Tenorox (Tenorox)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAtenolol + ChlortalidoneAtenolol + Chlortalidone
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    • Dosage form: & nbspcoated tablets
    Composition:

    Each coated tablet contains:

    Active substances:

    Atenolol 50 mg

    Chlortalidone 12.5 mg

    Each tablet, covered with a shell, forte contains:

    Active substances:

    Atenolol 100 mg

    Chlortalidone 25.0 mg

    Excipients: maize starch, lactose, isopropyl alcohol, sodium lauryl sulfate, purified talc, povidone, colloidal silicon dioxide, magnesium stearate, hydroxypropyl methylcellulose, methylene chloride, titanium dioxide, light liquid paraffin, polyethylene glycol-400, white beeswax, Carnauba wax, carbon tetrachloride .

    Description:

    Tablets are white or almost white in color, round, biconvex, covered with a sheath, and a line of division on one side.

    On the fracture: the core is uniform, almost white, and the coat layer is white.

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

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

    Pharmacodynamics:

    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).

    Atenolol: cardioselective beta-1-adrenoblocker, acting predominantly 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 the heart rate, and therefore it is not recommended for heart failure.

    Chlorthalidone: a non-ioside sulfonamide diuretic, enhances 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.

    Pharmacokinetics:

    After oral administration atenolol It is absorbed from the gastrointestinal tract by 50%. The maximum concentration in the blood plasma is achieved 2-4 hours after ingestion. Atenolol does not undergo a pronounced hepatic metabolism and more than 90% of the absorbed drug is excreted unchanged. The half-life 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 oral administration chlorthalidone absorbed from the gastrointestinal tract by 60%, the maximum concentration in the blood plasma was noted approximately 12 hours after ingestion. The half-life is approximately 50 hours, and the excretion occurs mainly through the kidneys. Chlorthalidone binds to blood plasma proteins by about 75%.

    At the same time, the use of chlorthalidone and atenolol has little effect on the pharmacokinetics of each of them.

    Tenorox is effective at least 24 hours after a single dose of one daily dose.

    Indications:

    Arterial hypertension.

    Contraindications:

    Hypersensitivity to any of the components of the drug.

    Pronounced bradycardia; cardiogenic shock; severe arterial hypotension; metabolic acidosis; severe peripheral circulatory disturbances; antriyventicular blockade of II and III degree; syndrome of weakness of the sinus node; pheochromocytoma; acute heart failure; chronic heart failure; angina of Prinzmetal; bronchial asthma, obstructive bronchitis; diabetes mellitus, hypokalemia; gout; myasthenia gravis; acute hepatitis; acute renal failure, children under 18 years.

    Carefully:

    With caution appoint patients with atrioventricular blockade I degree, patients with bronchoobstructive syndrome, in the event 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.

    Dosing and Administration:

    For adults

    Take inside, without chewing, 1 tablet a day.

    With arterial hypertension, the initial dose is 50 mg atenolol oneonce a day, with insufficient expression of the therapeutic effect, appoint "Tenorox" one tablet of forte containing 100 mg of atenolol per day.

    For the elderly

    For this age group, the dose often requires a lower dose of the drug (1/2 atenolol 50 mg tablet).

    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 effects:

    Tenorox is usually well tolerated.

    Laboratory indicators:

    Hyperuricemia; hyponatremia (associated with chlorthalidone); hypokalemia: a violation of glucose tolerance (see section "Special instructions").

    Side effects associated with its reception, appear rarely, in most cases are light and temporary.

    Termination of treatment with beta-blockers should be carried out gradually.

    There were reports of nausea and dizziness due to taking Chlorthalidone 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 of consciousness; 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 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.

    From the respiratory system: bronchospasm may occur in patients suffering from bronchial asthma or having an anamnesis of bronchospasm.

    From the sense organs: 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.

    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 carbon and laxatives, in order to prevent the absorption of the drug still present in the gastrointestinal tract; 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.

    Interaction:

    Concomitant therapy with dihydropyridines, such as nifedipine, may increase the risk of a marked reduction 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 that 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). The 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, an increase in the toxic effect of salicylates on the central nervous system can be observed.

    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 combination with "Tenorox". An anesthesiologist should be informed about the use of "Tenorox" and a general anesthetic should be chosen, with 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 raising blood pressure).

    Caution should be exercised when using the drug with angiotensin-converting enzyme (captopril, enalapril), 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.

    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 eyeball tone. Regularly monitor blood glucose levels.

    Tricyclic antidepressants, barbiturates, phenothiazines, diuretics, vasodilators, and other antihypertensive drugs, alcohol - may increase the antihypertensive effect of "Tenoroksa". Use of beta-blockers in combination with calcium channel blockers that have a negative inotropic effect, e.g., verapamil, diltiazem can exacerbate this effect, particularly in patients with reduced myocardial contractility, and / or with impaired atrioventricular conduction or sinoarterialnoy. This can cause a marked decrease in blood pressure, severe bradycardia and heart failure. The calcium channel blocker should not be used intravenously within 48 hours after the abolition of the beta-blocker.

    With the simultaneous administration of "Tenorox" with reserpine, clonidine, guanfacin, a pronounced bradycardia may occur.

    Special instructions:

    Conditioned by a beta-blocker (atenolol), which is part of the "Tenorox": can mask the phenomenon of thyrotoxicosis and hypoglycemia; when developing with bradycardia therapy (heart rate reduction to 50 cuts per minute) with clinical symptoms, the dose should be reduced or the drug should be withdrawn; Do not abruptly cancel "Tenorox" in patients with coronary heart disease; smokers may experience 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, so 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 important 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 level of potassium, 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 insufficiency (see the "Method of administration and dose" section); there may be a violation of glucose tolerance. Use with caution in patients with a known predisposition to diabetes mellitus; may occur hyperuricemia.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 in blood pressure either does not occur, or it is insignificant, but, if necessary, another hypotensive agent may additionally be prescribed.

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

    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.

    Form release / dosage:Pills.
    Packaging:For 10 tablets in a strip of aluminum foil with instructions for use.

    10 such packages in a cardboard bundle.

    For 14 tablets in the blister Al / PVC with the indication of the days of the week (for packaging and packaging at the Russian enterprise, the days of the week are not indicated on the blister).

    2 blisters for 14 tablets with instructions for medical use in one carton.
    Storage conditions:

    In dry, the dark place at a temperature below 25 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.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014664 / 01
    Date of registration:08.05.2009
    The owner of the registration certificate:Oxford Laboratories Pvt. Ltd.Oxford Laboratories Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspOXFORD LABORATORY Pvt. Ltd. OXFORD LABORATORY Pvt. Ltd. India
    Information update date: & nbsp08.05.2009
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