Tenoric tabs 100mg/25mg #28

Instruction for Tenoric

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Tenoric is a combined drug that has a long-term hypotensive effect.

Release form and composition

The dosage form of the release is film-coated tablets: biconvex, round, the color of the shell and core is almost white or white, on one side there is a risk (in blister or non-cell packs of 10 or 14 pcs., In a cardboard box 2-5 or 10 packs and instructions for use of Tenoric).
Active ingredients:
    atenolol - 50 or 100 mg;
    chlorthalidone - 12.5 or 25 mg.
Additional components (50 mg + 12.5 mg / 100 mg + 25 mg):
    kernel: corn starch - 69.95 / 139.8 mg; talc - 5/10 mg; lactose - 46.25 / 92.5 mg; povidone - 4.5 / 9 mg; sodium lauryl sulfate –1.25 / 2.5 mg; magnesium stearate - 3/6 mg; colloidal silicon dioxide - 4.8 / 9.7 mg;
    shell: macrogol-400 - 1 / 0.8 mg; hypromellose - 2.5 / 2 mg; titanium dioxide - 1.2 / 1.2 mg; talc - 1 / 0.8 mg; liquid paraffin - 0.2 / 0.2 mg; carnauba wax - 0.1 / 0.07 mg.

Pharmacodynamics

Tenoric is a combined antihypertensive drug with a long-term antihypertensive effect.
The therapeutic effect is due to the properties of the active ingredients:
    atenolol: belongs to the number of cardioselective beta1-blockers. When the dose is increased, the selectivity of its action decreases. The substance has no internal membrane stabilizing and sympathomimetic effects. Like other beta-blockers, it has a negative inotropic effect, slows down the heart rate;
    Chlorthalidone: is a non-thiazide sulfonamide diuretic that enhances the release of chlorine and sodium. Increases the secretion of bicarbonate, magnesium and potassium. The mechanism of antihypertensive action is believed to be related to sodium excretion.
The combined use of these components is more effective than the use of each of the substances as a monopreparation.
The effect of using Tenoric lasts for 24 hours after a single daily dose.

Pharmacokinetics

The combined use of atenolol and chlorthalidone has little effect on the pharmacokinetic parameters of each of them.

Atenolol

After oral administration, atenolol is absorbed from the gastrointestinal tract by 40-50%. Cmax (maximum concentration) in blood plasma is reached 2–4 hours after administration. Binds to plasma proteins at a level of approximately 6-16%.
Atenolol does not undergo pronounced hepatic metabolism; more than 90% of the substance absorbed into the systemic circulation is excreted unchanged. T1 / 2 (half-life) is in the range from 6 to 9 hours, in cases of severe renal failure, this indicator may increase, since the excretion of the substance occurs mainly by the kidneys.

Chlorthalidone

Chlorthalidone after oral administration is absorbed from the gastrointestinal tract by 60%. Time to reach Cmax in blood plasma is about 12 hours. Plasma protein binding is approximately 75%.
Excretion is carried out by the kidneys, T1 / 2 - about 50 hours.

Indications for use

The drug Tenoric is used to treat arterial hypertension.

Contraindications

Absolute:
    hereditary lactose intolerance, galactose / glucose malabsorption syndrome and lactase deficiency;
    collapse, cardiogenic shock;
    severe peripheral circulatory disorders;
    arterial hypotension in severe course (with systolic pressure below 90 mm Hg. Art.);
    myasthenia gravis;
    gout;
    metabolic acidosis;
    refractory hypokalemia;
    atrioventricular block II and III degree;
    pheochromocytoma (without combined use with alpha-blockers);
    sick sinus syndrome;
    acute heart failure and chronic heart failure in the stage of decompensation;
    acute hepatitis;
    renal failure (with creatinine clearance less than 35 ml / min);
    age up to 18 years (the safety profile for this group of patients has not been studied);
    individual intolerance to the components of the drug.
Relative (the use of Tenoric requires caution in the presence of the following diseases / conditions):
    Prinzmetal's angina;
    atrioventricular block I degree;
    chronic obstructive pulmonary disease, bronchial asthma;
    thyrotoxicosis;
    diabetes;
    disorders of renal function and water-electrolyte balance of the blood;
    elderly age.
It is not recommended to prescribe Tenoric to lactating and pregnant women.

Instructions for use: method and dosage

Tenoric tablets are taken orally with a sufficient amount of water, without chewing, in the morning before meals.
The initial daily dose for hypertension is 1 tablet 50 mg + 12.5 mg.
Maximum per day you can take 1 tablet 100 mg + 25 mg. A further increase in the dose does not lead to an increase in the Tenoric effect; if necessary, it is possible to use another drug with an antihypertensive effect.
For elderly patients, the dosage regimen is determined by the doctor (usually lower doses are required).
If creatinine clearance is less than 35 ml / min, Tenoric can be used only after titrating doses of individual active components of the drug.
Maximum dose of atenolol depending on creatinine clearance (ml / min / 1.73 m2):
    CC 15–35: 50 mg once a day;
    CC up to 15: 50 mg 1 time in 2 days.
The dose of Tenoric should be reduced by reducing the frequency of administration.
After long-term treatment, it is recommended to cancel the drug gradually.
If you miss a single dose, you should not double the next one. Missing a dose may be accompanied by a decrease in the effectiveness of therapy.

Side effects

    digestive tract: pancreatitis, dryness of the oral mucosa, gastrointestinal disorders (in the form of nausea, constipation, anorexia), functional liver disorders (may be accompanied by symptoms of intrahepatic cholestasis), increased activity of hepatic transaminases in the blood serum;
    cardiovascular system: Raynaud's syndrome, bradycardia, arrhythmias (including atrioventricular block), cold extremities, intermittent claudication, increased symptoms of chronic heart failure, orthostatic hypotension (may occur with fainting);
    central nervous system: disorientation, hallucinations, confusion, headache, dizziness, apathy, paresthesia, fatigue, sleep disturbances, mood lability, acute psychosis;
    respiratory system: bronchospasm (with bronchial asthma or indications of a history of bronchospasm);
    hematopoietic system: leukopenia, eosinophilia, purpura, agranulocytosis, thrombocytopenia;
    laboratory parameters: hypokalemia, hyponatremia (associated with chlorthalidone), hyperuricemia, impaired glucose tolerance;
    organ of vision: dryness of the mucous membrane of the eyes, visual impairment;
    skin: exacerbation of the course of psoriasis, alopecia, psoriasis-like skin reactions, photosensitivity, skin rash;
    others: a decrease in potency, an increase in the titer of antinuclear antibodies (the clinical significance of this disorder is not clear).

Overdose

The main symptoms: increased drowsiness, bronchospasm, arterial hypotension, severe bradycardia, acute heart failure, convulsions.
Therapy: careful monitoring of the patient's condition. If necessary, hospitalization is carried out in the intensive care unit, gastric lavage, activated charcoal and laxative agents are prescribed.
Other possible measures (depending on the symptoms of the overdose):
    bronchospasm: use of bronchodilators;
    arterial hypotension and shock: the introduction of plasma substitutes or plasma;
    significant diuresis: the introduction of electrolytes and fluids.
It is possible to carry out hemoperfusion or hemodialysis.

Special instructions

Possible effects of Tenoric associated with the active substance - atenolol:
    masking hypoglycemia (signs - tremor, tachycardia, general weakness, excessive sweating, decreased eyeball tone) and thyrotoxicosis phenomena;
    a decrease in the therapeutic effect against the background of smoking;
    the development of severe anaphylactic reactions (due to increased sensitivity to allergens), in this regard, patients on desensitized therapy Tenoric should be taken with great caution (such patients may not respond to usual doses of epinephrine);
    a decrease in the production of tear fluid (important for patients who wear contact lenses);
    deterioration in the background of coronary heart disease (therapy should not be abruptly canceled);
    the development of bradycardia (with a heart rate of less than 50 beats / min) with manifestations of clinical symptoms (dose reduction or drug withdrawal is required);
    deterioration of bronchial conduction in patients with broncho-obstructive syndrome (requires the appointment of beta-adrenergic agonists, for example, salbutamol).
Possible effects of Tenoric associated with the active substance - chlorthalidone:
    the development of hypokalemia, in connection with which it is necessary to regularly monitor the potassium content, especially in elderly patients, when combined with cardiac glycosides for the treatment of chronic heart failure, with complaints of gastrointestinal tract disorders and an unbalanced diet (low in potassium);
    the occurrence of impaired glucose tolerance; in the presence of a predisposition to the development of diabetes mellitus, care must be taken;
    development of hyperuricemia; as a rule, there is only a slight increase in the serum concentration of uric acid in the blood, however, in some cases, the use of drugs that promote its excretion may be required.
Reception of Tenoric should be discontinued 48 hours before surgery. The surgeon-anesthesiologist must be informed about the therapy being carried out. The general anesthetic with the least negative inotropic effect should be chosen for the operation.
During the use of Tenoric, care must be taken when driving vehicles and performing potentially hazardous activities that require increased concentration of attention and rapid psychomotor reactions.

Application during pregnancy and lactation

It is not recommended to use Tenoric tablets during pregnancy / lactation.

Childhood use

For patients under 18 years of age, the drug is not prescribed.

With impaired renal function

    renal failure (in patients with creatinine clearance less than 35 ml / min): therapy is contraindicated;
    impaired renal function: Tenoric should be used with caution.

For violations of liver function

Tenoric is contraindicated in patients with acute hepatitis.

Use in the elderly

Elderly patients should be careful during therapy.

Drug interactions

With the combined use of Tenoric with some drugs / substances, the following effects may develop:
    blockers of slow calcium channels, dihydropyridine derivatives: an increase in the likelihood of arterial hypotension; with latent (latent) heart failure - the appearance of signs of circulatory disorders;
    cardiac glycosides: an increase in the time of atrioventricular conduction;
    clonidine (after its cancellation): exacerbation of "rebound" hypertension, after the end of the combination, you must first cancel Tenoric, then a few days later clonidine;
    class I antiarrhythmics, including disopyramide: summation of the cardiodepressant effect (the combination requires caution);
    salicylates, estrogens, non-steroidal anti-inflammatory drugs, including indomethacin, ibuprofen: a decrease in the hypotensive effect of Tenoric, with a high dose of salicylates - an increase in their toxic effect on the central nervous system;
    sympathomimetic agents, including epinephrine, norepinephrine: neutralizing the Tenoric effect (in the form of a significant increase in blood pressure);
    preparations containing lithium: decreased renal clearance (the combination is not recommended);
    means for general anesthesia: development of interaction (combination requires caution);
    monoamine oxidase inhibitors: increased blood pressure (the combination should not be used);
    glucocorticosteroids, carbenoxolone, amphotericin B, furosemide: increased excretion of potassium ions;
    angiotensin-converting enzyme inhibitors: a sharp increase in its antihypertensive effect at the beginning of therapy (the combination requires caution);
    diuretics, tricyclic antidepressants, phenothiazides, barbiturates, vasodilators and other drugs with an antihypertensive effect, ethanol: increasing the antihypertensive effect of Tenoric;
    insulin and oral hypoglycemic agents: enhancing their action (requires regular monitoring of the concentration of glucose in the blood);
    reserpine, clonidine, guanfacine: development of severe bradycardia;
    blockers of slow calcium channels, which have a negative inotropic effect, including verapamil, diltiazem: an increase in this effect, especially with reduced myocardial contractility and / or violations of atrioventricular / sinoatrial conduction, which can lead to severe arterial hypotension, heart failure and severe bradycardia (after Withdrawal of Tenoric should not be injected intravenously with slow calcium channel blockers for 48 hours).

Terms and conditions of storage

Store in a dark and dry place at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.

Reviews

Patients recommend the drug as an inexpensive and effective means of controlling blood pressure. Reviews about Tenoric are mostly positive. A convenient dosing regimen and no decrease in efficacy with prolonged use are noted. The development of adverse reactions is rarely reported.

Terms of sell

You don't need a prescription to buy Tenoric.