Description
Release form
Coated tablets.
Packing
28 pcs.
Pharmacological action
Lopirel has an antiplatelet effect.
Indications
Prevention of atherothrombosis: – in patients who have had myocardial infarction, ischemic stroke, or with diagnosed peripheral artery disease
– in patients with acute coronary syndrome without ST segment elevation (unstable angina or cardiomyocardial infarction, myocardial infarction) combinations with acetylsalicylic acid.
Contraindications
Hypersensitivity, hemorrhagic syndrome, acute bleeding, intracranial hemorrhage and diseases predisposing to their development (peptic ulcer and duodenal ulcer in the acute stage, ulcerative colitis, tuberculosis, pulmonary tuberculosis, liver tumors) containing lactose (optional): hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Special instructions
In patients with acute myocardial infarction with an increase in the ST segment, treatment with clopidogrel should not be started during the first few days after myocardial infarction. Due to the lack of clinical data, clopidogrel is not recommended for use with. acute ischemic stroke (less than 7 days). With the development of bleeding during treatment with the drug, it is necessary to immediately conduct a clinical blood test (APTT, platelet count, platelet functional activity tests) and liver functional activity.
Like other antithrombotic drugs, clopidogrel should be used with caution in patients with an increased risk of bleeding due to trauma, surgery or pathological conditions, as well as in the case of combined use of clopidogrel with acetylsalicylic acid, NSAIDs, heparin, IIb / IIIa glycoprotein inhibitors or thrombolytics. Severe cases of bleeding were noted in patients taking clopidogrel simultaneously with acetylsalicylic acid or with acetylsalicylic acid and heparin.
In case of surgical interventions, if an antiplatelet effect is undesirable, the course of treatment with clopidogrel should be discontinued 7 days before surgery.
Patients should be warned that they should inform the doctor about each case of bleeding. Careful monitoring of the patient’s condition is necessary to detect signs of bleeding, including hidden bleeding, especially during the first weeks of treatment and / or after invasive cardiological procedures or surgical intervention.
Clopidogrel increases bleeding time and should be used with caution in patients at risk of bleeding (especially gastrointestinal and intraocular). Patients should be warned that since it takes a long time to stop the bleeding that occurs during use (both as monotherapy and in combination with acetylsalicylic acid), they must inform the doctor about each case of unusual (in terms of location and / or duration ) bleeding. Patients should also inform the doctor and dentist about taking the drug if they have surgery or if the doctor prescribes a new drug for the patient.
Composition
1 tablet contains clopidogrel hydrosulfate 97.87 mg, corresponding to 75 mg of clopidogrel base.
Excipients: lactose, microcrystalline cellulose, crospovidone (type A), glyceryl dibehenate, talc, Opadray II 85 G34669 pink (polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (E322, dye iron oxide red (E172)).
Dosage and administration of
Lopirel is taken orally. With myocardial infarction, ischemic stroke or occlusion of peripheral arteries – 75 mg once a day, regardless of food intake. Treatment should be started from a few days to 35 days in patients after myocardial infarction and from 7 days to 6 months in patients after ischemic stroke.
In acute coronary syndrome without ST segment elevation (unstable angina pectoris, myocardial infarction without Q wave) – start with a single loading dose (300 mg), then 75 mg once a day (in combination with acetylsalicylic acid). The maximum beneficial effect occurs after 3 months of treatment. The course of treatment is up to 1 year.
In acute coronary syndrome with ST segment elevation (acute myocardial infarction) – 75 mg once daily with an initial single dose of a loading dose in combination with acetylsalicylic acid and thrombolytics (or without thrombolytics). Combination therapy is started as soon as possible after the onset of symptoms and continues for at least 4 weeks.
In patients older than 75 years of age, treatment with clopidogrel should begin without a loading dose.
Side effects of
From the nervous system and sensory organs: fatigue, asthenia, headache, dizziness, paresthesia, leg cramps, hyperesthesia, neuralgia, cataract, conjunctivitis.
From the cardiovascular system and blood (hematopoiesis, hemostasis): peripheral edema, arterial hypertension, heart failure, generalized edema, syncope, palpitations, thrombocytopenia, anemia (aplastic or hypochromic), agranulocytosis, leukopenia,.
Coagulation disorders and bleeding: purpura, extravasate, epistaxis, gastrointestinal bleeding, joint hemorrhage, urinary tract bleeding, hemoptysis, intracranial hemorrhage, retroperitoneal hemorrhage, surgical wound bleeding, intraocular hemorrhage, hemothorax, pulmonary hemorrhage, allergic purpura, thrombocytopenic thrombohemolytic purpura.
From the digestive tract: abdominal pain, dyspepsia, diarrhea, nausea, vomiting, constipation, taste disturbance, perforation of a stomach ulcer, hemorrhagic gastritis, bleeding from an ulcer of the upper gastrointestinal tract, increased activity of liver enzymes, hyperbilirubinemia, hepatitis, liver steatosis.
From the musculoskeletal system: arthralgia, back pain, arthritis, arthrosis.
From the respiratory system: inflammation of the upper respiratory tract, shortness of breath, rhinitis, bronchitis, cough, pneumonia, sinusitis.
From the genitourinary system: urinary tract infections, cystitis, menorrhagia.
From the skin: rash, itching, eczema, skin ulceration, bullous dermatitis, erythematous rash, maculopapular rash, urticaria.
Other: chest pain, injury, flu-like symptoms, pain. Isolated cases of hemolytic uremic syndrome, membranous nephropathy and hypersensitivity reactions (angioedema, bronchospasm, anaphylactic reactions) have been reported.
Drug Interactions
Warfarin. The combined use of clopidogrel with warfarin is not recommended, since such a combination can increase the intensity of bleeding.
Inhibitors of glycoprotein IIb / IIIa. The administration of glycoprotein IIb / IIIa inhibitors together with clopidogrel requires caution.
Acetylsalicylic acid. Acetylsalicylic acid does not change the inhibitory effect of clopidogrel on ADP-induced platelet aggregation, however, clopidogrel potentiates the effect of acetylsalicylic acid on platelet aggregation induced by collagen. However, the simultaneous use of acetylsalicylic acid at a dose of 500 mg 2 times a day did not cause any significant increase in bleeding time, prolonged due to clopidogrel. The safety of long-term simultaneous use of acetylsalicylic acid and clopidogrel has not been established, however, clopidogrel and acetylsalicylic acid can be used simultaneously for up to one year.
heparin. According to a clinical trial conducted on healthy volunteers, the simultaneous use of clopidogrel and heparin does not require dose adjustment of the latter and does not affect the antiplatelet effect of clopidogrel, however, the safety of such a combination has not yet been established and the simultaneous use of these drugs requires caution.
Thrombolytic agents. The safety of the simultaneous use of clopidogrel with thrombolytics has not yet been established, so the simultaneous use of these drugs requires caution.
Nonsteroidal anti-inflammatory drugs (NSAIDs). In a clinical trial conducted with healthy volunteers, the combined use of clopidogrel and naproxen increased the number of latent gastrointestinal bleeding. However, due to the lack of trials of the drug s interaction with other NSAIDs, it has not yet been established whether there is an increased risk of gastrointestinal bleeding when using other drugs of this group. Thus, the combined use of NSAIDs and clopidogrel requires caution.
Other drug combinations. Clinically significant pharmacodynamic interactions with the use of clopidogrel together with atenolol and / or nifedipine have not been identified. The pharmacodynamic activity of LOPIRELA practically does not change with simultaneous use with phenobarbital, cimetidine or estrogens. The pharmacokinetic properties of digoxin or theophylline do not change when combined with clopidogrel. Antacids do not alter the absorption of clopidogrel.
Data from studies with human liver microsomes indicate that clopidogrel can inhibit the activity of one of the cytochrome P450 enzymes (CYP 2C9). As a result, the level of certain drugs, such as phenytoin and tolbutamide, can be increased in blood plasma, since they are metabolized by CYP 2C9. The results of the CAPRIE study indicate the safety of phenytoin and tolbutamide in combination with clopidogrel.
Overdose
May indicate an increase in bleeding time. There is no specific antidote. If rapid correction of increased bleeding time is required, the effect of clopidogrel may be eliminated by transfusion of platelet mass.
Storage conditions
At a temperature not exceeding 30 ° C.
Shelf life
3 years.
Deystvuyushtee substance
Clopidogrel
Dosage form
tablets
Prescribing
Nazna reading
Adults as prescribed by a doctor
actavis Co., Ltd., Iceland
