Kozaar

Kozaar is the antagonist of receptors of angiotensin II.

Form of release and structure

Dosage form – tablets, film coated: white color, a tablet of an oval form have dividing to risk on one party and an engraving "952" – on another, forms in the form of a drop – an engraving "960" on one of the parties and a smooth surface another (on 50 mg on 14 pieces; on 100 mg on 7 or 14 pieces in blisters, in a cardboard pack 1 or 2 blisters).

Active ingredient – лозартан potassium, in 1 tablet – 50 or 100 mg.

Auxiliary components: starch corn prezhelatinizirovanny, lactoses monohydrate, cellulose microcrystallic, magnesium stearate.

Structure of a cover: a gipromelloza, a hypro rod (from 0,3% of silicon of dioxide), wax of a Brazilian wax palm, titanium dioxide.

Indications to use

• Arterial hypertension;
• Chronic heart failure at inefficient therapy by inhibitors of an angiotensin-converting enzyme (APF);
• Proteinuria against the background of a diabetes mellitus of type 2 (for protection of kidneys at patients, delay of progressing of a renal failure with decrease in frequency of a giperkreatininemiya, frequency of development of an end-stage of a chronic renal failure, in need of performing transplantation of kidneys or a hemodialysis, for decrease in a proteinuria and rates of mortality);
• Arterial hypertension and hypertrophy of a left ventricle (for decrease in frequency of risk of a stroke, a myocardial infarction and cardiovascular mortality).

Contraindications

• Period of pregnancy and breastfeeding;
• Age up to 18 years;
• Hypersensitivity to drug components.

With care it is recommended to appoint drug sick with the diseases of kidneys and/or a liver specified in the anamnesis, to patients with a reduced the volume of the circulating blood (VCB) including against the background of therapy by diuretics in high doses.

Route of administration and dosage

Pill is taken in 1 times a day, irrespective of meal at any convenient time.

The dose of drug is appointed by the doctor on the basis of clinical indications.

The recommended Kozaar's dosing:

• Arterial hypertension: on 50 mg as an initial and maintenance dose, in need of achievement of bigger action it is possible to accept 100 mg. The steady hypotensive effect occurs after 3-6 weeks of therapy. To patients with reduced OTsK the initial dose of drug is appointed of 25 mg. At the instruction in the anamnesis on liver pathology the dose of drug should be lowered. To patients of advanced age and with a renal failure, including to patients on dialysis correction of initial dosing is not required;
• Chronic heart failure: the initial dose – 12,5 mg, titration is recommended to carry out once a week, bringing to an individual maintenance dose (12,5 mg, 25 mg or 50 mg);
• Diabetes mellitus of type 2 with a proteinuria: an initial dose – 50 mg, taking into account lowering of arterial pressure (ABP) it is necessary to lift a dose gradually to 100 mg. Combined use of drug with diuretics, alpha and beta adrenoblockers, blockers of calcium channels, drugs of the central action, other hypoglycemic means (glitazona, sulphonylurea derivatives, glucosidase inhibitors) and insulin is shown;
• Arterial hypertension and hypertrophy of a left ventricle: the initial dose for decrease in probability of development of the associated cardiovascular diseases and mortality makes 50 mg. Considering extent of decrease in the ABP, further therapy assumes increase in a dose of drug to 100 mg or purpose of low doses of a hydrochlorothiazide.

Side effects

During controlled clinical trials of use of Kozaar the following side effects were noted:

• From cardiovascular system: tachycardia, heartbeat increase;
• From respiratory system: rhinedema, cough, infections of upper parts of respiratory tracts, pharyngitis, sinusitis;
• From the alimentary system: nausea, dyspepsia, diarrhea;
• From a nervous system: sleeplessness, headache, dizziness;
• From a musculoskeletal system: muscular spasms, dorsodynia;
• From an organism in general: fatigue and weakness, a stethalgia and/or in a stomach, swelled;
• From laboratory indicators: a hyperpotassemia (the increased alaninaminotranspherase level after drug withdrawal usually was returned to norm).

The undesirable reactions against the background of administration of drug noted in broad clinical practice:

• Alimentary system: abnormal liver function; seldom – hepatitis;
• System of a hemopoiesis: thrombocytopenia, anemia;
• Musculoskeletal system: arthralgia, mialgiya; seldom – рабдомиолиз;
• Nervous system: migraine; seldom – a dysgeusia;
• Respiratory system: cough;
• Dermatological reactions: itch, urticaria, dermahemia;
• Allergic reactions: seldom – a vasculitis, Shenleyn-Genokh's disease, a Quincke's disease, including hypostasis of a glottis, throat, with obstruction of respiratory tracts, and/or hypostasis of lips, persons, language and/or a throat (some of patients transferred reactions of hypersensitivity at the previous reception of APF inhibitors).

In general Kozaar is well had, side effects have passing character and are shown benign, not demanding drug withdrawal.

Special instructions

Correction of reduced OTsK needs to be carried out prior to treatment by Kozaar or to appoint his lower initial doses.

Development of a Quincke's disease in patients with hypersensitivity to drug is possible.

Without consultation of the doctor contraindicated simultaneous use of drugs of potassium and the substitutes of table salt containing potassium.

At purpose of drug to patients with a renal failure for whom disturbance of water and electrolytic balance is a characteristic state, it is necessary to observe extra care, both in the presence of a diabetes mellitus, and without it.

At the instruction in the anamnesis it is necessary to appoint drug to a liver disease in lower dose.

Impact of drug on a renin-angiotenzinovuyu system can cause a renal failure, and at a bilateral stenosis of renal arteries or a stenosis of an artery of the only kidney to increase the level of serumal creatinine and urea of blood. After the termination of treatment recovery of functional changes is possible.

With a severe form of chronic heart failure use of drug can cause development of the accruing azotemia in patients, an oliguria and an acute renal failure with a lethal outcome.

There is no need for correction of dosing for patients of advanced age at Kozaar's appointment.

Medicinal interaction

Clinically significant interaction of drug with digoxin, warfarin, a hydrochlorothiazide, Cimetidinum, ketokonazoly, phenobarbital, erythromycin is not established.

Influence of decrease in level of an active metabolite against the background of reception of a flukonazol and rifampicin on clinical effect of drug is not studied.

Co-administration of the potassium additives, Triamterenum, Spironolactonum, amiloride and other drugs interfering formation of angiotensin II of the salts containing potassium can promote growth of level of content of potassium in blood.

Lozartan at a combination to drugs of lithium reduces excretion and increases its serumal concentration.

Hypotensive effect of drug is reduced by non-steroidal anti-inflammatory drugs (NPVS), the selection inhibitors of TsOG-2 cyclooxygenase.

Patients with a renal failure have a concomitant use of drug and NPVS, including the selection TsOG-2 inhibitors can promote further deterioration in function of kidneys. The effect of this interaction has reversible character.

Decrease in plasma concentration of an active metabolite against the background of use of a flukonazol at a combination to Kozaar increases concentration of a lozartan in a blood plasma.

Terms and storage conditions

To store in the place protected from light at a temperature up to 30 °C. To protect from children.

Period of validity – 3 years.