Clopidogrel tablets are coated. 75 mg 28 pcs. (clopidogrel)

release form s rdlkp film-coated tablets

Packing

28 pcs

Pharmacological action

Clopidogrel - a specific and active inhibitor of platelet aggregation has a coronary dilating effect. Selectively reduces the binding of ADP to platelet receptors and activation of GPI Ib / IIIa receptors by ADP. weakening platelet aggregation.

Reduces platelet aggregation caused by other agonists, preventing their activation by released ADP, does not affect the activity of phosphodiesterase (PDE). Irreversibly binds to platelet ADP receptors, which remain immune to ADP stimulation throughout the life cycle (about 7 days). Inhibition of platelet aggregation is observed 2 hours after ingestion (40% inhibition) of an initial dose of 400 mg. The maximum effect (60% inhibition of aggregation) develops after 4–7 days of continuous administration of a dose of 50–100 mg / day. The antiplatelet effect lasts the entire period of platelet life (7-10 days).

In the presence of an atherosclerotic lesion of the vessel, it prevents the development of atherothrombosis regardless of the localization of the vascular process (cerebrovascular, cardiovascular or peripheral lesions).

Indications

Prevention of thrombotic complications:

after myocardial infarction (from several days to 35 days), ischemic stroke (from 6 days to 6 months) or diagnosed with peripheral artery disease

in acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without pathological Q wave), including patients undergoing percutaneous coronary artery bypass surgery, in combination with with

acetylsalicylic acid in acute coronary syndrome with ST segment elevation (acute myocardial infarction) in combination with acetylsalicylic acid in patients receiving drug treatment with the possible use of thrombolytic therapy.

Contraindications

severe liver failure

acute bleeding (for example, with peptic ulcer or intracranial hemorrhage)

pregnancy

breastfeeding period

age up to 18 years (safety and efficacy of the component have not been established). With caution, the drug should be prescribed for diseases of the liver and kidneys (including with moderate hepatic and / or renal failure), injuries, preoperative conditions.

Special instructions

During the treatment period, it is necessary to monitor the hemostatic system parameters (activated partial thromboplastin time (APTT), platelet count, platelet functional activity tests) regularly examine the functional activity of the liver.

Clopidogrel should be used with caution in patients at risk of severe bleeding from trauma, surgical intervention of patients receiving acetylsalicylic acid, non-steroidal anti-inflammatory drugs (including COX-2 inhibitors), heparin, or IIb / IIIa glycoprotein inhibitors. Careful monitoring of patients is necessary to detect any signs of bleeding, including hidden, especially during the first weeks of using the drug and / or after invasive heart procedures or surgeries. With planned surgical interventions, treatment with clopidogrel should be discontinued 7 days before surgery.

Patients should be warned that stopping the bleeding will take longer than usual, so they should inform the doctor about each case of bleeding.

Rare cases of thrombotic thrombocytopenic purpura (TTP) after clopidogrel have been reported. This condition was characterized by thrombocytopenia and microangiopathic hemolytic anemia in combination with neurological symptoms, impaired renal function, or fever. The development of TTP poses a threat to life and requires urgent measures, including plasmapheresis. Due to insufficient data, clopidogrel should not be prescribed in the acute period of ischemic stroke (in the first 7 days). The drug should be prescribed with caution in patients with impaired renal function.

Clopidogrel should be used with caution in patients with moderate hepatic impairment in whom hemorrhagic diathesis may occur.

Clopidogrel should not be taken in patients with congenital galactose intolerance, glucose-galactase malabsorption syndrome and lactase deficiency.

Composition

1 tablet contains clopidogrel hydrosulfate 97.875 mg, in terms of clopidogrel - 75 mg

excipients:

pregelatinized starch.

anhydrous lactose (anhydrous milk sugar), macrogol (polyethylene glycol 6000).

magnesium stearate.

microcrystalline cellulose (PH 112),

hydrogenated castor oil

film coating composition:

Selekout AQ-01673 (hypromellose (hydroxypropyl methylcellulose),

macrogol (polyethylene glycol 400), golgolgoldolgdolgdolgdolgdr Ponceau dye 4 R).

Dosage and Administration

Clopidogrel is taken orally, regardless of food intake.

For the prevention of ischemic disorders in patients after myocardial infarction, ischemic stroke and diagnosed peripheral artery disease - 75 mg 1 time / day. Treatment should begin in the period from a few days to 35 days after myocardial infarction and from 7 days to 6 months after an ischemic stroke.

In acute coronary syndrome without ST-segment elevation (unstable angina or myocardial infarction without Q wave), treatment should be started with a single loading dose of 300 mg, and then continue to use the drug at a dose of 75 mg 1 time / day (with the simultaneous administration of acetylsalicylic acid in dose of 75-325 mg / day). Since the use of acetylsalicylic acid in high doses is associated with a high risk of bleeding, the recommended dose should not be higher than 100 mg. The course of treatment is up to 1 year.

In acute myocardial infarction with ST segment elevation, the drug is prescribed at a dose of 75 mg 1 time / day using the initial loading dose in combination with acetylsalicylic acid with or without thrombolytics. For patients over the age of 75 years, treatment with clopidogrel should be carried out without the use of a loading dose. Combination therapy is started as soon as possible after the onset of symptoms and continues for at least 4 weeks.

Side effects

The frequency of side effects is determined according to the following criteria:

very often - more than 1/10,

often - more than 1/100 and less than 1/10,

infrequently - more than 1/1000 and less than 1/100,

rarely - more than 1/10000 and less than 1/1000,

very rarely - less than 1/10000, including isolated cases,

From the blood coagulation system: often bleeding (in most cases, during the first month of treatment), purpura, hematomas infrequently - conjunctive bleeding rarely - intracranial bleeding, prolonged bleeding time, leukopenia, a decrease in the number of neutrophils and eosinophilia, a decrease in the number of platelets.

From the hemopoietic system: very rarely - thrombocytopenic thrombohemolytic purpura, severe thrombocytopenia (platelet count <30,000 / μl), granulocytopenia, agranulocytosis, anemia, including aplastic anemia, pancytopenia.

From the nervous system: infrequently - headache, dizziness, paresthesia rarely - vertigo very rarely - confusion, hallucinations.

From the cardiovascular system: often - hematoma is very rare - heavy bleeding, bleeding from an operating wound, vasculitis, lowering blood pressure.

From the respiratory system: very often - nosebleeds very rarely - bronchospasm, interstitial pneumonitis, pulmonary hemorrhage, hemoptysis.

From the digestive system: often - diarrhea, abdominal pain, dyspepsia, bleeding from the gastrointestinal tract infrequently - stomach and duodenal ulcer, gastritis, vomiting, nausea, flatulence, constipation rarely - retroperitoneal bleeding very rarely - pricks (including ulcerative or lymphocytic), pancreatitis, a change in taste, stomatitis, hepatitis, acute liver failure, increased activity of liver enzymes,

From the musculoskeletal system: very rarely - arthralgia, arthritis, myalgia.

From the urinary system: infrequently - hematuria is very rare - glomerulonephritis, hypercreatininemia.

Dermatological reactions: very rarely - bullous rash (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), erythematous rash, eczema, lichen planus.

Allergic reactions: very rarely - angioedema, urticaria, anaphylactoid reactions, serum sickness.

Other: very rare - fever.

Drug interaction

The combined use of clopidogrel with warfarin is not recommended, since such a combination can increase the intensity of bleeding.

Prescribing glycoprotein IIb / IIIa inhibitors together with clopidogrel increases the risk of bleeding.

The use of non-steroidal anti-inflammatory drugs in conjunction with clopidogrel increases the risk of bleeding.

Concomitant use of clopidogrel with CYP2C19 inhibitors (e.g. omeprazole) is not recommended.

No clinically significant pharmacodynamic interaction was observed with clopidogrel combined with atenolol, nifedipine, phenobarbital, cimetidine, estrogen, digoxin, theophylline, tolbutamide, antacids.

Overdose

Symptoms: prolonged bleeding time and subsequent complications.

Treatment: If bleeding occurs, appropriate therapy should be performed. If rapid correction of prolonged bleeding time is required, platelet transfusion is recommended. There is no specific antidote.

Storage conditions

Do not store above 25 ° C. Keep out of the reach and sight of children.

Shelf life

2 years.

Active ingredient

Clopidogrel

Prescription conditions from

pharmacies Prescription

dosage form

tablets

Indications

Indications

Angina, Stroke Prevention, prevention of thromboembolism, prevention of acute myocardial infarction, prevention of thrombosis

Canonfarmafonf194191919191919191919191919191919191919191919191919 . Russia



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