HYZAAR 50MG/12.5MG PILLS

Indications

- arterial hypertension (in patients for whom combination therapy is indicated);

- reducing the risk of cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy.

Dosage and administration

Gizaar® can be taken regardless of the meal.

At hypertension appoint 1 tab. 1 time / day

Gizaar® Forte is prescribed to patients without an adequate therapeutic response to taking 1 tab. drug Hyzaar ® 50 / 12.5 mg for 2–4 weeks. As a rule, the antihypertensive effect is achieved within 3 weeks after the start of therapy. In the absence of a therapeutic effect, the dose of Hyzaar® 50 / 12.5 mg can be increased to 2 tab. 1 time / day The maximum dose - 2 tab. drug Hyzaar® 50 / 12.5 mg 1 time / day or 1 tab. drug Hyzaar® Forte (100 / 12.5 mg).

Selection of the initial dose of Gizarar for elderly patients not required.

WITH to reduce the risk of cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy the drug is prescribed in the standard initial dose of Losartan, which is 50 mg 1 time / day. Patients who fail to achieve the target values ​​of blood pressure while receiving losartan 50 mg / day require therapy by combining losartan with low doses of hydrochlorothiazide (12.5 mg), and, if necessary,should increase the dose of losartan to 100 mg in combination with hydrochlorothiazide at a dose of 12.5 mg / day, in the future - increase the dose to 2 tab. Gizaara 50 mg / 12.5 mg (only 100 mg of losartan and 25 mg of hydrochlorothiazide once a day).

Gizaar® Forte on 1 tab. 1 time / day is prescribed to patients in whom it is not possible to achieve the target values ​​of blood pressure while taking 1 tab. drug Hyzaar® (50 / 12.5 mg).

Adverse effects

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

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 used with placebo. The frequency of discontinuation of therapy was also comparable to that in patients receiving placebo. In most cases, adverse reactions were mild, were transient, and did not require discontinuation of therapy.

In controlled clinical trials, dizziness was the only adverse reaction associated with taking the drug, the frequency of which was greater than that when taking placebo more than 1 percent or more.

Losartan in combination with hydrochlorothiazide is generally well tolerated in patients with arterial hypertension and left ventricular hypertrophy. The most frequent adverse reactions were dizziness, weakness, and fatigue.

During the post-marketing experience using the drug, the following additional adverse reactions have been reported.

Allergic reactions and immunopathological reactions: Anaphylactic reactions, angioedema, including laryngeal and glottis edema 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 indications of the development of angioedema in the history of using other drugs, including ACE inhibitors. There are rare reports of vasculitis development (including Schoenlein-Henoch purpura) with losartan.

Gastrointestinal: rarely - hepatitis, diarrhea (in patients taking losartan).

Respiratory: possible cough (in patients taking losartan).

Dermatologic: urticaria, increased light and photosensitivity.

From the laboratory indicators: in controlled clinical trials on the background of taking the drug Hyzaar® clinically significant changes in standard laboratory parameters were rarely observed. Hyperkalemia (serum potassium of more than 5.5 meq / l) was observed in 0.7% of patients, which did not require discontinuation of the drug. Increased ALT activity was rarely observed and usually disappeared after discontinuation of therapy.

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Contraindications

- anuria;

- pronounced impaired renal function (CC less than 30 ml / min);

- severe liver dysfunction;

- age up to 18 years (efficacy and safety of use have not been established);

- Hypersensitivity to any of the components of the drug;

- hypersensitivity to sulfonamide derivatives.

Tablets contain lactose, so patients with rare hereditary lactose intolerance, lactase deficiency or impaired absorption of glucose-galactose should not take this drug.

WITH caution the drug should be used in violation of the water-electrolyte balance of the blood, for example against the background of diarrhea or vomiting (hyponatremia, hypochloremic alkalosis, hypomagnemia, hypokalemia); in patients with renal insufficiency (CK 30-50 ml / min), with bilateral renal artery stenosis or arterial stenosis of a single kidney; diabetes; in patients with hypercalcemia, hyperuricemia, and / or gout; in patients with allergic history and bronchial asthma; with systemic diseases of the connective tissue (including SLE); with hypovolemia (including on the background of receiving diuretics in high doses); as well as with simultaneous administration with NSAIDs (including those with COX-2 inhibitors).

Use during pregnancy and lactation

Use of the drug Hyzaar® contraindicated in pregnancy.

The use of drugs that have a direct effect on the renin-angiotensin system in the II and III trimesters of pregnancy can cause harm to the developing fetus and even cause its death. Immediately after the pregnancy is established, the reception of Gizar should be stopped.

Adequate and strictly controlled clinical studies of the safety of the use of Gizar during pregnancy has not been conducted.

AT experimental studies it has been shown in animals that the use of losartan may have a teratogenic effect and cause death of the fetus and newborn, which is probably due to the effect of this active substance on the renin-angiotensin system.

In the human fetus, renal perfusion, which depends on the development of the renin-angiotensin system, begins in the second trimester; thus, the risk of impaired development and fetal death increases with the use of Hyzaar in the II or III trimesters of pregnancy.

Thiazides penetrate the placental barrier and are determined in the blood of the umbilical cord. Routine use of diuretics in pregnant healthy women is not recommended, because This increases the risk of adverse events such as fetal jaundice and jaundice of the newborn in the fetus, and thrombocytopenia in the mother.

There is no evidence that losartan is excreted in breast milk. However, it is known that thiazides are excreted in breast milk. In connection with the risk of adverse events in infants, in all cases an informed decision should be made about taking the drug during the breastfeeding period, taking into account the importance of therapy for the mother.

In the event that it is decided that you take the drug Hyzaar® breastfeeding should be discontinued.

Application for violations of the liver

The drug is contraindicated in marked disorders of the liver.

Application for violations of kidney function

The drug is contraindicated in marked impaired renal function (CC less than 30 ml / min).

Use in children

Contraindication: age up to 18 years (efficacy and safety of use have not been established).

Use in elderly patients

Selection of the initial dose of Gizarar for elderly patients not required.

Special notes

Gizaar® can be administered in combination with other antihypertensive drugs.

Losartan

There are reports that a number of patients taking the drug, in connection with the suppression of the function of the renin-angiotensin system, showed changes in renal function, including renal failure; these changes were reversible and disappeared after discontinuation of therapy.

Other agents affecting the renin-angiotensin system can lead to an increase in urea and creatinine in the blood of patients with bilateral renal artery stenosis and arterial stenosis of a single kidney. Similar effects have been observed while taking losartan; these changes in renal function were reversible and disappeared after discontinuation of therapy.

Hydrochlorothiazide

As in the case of taking any antihypertensive drugs, in some patients symptomatic arterial hypotension may be observed. Patients require monitoring in order to timely detect the clinical signs of impaired water and electrolyte balance, for example, dehydration,hyponatremia, hypochloremic alkalosis, hypomagnesaemia or hypokalemia, which can develop against the background of intercurrent diarrhea or vomiting. In such patients, it is necessary to control the level of serum electrolytes.

Thiazide therapy can lead to impaired glucose tolerance. In some cases, it may be necessary to adjust the dose of hypoglycemic agents (including insulin).

Thiazides can reduce the excretion of Calcium in the urine and cause an episodic and insignificant increase in the serum calcium level. Severe hypercalcemia may indicate latent hyperparathyroidism.

Due to the effect of thiazides on calcium metabolism, their intake may distort the results of the study of the function of the parathyroid glands, therefore, before the study of the functions of the parathyroid glands, the thiazide diuretic should be canceled.

Increased blood cholesterol and triglycerides may also be associated with thiazide diuretic therapy.

In some patients, the administration of thiazide diuretics can lead to hyperuricemia and / or the development of gout. Since losartan reduces uric acid levels, its combination with hydrochlorothiazide reduces the severity of diuretic hyperuricemia.

In patients receiving thiazides, hypersensitivity reactions can be observed even in the absence of indications of allergies or bronchial asthma in the anamnesis. There are reports of the development of exacerbation or the progression of SLE in patients receiving thiazide diuretics.

When analyzing the entire population of patients included in the LIFE study (Losartan Intervention for Endpoint Reduction in Hypertension), the effect of losartan on reducing the frequency of end points in patients with arterial hypertension, n = 9193, was accompanied by a decrease in the risk of reaching the primary combined end point vascular death, stroke, and myocardial infarction) by 13% (p = 0.021) compared with Atenolol . However, patients of the Negroid race who received atenolol had a lower risk of developing the events of the primary combined endpoint compared with black patients who received Losartan (p = 0.03).

Use in pediatrics

The efficacy and safety of the drug in children under the age of 18 years has not been established.

Overdose

Data overdose losartan people are limited. Most likely by symptoms overdose are marked reduction in blood pressure and tachycardia; bradycardia may be due to parasympathetic (vagal) stimulation.

Treatment: in the case of symptomatic hypotension, supportive therapy is indicated. Losartan and its active metabolite are not excreted by hemodialysis.

Most frequent the symptoms overdose hydrochlorothiazide are the result of electrolyte deficiency (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive diuresis. With simultaneous intake of cardiac glycosides, hypokalemia can aggravate the course of arrhythmias.It has not been established to what extent hydrochlorothiazide can be removed from the body through hemodialysis.

There is no data on the specific treatment of Hyzaar overdose.®. Treatment is symptomatic and supportive. The drug should be discontinued, and the patient should be monitored. If the drug is taken recently, it is recommended provocation of vomiting, as well as the elimination of dehydration, electrolyte abnormalities, hepatic coma and reduction of blood pressure by standard methods.

Drug interaction

Losartan

In clinical studies of pharmacokinetics, no clinically significant interaction of losartan with hydrochlorothiazide, Digoxin, Warfarin, cimetidine, phenobarbital, Ketoconazole and Erythromycin was detected.

The combination of losartan, as well as other agents blocking angiotensin II or its effects, with potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride), potassium supplements or potassium salts can lead to an increase in serum potassium.

NSAIDs (including selective COX-2 inhibitors) can reduce the effect of diuretics and other antihypertensive drugs. Therefore, the hypotensive effect of angiotensin II receptor antagonists may be attenuated with simultaneous use with NSAIDs (including COX-2 inhibitors).

In some patients with impaired renal function who received NSAID therapy (including COX-2 inhibitors), treatment with angiotensin II receptor antagonists may cause further deterioration in renal function. These effects are usually reversible.

Hydrochlorothiazide

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

With simultaneous use may require dose adjustment hypoglycemic agents (for oral administration and insulin).

When using hydrochlorothiazide with other antihypertensive agents, an additive effect is observed.

In the presence of anionic exchange resins, the absorption of hydrochlorothiazide is impaired. Kolestiramin 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 the level of electrolytes, in particular, can cause hypokalemia.

Perhaps a decrease in the severity of the response to the introduction of pressor amines (eg, epinephrine).

May increase the action of muscle relaxants non-depolarizing type of action (for example, tubocurarine).

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

In some cases, the use of NSAIDs (including selective COX-2 inhibitors) can reduce the diuretic, natriuretic and antihypertensive effects of diuretics.

Terms and conditions of storage

The drug should be stored at a temperature of 15-30 ° C out of the reach of children.