blocker acting primarily on beta-1-adrenergic receptors of the heart. Selectivity decreases with increasing dose.

    Atenolol has no internal sympathomimetic and membrane-stabilizing effects. Like other beta-blockers has a negative inotropic effect, and therefore, it is not recommended for uncontrolled heart failure.

    As with the use of other beta-blockers, the mechanism of action of atenolol in the treatment of hypertension is not fully understood. Atenolol effective and well tolerated by representatives of most ethnic groups.

    The combination of atenolol with thiazide diuretics is compatible and, as a rule, more effective than the use of each of these medicines.

    Chlorthalidone

    Chlortalidone, being a non-iazide diuretic, sulfonamide, increases the release of sodium and chloride. Natriuresis is accompanied by some loss of potassium. The mechanism of lowering blood pressure (BP) is not completely known, but is most likely associated with the release and redistribution of sodium in the human body.Tenoretic ® is effective for at least 24 hours after ingestion of a single daily dose.

    Pharmacokinetics:

    Atenolol

    After oral administration atenolol absorbed from the gastrointestinal tract by 40-50%. The maximum concentration in the blood plasma is reached in 2-4 hours after taking the drug inside. Atenolol is exposed to insignificant "hepatic" metabolism, and more than 90% of absorbed atenolol falls into the large circle of blood circulation unchanged. The half-life is about 6 hours, but it can increase in cases of severe renal failure, as excretion occurs, the main way, through the kidneys. Atenolol is characterized by low solubility in fats, therefore poorly penetrates into tissues, concentration in the brain tissues is low. Slightly (approximately 3%) binds to blood plasma proteins.

    Chlorthalidone

    After oral administration chlorthalidone absorbed from the gastrointestinal tract by 60%, the maximum concentration in the blood plasma is observed about 12 hours after admission. The half-life is about 50 hours; the excretion of chlorthalidone occurs mainly through the kidneys. Chlorthalidone binds to blood plasma proteins by about 75%.

    The simultaneous use of chlorthalidone and atenolol has little effect on the pharmacokinetics of each of them.

    Indications:

    Arterial hypertension.

    Contraindications:

    - hypersensitivity to any of the components of the drug;

    - severe bradycardia (heart rate less than 45-50 beats per minute);

    - cardiogenic shock;

    - severe arterial hypotension;

    - metabolic acidosis;

    - severe peripheral circulatory disturbances;

    - atrioventricular block II and III degree;

    - syndrome of weakness of the sinus node;

    - untreated pheochromocytoma (without simultaneous use of alpha-blockers);

    - acute and chronic heart failure in the stage of decompensation;

    - age under 18 years (effectiveness and safety not established);

    - pregnancy and the period of breastfeeding.

    Carefully:

    Carefully: atrioventricular block I prinzmetal angina, bradycardia (heart rate less than 60 beats per minute), water-electrolyte disturbances, blood balance, elderly age, renal dysfunction (KC less than 35 ml / min), anuria, bronchial asthma (in anamnesis) ,chronic obstructive pulmonary disease (COPD), thyrotoxicosis, diabetes mellitus, pheochromocytoma, chronic heart failure (compensated), ischemic heart disease (with withdrawal of the drug), desensitizing therapy.

    Pregnancy and lactation:

    The drug Tenoretic® is not recommended for use during pregnancy and lactation. If you need to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Inside, 1 tablet a day. In most patients with arterial hypertension, the use of one tablet of Tenoretic® per day gives satisfactory results. An increase in the dose is not effective, if necessary, another hypotensive agent, such as a vasodilator (vasodilator) in a small dose, may additionally be prescribed.

    Elderly patients

    For this age group, a lower dose of the drug (for atenolol) is often required, which is determined by the attending physician (ie, half the tablet).

    Patients with impaired renal function

    Caution should be exercised in the treatment of patients with impaired renal function.In patients with creatinine clearance (less than 35 ml / min), the drug can be used only after titrating the dose of individual components of the drug (see section "Special instructions").

    Creatinine clearance (ml / min / 1.73 m2)

    The maximum dose of atenolol

    15-35

    50 mg per day

    <15

    50 mg every other day

    Children

    Data on the use of the drug in children under the age of 18 years are absent. Not it is recommended to prescribe the drug to children.

    Side effects:

    Tenoretic ® is usually well tolerated.

    When using Tenoretic® or any of its components with a frequency of development often (> 1/100), infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000), very rarely <1/10000) and unspecified frequency, the following side effects were reported:

    Laboratory indicators:

    Often - associated with chlorthalidone hyperuricemia, hyponatremia, hypokalemia, violation of glucose tolerance (see section "Special instructions").

    Infrequently, an increase in the activity of "hepatic" transaminases.

    Very rarely - an increase in the titer of antinuclear antibodies, although the clinical significance of this fact is not clear.

    From the cardiovascular system:

    Often - bradycardia, manifestations of angiospasm (cooling of the lower limbs)

    Rarely, the development (aggravation) of symptoms of heart failure, the triggering of cardiac blockade, orthostatic hypotension, which can be accompanied by syncope, the manifestation of the symptom of "intermittent" lameness, in the susceptible patients may appear Raynaud's syndrome.

    From the side of the blood and lymphatic system:

    Rarely - purpura, thrombocytopenia, leukopenia (associated with chlorthalidone).

    From the central nervous system:

    Infrequent sleep is infrequent.

    Rarely - confusion, dizziness, headache, paresthesia, mood lability, "nightmarish" dreams, psychosis and hallucinations.

    From the digestive system:

    Often - gastrointestinal disorders, nausea (associated with chlorthalidone).

    Rarely, dryness of the oral mucosa.

    Unspecified frequency - constipation.

    From the liver and bile excretory system:

    Rarely, hepatotoxicity with intrahepatic cholestasis, pancreatitis (associated with chlorthalidone).

    From the skin:

    Rarely - alopecia, psoriasis-like skin reactions, exacerbation of psoriasis, skin rash.

    Unspecified frequency - reactions of hypersensitivity, including angioedema and urticaria.

    From the respiratory system:

    Rarely is the occurrence of bronchospasm in patients with bronchial asthma, including those who have an indication of bronchospasm in the anamnesis.

    From the sense organs:

    Rarely - dry eyes, visual impairment.

    On the part of the reproductive system:

    Rarely, impotence.

    Are common:

    Often - increased fatigue.

    In the event that any of the above reactions may adversely affect a patient's health, consideration should be given to the withdrawal of the drug.

    In the postmarketing application, the following adverse events were also reported: Increase in activity of "liver" enzymes and / or content bilirubin, Peyronie's disease, sick sinus syndrome, lupus syndrome (as well as the use of other beta-blockers), anorexia, gastric irritation, vomiting, convulsions, jaundice (intrahepatic cholestatic jaundice), vertigo, xanthopsia, agranulocytosis, aplastic anemia, photosensitivity, necrotizing vasculitis (vasculitis, cutaneous vasculitis), Lyell syndrome (toxic epidermal necrolysis), hyperglycemia, glycosuria, cramping, weakness, anxiety.

    Overdose:

    Symptoms

    Symptoms of overdose include pronounced bradycardia, marked decrease in blood pressure, acute heart failure and bronchospasm.

    Treatment

    Careful observation; treatment in the intensive care unit; gastric lavage, the use of activated carbon and laxatives, in order to prevent the absorption of the drug still present in the gastrointestinal tract; the use of plasma or plasma substitutes for the treatment of arterial hypotension and hypovolemic shock. It is possible to use hemodialysis or hemoperfusion.

    With severe bradycardia - intravenous injection of 1-2 mg of atropine and / or setting up a temporary artificial pacemaker. If necessary, you can then enter intravenously bolus 10 mg of glucagon, which is indicated for intoxication with beta-blockers. This procedure, if necessary, can either be repeated, or after it, intravenously administered glucagon at a rate of 1-10 mg / hour, depending on the response. If there is no response to glucagon or in the absence of glucagon itself, you can enter intravenously beta-1-adrenomimetic - dobutamine in a dose of 5-10 μg / kg / min.Due to a positive inotropic effect, dobutamine can be used to treat arterial hypotension and acute heart failure. Probably, these doses will not be enough to stop the cardiovascular symptoms associated with beta-adrenoblockade, in cases of a large overdose. Therefore, if necessary, the dose of dobutamine should be increased to achieve a therapeutic effect in accordance with the clinical condition of the patient.

    Bronchospasm is usually stopped with the help of bronchodilators.

    With a significant diuresis - the introduction of fluid and electrolytes.

    Interaction:

    The use of beta-blockers in combination with blockers of "slow" calcium channels, which have a negative inotropic effect, such as verapamil, diltiazem, may lead to an increase in this effect, especially in patients with reduced myocardial contractility and / or with violations of sinoatrial or atrioventricular conduction. This can cause severe arterial hypotension, severe bradycardia and heart failure.The blockers of "slow" calcium channels should not be used intravenously within 48 hours after the abolition of the beta-blocker.

    Concomitant therapy with the use of dihydropyridine blockers of "slow" calcium channels, for example, nifedipine, may increase the risk of hypotension, patients with latent cardiac insufficiency may have signs of circulatory disorders.

    Cardiac glycosides in combination with beta-adrenoblockers can increase the time of atrioventricular conduction.

    Beta-adrenoblockers can aggravate the "ricochet" arterial hypertension that can occur after the withdrawal of clonidine. If both drugs are prescribed, the beta-adrenoblocker should be withdrawn a few days before cessation of clonidine. If necessary, appoint a few days after stopping the use of clonidine.

    It is necessary to use caution in prescribing a beta-blocker in combination with amiodarone, class I antiarrhythmics, such as disopyramide (cardiodepressive effect can be summarized).

    The concomitant use of sympathomimetic drugs, for example, epinephrine, can neutralize the effect of beta-blockers (a significant increase in blood pressure).

    Concomitant use of non-steroidal anti-inflammatory drugs (eg, ibuprofen, indomethacin) may reduce the antihypertensive effect of beta-blockers.

    Preparations containing lithium should not be used with diuretics, since they can reduce their kidney clearance.

    Caution should be exercised when using general anesthetics in combination with the Tenoretic® preparation. An anesthesiologist is necessary inform about the use of the drug Tenoretic®, an anesthetic should be chosen, possibly having the smallest negative inotropic effect. The use of beta-blockers along with the means for general anesthesia can lead to an increased risk of hypotension. The use of agents for general anesthesia that reduce the contractility of the myocardium should be avoided.

    Concomitant use with insulin or hypoglycemic drugs for oral administration may increase their hypoglycemic effects.

    Concomitant use of baclofen may increase the hypotensive effect of the drug Tenoretic® and require dose adjustment.

    Special instructions:

    Special instructions due to the beta-blocker (atenolol) included in the preparation Tenoretic®:

    Although Tenoretic® is contraindicated in heart failure during decompensation (see Contraindications), it can be used for those patients in whom signs of heart failure are controlled, and caution should be exercised in patients with a reduced ejection fraction.

    With caution appoint patients with atrioventricular blockade I degree, with angina prinzmetal (see section "With caution").

    Although the preparation Tenoretic® is contraindicated in severe peripheral circulation disorders (see the section "Contraindications"), it may also aggravate and less pronounced violations of the peripheral circulation.

    When applying the drug, it is possible to mask tachycardia caused by hypoglycemia, masking the symptoms of thyrotoxicosis.

    With the development of bradycardia (heart rate less than 60 beats / min) with clinical symptoms should reduce the dose of the drug (the dose is determined by the attending physician).

    Do not abruptly cancel Tenoretic® in patients with ischemic heart disease.

    Against the background of taking the drug, hypersensitivity reactions, including allergens, angioneurotic edema and urticaria, are possible. Therefore, care should be taken when prescribing Tenoretic® to patients on desensitized therapy. These patients may not respond to conventional doses of epinephrine used to treat allergic reactions.

    Although cardioselective beta-blockers have less effect on lung function than non-selective beta-blockers, patients with obstructive pulmonary disease, Tenoretic® should be administered with caution. In case of worsening bronchial conductivity, Tenoretic® should be withdrawn and beta-adrenomimetic therapy (eg, salbutamol) should be prescribed.

    Special instructions due to the action of chlorthalidone, which is part of the preparation Tenoretic®:

    Against the background of taking the drug Tenoretic ® hypokalemia may occur. The content of potassium should be monitored regularly, especially in elderly patients, patients taking cardiac glycosides for the treatment of chronic heart failure, in patients with an unbalanced diet (low-potassium food) or in patients with gastrointestinal disorders (vomiting, diarrhea). In patients taking cardiac glycosides, hypokalemia can predispose to cardiac arrhythmias.

    Caution should be exercised when prescribing the drug to patients with severe renal failure (see section "Method of administration and dose").

    There may be a violation of glucose tolerance. Caution should be exercised if the drug is used in patients with a known predisposition to diabetes mellitus.

    There may be hyperuricemia. Usually there is only a slight increase in the concentration of uric acid in the blood serum, but in some cases, the use of agents that promote the excretion of uric acid may be required.

    Effect on the ability to drive transp. cf. and fur:

    Care must be taken when driving vehicles and other mechanisms (risk of dizziness and fatigue).

    Form release / dosage:

    Tablets, film-coated 100 mg + 25 mg.

    Packaging:For 14 tablets in blisters of aluminum foil and PVC, 2 blisters in a cardboard box with instructions for use.
    Storage conditions:

    In dry, the dark place at a temperature below 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013482 / 01
    Date of registration:30.12.2011
    The owner of the registration certificate:AstraZeneca UK LtdAstraZeneca UK Ltd United Kingdom
    Manufacturer: & nbsp
    ASTRAZENECA UK, Ltd. United Kingdom
    Representation: & nbspAstraZeneca Pharmaceuticals Ltd.AstraZeneca Pharmaceuticals Ltd.
    Information update date: & nbsp30.12.2011
    Illustrated instructions
      Instructions
      Up