Gizaar forte, 12.5mg+100 mg 28 pcs

Gizaar Forte is a combined drug;

hypotensive effect.

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

Indications

Arterial hypertension.

Risk reduction in cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy.

Active ingredient

Composition

1 tablet contains:

Potassium losartan 100 mg;

Hydrochlorothiazide 12.5 mg.

How to take, the dosage

Gizaar Forte is taken orally, 1 tablet/day, regardless of meals.

The maximum dose is 2 tablets 1 time/day.

The maximum hypotensive effect is reached within 3 weeks after treatment start.

Interaction

The simultaneous use of hydrochlorothiazide:

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

Hypoglycemic oral medications and insulin may require dose adjustment of hypoglycemic medications;

Additive effect is possible with other hypotensive drugs;

with colestyramine and colestipol – impaired absorption of hydrochlorothiazide.

A single dose of colestiramine or colestipol may decrease absorption of hydrochlorothiazide in the GI tract by 85 and 43%, respectively.

Concomitant use of hydrochlorothiazide:

with GCS, ACTH, increased loss of electrolytes, aggravation of hypokalemia; with pressor amines (norepinephrine, epinephrine) a slight decrease in the effect of pressor amines is possible, not preventing their use;

with nondepolarizing myorelaxants (tubocurarine) – enhancement of their action;

Special Instructions

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

Combined administration with other hypotensive drugs is possible. May increase plasma concentrations of urea and creatinine in patients with bilateral renal artery stenosis or renal artery stenosis of the only kidney.

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

The administration of drugs acting directly on the RAAS in the II-III trimesters of pregnancy may lead to fetal death. If pregnancy occurs, withdrawal is indicated (thiazides penetrate the HEB). In relatively healthy pregnant women, the use of diuretics is generally not recommended due to the risk of fetal and neonatal jaundice and maternal thrombocytopenia. Diuretic therapy does not prevent the development of toxemia of pregnancy.

Contraindications

Hypersensitivity.

Anuria.

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

Hepatic and/or renal insufficiency.

Pregnancy.

The lactation period.

Side effects

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

Csymptoms: Losartan – decreased BP, tachycardia, bradycardia (due to vagus stimulation). Hydrochlorothiazide – loss of electrolytes (hypokalemia, hypochloremia, hyponatremia); dehydration (excessive diuresis).

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

Pregnancy use

The administration of drugs acting directly on the RAAS in the II-III trimesters of pregnancy may lead to fetal death.

Cancellation is indicated if pregnancy occurs (thiazides penetrate the HEB).

In relatively healthy pregnant women, the use of diuretics is generally not recommended because of the risk of fetal and neonatal jaundice and maternal thrombocytopenia.

Diuretic therapy does not prevent the development of toxemia of pregnancy.

Similarities