Hyzaar forte, pills 12.5+100mg, 28pcs

Composition

1 tablet contains:

Losartan potassium 100 mg;

Hydrochlorothiazide 12.5 mg

Pharmacological action

Hyzaar Forte-a combined drug;

has a hypotensive effect.

Contains losartan, an angiotensin II receptor antagonist (type AT1) and a hydrochlorothiazide-thiazide diuretic.

Indications

• Arterial hypertension.

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

Use during pregnancy and lactation

Taking medications that directly affect the RAAS in the II-III trimesters of pregnancy can lead to fetal death.

If pregnancy occurs, withdrawal is indicated (thiazides pass through the BBB).

For relatively healthy pregnant women, the use of diuretics is usually not recommended due to the risk of jaundice of the fetus and newborn, and maternal thrombocytopenia.

Diuretic therapy does not prevent the development of pregnancy toxicosis.

Contraindications

• Hypersensitivity.

• Anuria.

• Hypovolemia (including high-dose diuretics).

• Hepatic and / or renal insufficiency.

• Pregnancy.

• Lactation period.

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

When taking hydrochlorothiazide at the same time:

• with ethanol, barbiturates, opioid analgesics, the risk of orthostatic hypotension increases;

• with oral hypoglycemic drugs and insulin, dose adjustment of hypoglycemic drugs may be required;

• with other antihypertensive drugs, an additive effect is possible;

• with colestyramine and colestipol, a violation of the absorption of hydrochlorothiazide.

A single dose of colestyramine or colestipol can reduce the absorption of hydrochlorothiazide in the gastrointestinal tract by 85 and 43%, respectively.

With simultaneous use of hydrochlorothiazide:

• with corticosteroids, ACTH, it is possible to increase the loss of electrolytes, aggravation of hypokalemia; with pressor amines (norepinephrine, epinephrine), a slight decrease in the effect of pressor amines is possible, which does not prevent their use;

• with non – depolarizing muscle relaxants (tubocurarin) – an increase in their action;

• with NSAIDs-a decrease in diuretic, natriuretic, hypotensive action is possible.

Do not use concomitantly with lithium preparations, as diuretics reduce the renal clearance of lithium and increase the risk of intoxication.

How to take, course of use and dosage

Hyzaar Forte is taken orally,1 tablet/day, regardless of food intake.

The maximum dose is 2 tablets 1 time/day.

The maximum hypotensive effect develops within 3 weeks after the start of treatment.

Overdose

Symptoms:  Losartan – reduced blood pressure, tachycardia, bradycardia (as a result of vagal stimulation). Hydrochlorothiazide – loss of electrolytes (hypokalemia, hypochloremia, hyponatremia); dehydration (excessive diuresis).

Treatment:  symptomatic and supportive care. If the drug is taken recently, the stomach should be washed; if necessary, correction of water-electrolyte disorders is carried out. Losartan and its active metabolites are not removed by hemodialysis.

Special instructions

There is no need for a special selection of the initial dose for elderly patients.

Co-use with other antihypertensive drugs is possible. May increase the concentration of urea and creatinine in plasma in patients with bilateral renal artery stenosis or stenosis of the renal artery of a single kidney.

Hydrochlorothiazide can increase hypotension and water-electrolyte balance disorders (decrease in BCC, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia), disrupt glucose tolerance, reduce urinary calcium excretion and cause a transient slight increase in plasma calcium concentration, increase cholesterol and TG concentrations, provoke the occurrence of hyperuricemia and/or gout.

Taking medications that directly affect the RAAS in the II-III trimesters of pregnancy can lead to fetal death. If pregnancy occurs, withdrawal is indicated (thiazides pass through the BBB). For relatively healthy pregnant women, the use of diuretics is usually not recommended due to the risk of jaundice of the fetus and newborn, and maternal thrombocytopenia. Diuretic therapy does not prevent the development of pregnancy toxicosis.

Form of production

Film-coated tablets.

Storage conditions

The drug should be stored in a dry, inaccessible place for children at a temperature of up to 25°C.

Shelf

life is 2 years.

Active ingredient

Hydrochlorothiazide, Losartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Hypertension, Prevention of heart attacks and strokes