Gizaar, 12.5mg+50 mg 14 pcs.

Gyzaar is a hypotensive, diuretic.

Blocks angiotensin II receptors (AT₁ subtype).

Pharmacodynamics

The maximum hypotensive effect is achieved within 3 weeks after initiation of treatment. Efficacy is independent of age and gender.

• Reduces potassium loss and hyperuricemia seen with hydrochlorothiazide alone;

• Does not require dose adjustment for the elderly and patients with renal impairment (except severe cases);

• Preferred for patients for whom combination therapy is recommended.

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Indications

Arterial hypertension.

Chronic heart failure.

Pharmacological effect

Gizaar – hypotensive, diuretic.

Blocks angiotensin II receptors (AT1 subtype).

Pharmacodynamics

The maximum hypotensive effect is achieved within 3 weeks after the start of treatment. Efficiency does not depend on age and gender.

Reduces potassium loss and hyperuricemia observed with isolated use of hydrochlorothiazide;

Does not require dose selection for the elderly and patients with renal failure (except for severe cases);

Preferred for patients for whom combination therapy is recommended.

Special instructions

Use for liver dysfunction The drug is contraindicated for use in severe liver dysfunction.

Use for impaired renal function The drug is contraindicated for use in severe impaired renal function (creatinine clearance less than 30 ml/min). There are reports that in a number of patients taking the drug, changes in renal function, including renal failure, were observed due to suppression of the function of the renin-angiotensin system; these changes were reversible and disappeared after discontinuation of therapy.

Precautions for losartan

There are reports that in a number of patients taking the drug, changes in renal function, including renal failure, were observed due to suppression of the function of the renin-angiotensin system; these changes were reversible and disappeared after discontinuation of therapy. Other drugs that affect the renin-angiotensin system may lead to increased blood urea and creatinine in patients with bilateral renal artery stenosis and arterial stenosis of a solitary kidney. Similar effects were observed while taking losartan; These changes in renal function were reversible and disappeared after discontinuation of therapy.

Precautions for hydrochlorothiazide

As with any antihypertensive drug, symptomatic hypotension may occur in some patients. Patients require monitoring for early detection of clinical signs of fluid and electrolyte imbalance, for example, dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may develop against the background of intercurrent diarrhea or vomiting. In such patients, monitoring of serum electrolyte levels is necessary. Thiazide therapy may lead to impaired glucose tolerance. In some cases, dose adjustment of hypoglycemic agents (including insulin) may be required. Thiazides may reduce urinary calcium excretion and cause occasional and mild increases in serum calcium levels. Severe hypercalcemia may indicate latent hyperparathyroidism. The thiazide diuretic should be discontinued before testing parathyroid function. Increases in blood cholesterol and triglyceride levels may also be associated with thiazide diuretic therapy. In some patients, taking thiazide diuretics can lead to hyperuricemia and/or the development of gout. Because losartan reduces uric acid levels, its combination with hydrochlorothiazide reduces the severity of diuretic-induced hyperuricemia. In patients receiving thiazides, hypersensitivity reactions may occur even in the absence of indications of allergies or a history of bronchial asthma. There are reports of exacerbation or progression of SLE while taking thiazide diuretics. In an analysis of the entire population of patients enrolled in the LIFE trial (Losartan Intervention For Endpoint reduction in hypertension, n=9193), treatment with losartan was associated with a 13% (p=0.021) reduction in the risk of achieving the primary composite endpoint of cardiovascular death, stroke and myocardial infarction. atenolol. However, black patients receiving atenolol had a lower risk of developing the primary composite endpoint compared with black patients receiving losartan (p=0.03).

Use in pediatrics

There are no data on the effectiveness and safety of Gizaar in children, so use in this category of patients is not recommended.

Active ingredient

Hydrochlorothiazide, Losartan

Composition

Active ingredients:

Losartan potassium 50 mg;

Hydrochlorothiazide 12.5 mg;

Excipients:

Microcrystalline cellulose;

Lactose aqueous;

Pregelatinized starch;

Magnesium stearate.

Shell composition:

Hydroxypropyl methylcellulose;

Hydroxypropyl cellulose;

Titanium dioxide;

Aluminum varnish quinoline yellow;

Carnauba wax.

Contraindications

Hypersensitivity (including to sulfonamide derivatives);

Anuria;

Childhood.

Side Effects

In clinical studies with losartan/hydrochlorothiazide, no adverse events specific to this combination drug were observed.

Adverse reactions were limited to those already reported with losartan and/or hydrochlorothiazide alone. The overall incidence of adverse reactions reported with this combination was comparable to that observed with placebo. Treatment discontinuation rates were also comparable to those in patients receiving placebo. In most cases, adverse reactions were mild, transient and did not require discontinuation of therapy.

In controlled clinical trials, dizziness was the only drug-related adverse reaction that was greater than 1 percent or more in incidence compared with placebo.

Losartan in combination with hydrochlorothiazide is generally well tolerated in patients with arterial hypertension and left ventricular hypertrophy. The most common adverse reactions were dizziness, weakness and fatigue.
During post-marketing experience with the drug, the following additional adverse reactions were reported:

Allergic reactions and immunopathological reactions: anaphylactic reactions, angioedema, incl. swelling of the larynx and glottis with the development of airway obstruction and/or swelling of the face, lips, pharynx and/or tongue in patients taking losartan; Some of these patients had a history of developing angioedema when using other drugs, incl. ACE inhibitors. There are rare reports of the development of vasculitis (including Henoch-Schönlein purpura) while taking losartan.

From the digestive system: rarely – hepatitis, diarrhea (in patients taking losartan).

From the respiratory system: cough is possible (in patients taking losartan).

Dermatological reactions: urticaria, increased light and photosensitivity.

From the laboratory parameters:
In controlled clinical studies while taking the drug Gizaar®, clinically significant changes in standard laboratory parameters were rarely observed. Hyperkalemia (serum potassium more than 5.5 mEq/L) was observed in 0.7% of patients, which did not require discontinuation of the drug. Increases in ALT activity were rare and usually disappeared after discontinuation of therapy.

Interaction

Losartan

In clinical pharmacokinetic studies, no clinically significant interactions of losartan with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin were identified.

Rifampicin and fluconazole have been reported to reduce the level of the active metabolite. The clinical significance of this interaction has not been studied.

The combination of losartan, as well as other drugs that block angiotensin II or its effects, with potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or potassium salts may lead to an increase in serum potassium levels.

NSAIDs (including selective COX-2 inhibitors) may reduce the effect of diuretics and other antihypertensive drugs. Therefore, the hypotensive effect of angiotensin II receptor antagonists may be weakened when used simultaneously with NSAIDs (including COX-2 inhibitors). In some patients with impaired renal function who have been treated with NSAIDs (including COX-2 inhibitors), treatment with angiotensin II receptor antagonists may cause further deterioration of renal function, including acute renal failure, which is usually reversible.

The antihypertensive effect of losartan, like other antihypertensive drugs, may be weakened when taking indomethacin.

Hydrochlorothiazide

When thiazide diuretics are used simultaneously with barbiturates, opioid analgesics, and ethanol, the risk of developing orthostatic arterial hypotension may increase.

With simultaneous use, dose adjustment of hypoglycemic agents (for oral administration and insulin) may be required. When hydrochlorothiazide is used with other antihypertensive agents, an additive effect is observed.

In the presence of anion exchange resins, the absorption of hydrochlorothiazide is impaired.

Cholestyramine or colestipol in single doses bind hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by 85% and 43%, respectively.

The use of corticosteroids and ACTH leads to a marked decrease in electrolyte levels, in particular, it can cause hypokalemia.

The response to pressor amines (for example, epinephrine) may be reduced. It is possible to enhance the effect of muscle relaxants of a non-depolarizing type (for example, tubocurarine).

Diuretics reduce the renal clearance of lithium and increase the risk of its toxic effects; The combined use of diuretics and lithium preparations is not recommended.

In some cases, taking NSAIDs (including selective COX-2 inhibitors) may reduce the diuretic, natriuretic and antihypertensive effects of diuretics. Due to the effect of thiazides on calcium metabolism, their intake may distort the results of studies of parathyroid function.

Overdose

There are no data on specific treatment for Gizaar overdose. The drug should be discontinued and the patient should be monitored. Symptomatic therapy is indicated – induction of vomiting if the drug has been taken recently, as well as elimination of dehydration, electrolyte disturbances, hepatic coma and lowering blood pressure using standard methods.

Data on overdose of losartan in humans are limited. The most likely symptoms of overdose are a pronounced decrease in blood pressure and tachycardia; bradycardia may be a consequence of parasympathetic (vagal) stimulation.

Treatment: in case of symptomatic arterial hypotension, maintenance therapy is indicated. Losartan and its active metabolite are not eliminated by hemodialysis.

The most common symptoms of hydrochlorothiazide overdose are the result of electrolyte deficiency (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive diuresis. When taking cardiac glycosides simultaneously, hypokalemia may aggravate the course of arrhythmias. It has not been established to what extent hydrochlorothiazide can be removed from the body by hemodialysis.

Storage conditions

At a temperature not exceeding 30 °C (do not freeze).

Shelf life

3 years.

Manufacturer

Merck Sharp and Dome B.V., The Netherlands