Zisakar - instructions for use, dose, side effects, contraindications

Excipients: starch, microcrystalline cellulose, sodium carboxymethyl starch, sodium lauryl sulfate, magnesium stearate, talc, silicon dioxide colloid, hypromellose, macrogol 6000.

Description:

Tablets in the form of "heart", with a facet, white or almost white color, with engraving "Z"on one side and engraved" 25 "(for a dosage of 25 mg) and" 50 "(for a dosage of 50 mg) on the other.

Pharmacotherapeutic group:Angiotensin II receptor antagonist

ATX: & nbsp

C.09.C.A.01 Losartan

C.09.C.A Angiotensin II antagonists

Pharmacodynamics:

A hypotensive drug, is a specific antagonist of angiotensin II receptors (subtype AT1).Does not inhibit kinase II - an enzyme that destroys bradykinin. Reduces the overall peripheral vascular resistance (OPSS), the concentration in the blood of adrenaline and aldosterone, blood pressure (BP), pressure in the small circle of the circulation; reduces afterload, has a diuretic effect. It interferes with the development of myocardial hypertrophy, increases tolerance to exercise in patients with heart failure.

After a single dose, the hypotensive effect (decreases systolic and diastolic blood pressure) reaches a maximum after 6 hours, then gradually decreases within 24 hours.

The maximum hypotensive effect is achieved in 3-6 weeks after the start of the drug.

Pharmacological data indicate that the concentration of losartan in the blood plasma in patients with cirrhosis of the liver is significantly increased, so patients with liver disease in the history should be used in a lower dose.

Pharmacokinetics:

Losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. Has the effect of "first passage" through the liver, is metabolized by carboxylation with the participation of the isoenzyme 2C9 cytochrome P₄₅₀ with the formation of an active metabolite. Connection with blood plasma proteins - 99%.

The time to reach the maximum concentration of losartan is 1 hour, active metabolite 3-4 hours after ingestion. The half-life is 1.5-2 h, and its main metabolite is 6-9 h, respectively. About 35% dose is excreted in the urine, about 60% - through the intestine.

Indications:

- Arterial hypertension;

- Chronic heart failure (as part of combination therapy, with intolerance or ineffective therapy with ACE inhibitors).

Contraindications:

- Hypersensitivity to the components of the drug;

- arterial hypotension;

- gIperkalemia;

- dhydration;

- bVariability and lactation period;

- atozrast to 18 years (efficiency and safety not established).

Carefully:PRenal and / or renal failure.

Pregnancy and lactation:

There are no data on the use of losartan in pregnancy. However, it is known that drugs acting directly on the renin-angiotensin system, when applied in the II and III trimesters of pregnancy, can cause a developmental defect or even the death of a developing fetus.Therefore, if pregnancy occurs, losartan should be discontinued immediately.

When appointing during lactation, a decision should be made to stop breastfeeding or stop treatment with losartan.

Dosing and Administration:

Losartan is taken orally, regardless of the meal, the frequency of reception - 1 time per day.

When arterial hypertension the average daily dose is 50 mg. In some cases, to achieve a greater effect, the dose is increased to 100 mg in two divided doses or once a day.

Initial dose for patients from heart failure is 12.5 mg once a day. Typically, the dose increases with a weekly interval (ie 12.5 mg / day, 25 mg / day and 50 mg / day) to an average maintenance dose of 50 mg 1 time per day, depending on the patient's tolerability.

When the drug is prescribed patients receiving diuretics in high doses, The initial dose of losartan should be reduced to 25 mg once a day.

It is not necessary to adjust the dose to elderly patients or patients with impaired renal function, including patients on hemodialysis.

Patients with impaired hepatic function lower doses of losartan should be given.

In elderly patients, as well as in patients with impaired renal function, including patients on dialysis, there is no need to adjust the initial dose.

Pediatric Use

Safety and efficacy of the drug in children are not established.

Side effects:

* There are side effects, the incidence of which is comparable to placebo.

The association of side effects occurring with a frequency of less than 1% of cases with the use of losartan is not proven.

In most cases losartan well tolerated, side effects are transient in nature and do not require withdrawal of the drug.

From the nervous system and sense organs: 1% and more - dizziness, asthenia, headache, fatigue, insomnia; less than 1% - anxiety, sleep disturbance, drowsiness, memory disorders, peripheral neuropathy, paresthesia, hypostasis.

Form release / dosage:

Film-coated tablets, 25 mg and 50 mg.

Packaging:

10 tablets per blister of aluminum foil and PVC film; 3 blisters together with instructions for use are placed in a pack of cardboard.

Storage conditions:

There is no information.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002240/07

Date of registration:17.08.2007

Expiration Date:Unlimited

The owner of the registration certificate:Cadil Haltkar Co., Ltd.Cadil Haltkar Co., Ltd. India

Manufacturer: & nbsp

CADILA HEALTHCARE, Ltd. India

Representation: & nbspCADILA HELTKER LTD. CADILA HELTKER LTD. India

Information update date: & nbsp14.10.2017

Illustrated instructions

Instructions

Zisakar (Zisakar)