Zilt refers to drugs that affect blood clotting.
Release form and composition
Zylt is available in the form of pink film-coated tablets. Tablets of 7 pcs. posted in blisters. Sold in packs of cardboard, containing 2, 4 or 12 blisters.
The active substance Zilta - clopidogrel hydrosulfate. Excipients - anhydrous lactose, 108.125 mg, pregelatinized starch, 12 mg, microcrystalline cellulose, 30 mg, hydrogenated castor oil, 4 mg, macrogol 6000, 8 mg. The film shell of the tablets contains: gipromelloza bsr, 5.6 mg, talc, 0.5 g, titanium dioxide, 1.4 6 mg, propylene glycol, 0.4 mg, iron red oxide, 0.04 mg.
Indications for use
Zylt is used to prevent atherothrombotic complications in adults with the following diseases:
- Myocardial infarction (from 2 to 35 days old), ischemic stroke (from 7 days to 6 months old), diagnosed occlusive peripheral artery disease;
- Acute coronary syndrome without ST segment elevation (myocardial infarction without Q wave formation or unstable angina), including patients after stenting for percutaneous coronary intervention, simultaneously with acetylsalicylic acid;
- Acute coronary syndrome with ST-segment elevation (acute myocardial infarction) with drug therapy and the possibility of thrombolytic treatment simultaneously with acetylsalicylic acid.
Zylt is prescribed for the prevention of thromboembolic and atherothrombotic complications, including stroke, in atrial fibrillation (atrial fibrillation) in patients with atrial fibrillation who have at least one risk factor for the occurrence of vascular complications, have a small risk of bleeding (simultaneously with acetylsalicylic acid), and also can not accept indirect coagulants.
Zylt is contraindicated in patients who have such diseases and conditions:
- Severe liver failure;
- Acute bleeding, including bleeding from peptic ulcers and intracranial hemorrhage;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
- Period of pregnancy and lactation;
- Age up to 18 years;
- Individual hypersensitivity to the drug.
Zilt is prescribed with caution in the following cases:
- Mild hepatic impairment;
- Diseases that increase the risk of bleeding (lung tumors, hyperfibrinolysis, ulcerative colitis, tuberculosis, gastric ulcer and duodenal ulcer during the period of exacerbation, trauma and surgery);
- Hereditary decrease in the functions of the isoenzyme CYP2C19;
- Tendency to bleed;
- Taking acetylsalicylic acid, NSAIDs (including COX-2 inhibitors), warfarin, heparin, as well as glycoprotein IIb / IIIa inhibitors.
Dosing and Administration
Zilt tablets are taken orally, regardless of the food.
For the prevention of thrombotic complications in patients with occlusion of peripheral arteries, myocardial infarction, ischemic cerebrovascular accident, Zilt is prescribed 75 mg once a day. In case of myocardial infarction, drug therapy is carried out from 1 to 35 days of the disease, with ischemic stroke, the drug is used starting from the 7th day of the disease up to 6 months after the stroke.
Patients with acute coronary syndrome in the absence of ST elevation are prescribed Zylt according to the following scheme: a single dose of a loading dose (300 mg), then 1 tablet (75 mg) per day. At the same time taking Zilta with acetylsalicylic acid (at a dosage of 75-325 mg), the recommended daily dosage of the drug is 100 mg. After three months, the maximum therapeutic effect is noted, the course of treatment is usually 12 months.
In the case of acute coronary syndrome with ST-segment elevation, Zilt is prescribed 75 mg once daily with a single initial dose of the loading dose simultaneously with acetylsalicylic acid and thrombolytic, or without it.
Zilta loading dosage is not used in patients older than 75 years. Perhaps a decrease in the effectiveness of the drug in patients who suffer from a genetically determined decrease in the function of the isoenzyme CYP2C19.
According to studies, the most frequent side effects of Zilt are bleeding, which is usually observed during the first month of treatment.
In addition, the following conditions are side effects when taking Zilta:
- Infrequently - eosinophilia, leukopenia, thrombocytopenia; seldom - neutropenia, including severe; very rarely - anemia, granulocytopenia, severe thrombocytopenia, agranulocytosis, pancytopenia, aplastic anemia, thrombotic thrombocytopenic purpura (TTP);
- Infrequently - dizziness, paresthesia, headache, intracranial hemorrhage; very rarely - confusion, hallucinations;
- Often - hematomas; very rarely - arterial hypotension, vasculitis;
- Often - diarrhea, gastrointestinal bleeding, dyspepsia, abdominal pain; infrequently - flatulence, constipation, nausea, vomiting, gastritis, gastric and duodenal ulcers; rarely, retroperitoneal hemorrhage; very rarely - acute liver failure, hepatitis, impaired liver function indicators, stomatitis, colitis, pancreatitis, retroperitoneal and gastrointestinal bleeding, sometimes fatal;
- Often - nosebleeds, very rarely - interstitial pneumonitis, bronchospasm, airway bleeding (pulmonary hemorrhage, hemoptysis);
- Often - subcutaneous hematomas; infrequently - skin hemorrhages, pruritus, rash; very rarely - lichen planus, eczema, urticaria, erythematous rash, bullous dermatitis (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
- Very rarely - myalgia, arthralgia, arthritis, hemorrhages in the joints and muscles;
- Infrequently - hematuria; very rarely - an increase in serum creatinine level, glomerulonephritis;
- Infrequently - intraocular hemorrhages; rarely - vertigo; very rarely - taste disturbances;
- Very rarely - anaphylactoid reactions, serum sickness, angioedema; sometimes a drug rash with systemic signs and eosinophilia, drug-induced hypersensitivity syndrome, cross-reactive hypersensitivity to thienopyridine;
- Often - bleeding from the puncture of the vessels; very rarely - severe bleeding from the surgical wound, fever.
A side effect when taking Zylt is a change in laboratory parameters, in particular, a decrease in the level of platelets and neutrophils, lengthening the time of bleeding.
During therapy Zilt requires strict control to prevent the occurrence of bleeding. Given the high risk of bleeding and other adverse events, if clinical signs of possible bleeding occur, a blood test and other necessary studies should be carried out immediately.
Care must be taken while taking Zilta and warfarin.
Zilt is canceled 5-7 days before the planned surgical intervention.
Patients should inform the doctor about taking this drug before any surgery, including dental, or before starting a new drug.
During Zylt therapy, it is important to monitor liver function. It is carefully prescribed to patients with impaired renal function, as well as in chronic renal failure.
Zilt does not significantly affect the ability to drive vehicles, to engage in potentially hazardous types of work that require quick psychomotor reactions and increased concentration of attention.
Analogues of the drug Zilt are the following drugs: Plavix, Troken, Agregal, Egitrombe.
Terms and conditions of storage
Zylt should be stored at a temperature not exceeding 25 ºC, in places inaccessible to sunlight. The shelf life of tablets is three years.