Hyzaar, pills 12.5+50mg, 14pcs

Composition

Active ingredients:

Losartan potassium 50 mg;

Hydrochlorothiazide 12.5 mg;

Auxiliary substances:

Microcrystalline cellulose;

Water-based lactose;

Pregelatinized starch;

Magnesium stearate.

Shell composition:

Hydroxypropylmethylcellulose;

Hydroxypropylcellulose;

Titanium dioxide;

Aluminum varnish quinoline yellow;

Carnauba wax.

Pharmacological action

Hyzaar – hypotensive, diuretic.

Blocks angiotensin II receptors (AT subtype₁).

Pharmacodynamics

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

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

• It does not require dose adjustment for the elderly and patients with renal insufficiency (except in severe cases).

• It is preferred for patients who are recommended for combination therapy.

Indications

• Arterial hypertension.

• Chronic heart failure.

Contraindications

• Hypersensitivity (including to sulfonamide derivatives);

• Anuria;

• Children’s age.

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 frequency of adverse reactions reported with this combination was comparable to that reported with placebo. The frequency of discontinuation was also comparable to that of placebo-treated patients. In most cases, adverse reactions were mild, transient and did not require discontinuation of therapy.

In controlled clinical trials, vertigo was the only drug-related adverse reaction that was more than 1 percent or more more frequent than placebo-related adverse reactions.

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. The following additional adverse reactions have been reported during the post-marketing experience with the drug:

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 a history of angioedema when using other drugs, including ACE inhibitors. There are rare reports of the development of vasculitis (including Schonlein-Henoch purpura) while taking losartan.

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

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

Dermatological reactions: urticaria, increased light and photosensitivity.

From the side of laboratory parameters: in controlled clinical trials, clinically significant changes in standard laboratory parameters were rarely observed while taking Hyzaar®. Hyperkalemia (serum potassium greater 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.

Interaction

Losartan

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

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 agents that block angiotensin II or its effects, with potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride), potassium-containing supplements or potassium salts can 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 antihypertensive effect of angiotensin II receptor antagonists may be weakened when used concomitantly with 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 with other antihypertensive agents, may be weakened by taking Indometacin.

Hydrochlorothiazide

Concomitant use of thiazide diuretics with barbiturates, opioid analgesics, and ethanol may increase the risk of orthostatic hypotension.

With simultaneous use, it may be necessary to adjust the dose of hypoglycemic agents (for oral use 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.

Colestyramine 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 pronounced decrease in the level of electrolytes, in particular, it can cause hypokalemia.

It is possible to reduce the severity of the response to the introduction of pressor amines (for example, epinephrine). It is possible to increase the effect of non-depolarizing muscle relaxants (for example, tubocurarin).

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, the use of 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 use may distort the results of studies of parathyroid function.

How to take, course of use and dosage

Hyzaar can be used in combination with other antihypertensive agents. Hyzaar can be taken regardless of food intake.

For arterial hypertension: The usual initial and maintenance dose of the drug is 1 tab. Hyzaara 1 time/day. In the absence of an adequate therapeutic effect within 2-4 weeks, the dose of the drug should be increased to 2 tablets. Hyzaara 50/12.5 mg 1 time/day. The maximum dose is 2 tablets. Hyzaara 50/12.5 mg 1 time/day. As a rule, the antihypertensive effect is achieved within 3 weeks after the start of therapy. Selection of the initial dose of Hyzaar for elderly patients is not required.

In order to reduce the risk of cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy: The drug is prescribed in a standard initial dose of losartan,50 mg 1 time/day. Patients who fail to achieve the target blood pressure values while taking losartan 50 mg / day should choose therapy by combining losartan with low doses of hydrochlorothiazide (12.5 mg), and, if necessary, increase the dose of losartan to 100 mg in combination with hydrochlorothiazide at a dose of 12.5 mg / day, then increase the dose to 2 tablets. Hyzaara 50 mg / 12.5 mg (total of 100 mg of losartan and 25 mg of hydrochlorothiazide per day once).

Overdose

There are no data on the specific treatment of Hyzaar overdose. The drug should be discontinued and the patient should be monitored. It is indicated to conduct symptomatic therapy-the induction of vomiting if the drug is taken recently, as well as the elimination of dehydration, electrolyte disorders, hepatic coma and lowering blood pressure by standard methods.

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

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

The most common symptoms of hydrochlorothiazide overdose are due to electrolyte deficiencies (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive diuresis. Hypokalemia may worsen the course of arrhythmias when cardiac glycosides are taken at the same time. It has not been established to what extent hydrochlorothiazide can be removed from the body by hemodialysis.

Special instructions

• Use in patients with impaired liver function The drug is contraindicated in patients with severe liver function disorders.

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

Precautions for Losartan

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

Precautions for Hydrochlorothiazide

As with any antihypertensive medication, some patients may experience symptomatic hypotension. Patients should be monitored for timely detection of clinical signs of impaired water-electrolyte balance, such as dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may develop against the background of intercurrent diarrhea or vomiting. In such patients, it is necessary to monitor 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 urinary calcium excretion and cause an occasional and minor increase in serum calcium levels. Severe hypercalcemia may indicate latent hyperparathyroidism. The thiazide diuretic should be discontinued prior to parathyroid function testing. Increased blood cholesterol and triglyceride levels may also be associated with thiazide diuretic therapy. In some patients, taking 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 indication of a history of allergies or bronchial asthma. Acute or progressive SLE has been reported with 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 endpoints in patients with hypertension, n=9193), losartan treatment was accompanied by a 13% (p=0.021) reduction in the risk of reaching the primary combined endpoint (cardiovascular death, stroke, and myocardial infarction) compared with atenolol. However, black patients treated with atenolol had a lower risk of developing primary combined endpoint events compared to black patients treated with losartan (p=0.03).

Use in pediatrics

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

Form of production

Pills.

Storage conditions

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

Shelf

life is 3 years.

Active ingredient

Hydrochlorothiazide, Losartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Prevention of heart attacks and strokes