Cozaar is a drug with hypotensive action.
Release form and composition
Cozaar is produced in the form of film-coated tablets -
- 50 mg each: white, oval, with the inscription "952" on one side and a risk on the other, 14 pieces each. in blisters, 1 or 2 blisters in carton packs;
- 100 mg: white, drop-shaped, with the inscription "960" on one side and smooth on the other hand, 7 or 14 pcs. in blisters, 1 or 2 blisters in carton packs.
The composition of 1 tablet includes:
- Active ingredient: losartan potassium - 50 or 100 mg;
- Auxiliary components (respectively): microcrystalline cellulose - 52.5 / 105 mg; lactose monohydrate - 25.5 / 51 mg; pregelatinized corn starch - 20.95 / 41.9 mg; magnesium stearate - 1.05 / 2.1 mg;
- The composition of the shell (respectively): hyprolosis (with 0.3% silicon dioxide) - 1.8 / 3.6 mg; hypromellose - 1.8 / 3.6 mg; titanium dioxide - 0.9 / 1.8 mg; carnauba wax - 0.05 / 0.05 mg.
Indications for use
- Reducing the risk of associated cardiovascular morbidity and mortality in patients with left ventricular hypertrophy and arterial hypertension, manifested by a decrease in the total frequency of stroke, cardiovascular mortality and myocardial infarction;
- Arterial hypertension;
- Kidney protection in patients with diabetes mellitus type 2 with proteinuria - slowing the progression of renal failure, manifested as a decrease in the frequency of hypercreatininemia, the incidence of end-stage chronic renal failure, requiring kidney transplantation or hemodialysis, mortality rates, as well as a decrease in proteinuria;
- Chronic heart failure with the ineffectiveness of the use of angiotensin-converting enzyme inhibitors.
- Severe functional disorders of the liver (no experience);
- Lactase deficiency, hereditary lactose intolerance, glucose-galactose malabsorption syndrome;
- Simultaneous use with aliskiren (in patients with diabetes mellitus);
- Pregnancy and lactation;
- Age up to 18 years (efficacy and safety of use for this age group of patients have not been established);
- Hypersensitivity to the drug.
- The drug should be prescribed with caution in patients with: cerebrovascular diseases, obstructive hypertrophic cardiomyopathy, heart failure with life-threatening arrhythmias, history of angioedema, coronary heart disease, bilateral stenosis of the renal arteries or stenosis of the only kidney, heart failure, and an inadequate treatment. conditions after kidney transplantation, aortic or mitral stenosis, severe heart failure ti (IV NYHA functional class classification), primary hyperaldosteronism, reduced circulating blood volume (symptomatic hypotension may occur).
Dosing and Administration
Cozaar should be taken orally, regardless of the meal. It is possible to use both as monotherapy and simultaneously with other antihypertensive drugs.
In the treatment of hypertension, Cozaar is usually prescribed in the initial and maintenance daily dose of 50 mg. As a rule, the maximum hypotensive effect is achieved in 21-28 days after the start of treatment. In some patients, to achieve a greater effect, it is possible to increase the dose by 2 times.
In patients with a reduced circulating blood volume (for example, when taking high doses of diuretics), the initial daily dose of Cozaar is reduced to 25 mg.
In the selection of the initial dose in elderly patients and in patients with renal insufficiency, including those on dialysis, there is no need.
Patients with a history of liver disease should begin with a lower dose.
To reduce the risk of associated cardiovascular morbidity and mortality in patients with left ventricular hypertrophy and arterial hypertension, the drug is prescribed in a standard initial daily dose of 50 mg. In the future, taking into account the degree of reduction in blood pressure, the dose can be increased by 2 times. It is also possible to add low-dose hydrochlorothiazide to therapy.
To protect the functional state of the kidneys in patients with proteinuria and type 2 diabetes mellitus, the drug is used in a standard initial daily dose of 50 mg. In the future, taking into account the degree of blood pressure reduction, it is recommended to increase the dose by 2 times. Cozaar can be administered simultaneously with other antihypertensive drugs (calcium channel blockers, diuretics, centrally acting drugs, alpha- and beta-blockers), insulin and other hypoglycemic drugs (glucosidase inhibitors, glitazones, sulfonylurea derivatives).
The initial daily dose of Cozaar in the treatment of chronic heart failure is 12.5 mg. Depending on the individual tolerance, the dose is titrated at a weekly interval to the usual maintenance daily dose of 50 mg (ie, 12.5 mg, 25 mg, 50 mg).
Cozaar is generally well tolerated, the resulting side effects are usually transient and mild, and do not require the abolition of therapy. The overall incidence of side effects is comparable to that of placebo.
In clinical studies of Kozaar in patients with essential arterial hypertension, it was found that the only side effect associated with taking the drug was dizziness (in more than 1% of patients). More rarely, there were cases of orthostatic reactions, depending on the dose of the drug. Occasionally, a rash has also been noted.
Cozaar is usually well tolerated by patients with left ventricular hypertrophy, patients with proteinuria and type 2 diabetes mellitus. Most often, side effects were manifested as dizziness (systemic and non-systemic), weakness / asthenia, low blood pressure and hyperkalemia.
More than 1% of patients noted the development of disorders on the part of some body systems:
- The digestive system: diarrhea, nausea, dyspepsia;
- Cardiovascular system: increased heart rate, tachycardia;
- Central nervous system: headache, dizziness, insomnia;
- Musculoskeletal system: muscle cramps, back pain;
- Respiratory system: infections of the upper respiratory tract, swelling of the nasal mucosa, cough, sinusitis, pharyngitis;
- The body as a whole: pain in the stomach, fatigue and weakness, swelling, chest pain.
The following side effects were noted when Cozaar was used in general clinical practice:
- Digestive system: abnormal liver function; rarely, hepatitis;
- Musculoskeletal system: arthralgia, myalgia; rarely - rhabdomyolysis;
- Hematopoietic system: thrombocytopenia, anemia;
- Respiratory system: cough;
- Central nervous system: migraine, rarely - dysgeusia;
- Dermatological reactions: itching, urticaria, skin flushing;
- Allergic reactions: rarely - angioedema, including swelling of the glottis and larynx, causing airway obstruction, and / or swelling of the lips, face, tongue and / or pharynx. Some of these patients had indications of a history of transferred angioedema in their history of taking angiotensin-converting enzyme inhibitors. In some cases, vasculitis, including Schoenlein-Henoch purpura;
- Laboratory indicators: in patients with essential arterial hypertension, clinically significant changes in standard laboratory parameters (hyperkalemia) were rarely observed; in patients with type 2 diabetes mellitus with proteinuria, hyperkalemia, an increased level of alanine aminotransferase (after discontinuation of therapy usually returns to normal).
During therapy, in the presence of hypersensitivity, may develop angioedema.
Symptomatic arterial hypotension may occur in patients with reduced circulating blood volume. Correction of these conditions should be carried out before the appointment of the drug or start therapy with a lower dose.
During the period of treatment, patients without prior consultation with the doctor should not take potassium preparations or potassium substitutes for table salt.
Cozaar concentration in the blood plasma of patients with cirrhosis of the liver increases significantly, so patients with a history of liver disease are advised to take the drug in lower doses.
In patients with severe chronic heart failure, in some cases, the use of Cozaar was accompanied by the occurrence of increasing azotemia and / or oliguria, acute renal failure (rarely) and / or conditions with a lethal outcome.
No clinically significant interaction of Cozaar with drugs such as erythromycin, cimetidine, digoxin, hydrochlorothiazide, warfarin, ketoconazole and phenobarbital was observed.
Fluconazole and rifampin reduce the level of the active metabolite.
Simultaneous use with potassium-sparing diuretics (triamterene, spironolactone, amiloride) containing potassium salts and potassium supplements can lead to an increase in serum potassium.
During therapy, there may be a decrease in excretion and an increase in the serum concentration of lithium, and therefore, with simultaneous use of Cozaar with lithium preparations, its serum concentration must be monitored.
The antihypertensive effect of Kozar can be weakened while being used with non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors. In patients with impaired renal function, further deterioration in these functions is possible. Usually this effect is reversible.
Terms and conditions of storage
Store in a dark, out of reach of children in tightly closed packaging at temperatures up to 30 ° C.
Shelf life - 3 years.