Clopidogrel pills 75mg, 14pcs

Composition

1 tablet contains clopidogrel hydrosulfate 97.875 mg, based on clopidogrel-75 mg;

excipients:

pregelatinized starch.

lactose anhydrous (anhydrous milk sugar),

macrogol (polyethylene glycol 6000).

magnesium stearate.

microcrystalline cellulose (PH 112),

hydrogenated castor oil;

composition of the film shell:

Selekout AQ-01673 (hypromellose (hydroxypropylmethylcellulose), macrogol (polyethylene glycol 400), macrogol (polyethylene glycol 6000), titanium dioxide, aluminum varnish based on Ponso dye 4 R).

Pharmacological action

Clopidogrel is a specific and active inhibitor of platelet aggregation; it has a coronary dilating effect.

Selectively reduces ADP binding to platelet receptors and activation of GPI Ib/IIIa receptors by ADP. by reducing platelet aggregation. Reduces platelet aggregation caused by other agonists, preventing their activation by released ADP, does not affect the activity of phosphodiesterase (PDE).

It 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 use (40% inhibition) of the initial dose of 400 mg.

The maximum effect (60% suppression of aggregation) develops after 4-7 days of continuous use of a dose of 50-100 mg / day. The antiplatelet effect persists for the entire period of platelet life (7-10 days).

If there is 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 a few days to 35 days), ischaemic stroke (from 6 days to 6 months) or when diagnosed with the disease of the peripheral arteries
• in acute coronary syndrome without ST-segment elevation (unstable angina or myocardial infarction without pathological Q-wave), including patients undergoing surgery for percutaneous coronary bypass surgery, in combination with acetylsalicylic acid;
• in acute coronary syndrome with ST-segment elevation (acute myocardial infarction) in combination with acetylsalicylic acid in patients receiving medication with possible use of thrombolytic therapy.

Contraindications

• severe hepatic insufficiency;
• acute bleeding (for example, with peptic ulcer or intracranial hemorrhage);
• pregnancy;
• breast-feeding period;
• age up to 18 years (safety and efficacy of the drug have not been established);
• hypersensitivity to the components of the drug. With caution, the drug should be prescribed for liver and kidney diseases (including moderate hepatic and/or renal failure), injuries, and preoperative conditions.

Side effects

Frequency: 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.

Hematopoietic disorders: infrequently-thrombocytopenia, leukopenia, eosinophilia; rarely-neutropepia, including severe; very rarely-thrombotic thrombocytopenic purpura, anemia including aplastic, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia.

Allergic reactions: very rarely-anaphylactic reactions, serum sickness.

From the nervous system: infrequently-headache, dizziness, paresthesia, intracranial bleeding, including with a fatal outcome; very rarely-confusion, hallucinations, taste disorders.

From the sensory organs: infrequently – hemorrhage in the conjunctiva, eyes, retina; rarely-vertigo.

From the cardiovascular system: often-hematoma; very rarely-severe bleeding, bleeding from the surgical wound, vasculitis, decreased 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, constipation, flatulence; rarely-retroperitoneal bleeding; very rarely – pancreatitis, colitis, including ulcerative or lymphocytic, stomatitis, acute liver failure, hepatitis, impaired liver function tests, bleeding from the liver Gastrointestinal tract with a fatal outcome.

From the skin: often-subcutaneous hemorrhage; infrequently-skin rash, pruritus, purpura; very rarely-angioedema, urticaria, erythematous rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, lichen planus.

Musculoskeletal disorders: very rare – hemarthrosis, arthritis, arthralgia, myalgia.

From the genitourinary system: infrequently-hematuria; very rarely-glomerulonephritis, hypercreatininemia. Local reactions: often-bleeding at the injection site.

Laboratory parameters: infrequently-prolongation of bleeding time.

Other: very rare – fever.

Interaction

Concomitant use of clopidogrel with warfarin is not recommended, as this combination may increase the intensity of bleeding.

The use of glycoprotein IIb/IIIa inhibitors in combination with clopidogrel increases the risk of bleeding.

The use of nonsteroidal anti-inflammatory drugs in combination with clopidogrel increases the risk of bleeding. Concomitant use of clopidogrel with CYP2C19 inhibitors (e. g. omeprazole) is not recommended.

There was no clinically significant pharmacodynamic interaction when using clopidogrel together with atenolol, nifedipine, phenobarbital, cimetidine, estrogens, digoxin, theophylline, tolbutamide, antacids.

How to take, course of use and dosage

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 within a few days to 35 days after a myocardial infarction and from 7 days to 6 months after an ischemic stroke.

Non-ST-segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) treatment should begin with a single loading dose of 300 mg, and then continue using the drug at a dose of 75 mg 1 time/day (with simultaneous use of acetylsalicylic acid at a 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 exceed 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 an initial loading dose in combination with acetylsalicylic acid in combination or without thrombolytics.

For patients over 75 years of age, treatment with clopidogrel should be performed without the use of a loading dose. Combination therapy should be initiated as early as possible after the onset of symptoms and continued for a minimum of 4 weeks.

Overdose

Symptoms:  prolongation of bleeding time and subsequent complications.

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

Special instructions

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

Clopidogrel should be used with caution in patients at risk of severe bleeding from trauma, surgery; patients receiving acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors), heparin or glycoprotein IIb/IIIa inhibitors. Patients should be closely monitored for any signs of bleeding, including latent bleeding, especially during the first weeks of use of the drug and/or after invasive heart procedures or surgical operations. In case of planned surgical interventions, the course of treatment with clopidogrel should be discontinued 7 days before the operation.

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) have been reported after taking clopidogrel. This condition was characterized by thrombocytopenia and microangiopathic hemolytic anemia in combination with neurological symptoms, impaired renal function, or fever. The development of TTP is life-threatening 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 administered with caution in patients with impaired renal function.

Clopidogrel should be administered with caution in patients with moderate hepatic impairment who may have hemorrhagic diathesis.

Patients with congenital galactose intolerance, glucose-galactase malabsorption syndrome, and lactase deficiency should not take clopidogrel.

Form of production

Film-coated tablets.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Clopidogrel

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Adults as prescribed by a doctor

Indications

Angina, Prevention of acute myocardial infarction, Prevention of thromboembolism, Prevention of heart attacks and strokes, Prevention of thrombosis