Tenonorm - instructions for use, dose, side effects, contraindications

Excipients: lactose, corn starch, sodium lauryl sulfate, polyvinylpyrrolidone, purified talc, silicon dioxide colloid, magnesium stearate, hydroxypropylmethylcellulose (hypromelose), titanium dioxide, liquid light paraffin, polyethylene glycol-400.

Description:

Round, biconcave, white tablets covered with a shell.

Color of tablets on a break white or white with a grayish shade.

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:

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-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, 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 reached in 2-4 hours after taking the drug inside. Atenolol is not exposed to expressed hepatic metabolism and More than 90% of the absorbed drug is excreted unchanged. Period 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. The connection with blood plasma proteins is 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%.

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

Tenonorm is effective at least within 24 hours after a single intake of a single 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; atrioventricular blockade II andIII 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.

Age to 18 years (effectiveness and safety not established).

Carefully:

With caution appoint patients with atrioventricular blockade I degree, patients with bronchoobstructive syndrome, in case of worsening of bronchial conductance due to the use of Tenonorm therapy is prescribed beta-adrenomimetics (for example, salbutamol).

Pregnancy and lactation:

The use of Tenonorm 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 of atenolol once a day, with insufficient severity of the therapeutic effect, Tenonorm is prescribed one tablet 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 violations of kidney 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:

Tenonomor 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 not heavy 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 disturbance, fatigue, apathy; disorientation.

From the digestive system: dry mouth, rarely - increased levels "hepatic" 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: ythe 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:

close observation; treatment in the intensive care unit; gastric lavage, the use of activated carbon and laxatives, so as 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 decrease in blood pressure, in patients with latent cardiac insufficiency, there may be signs of circulatory disorders.

Cardiac glycosides in combination with beta-blockers can increase time 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 conjunction with the Tenonorm. An anesthesiologist should be informed of the use of Tenonorm and a general anesthetic should be chosen that has the least possible negative inotropic effect, The use of beta-blockers along 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 "Tenonorm" is possible.

When combined with glucocorticosteroids, carbenoxolane, amphotericin B, furosemide potentiation of potassium excretion is possible.

Means for general anesthesia: increased hypotensive effect and summation of negative inotropic effect of bothmeans.

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 "Tenonorm".

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 violation of sinoatrial or atrioventricular conduction. This can cause a marked decrease in blood pressure, severe bradycardia and heart failure. The blocker of "slow" calcium channels should not be used intravenously within 48 hours after the abolition of the beta-blocker.

With the simultaneous appointment of "Tenonorm" with reserpine, clonidine, guanfacin, there may be a pronounced bradycardia.

Special instructions:

Conditioned by beta-blocker atenolol, which is part of the "Tenonorm":

- 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 "Tenonorm" in patients with coronary heart disease;

- 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 important for patients using contact lenses.

Due to the action of chlorthalidone, which is a part of "Tenonorm":

- 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 section "Method of administration and dose");

- 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 100 mg of Tenonorm 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:The tablets covered with a cover, 50 mg + 12,5 mg, 100 mg + 25 mg.

Packaging:For 7, 10 or 14 tablets in a blister AL / PVC.

For 1, 2, 3, 4 or 10 blisters together with the instructions for use are placed in a pack of cardboard.

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

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:P N 015438/01

Date of registration:05.03.2009

The owner of the registration certificate:M. J. Biofarm Pvt. Ltd.M. J. Biofarm Pvt. Ltd. India

Manufacturer: & nbsp

M.J. BIOPHARM, Pvt. Ltd. India

Representation: & nbspM.J. BIOFARM Pvt. Ltd. division of the corporation MJ Group M.J. BIOFARM Pvt. Ltd. division of the corporation MJ Group India

Information update date: & nbsp21.01.2011

Illustrated instructions

Instructions

Tenonorm® (Tenonorm®)