Lopirel pills 75mg №100

Release form

Coated Tablets

Active ingredient

1 pill contains Clopidogrel hydrogensulfate 97.87 mg, corresponding to 75 mg of clopidogrel base.
Excipients: lactose, microcrystalline cellulose, crospovidone (type A), glyceryl dibehenate, talc, Opadry II 85 G34669 pink (polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (E322), iron dye red oxide (E172).

Packaging

100 pieces.

Pharmacology

Lopirel has anti-aggregation effect.

Indications

Prevention of atherothrombosis:
- in patients undergoing myocardial infarction, ischemic stroke, or diagnosed with peripheral artery disease;
- in patients with acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without Q wave on the ECG), in combination with Acetylsalicylic acid.

Contraindications

Hypersensitivity, hemorrhagic syndrome, acute bleeding, intracranial hemorrhage and diseases predisposing to their development (gastric ulcer and duodenal ulcer in the acute stage, ulcerative colitis, tuberculosis, lung tumors, hyperfibrinolysis), severe hepatic failure; for dosage forms containing lactose (optional): hereditary intolerance to galactose, lactase deficiency and glucose-galactose malabsorption syndrome.

Pregnanacy and breastfeeding

Contraindicated in pregnancy and lactation.

Dosage and administration

Lopirel take orally. In case of myocardial infarction, ischemic stroke or occlusion of peripheral arteries - 75 mg 1 time per day, regardless of the meal. Treatment should begin in terms from several 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, myocardial infarction without Q wave) - start with a single dose of the 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 1 time per day with an initial single dose of a loading dose in combination with acetylsalicylic acid and thrombolytics (or without thrombolytics). Combination therapy begins as soon as possible after the onset of symptoms and continues for at least 4 weeks.
In patients older than 75 years, treatment with clopidogrel should begin without a loading dose.

Adverse effects

From the nervous system and sensory organs: fatigue, asthenia, headache, dizziness, paresthesia, leg cramps, hyperesthesia, neuralgia, cataracts, conjunctivitis.
Since the cardiovascular system and blood (hematopoiesis, hemostasis): peripheral edema, arterial hypertension, heart failure, generalized edema, syncope, palpitations, thrombocytopenia, anemia (aplastic or hypochromic), agranulocytosis, leukopenia, neutropenia.
Coagulation and bleeding thrombohemolytic purpura.
On the part of the digestive tract: abdominal pain, dyspepsia, diarrhea, nausea, vomiting, constipation, taste disturbance, perforation of gastric ulcers, hemorrhagic gastritis, bleeding from ulcers of the upper GI tract, increased activity of liver enzymes, hyperbilirubinemia, hepatitis, hepatic steatosis.
Musculoskeletal system: arthralgia, back pain, arthritis, arthrosis.
Respiratory: 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, trauma, flu-like symptoms, pain.Individual cases of hemolytic uremic syndrome, membranous nephropathy and hypersensitivity reactions (angioedema, bronchospasm, anaphylactic reactions) have been reported.

Special notes

In patients with acute myocardial infarction with ST-segment elevation, treatment with clopidogrel should not be initiated 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 drug treatment, it is necessary to immediately conduct a clinical analysis of blood (APTT, platelet count, tests of the functional activity of platelets) and functional activity of the liver.
Like other antithrombotic drugs, clopidogrel should be used with caution in patients with an increased risk of bleeding due to trauma, surgical interventions or pathological conditions, as well as in the case of the combined use of clopidogrel with acetylsalicylic acid, NSAIDs, Heparin, glycoprotein IIb / IIIa inhibitors or thrombolytics. Severe cases of bleeding were noted in patients taking clopidogrel simultaneously with acetylsalicylic acid or with acetylsalicylic acid and heparin.
In the case of surgical interventions, if the antiplatelet effect is undesirable, treatment with clopidogrel should be stopped 7 days before the operation.
Patients should be warned that they should inform the doctor about each case of bleeding. Careful monitoring of the condition of patients is necessary to detect signs of bleeding, including hidden bleeding, especially during the first weeks of treatment and / or after invasive cardiac procedures or surgery.
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 stopping the bleeding that occurs on the background (both as monotherapy and in combination with acetylsalicylic acid) takes a long time, they should inform the doctor about each unusual case (in terms of location and / or duration). a) bleeding. Patients should also inform the doctor and dentist about taking the drug if they are to undergo surgery or if the doctor prescribes a new drug for the patient.

Drug interactions

Warfarin. The combined use of clopidogrel with Warfarin is not recommended, since such a combination may increase the intensity of bleeding.
Glycoprotein IIb / IIIa inhibitors. The prescription of glycoprotein IIb / IIIa inhibitors together with clopidogrel requires caution.
Acetylsalicylic acid.Acetylsalicylic acid does not alter the inhibitory effect of clopidogrel on ADP-induced platelet aggregation, but clopidogrel potentiates the effect of acetylsalicylic acid on platelet aggregation induced by collagen.However, the simultaneous use of acetylsalicylic acid in a dose of 500 mg 2 times a day did not cause any significant increase in bleeding time, extended due to the use of 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 clinical trials 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, but the safety of this combination has not yet been established and the simultaneous use of these drugs requires caution.
Thrombolytic agents.The safety of simultaneous use of clopidogrel with thrombolytics is not currently established, therefore 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 hidden Gastrointestinal bleeding. However, due to the lack of testing the interaction of the drug with other NSAIDs is not currently established whether there is an increased risk of gastrointestinal bleeding when using other drugs in this group.Thus, the combined use of NSAIDs and clopidogrel requires caution.
Other combinations of drugs.Clinically significant pharmacodynamic interaction with the use of clopidogrel together with Atenolol and / or Nifedipine was not detected. The pharmacodynamic activity of Lopirel is almost unchanged when used simultaneously with phenobarbital, cimetidine or estrogen. The pharmacokinetic properties of Digoxin or theophylline do not change when combined with clopidogrel. Antacid agents do not alter the absorption of clopidogrel.
The data obtained in the course of research with human liver microsomes indicate that clopidogrel can inhibit the activity of one of the enzymes of cytochrome P450 (CYP 2C9). As a result, the level of certain drugs, such as phenytoin and tolbutamide, may be elevated in the blood plasma, since they are metabolized by CYP 2С9. The results of the study CAPRIE indicate the safety of phenytoin and tolbutamide together with clopidogrel.

Overdose

May indicate an increase in bleeding time. There is no specific antidote. If rapid correction of increased bleeding time is necessary, the effect of clopidogrel can be eliminated by platelet transfusions.

Storage conditions

At a temperature not higher than 30 ° C.