ZILT

Active material: Clopidogrel
When ATH: B01AC04
CCF: Antiplatelet
ICD-10 codes (testimony): I21, I63, I74, I82
When CSF: 01.12.11.06.01
Manufacturer: Krka-RUS OOO (Russia)

DOSAGE FORM, STRUCTURE AND PACKAGING

Pills, coated, film, Pink colour, round, slightly biconcave.

Excipients: lactose bezvodnaya, microcrystalline cellulose, pre-gelatinized starch, macrogol 6000, Hydrogenated castor oil, gipromelloza, Titanium dioxide (E171), iron oxide red (E172), talc, propylene glycol.

7 PC. – blisters (2) – packs cardboard.
7 PC. – blisters (4) – packs cardboard.
7 PC. – blisters (8) – packs cardboard.
7 PC. – blisters (12) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
10 PC. – blisters (9) – packs cardboard.

Pharmacological action

Antiplatelet. Clopidogrel prevents the binding of adenosine diphosphate (ADF) c receptors, located on the platelet surface, and activation of GP IIb / IIIa complex. This leads to the inhibition of ADP-dependent platelet aggregation. This also leads to inhibition of platelet aggregation under the influence of other incentives; reduces the effect of ADP, produced in each activated platelet, and stimulated platelet aggregation remaining. Effect of clopidogrel lasts throughout the life of the platelet, platelet function is restored through 7-10 days after discontinuation of clopidogrel.

With long-term appointment of therapeutic doses of clopidogrel (75 mg / day) marked inhibition of platelet aggregation observed in the first day of treatment, then antiplatelet effect gradually increases and reaches a maximum at 3-7 day of the regular ingestion. Chronic administration of therapeutic doses of the average level of inhibition is between 40% and 60%. After the treatment the effect of clopidogrel on the aggregation and bleeding time usually decreases over 5 days.

Pharmacokinetics

The data on the pharmacokinetics Zilt^® not provided.

Testimony

- Prevention of ischemic disorders (myocardial infarction, stroke, peripheral arterial thrombosis, sudden vascular death) in patients with atherosclerosis, incl. after myocardial infarction (to 35 days), ischemic stroke (from 7 days before 6 Months), or background diagnosed occlusive peripheral arterial disease.

Dosage regimen

The usual dose for Adult (including elderly patients) is 1 tab. (75 mg)/d, regardless of the meal.

Side effect

Adverse events rarely require discontinuation of treatment with clopidogrel.

From the body as a whole: chest pain, injury, flu-like symptoms, pain, fatiguability, asthenia, hernia.

From the central and peripheral nervous system: headache, dizziness, paresthesia, leg cramps, giperesteziya, neuralgia.

Cardio-vascular system: peripheral edema, arterial hypertension, heart failure, swoon, palpitations.

From the digestive system: abdominal pain, dyspepsia, diarrhea, nausea, constipation, vomiting, taste disturbances, perforation of stomach ulcers, hemorrhagic gastritis, bleeding from the upper gastrointestinal tract, increase in liver enzymes, giperʙiliruʙinemija, hepatitis, hepatic steatosis.

From the hematopoietic system: thrombocytopenia, anemia (aplastic or hypochromic), agranulocytosis, leukopenia, neutropenia.

From the blood coagulation system: extravasation, nose bleed, gastrointestinal bleeding, bleeding into joints, bleeding from the urinary tract, hemoptysis, intracranial hemorrhage, retroperitoneal haemorrhage, bleeding from surgical wounds, eye hemorrhage, gemotoraks, pulmonary hemorrhage, purpura (incl. allergic), tromboticheskaya trombotsitopenicheskaya purpura.

On the part of the musculoskeletal system: arthralgia, backache, arthritis, arthrosis.

The respiratory system: inflammation of the upper respiratory tract, breathlessness, rhinitis, bronchitis, cough, pneumonia, sinusitis.

Dermatological reactions: rash, itch, eczema, skin ulceration, bullous dermatitis, erythematous rash, maculo-papular rash, hives.

On the part of the organ of vision: Cataract, conjunctivitis.

With the genitourinary system: urinary tract infection, cystitis, menorragija.

In addition to the above the expected adverse effects of the treatment with clopidogrel was reported a few cases of hemolytic uremic syndrome, membranous nephropathy and hypersensitivity reactions (angioedema, bronchospasm, anaphylactic reactions).

Contraindications

- Severe hepatic impairment;

- Hemorrhagic syndrome;

- Severe bleeding (incl. intracranial hemorrhage);

- Diseases, predisposing to bleeding (gastric ulcer and duodenal ulcer in the acute phase, nespetsificheskiy yazvennыy colitis, tuberculosis, lung tumor, giperfiʙrinoliz);

- Pregnancy;

- Lactation (breast-feeding);

- Up to 18 years;

- Hypersensitivity to clopidogrel and / or any of the components of the drug.

The drug is not administered during the first few days after myocardial infarction.

FROM caution should be prescribed at an increased risk of bleeding after injuries, operations, or by other pathological conditions, as well as patients with a propensity to bleed (particularly gastrointestinal and intraocular hemorrhage), patients with impaired renal function and / or liver.

Pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (breast-feeding).

Cautions

Clopidogrel prolongs bleeding time. Therefore, caution should be prescribed to patients with an increased risk of bleeding after injuries, operations, or by other pathological conditions, as well as patients with a propensity to bleed (particularly gastrointestinal and intraocular hemorrhage). Treatment with clopidogrel should be discontinued at least 7 days before the planned surgery (including dental procedures).

Patients should be warned, that during treatment with clopidogrel has an increased tendency to bleeding, and bleeding can continue for a little longer, than usual, before you stop yourself. In the case of minor cuts (eg, shaving) and trauma normally not require any special measures. A more extensive injuries should consult a doctor.

During the period of treatment is necessary to monitor the performance of the hemostatic system (the number of platelets, Platelet function tests), regularly examine the functional activity of the liver.

Patients with severe hepatic impairment, caution should prescribe clopidogrel because of the increased risk of bleeding.

Use in Pediatrics

The safety and efficacy of clopidogrel use at children and adolescents up to 18 years not installed, why do not prescribe clopidogrel in patients in this age group.

Effects on ability to drive vehicles and management mechanisms

It does not set the effect of the drug on the ability to drive vehicles and operate machinery.

Overdose

In the literature, there is one report of an intentional overdose (intoxication). At reception 1050 mg of clopidogrel (14 tablets) not observed symptoms and signs of overdose.

Drug Interactions

We do not recommend co-administration of clopidogrel and warfarin due to the increased risk of bleeding.

Aspirin does not alter ADP-induced platelet aggregation, induced by clopidogrel. However, the periodic appointment of acetylsalicylic acid (500 mg 2 times / day) It did not cause prolonged bleeding. Clopidogrel may potentiate the effect of acetylsalicylic acid on platelet aggregation, collagen-induced. Potential pharmacodynamic interaction between clopidogrel and acetylsalicylic acid increases the risk of bleeding, so concomitant use of clopidogrel and acetylsalicylic acid is possible no more 1 year.

Due to the increased risk of bleeding is recommended to be cautious while appointing clopidogrel and heparin or other thrombolytic agents.

Co-administration of clopidogrel and NSAIDs increases the risk of erosive and ulcerative lesions of the gastrointestinal tract and ulcer bleeding. Therefore, this combination is used with caution and in exceptional cases.

There were no clinical interaction with concomitant administration of clopidogrel and atenolol, ACE inhibitors, means, lowering blood cholesterol, Nifedipine, digoksina, fenoʙarʙitala, cimetidine, estrogen, teofillina.

Clopidogrel inhibits isoenzyme CYR2C9 while the use of drugs, metabolized with the participation of the enzyme (phenytoin, tolbutamid), however possible to increase their concentration in the blood plasma.

Antacids do not affect the absorption of clopidogrel.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.