Gizaar Forte tablets 12.5 + 100 mg, 28 pcs. (Hydrohlorotyazyd, Losartan)

Release form

Film-coated tablets.

Packing

28 pcs.

Pharmacological action

Gizaar Forte - the combined drug has a hypotensive effect. It contains losartan, an angiotensin II receptor antagonist (type AT1), and hydrochlorothiazide, a thiazide diuretic.

Indications

Arterial hypertension.

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

Contraindications

Hypersensitivity.

anuria.

Hypovolemia (including against the background of high doses of diuretics).

Hepatic and / or renal failure.

Pregnancy.

Lactation.

Use during pregnancy and lactation

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

Composition

1 tablet contains:

losartan potassium 100 mg

hydrochlorothiazide 12.5 mg.

Dosage and administration

Gizaar 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.

Side effects of

In clinical trials 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 total incidence of adverse reactions reported with this combination was comparable to that with placebo. The frequency of discontinuation of therapy was also comparable to that of 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 whose frequency exceeded that of a placebo by 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 common adverse reactions were dizziness, weakness, and fatigue.

In the course of the post-marketing experience of using the drug, the following additional adverse reactions were reported: Allergic reactions and immunopathological reactions: anaphylactic reactions, angioedema, including swelling of the larynx and glottis with the development of obstruction of the respiratory tract and / or swelling of the face, lips, pharynx and / or tongue, patients taking losartan in some of these patients had indications of a history of angioedema when using other drugs, i.e. h ACE inhibitors. There are rare reports of the development of vasculitis (including Shenlein-Genoch purpura) with 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.

On the part of laboratory parameters: in controlled clinical trials while taking Gizaar®, 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. An increase in ALT activity was rare and usually disappeared after discontinuation of therapy.

Overdose

Symptoms: Losartan - decreased blood pressure, tachycardia, bradycardia (as a result of vaginal stimulation). Hydrochlorothiazide - loss of electrolytes (hypokalemia, hypochloremia, hyponatremia) dehydration (excess diuresis).

Treatment: symptomatic and supportive therapy. If the drug is taken recently, it is necessary to wash the stomach, if necessary, correct the water-electrolyte disorders. Losartan and its active metabolites are not removed by hemodialysis.

Storage conditions

The drug should be stored in a dry place inaccessible to children at temperatures up to 25 ° C.

Expiration

2 years.



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Dosage form

Dosage form

tablets

Merck Sharp and Doom BV, USA



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