Plavix tab. of p/o of 75 mg No. 28

Tablets "Plavix of ^® " are applied at indications which are provided below.

Secondary prevention of manifestations of an aterotromboz at adults:

• patients, who had a myocardial infarction (an initiation of treatment - in several days, but not later than in 35 days after emergence), an ischemic stroke (an initiation of treatment - in 7 days, but not later than in 6 months after emergence) or for which the disease of peripheral arteries is diagnosed (damage of arteries and aterotromboz vessels of the lower extremities);
• patients with a sharp coronary syndrome:
  • with a sharp coronary syndrome without raising of a segment of ST (unstable stenocardia or a myocardial infarction without tooth Q), including at patients to whom the stent was established during performing transdermal coronary angioplasty, in a combination with acetylsalicylic acid (ASK);
  • with an acute myocardial infarction with raising of a segment of ST, in a combination with acetylsalicylic acid (at the patients receiving standard medicament treatment and to which thrombolytic therapy is shown).

Prevention of aterotrombotichesky and thromboembolic events at fibrillation of auricles: klopidogret in a combination with ASK it is shown to adult patients with fibrillation of auricles which have at least one risk factor of emergence of vascular events which have contraindications to treatment by the antagonists of vitamin K (AVK) and which have low risk of developing of bleedings, for prevention of aterotrombotichesky and thromboembolic events, including a stroke.

Structure

(one tablet contains klopidogrelya hydrosulphate in the form of a basis 75 mg).

Excipients: a mannitol (E 421), cellulose microcrystalline, polyethyleneglycol, hydroxypropyl cellulose low-substituted, the castor oil hydrogenated; cover: Opadri 32K14834, type ІІ (lactoses monohydrate, gipromelloz, titan dioxide (E 171), triacetin, ferrous oxide red (E172)), wax of karnaubskiya.

Contraindication

• hypersensitivity to active ingredient or to any component of drug;
• heavy liver failure;
• acute bleeding (for example ulcer or intracraneal hemorrhage).

Route of administration

Adult, including patients of advanced age

"Plavix of ^® " to accept on 75 mg of 1 times a day irrespective of meal.

At patients with a sharp coronary syndrome without raising of a segment of ST (unstable stenocardia or a myocardial infarction without Q tooth on the ECG) with a single load dose 300 mg, and then to continue in a dose 75 mg of 1 times a day (with acetylsalicylic acid (ASK) in a dose of 75-325 mg a day). As use of higher doses of ASK increases risk of bleeding, it is recommended not to exceed a dose of acetylsalicylic acid of 100 mg. The optimum duration of treatment is formally not established. Results of clinical trials testify in favor of use of medicament up to 12 months, and the maximum effect was observed in 3 months of treatment.

to accept 75 mg of 1 times a day, since a single load dose of 300 mg in a combination with ASK, using thrombolytic medicaments or without them. To begin treatment of patients aged from 75 years without load dose klopidogrelya. Combination therapy should be begun as soon as possible after emergence of symptoms and to continue at least 4 weeks. The advantage of use of a combination klopidogrelya with ASK in this disease was not studied more than four weeks.

to apply 75 mg in a single dose. Together with klopidogrely it is necessary to begin and continue use of ASK (in a dose of 75-100 mg a day).

in case of the admission of a dose:

• if since the moment when it was necessary to accept the next dose, there passed less than 12 hours, the patient has to accept immediately passed dose, and already to accept the following dose in usual time;
• if there passed more than 12 hours, the patient has to accept the following next dose in usual time but not double a dose for the purpose of compensation of the passed dose.

Feature of use

Pregnant

due to the lack of clinical data on use klopidogrelya during pregnancy it is undesirable to li to appoint medicament to pregnant women (precautionary measure).

whether it is removed klopidogret in breast milk. In researches on animals it was shown that it is removed in breast milk therefore during treatment "Plavix of ^® " feeding by a breast should be stopped.

during the researches on laboratory animals did not reveal negative influence klopidogrelya on fertility.

Children

Klopidogrel should not be applied to children as there are no data on efficiency of medicament for this age category of patients.

Drivers

Klopidogrel does not influence or has insignificant impact on speed of response at control of motor transport or work with other mechanisms.

At overdose klopidogrelya lengthening of a bleeding time with the subsequent complications is possible

. In case of developing of bleeding the symptomatic treatment is recommended. Antidote of pharmacological activity klopidogrelya is unknown. In need of immediate correction of the extended bleeding time klopidogrelya it can be terminated by transfusion of platelet concentrate.

Side effects

Bleeding is the most widespread side reaction which was observed both in clinical trials, and during the post-marketing period during which it most often arose in the first month of treatment.

to Store

in original packing out of children's reach.

Expiration date - 3 years.