Tonorma 10 tablets — Made in Ukraine — Free Delivery

(Tonorma)
Tonorma 10 tablets — Made in Ukraine — Free Delivery
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Description Tonorma 10 tablets — Made in Ukraine — Free Delivery

Pharmacological properties

Pharmacodynamics. Tonorma is a combined antihypertensive preparation containing atenolol, nifedipine and chlorthalidone. the antihypertensive effect of the preparation is due to the mechanism of action of its components and, first of all, the main one - atenolol.

Atenolol is a cardioselective β1-adrenergic receptor blocker. It has antihypertensive, antianginal and antiarrhythmic effects. It has no internal sympathomimetic activity and membrane stabilizing action. It blocks mainly β-adrenergic receptors of the heart and reduces the stimulating effect on the heart of the sympathetic nervous system and catecholamines circulating in the blood, as a result of which the automatism of the sinus node, heart rate decreases, AV-conduction slows down, myocardial contractility decreases, myocardial oxygen demand decreases.

Chlorthalidone is a long-acting thiazide-like diuretic. Blocks the reabsorption of sodium ions, chlorine and, accordingly, fluid in the distal tubules of the nephron. Increases the excretion of potassium and magnesium ions from the body. Delays the excretion of calcium and uric acid ions. Reduces blood pressure by reducing the BCC, reducing cardiac output, as well as decreasing the systemic vascular resistance with prolonged use.

Nifedipine is a calcium 1,4-dihydropyridine-type antagonist. It inhibits the transmembrane flow of calcium ions through slow calcium channels into the cell. Acts on the cells of the myocardium and smooth muscles of the coronary arteries and peripheral vessels. In the heart, nifedipine dilates the coronary arteries, especially the large blood supply vessels, and even the intact segments of the walls of partially stenotic vessels. In addition, nifedipine reduces the tone of the smooth muscles of the coronary arteries, which leads to an increase in coronary blood flow and prevents angiospasm. With prolonged use, it prevents the development of atherosclerotic plaques in the vascular wall. Reduces myocardial oxygen demand by reducing afterload. Reduces the tone of smooth muscles of arterioles, thereby reducing the increased resistance of peripheral vessels, which leads to a decrease in blood pressure. Nifedipine increases the excretion of sodium and water from the body. The antihypertensive effect is especially pronounced in patients with hypertension.

Pharmacokinetics. The active ingredients of the preparation do not interact with each other, therefore, the metabolism of each component goes its own way. After oral administration, its main component atenolol is absorbed in the gastrointestinal tract in an amount of 50-60%. 5% of the preparation binds to plasma proteins, the volume of distribution is 0.7 l / kg. Penetrates through the placental barrier and into breast milk. Atenolol practically does not penetrate the BBB. T½ is 6-9 hours and can be lengthened with impaired renal function. The pharmacological effect of atenolol persists for a long period - up to 24 hours. 85% of the dose taken is excreted in the urine unchanged.

Nifedipine is rapidly absorbed after oral administration. Cmax in blood plasma is reached 30 minutes after administration. T½ is 3-4 hours. Approximately 80% is excreted by the kidneys in the form of inactive metabolites, ≈15% - with feces.

Chlorthalidone is well absorbed when administered orally, absorbed in the systemic circulation on the surface of erythrocytes, and binds less to blood plasma proteins. The diuretic effect begins 2–4 hours after administration and persists for ≥1 day, sometimes up to 3 days. T½ long - 30-40 hours. It is excreted in the urine (≈25%) and feces (≈75%). A feature of the action of chlorthalidone is the relative duration of the diuretic effect, which is due to its slow excretion by the kidneys.

Indications

Ag, if therapy with one or two components of the preparation is ineffective.

Application

The preparation is used by adults inside during or after meals, without chewing, mainly at the same time. the dose and duration of treatment are set by the doctor individually. the average dose for adults is 1-2 tablets per day.

Contraindications

Hypersensitivity to atenolol, chlorthalidone, nifedipine, other dihydropyridines and β-adrenergic receptor blockers or other components of the preparation.

Myocardial infarction and the first month after myocardial infarction.

Unstable angina.

Acute heart failure.

Heart failure (NYHA III – IV).

Sick sinus syndrome.

Sinus bradycardia (heart rate 50 bpm).

AV block II and III degrees.

Sinoatrial blockade.

Clinically significant aortic stenosis.

Arterial hypotension (systolic blood pressure 90 mm Hg).

Cardiogenic shock.

Severe peripheral circulatory disorders.

BA, broncho-obstructive syndrome.

Metabolic acidosis.

Untreated pheochromocytoma.

Ileostomy, colostomy.

Severe hepatic and / or renal failure (glomerular filtration rate 30 ml / min), anuria.

Simultaneous use with lithium preparations, MAO inhibitors (with the exception of MAO-B inhibitors), rifampicin.

The preparation is contraindicated in patients who have taken verapamil within the past 48 hours.

Side effects

Cardiac disorders: bradycardia, tachycardia, palpitations, worsening heart failure, abnormal av-conduction, angina pectoris, hot flashes, edema.

Vascular disorders: cold extremities, vasodilation, arterial hypotension, orthostatic hypotension, syncope, increased intermittent claudication in patients with Raynaud's syndrome. Patients with malignant hypertension and hypovolemia on hemodialysis may experience a significant decrease in blood pressure due to vasodilation.

From the blood and lymphatic system: thrombocytopenia, agranulocytosis, leukopenia, purpura, neutropenia, pancytopenia.

Neurological disorders: headache, vertigo, migraine, dizziness, tremor, syncope, paresthesia / dysesthesia, hypesthesia, drowsiness.

Mental disorders: sleep disturbances, insomnia, anxiety, mood changes (including depression), nightmares, confusion, psychosis, agitation, aggressiveness, hallucinations, deterioration in concentration.

From the side of the organ of vision: visual impairment, decreased secretion of lacrimal fluid, conjunctivitis, dry eyes, sensation of pain in the eyes.

From the respiratory system, chest and mediastinal organs: nosebleeds, nasal congestion, dyspnea, symptoms of bronchial obstruction; bronchospasm in BA patients in history.

From the gastrointestinal tract: gastrointestinal disorders, constipation, diarrhea, abdominal pain, nausea, dyspepsia, flatulence, dry mouth, gingival hyperplasia, vomiting, insufficiency of the gastroesophageal sphincter, dysphagia, bezoar, intestinal obstruction, intestinal ulcer.

From the hepatobiliary system: hepatotoxicity, including hepatitis, intrahepatic cholestasis, a transient increase in the activity of liver enzymes, jaundice, pancreatitis (mainly in women).

From the urinary system: polyuria, dysuria, difficulty urinating, interstitial nephritis.

From the musculoskeletal system and connective tissue: muscle cramps, joint edema, arthralgia, myalgia.

From the side of metabolism and metabolism: hypoglycemia in patients with diabetes mellitus, hyperglycemia, impaired carbohydrate tolerance.

From the reproductive system: impaired libido, erectile dysfunction, impotence, gynecomastia.

From the immune system, skin and subcutaneous tissue: hypersensitivity reactions, including allergic edema (including laryngeal edema), anaphylactic / anaphylactoid reactions, hyperemia, itching, rash, urticaria, Quincke's edema, dermatitis; alopecia, psoriasis-like skin reactions, exacerbation of psoriasis, photosensitivity, purpura, toxic epidermal necrolysis, exfoliative dermatitis.

Laboratory tests: hyperuricemia, hyponatremia, hypomagnesemia, hypercalcemia, hypercholesterolemia, hypertriglyceridemia, increased levels of antinuclear antibodies.

Others: general weakness, increased fatigue, malaise, nonspecific pain, chills, increased sweating, fever.

Special instructions

Treatment with the preparation should be carried out under the supervision of a physician.

When used with other antihypertensive preparations, postural arterial hypotension may occur. Blood pressure should be monitored in patients.

The preparation reduces heart rate. If the heart rate slows down, dose adjustments should be made.

Cancellation of the preparation should be carried out gradually, as angina pectoris may worsen and, in some cases, the onset of myocardial infarction (withdrawal syndrome) may accelerate.

The preparation  is used with caution in patients with impaired liver and kidney function, AV-blockade Ι degree, heart failure (NYHA ΙΙ), impaired peripheral circulation (Raynaud's syndrome, obliterating diseases of the vessels of the lower extremities), Prinzmetal's angina, impaired water and electrolyte balance, gout , psoriasis, depression; in elderly patients.

The preparation is used with caution in patients with congestive heart failure. At the first signs of heart failure decompensation, you should stop using the preparation and consult a doctor.

The preparation is used with caution in persons with diabetes mellitus due to the possibility of masking the symptoms of hypoglycemia. Plasma glucose should be monitored.

The preparation is used with caution in patients with an existing pronounced narrowing of the gastrointestinal tract due to the possibility of symptoms of obstruction. Bezoars may occur and may require surgery.

The preparation is used with caution in patients with a history of severe hypersensitivity reactions and those receiving desensitizing therapy to reduce adrenergic resistance.

The preparation is used with caution in patients with malignant hypertension and hypovolemia on hemodialysis, since a significant decrease in blood pressure may occur due to vasodilation.

When prescribing the preparation to patients with pheochromocytoma, it is necessary to prescribe α-adrenergic receptor blockers in advance to prevent the development of a hypertensive crisis.

In most cases, there is no need to stop taking the preparation before surgery using general anesthesia. However, the preparation should be used with caution in combination with anesthetics due to a decrease in the severity of reflex tachycardia and an increased risk of arterial hypotension.

The preparation should not be used in patients with broncho-obstructive syndrome, other bronchospastic diseases and acute attacks of stable angina pectoris.

It is required to periodically determine the levels of electrolytes in blood plasma and urine to detect possible electrolyte imbalance, this is especially important for patients with indomitable vomiting or with the introduction of parenteral fluids.

Potassium levels should be measured periodically, especially in the elderly, in patients taking digitalis medications for the treatment of heart failure, in patients with an unbalanced diet, or in patients with complaints of disorders of the digestive tract.

In the event that in vitro fertilization attempts are unsuccessful, in the absence of other explanations, calcium antagonists such as nifedipine can be considered as a possible cause of this phenomenon.

The use of the preparation can lead to false positive results on x-rays using barium contrast media (for example, filling defects are interpreted as a polyp).

When using the preparation, a positive doping test reaction is possible.

During treatment, you should stop drinking alcohol.

Use during pregnancy and lactation. The preparation is contraindicated during pregnancy and lactation.

Children. The preparation is not used in children.

The ability to influence the reaction rate when driving or working with other mechanisms. During treatment, care should be taken when driving vehicles or working with mechanisms, and in case of dizziness, refrain from potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Interactions

With simultaneous use with other preparations, it is possible:

  • with preparations for anesthesia, antiarrhythmic preparations, blockers of slow calcium channels, blockers of β-adrenergic receptors - an increase in the severity of negative chrono-, ino- and dromotropic action;
  • with cardiac glycosides - the occurrence of tachy- or bradycardia, arrhythmias, as well as increased hypokalemia; with the simultaneous use of these preparations, laboratory parameters should be monitored;
  • with dihydropyridines - increased hypotensive effect, heart failure in patients with chronic heart failure;
  • with reserpine, guanethidine, guanfacine, clonidine - the occurrence of bradycardia. With the simultaneous use of these preparations, clonidine can be stopped only a few days after the preparation is discontinued;
  • with methyldopa - increased hypotensive effect and the occurrence of bradycardia;
  • with NSAIDs, estrogens, α- and β-adrenergic agonists - a decrease in the severity of the effect of atenolol, which is part of the preparation;
  • with inhibitors of the cytochrome P450 3A4 system (in particular macrolide antibiotics, HIV protease inhibitors, antimycotics of the azole group, fluoxetine, nefazodone, cisapride, valproic acid, diltiazem, cimetidine, quinupristine / dalfopristin); with the simultaneous use of these preparations, the level of blood pressure should be monitored; azithromycin, which is structurally similar to representatives of the class of macrolide antibiotics, does not inhibit cytochrome P450 3A4;
  • with inducers of the cytochrome P450 3A4 system (in particular phenytoin, carbamazepine, phenobarbital) - weakening the effect of nifedipine;
  • with antihypertensive preparations of different groups, ACE inhibitors, antagonists of AT1-receptors, diuretics, peripheral vasodilators (PDE-5 inhibitors), nitrates, tricyclic antidepressants, antiepileptic preparations, barbiturates, phenothiazlophthalmic effect - narcotic preparations, magnetizing effect
  • with antidepolarizing muscle relaxants - strengthening the effect of the latter;
  • with adrenaline, norepinephrine - increasing the effect of the latter;
  • with sympathomimetic agents - a decrease in bronchodilator activity;
  • with indirect anticoagulants - potentiation of the effect of the latter;
  • with oral hypoglycemic agents, insulin - strengthening the effect of the latter; with the simultaneous use of these preparations, the level of glucose in the blood plasma should be monitored;
  • with lidocaine - a decrease in its excretion and an increase in the risk of toxic effects;
  • with tacrolimus, theophylline - an increase in the concentration of the latter in the blood plasma; their concentration in blood plasma should be carefully monitored and, if necessary, the dose should be adjusted;
  • with quinidine - a decrease in the concentration of the latter in the blood plasma; with the simultaneous use of these preparations, the level of blood pressure should be monitored; after discontinuation of the preparation, it is required to carefully monitor the concentration of quinidine and, if necessary, adjust the dose.

Grapefruit juice inhibits the cytochrome P450 3A4 system. The simultaneous use of the preparation with the use of grapefruit juice leads to an increase in the concentration of nifedipine in the blood plasma and prolongation of its effect due to a decrease in metabolism. This can lead to an increase in the hypotensive effect.

The use of nifedipine can cause falsely elevated spectrophotometric values ​​of vanillyl mandelic acid in blood plasma. However, when determined using the method of high performance liquid chromatography, such an effect is not observed.

Ethyl alcohol potentiates the effect of the preparation.

Quitting smoking increases the therapeutic effect of atenolol as a result of a decrease in its metabolism and an increase in the level of the preparation in the blood.

Overdose

Symptoms: the clinical picture depends on the degree of intoxication and is manifested mainly by disorders of the cardiovascular system and central nervous system.

Overdose can lead to arterial hypotension, bradycardia, heart failure and cardiogenic shock. In severe cases, breathing disorders, bronchospasm, vomiting, impaired consciousness, up to coma, hyperglycemia, metabolic acidosis, hypoxia, cardiogenic shock, accompanied by pulmonary edema, tachycardia are observed; extremely rare - generalized seizures.

Treatment: in case of an overdose or with a threatening decrease in heart rate and / or blood pressure, preparation treatment is discontinued. In intensive care units, vital signs should be closely monitored and, if necessary, corrected.

If necessary, appoint:

  • atropine (0.5–2 mg IV bolus);
  • glucagon: an initial dose of 1–10 mg i.v. (jet), then 2–2.5 mg / h as a continuous infusion;
  • sympathomimetics depending on body weight and effect (dopamine, dobutamine, isoprenaline, oxyprenaline or adrenaline).
  • If medical treatment for bradycardia is ineffective, pacing is possible.

With bronchospasm, β2-sympathomimetics are prescribed in the form of an aerosol (if the effect is insufficient, also IV) or aminophylline IV.

For generalized convulsions, a slow intravenous injection of diazepam is prescribed.

Storage conditions

In its original packaging at a temperature not exceeding 25 ° C.

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