Plagril tabs 75mg #30

Plagril user manual

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Composition

One tablet coated with a film coating contains 97.875 mg of the active compound - clopidogrel hydrogensulfate, which is equivalent to 75 mg of clopidogrel.
As auxiliary inactive substances used: MCC, mannitol, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate.
The film sheath is 13.475 mg of Opadry 03B54202 in pink, which consists of hypromellose 62.5%, titanium dioxide 30.6%, 6.25% macrogel 400, and 0.65% iron dye red oxide.

Form of issue

Plagril is available in round biconvex shaped tablets. They are covered with a pink film shell, they have an embossing "C 127" on one side.
The drug is produced in blisters for 10 tablets. In 1 cardboard bundle there may be 3 or 10 blisters.

pharmachologic effect

Antiaggregational, coronarodulatory.

Pharmacodynamics and pharmacokinetics

Active substance Plagril - clopidogrel hydro sulfate is a specific inhibitor of platelet aggregation. Due to the selective decrease in the binding of ADP to receptors located on platelets and activation of the receptors GPIIb and IIIa weakens the actual platelet aggregation.
The drug is characterized by high absorption and bioavailability. The concentration in the plasma after 2 hours does not reach the standard measurement limit of 0.025 μg / l. Metabolism occurs in the liver. The half-life of the metabolite, an inactive carboxylic acid derivative after repeated doses after 1 hour, reaches a maximum concentration of 3 mg per 1 liter. The excretion occurs by the kidneys approximately by 50%, through the intestine somewhat less - 46%, with the period after a single and repeated application - 8 hours.

Indications for use

The drug is often prescribed as a preventive agent of such conditions and diseases:
    thrombotic complications after myocardial infarction (MI), ischemic stroke, occlusion of peripheral arteries;
    thrombotic complications in the acute form of coronary syndrome accompanied by an ST-elevation of the ST and admissibility of thrombolytic therapy, with unstable angina, a non-Q wave infarction, including after stenting.

Contraindications

    individual intolerance to the components of the drug;
    severe forms of liver failure;
    hemorrhagic syndrome, acute hemorrhages, intracranial hemorrhages, diseases leading to their development, for example peptic ulcer of the stomach and duodenum during periods of exacerbation, tuberculosis, swelling of the lungs;
    pregnancy and the period of breastfeeding;
    age group - up to 18 years.
It is recommended to use caution if:
    hepatic or renal insufficiency is diagnosed;
    injuries or a condition with an increased risk of bleeding, postoperative period were transferred;
    when used simultaneously with cyclooxygenase-2 inhibitors, glycoprotein receptors (integrin IIb-IIIa), and also with heparin.

Side effects

On the part of various organs and systems of the human body, the following adverse reactions can occur:
    The system of hematopoiesis: infrequent cases of thrombocytopenia, in addition, the development of neutropenia, leukopenia, eosinophilia, more rarely thrombocytopenic purpura, granulocytopenia, agranulocytosis, anemia.
    Blood clots: gastrointestinal, nasal bleeding, lengthening of their time, hemorrhagic stroke, more rare cases of hematuria, conjunctival hemorrhages, hematomas.
    Nervous system: headaches, dizziness and paresthesia were infrequent, cases of vertigo, confusion and hallucinations were rare.
    Cardiovascular: vasculitis, lowering of blood pressure.
    Respiratory system: bronchospasm, interstitial pneumonia.
    Digestive system: more than 1% of the patients studied had indigestion, diarrhea, and abdominal pain. To a lesser extent, side effects such as nausea, development of gastritis, flatulence, constipation or vomiting, ulceration of the gastrointestinal mucosa, exacerbation of stomach ulcers and duodenal ulcer, as well as cases of colitis ulcerative or lymphocytic, pancreatitis, changes in taste sensations, acute liver failure or increased activity of its enzymes, inflammations such as stomatitis, hepatitis.
    Musculoskeletal system: arthralgia, arthritis or myalgia.
    Urinary system: glomerulonephritis.
    Skin: pruritus, bullous or erythematous rash, erythema, toxic necrolysis, eczema, flat lichen, Stevens-Johnson syndrome.
    Immune system: angioedema, anaphylactoid reactions, urticaria, serum sickness.
    Among other adverse reactions is possible: fever, an increase in the concentration of creatinine in the bloodstream.

Instructions for use Plagril (Method and dosage)

Take oral tablets orally, regardless of meals.
For the prevention of ischemic disorders, no later than 35 days after myocardial infarction and 1-25 weeks after an ischemic stroke: adults and the elderly are prescribed a dose of 75 mg per day for 1 dose.
In acute coronary syndrome without raising ST on ECG: treatment requires a single loading dose of 300 mg, and subsequent administration of the drug - 75 mg per day for 1 time. Instructions for use Plagril in this case involves a combination with acetylsalicylic acid at a dose of 75-325 mg per day. The optimal course of treatment should last up to 1 year.
In acute coronary syndrome with a rise of ST on the ECG: take the drug at 75 mg (1 tab.) Per day, starting with a loading dose, combined with acetylsalicylic acid or without thrombolytics. Patients over 75 years of age can be treated with clopidogrel without a loading dose. Such a combination therapy should last at least 4 weeks.

Overdose

Oral administration of 600 mg of clopidogrel (8 tablets) at the time of the study showed no side effects. The time of bleeding increased by 1.7 times, as well as when taking a therapeutic dose of 75 mg / day.
As a treatment, transfusion of platelet mass is effective. Specific antidote for today was not open.

Interaction

Plagril can cause various reactions with simultaneous application with the following drugs:
    With acetylsalicylic acid, heparin, indirect anticoagulants and NSAIDs: there is an increase in antiaggregant effects, as well as an increased risk of development of bleeding of the gastrointestinal tract.
    With drugs metabolized with the participation of CYP2C9 (eg, Phenytoin, Tolbutamide): Plagril, by inhibiting the activity of CYP2C9, causes an increase in the concentration of drugs.

Storage conditions

In a dry dark place, the temperature is not more than 25 ° Celsius.
Inaccessible place for children.
Shelf life - 2 years from the date of manufacture.

special instructions

If the antiaggregant effect of Plagril is undesirable during surgery, stop taking the pill 7 days before the planned surgery.
Attention! When taking Plagril, you should notify your doctor at each unusual bleeding, as it may take longer to stop. And also it is necessary to inform about therapy when planning surgical interventions or prescribing a new medication.

Reviews of Plagril

Reviews on Plagril on the forums are positive, many people prescribe the drug after a stroke and heart attack to prevent the formation of blood clots, since another attack can be critical. As an antiplatelet drug, the drug is used often enough to confirm its effectiveness and safety.