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

Kernel: corn starch 69.95 mg, lactose 46.25 mg, povidone 4.50 mg, sodium lauryl sulfate 1.25 mg, talc 5.00 mg, silicon dioxide colloid 4.80 mg, magnesium stearate 3.00 mg; shell: hypromellose 2.50 mg, talc 1.00 mg, titanium dioxide 1.20 mg, paraffin liquid 0.20 mg, macrogol-400 1.00 mg, carnauba wax 0.10 mg.

Each tablet coated with a film coating of 100 mg + 25 mg contains:

Active substances:

Atenolol 100.00 mg

Chlortalidone 25.00 mg

Excipients:

Kernel: corn starch 139,80 mg, lactose 92,50 mg, povidone 9,00 mg, sodium lauryl sulfate 2.50 mg, talc 10.00 mg, silicon dioxide colloid 9.70 mg, magnesium stearate 6.00 mg; shell: hypromellose 2.00 mg, talc 0.80 mg, titanium dioxide 1.20 mg, paraffin liquid 0.20 mg, macrogol-400 0.8 mg, carnauba wax 0.07 mg.

Description:

Round, biconcave, film-coated tablets white or almost white, with a risk on one side; the core is white or almost white in cross section.

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 antihypertensive effect. The effect is due to the action of two components - beta-1-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. As with the use of other beta-blockers, the mechanism of action of atenolol in the treatment of hypertension is not fully understood.

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

Chlorthalidone: thiazide-like diuretic, has a long-lasting effect. It disrupts the reabsorption of sodium, chlorine and equivalent amounts of water in the distal tubules of the kidneys. In addition, increases the excretion of the ions of potassium, magnesium and bicarbonate, delays the excretion of uric acid. The mechanism by which chlorthalidone lowers blood pressure (BP), is not completely known, but can be associated with elimination of sodium ions.

The combination of atenolol with diuretics is possible and, as a rule, more effective than the use of each of the components separately.

Pharmacokinetics:

Atenolol: after oral administration atenolol absorbed from the gastrointestinal tract by 40-50%. The maximum concentration in the blood plasma is achieved in 2-4 hours after ingestion. Atenolol slightly metabolized in the liver, more than 90 % The absorbed drug is excreted unchanged. The half-life is 6-9 hours, but may increase in cases of severe renal failure, since excretion occurs mainly through the kidneys. Linkage to blood plasma proteins is approximately 6-16%.

Chlorthalidone: 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 about 50 hours, 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.

Tenorik® is effective for at least 24 hours after a single intake of one daily dose.

Indications:

Arterial hypertension.

Contraindications:

- hypersensitivity to any of the components of the drug;

- cardiogenic shock, collapse;

- severe arterial hypotension (systolic pressure below 90 mm Hg);

- metabolic acidosis;

- severe peripheral circulatory disturbances;

- atrioventricular blockade of II and III degree;

- syndrome of weakness of the sinus node;

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

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

- refractory hypokalemia;

- gout;

- myasthenia gravis;

- acute hepatitis;

- renal failure (creatinine clearance less than 35 ml / min);

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

- hereditary lactose intolerance, lactase deficiency and glucose malabsorption / galactose syndrome.

Carefully:

- atrioventricular blockade of the 1st degree;

- angina of Prinzmetal;

- bronchial asthma, chronic obstructive pulmonary disease;

- diabetes;

- disturbance of water-electrolyte balance of blood;

- impaired renal function;

- elderly age;

- thyrotoxicosis.

Pregnancy and lactation:

The use of the preparation Tenorik® during pregnancy and during breast-feeding is not recommended.

Dosing and Administration:

The drug should be taken orally, in the morning, before eating, without chewing and drinking with sufficient water.

When arterial hypertension the initial dose is 1 tablet of the drug, containing 50 mg of atenolol and 12.5 mg of chlorthalidone, per day.

The maximum daily dose is 100 mg of atenolol and 25 mg of chlorthalidone per day. With an increase in the dose of further decrease in blood pressure either does not occur, or it is insignificant, but if necessary, another antihypertensive agent can be used.

Elderly patients

For this age group, a lower dose of the drug (for atenolol), which is determined by the doctor, is often required.

Impaired renal function

Care should be taken when treating 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.

Creatinine clearance	The maximum dose of atenolol
(ml / min / 1.73 m²)
15-35	50 mg per day
Less than 15	50 mg every other day

The dose of the drug should be reduced, reducing the frequency of reception (see section "Precautions for use").

Features of the drug at the first admission or when it is canceled

No special actions for the first time you take Tenorik® is not required. The withdrawal of the drug after prolonged treatment should be carried out, if possible, gradually.

The actions of the doctor (paramedic), the patient, if one or several doses of Tenorik® are missed

If you miss a dose, you should not double the dose. Skipping the next dose of the drug may be accompanied by a decrease in the effectiveness of treatment.

Side effects:

Laboratory indicators: hyperuricemia, hyponatremia (associated with chlorthalidone), hypokalemia, impaired glucose tolerance.

From the cardiovascular system: bradycardia, increased symptoms chronic heart failure; Orthostatic hypotension, which may be accompanied by syncope. There may be arrhythmias, including atrioventricular blockade; intermittent claudication, cold extremities, the development of Raynaud's syndrome.

From the central nervous system: confusion, dizziness, headache, mood lability, acute psychosis, hallucinations, paresthesia, sleep disorders, fatigue, apathy, disorientation.

From the digestive tract: dryness of the oral mucosa, gastrointestinal disorders (nausea, constipation, anorexia), increased activity of "hepatic" transaminases in the blood serum; abnormal liver function with intrahepatic cholestasis; pancreatitis.

On the part of the hematopoiesis system: leukopenia, purpura, thrombocytopenia, agranulocytosis, eosinophilia.

From the side skin integument: alopecia, photosensitivity, psoriasis-like skin reactions, exacerbation of psoriasis, skin rash.

From the side respiratory system: bronchospasm may occur in patients with bronchial asthma or have a history of bronchospasm.

From the side of the organ of vision: visual impairment, dryness of the eye mucosa.

Other: an increase in the titer of antinuclear antibodies, although the clinical significance of this fact is not clear; decreased potency.

Overdose:

Symptoms: pronounced bradycardia, marked decrease in blood pressure, acute heart failure and bronchospasm, cramps, drowsiness.

Treatment: gastric lavage, the use of laxatives and activated charcoal 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 arterial hypotension and shock.

With severe bradycardia - intravenous injection of 1-2 mg of atropine and / or installation of an artificial pacemaker.

It is possible to use hemodialysis or hemoperfusion.

Bronchospasm is usually stopped with the help of bronchodilators.

Interaction:

Simultaneous use of "slow" calcium channels (BCCC), dihydropyridine derivatives, such as nifedipine, with antibiotics may increase the risk of hypotension, patients with latent (hidden) heart failure may have signs of circulatory disorders.

Cardiac glycosides with simultaneous application with beta-blockers 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 used, the beta-adrenoblocker should be withdrawn a few days before discontinuation clonidine. If it is necessary to replace clonidine with a beta-blocker, the latter should be used several days after cessation of clonidine treatment. It is necessary to use with caution beta-blockers in combination with antiarrhythmic drugs of the first class, such as disopyramide (cardiodepressive effect can be summarized).

Simultaneous use with sympathomimetic agents, 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 antihypertensive 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 simultaneously with general anesthetics.

Do not use the drug with monoamine oxidase (MAO) inhibitors (possibly increasing blood pressure).

Care should be taken when using the drug with angiotensin-converting enzyme (ACE) inhibitors, because at the beginning of therapy, a sharp increase in its antihypertensive effect (due to atenolol) is possible.

When used simultaneously with glucocorticosteroids, carbenoxolan, amphotericin B, furosemide, potassium ions can be enhanced.

Insulin and hypoglycemic agents for oral administration: the effect of the latter can be intensified.Regular monitoring of glucose concentration in the blood is necessary. Tricyclic antidepressants, barbiturates, phenothiazides, diuretics, vasodilators and other antihypertensives, ethanol - it is possible to increase the anti-hypertensive effect of the drug.

The use of beta-adrenoblockers in combination with BCCC, which have a negative inotropic effect, for example, 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 atrioventricular conduction. This can cause severe arterial hypotension, severe bradycardia and heart failure. BCCI should not be administered intravenously within 48 hours after the abolition of the beta-blocker.

When used simultaneously with reserpine, clonidine, guanfacin, a pronounced bradycardia may develop.

Special instructions:

Conditioned by a beta-blocker (atenolol), included in the preparation:

- with caution appoint patients with atrioventricular blockade I degree;

- can mask the phenomenon of thyrotoxicosis and hypoglycemia.Signs of hypoglycemia: tachycardia, tremor, increased sweating, general weakness, decreased tone of the eyeball;

- when developing on the background of therapy with bradycardia (heart rate less than 50 beats / min) with clinical symptoms should reduce the dose or cancel the drug;

- Do not abruptly cancel Tenorik® in patients with ischemic 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. It is necessary to inform the anesthesia surgeon about the use of the preparation Tenorik®, and a general anesthetic having the least possible negative inotropic effect should be chosen;

- can increase sensitivity to allergens and cause severe anaphylactic reactions, so that patients on desensitized therapy, should take the drug with great care. These patients may not respond to conventional doses of epinephrine (adrenaline), used to treat allergic reactions;

- with caution appoint patients with bronchoobstructive syndrome, in the event of worsening of bronchial conductance due to taking the drug prescribed therapy with beta-adrenomimetics (for example, salbutamol);

- with the use of atenolol may reduce the production of tear fluid, which is important for patients using contact lenses.

Caused by the action of chlorthalidone, which is a part of the drug:

- hypokalemia may occur. Regular monitoring of potassium is required, especially in elderly patients, in patients taking cardiac glycosides for the treatment of chronic heart failure, in patients with an unbalanced diet (low in potassium) or in patients with gastrointestinal complaints. In patients taking cardiac glycosides, hypokalemia may predispose to arrhythmia;

- caution should be exercised in patients with severe renal insufficiency (see section "Method of administration and dose");

- there may be a violation of glucose tolerance.Care should be taken if chlorthalidone apply in patients with a known predisposition to diabetes mellitus (impaired glucose tolerance);

- may occur 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.

Termination of treatment with beta-blockers should be carried out gradually. The use of beta-blockers along with the means for general 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 curare-like muscle relaxants increases.

The use of the drug by children under the age of 18 is contraindicated.

Caution should be exercised in the treatment of patients with impaired renal function (see section "Method of administration and dose").

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

Care should be taken to administer the drug to patients who administer vehicles and engage in potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets 50 mg + 12.5 mg, 100 mg + 25 mg.

Packaging:

Primary packaging: 14 tablets per blister Al / PVC.

Secondary packaging: 2 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

Shelf life 3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N014736 / 01-2003

Date of registration:23.12.2008

The owner of the registration certificate:REPRESENTATIVE OFFICE OF LABORATORIS LIMITED REPRESENTATIVE OFFICE OF LABORATORIS LIMITED Russia

Manufacturer: & nbsp

IPCA LABORATORIES, Ltd. India

Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India

Information update date: & nbsp12.11.2012

Illustrated instructions

Instructions

Tenorik® (Tenoric®)