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.

Active ingredient

Composition

Active substances:

Potassium losartan 50 mg;

Hydrochlorothiazide 12.5 mg;

Associates:

Cellulose microcrystalline;

Lactose aqueous;

Pregelatinized starch;

Magnesium stearate.

CCompound of the shell:

Hydroxypropyl methylcellulose;

Hydroxypropylcellulose;

p> Titanium dioxide;

Quinoline aluminum varnish yellow;

Carnauba wax.

How to take, the dosage

Gizaar can be prescribed in combination with other antihypertensive agents. Gizaar can be taken regardless of meals.

In arterial hypertension: The usual starting and maintenance doses of the drug are 1 tablet. Gizaar once daily. If there is no adequate therapeutic effect within 2-4 weeks, the drug dose should be increased to 2 tablets. Gizaar 50/12.5 mg once a day. Maximal dose is 2 tablets. Gizaar 50/12.5 mg once daily. As a rule, antihypertensive effect is achieved within 3 weeks after the therapy start. Selection of the initial dose of Gizaar for elderly patients is not required.

To reduce the risk of cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy:The drug is prescribed at the standard starting dose of losartan of 50 mg once daily. In patients who do not achieve target BP values on losartan 50 mg/day, therapy should be selected by combining losartan with low-dose hydrochlorothiazide (12.5 mg) and, if necessary, the dose of losartan should be increased to 100 mg combined with 12.5 mg hydrochlorothiazide daily and subsequently increased to 2 tablets. Gizaar 50 mg/12.5 mg (total of 100 mg of losartan and 25 mg of hydrochlorothiazide once daily).

Interaction

Losartan

. No clinically significant interactions of losartan with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, and erythromycin have been found in clinical pharmacokinetic studies.

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

The combination of losartan, as well as other agents that block angiotensin II or its effects, with potassium-saving diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or potassium salts may result in increased serum potassium levels.

The NSAIDs (including selective COX-2 inhibitors) may decrease the effect of diuretics and other hypotensive drugs. Therefore, the hypotensive effect of angiotensin II receptor antagonists may be weakened with concomitant use of NSAIDs (including COX-2 inhibitors). In some patients with impaired renal function 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, as well as other antihypertensive agents, may be impaired by administration of indomethacin.

Hydrochlorothiazide

The simultaneous use of thiazide diuretics with barbiturates, opioid analgesics, ethanol may increase the risk of orthostatic arterial hypotension.

In concomitant use it may be necessary to correct the dose of hypoglycemic agents (oral and insulin). When using hydrochlorothiazide with other antihypertensive agents an additive effect is observed.

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

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

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

The response to administration of pressor amines (e.g., epinephrine) may decrease. The effect of myorelaxants of non-depolarizing type of action (e.g., tubocurarin) may be enhanced.

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

In some cases, use of NSAIDs (including selective COX-2 inhibitors) may decrease diuretic, natriuretic and antihypertensive effects of diuretics. In connection with the effect of thiazides on calcium metabolism, their administration may distort the results of parathyroid gland function tests.

Special Instructions

Application in liver dysfunction The drug is contraindicated in severe liver dysfunction.

Application in renal dysfunction The drug is contraindicated in severe renal dysfunction (CK values less than 30 ml/min). Due to inhibition of renin-angiotensin system function, there have been reports of renal dysfunction, including renal failure, in some patients treated with the drug; these changes were reversible and disappeared after discontinuation of therapy.

Cautions for losartan

There have been reports of changes in renal function, including renal failure, in a number of patients taking the drug due to suppression of renin-angiotensin system function; these changes were reversible and disappeared after discontinuation of therapy. Other drugs acting on the renin-angiotensin system may lead to an increase in urea and creatinine in the blood in patients with bilateral renal artery stenosis and artery stenosis of the single kidney. Similar effects have been noted with losartan; these changes in renal function have been reversible and disappeared after discontinuation of therapy.

Mcautions for hydrochlorothiazide

As with any antihypertensive medication, symptomatic arterial hypotension may occur in some patients. Patients require monitoring for timely detection of clinical signs of electrolyte-water imbalance, such as dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia that may develop with intermittent diarrhea or vomiting. Control of serum electrolyte levels is necessary in such patients. Thiazide therapy may lead to impaired glucose tolerance. In some cases, it may be necessary to adjust the dose of hypoglycemic agents (including insulin). Thiazides may decrease urinary calcium excretion and cause occasional and slight increase in serum calcium levels. Severe hypercalcemia may indicate occult hyperparathyroidism. Thiazide diuretic should be discontinued before parathyroid function tests. Elevated blood cholesterol and triglyceride levels may also be associated with thiazide diuretic therapy. In some patients, thiazide diuretics may lead to hyperuricemia and/or gout. Since losartan reduces uric acid levels, its combination with hydrochlorothiazide reduces the severity of diuretic-induced hyperuricemia. Hypersensitivity reactions may occur in patients receiving thiazides even if there is no history of allergy or bronchial asthma. There are reports of exacerbation or progression of SLE on thiazide diuretics. In an analysis of the entire patient population enrolled in the Losartan Intervention For Endpoint Reduction in hypertension (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 combined endpoint (cardiovascular death, stroke, and myocardial infarction) compared to atenolol. However, black patients receiving atenolol had a lower risk of primary combined endpoint events compared with black patients taking losartan (p=0.03).

Use in pediatrics

There are no data on the efficacy and safety of Gizaar in children, so use in this patient population is not recommended.

Contraindications

Hypersensitivity (including. to sulfonamide derivatives);

Anuria;

Childhood.

Side effects

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

The adverse reactions were limited to those already reported with losartan and/or hydrochlorothiazide alone. The cumulative incidence of adverse reactions reported with this combination was comparable to that with placebo. The rate of therapy withdrawal was also comparable to that of patients receiving placebo. In most cases, adverse reactions were mild, transient and did not require therapy withdrawal.

In the controlled clinical trials, dizziness was the only adverse reaction associated with taking the drug with an incidence greater than or equal to that of placebo.

Lozartan 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.
The following additional adverse reactions have been reported during postmarketing experience with the drug:

Allergic reactions and immunopathological reactions: anaphylactic reactions, angioedema, including laryngeal and vocal cleft edema with development of airway obstruction and/or edema of the face, lips, pharynx, and/or tongue in patients taking losartan; some of these patients have had a history of angioedema with other drugs, including ACE inhibitors. There have been rare reports of vasculitis (including Schoenlein-Henoch purpura) with losartan.

Digestive system disorders: Rarely, hepatitis, diarrhea (in patients taking losartan).

Respiratory system:possible cough (in patients taking losartan).

Dermatological reactions: urticaria, increased light and photosensitivity.

Laboratory findings: In controlled clinical studies with Gizaar®, clinically significant changes in standard laboratory values have rarely been observed. Hyperkalemia (serum potassium over 5.5 mEq/L) was observed in 0.7% of patients, which did not require discontinuation of the drug. Increase in ALT activity was rare and usually disappeared after discontinuation of therapy.

Overdose

There are no data on the specific treatment of Gizaar overdose. Administration of the drug should be discontinued, the patient should be monitored. Symptomatic therapy – induction of vomiting if the drug has been taken recently, as well as elimination of dehydration, electrolyte disturbances, hepatic coma and BP reduction by standard methods are indicated.

The data on losartan overdose in humans are limited. The most likely symptoms of overdose are marked BP reduction and tachycardia; bradycardia may result from parasympathetic (vagus) stimulation.

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

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

Similarities