Plagril pills coated 75mg №30

Indications

- prevention of thrombotic complications in patients with myocardial infarction, ischemic stroke or occlusion of peripheral arteries;

- in combination with Acetylsalicylic acid for the prevention of thrombotic complications in acute coronary syndrome: with elevation of the ST segment with the possibility of thrombolytic therapy; without ST segment elevation (unstable stenocardia, myocardial infarction without Q wave formation), incl. in patients undergoing stenting.

Dosage and administration

Tablets are taken orally, regardless of the meal.

For prevention of ischemic disorders in patients after myocardial infarction, ischemic stroke, or against the background of diagnosed diseases of peripheral arteries for adults (including elderly patients)^® prescribed in a dose of 75 mg 1 time / day. Treatment should begin in terms of up to 35 days after suffering a Q-forming myocardial infarction and from 7 days to 6 months after ischemic stroke.

At acute coronary syndrome without ST segment elevation (unstable stenocardia or myocardial infarction without Q wave formation) Treatment should begin with the appointment of a single loading dose of 300 mg, then continue to use the drug at a dose of 75 mg 1 time / day (while taking 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.

At acute coronary syndrome with ST-segment elevation (acute myocardial infarction) the drug is prescribed at a dose of 75 mg 1 time / day using an initial loading dose in combination with acetylsalicylic acid, with or without a combination of thrombolytics.

For patients over the age of 75 treatment with Clopidogrel should be administered without the use of a loading dose. Combination therapy starts as soon as possible after the onset of symptoms and continues for at least 4 weeks.

Adverse effects

Determination of the frequency of side effects: often (> 1%), sometimes (0.1-1%), rarely (0.01-0.1%), very rarely (<001%).

From the blood coagulation system: often - Gastrointestinal bleeding; sometimes - hemorrhagic stroke, prolonged bleeding time, nosebleeds; rarely, hematomas, hematuria, and conjunctival bleeding.

From the hemopoietic system: sometimes - thrombocytopenia, neutropenia, leukopenia, eosinophilia; very rarely - thrombocytopenic purpura, granulocytopenia, agranulocytosis, anemia and aplastic anemia.

From the side of the central nervous system and peripheral nervous system: sometimes - headache, dizziness, paresthesia; rarely - vertigo; very rarely - confusion, hallucinations.

Since the cardiovascular system: very rarely - vasculitis, lowering blood pressure.

On the part of the respiratory system: very rarely - bronchospasm, interstitial pneumonitis.

From the digestive system: often - dyspepsia, diarrhea, abdominal pain; sometimes nausea, gastritis, flatulence, constipation, vomiting, ulceration of the mucous membrane of the gastrointestinal tract, exacerbation of gastric ulcer and duodenal ulcer; very rarely - colitis (including ulcerative or lymphocytic colitis), pancreatitis, 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: very rarely - glomerulonephritis.

Dermatological reactions: sometimes itching; 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 rarely - an increase in body temperature, an increase in serum creatinine.

Contraindications

- severe liver failure;

- hemorrhagic syndrome;

- acute bleeding (including intracranial hemorrhage) and diseases predisposing to its development (peptic ulcer of the stomach and duodenum in the acute phase, UC, tuberculosis, lung tumors, hyperfibrinolysis);

- pregnancy

- lactation period (breastfeeding);

- children's age up to 18 years;

- hypersensitivity to the drug.

WITH caution the drug should be used for moderate hepatic and / or renal failure, injuries, conditions that increase the risk of bleeding (including trauma, surgery), while taking acetylsalicylic acid and other NSAIDs (including COX-2 inhibitors), Heparin and inhibitors glycoprotein IIb / IIIa.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of the liver

WITH caution the drug should be used for moderate liver failure.

For severe violations of liver function, you should remember the risk of hemorrhagic diathesis.

Application for violations of kidney function

WITH caution the drug should be used for moderate renal failure

Use in children

Contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

For patients over the age of 75 treatment with clopidogrel should be administered without the use of a loading dose. Combination therapy starts as soon as possible after the onset of symptoms and continues for at least 4 weeks.

Special notes

In the case of surgical interventions, if the antiplatelet effect is undesirable, the treatment should be stopped 7 days before the operation.

Patients should be warned that since stopping the bleeding arising from the use of the drug requires more time, they should inform the doctor about each case of unusual bleeding. Patients should also inform the doctor about taking the drug if they are to undergo surgery or if the doctor prescribes a new drug for the patient.

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

For severe violations of liver function, you should remember the risk of hemorrhagic diathesis.

Use in pediatrics

The drug is not prescribed children under the age of 18 due to the fact that safety and effectiveness of its use in this age group have not been established.

Influence on ability to drive motor transport and control mechanisms

There were no signs of deterioration of the ability to drive a car or decrease mental performance after taking Plagril.

Overdosage

Symptoms: with a single oral administration by healthy people, 600 mg of clopidogrel (8 tab. 75 mg each), no side effects were noted. The bleeding time was extended by 1.7 times, which corresponds to the value recorded after taking the therapeutic dose (75 mg / day).

Treatment: platelet transfusion. The specific antidote is absent.

Drug interaction

With the simultaneous use of Plagril^® enhances the antiplatelet effect of acetylsalicylic acid, heparin, indirect anticoagulants, NSAIDs, increases the risk of bleeding from the gastrointestinal tract.

By inhibiting CYP2C9 activity, clopidogrel increases the concentration of drugs metabolized by this isoenzyme (phenytoin, tolbutamide).

No clinically significant pharmacodynamic interactions were observed with the use of clopidogrel together with Atenolol, Nifedipine, phenobarbital, cimetidine, estrogen, Digoxin, theophylline, tolbutamide, antacid agents.

Terms and conditions of storage

The drug should be stored in a dry, protected from light, out of reach of children at a temperature not exceeding 25 ° C.