Description
Release form
film-coated tablets.
Packing
14 pcs.
Pharmacological action
Zilt – antiplatelet agent.
Clopidogrel prevents the binding of adenosine phosphate (ADP) to receptors located on the surface of platelets and the activation of the GP IIb / IIIa complex. This leads to inhibition of ADP-dependent platelet aggregation. This also leads to inhibition of platelet aggregation under the influence of other stimuli, the effect of ADP produced in each activated platelet is reduced, and aggregation of the remaining platelets is stimulated.
The effect of clopidogrel lasts throughout the life of the platelet, platelet function is restored 7-10 days after the cancellation of clopidogrel.
Indications
Prevention of ischemic disorders (myocardial infarction, stroke, peripheral arterial thrombosis, sudden vascular death) in patients with atherosclerosis, including after myocardial infarction (up to 35 days), ischemic stroke (from 7 days to 6 months), or against a background of diagnosed peripheral arterial occlusion diseases.
Contraindications
Hypersensitivity to clopidogrel and / or any of the components Sylt
Severe hepatic insufficiency
Hemorrhagic syndrome, acute bleeding (including intracranial hemorrhage) and diseases that predispose the intestine to the stomach ( , ulcerative colitis, tuberculosis, lung tumors, hyperfibrinolysis)
Pregnancy
Lactation
Age up to 18 years.
Special instructions
In patients with myocardial infarction, treatment with Zilt should not begin in the first few days after a heart attack. Clopidogrel prolongs bleeding time. Zilt should be prescribed with caution to patients with an increased risk of bleeding after injuries, operations or as a result of other pathological conditions, as well as to patients with a tendency to bleeding (especially gastrointestinal and intraocular hemorrhages). Clopidogrel treatment should be discontinued at least 7 days before the planned surgical intervention (including dental procedures).
Composition
Active ingredient:
Clopidogrel hydrosulfate.
Excipients:
Anhydrous lactose – 108.125 mg
MCC – 30 mg
Pregelatinized starch – 12 mg
Macrogol 6000 – 8 mg hydrogenated castor oil – 4 mg
Cellulose 6g E171) – 1.46 mg
Talc – 0.5 mg
Iron dye red oxide (E172) – 0.04 mg
Propylene glycol – 0.4 mg
Dosage and administration
Inside, regardless of food intake. The recommended dose of Zilt for adults (including elderly patients) is 75 mg / day (1 tablet).
Side effects
Adverse events rarely require discontinuation of clopidogrel treatment.
General: chest pain, trauma, flu-like symptoms, pain, fatigue, asthenia, hernia.
Central and peripheral nervous system: headache, dizziness, paresthesia, leg cramps, hypersthesia, neuralgia.
Autonomic nervous system: syncope, palpitations.
Cardiovascular system: peripheral edema, arterial hypertension, heart failure, generalized edema.
Gastrointestinal tract: abdominal pain, dyspepsia, diarrhea, nausea, constipation, vomiting, taste disturbances, perforation of gastric ulcers, hemorrhagic gastritis, bleeding from an ulcer of the upper gastrointestinal tract.
Liver and biliary tract: increased activity of liver enzymes, hyperbilirubinemia, hepatitis, liver steatosis.
Blood and blood-forming organs: thrombocytopenia, anemia (aplastic or hypochromic), agranulocytosis, leukopenia, neutropenia.
Coagulation disorders and bleeding: purpura, extravasate, epistaxis, gastrointestinal bleeding, joint hemorrhage, bleeding from the urinary tract, hemoptysis, intracranial hemorrhage, retroperitoneal hemorrhage, bleeding from postoperative wounds, eye hemorrhage, hemothorax, pulmonary hemorrhage, allergic purpura, thrombotic thrombocytopenic purpura.
Musculoskeletal system: arthralgia, back pain, arthritis, arthrosis.
Drug Interactions
Concomitant use of clopidogrel and oral anticoagulants is not recommended (increased bleeding intensity is possible).
The simultaneous use of clopidogrel and IIb / IIIa receptor blockers requires caution in patients with an increased risk of bleeding (for injuries, surgical interventions or other pathological conditions requiring the simultaneous administration of IIb / IIIa glycoprotein inhibitors).
Acetylsalicylic acid (ASA) does not affect clopidogrel-induced platelet aggregation inhibition induced by ADP, but clopidogrel potentiates the effect of ASA on collagen-induced platelet aggregation. However, the simultaneous administration of ASA in a dose of 500 mg 2 times / day. within one day does not significantly extend the bleeding time caused by clopidogrel. The pharmacodynamic interaction between clopidogrel and ASA is possible, and leads to an increased risk of bleeding. Given this, caution should be exercised while taking these drugs, although in clinical trials, patients took combination therapy with clopidogrel and ASA for one year.
According to a clinical study in healthy individuals, when taking clopidogrel, there was no need to change the dose of heparin, and also did not change the anticoagulant effect of heparin. The combined use of heparin did not affect the suppression of platelet aggregation by clopidogrel. A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to an increased risk of bleeding. Therefore, the simultaneous use of these drugs requires caution.
The safety of the simultaneous use of clopidogrel, fibrin-specific or non-specific thrombolytics and heparin has been evaluated in patients with acute myocardial infarction. The incidence of clinically significant bleeding was comparable to that with the simultaneous use of thrombolytics, heparin with ASA.
According to a clinical study involving healthy volunteers, the simultaneous use of clopidogrel and naproxen increased latent gastrointestinal bleeding. However, due to the lack of studies on interactions with other NSAIDs, it is currently unknown whether the risk of gastrointestinal bleeding increases for all NSAIDs. Therefore, simultaneous therapy of NSAIDs, including COX-2 inhibitors, and clopidogrel should be carried out with caution.
Another combination therapy: several clinical studies have been performed with clopidogrel and other concurrently used drugs to study possible pharmacodynamic and pharmacokinetic interactions.
– with the simultaneous use of clopidogrel with atenolol and / or nifedipine, no clinically significant pharmacodynamic interaction was detected
– the pharmacodynamic activity of clopidogrel did not change significantly when combined with phenobarbital, cimetidine or estrogens
– the pharmacokinetics of digoxin or theophylline did not change
– antacids do not significantly affect the degree of absorption clopidogrel. However, it is possible to inhibit the activity of cytochrome P450 with the 2C9 isoenzyme by the carboxyl metabolite of clopidogrel. Potentially, this can lead to increased plasma concentrations of drugs, such as phenytoin and tolbutamide, as well as NSAIDs that are metabolized by cytochrome P450 2C9
– in addition to the specific interactions with the drugs described above, other studies have not been conducted. However, in patients participating in clinical studies with clopidogrel and simultaneously taking diuretics, beta-blockers, ACE inhibitors, calcium antagonists, hypolipidemic agents, coronary vasodilators, hypoglycemic agents (including insulin), antiepileptic drugs and antagonists glycoprotein IIb / IIIa has not been identified clinically significant interactions.
Overdose
Symptoms: an overdose of clopidogrel can lead to an increase in bleeding time and subsequent complications in the form of bleeding.
Treatment: in order to correct the prolonged bleeding time, platelet transfusion is necessary. There is no antidote.
Storage Conditions
The product should be stored in a dry, dark place at a temperature not exceeding 20 ° C.
Deystvuyuschee substances
clopidogrel
Pharmacy terms
Prescription
Dosage form
tablet
Appointment
Vzrosl m on purpose doctor
Indications
Prevention of thromboembolism, prevention of acute myocardial infarction, prevention of thrombosis, prevention of heart attacks and strokes
Possible product names
ZILT 0,075 N14 TABLE P / O
Zilt 75mg tab. PO X14 (R)
Zilt 75mg tab p / o X14 (R) /! until 11.13g /
Zilt 75mg tab. p / o X14 (R) /! until 12.11g /
Zilt 75mg Tab. p / pl / rev X14 (R)
KRKA d.d. Novo mesto AO, Slovenia
