Trombonet (clopidogrel) coated tablets 0.075 g. №60

Description

Trombonet (clopidogrel) coated tablets 0.075 g. №60

Composition

active ingredient: clopidogrel;

1 tablet contains clopidogrel bisulfate (clopidogrel hydrosulfate) 97.875 mg in terms of clopidogrel 75 mg;

excipients: lactose monohydrate, microcrystalline cellulose (101), corn starch, hydrogenated castor oil, macrogol 6000, magnesium stearate;

shell composition: hydroxypropyl methylcellulose (5), titanium dioxide (E 171), macrogol 6000, kandurin (silver sheen), iron oxide red (E 172).

Dosage form

Film-coated tablets.

Basic physical and chemical properties: round-shaped tablets with a biconvex surface, film-coated dark pink color with a pearly tint.

Pharmacological group

Antithrombotic agents.
ATX code B01A C04.

Pharmacological properties

It is an antithrombotic agent. This drug disrupts platelet aggregation (pooling) by blocking the binding of adenosine diphosphate to receptors located on the platelet membrane, as well as activating glycoprotein IIb / IIIa receptors. The drug also helps to reduce platelet aggregation caused by other agonists, inhibits their activation by released adenosine diphosphate.

Indications

Trombonet coated tablets is used to prevent manifestations of atherothrombosis:

• in individuals who have had myocardial infarction, ischemic stroke with diagnosed lesions of peripheral arteries (atherothrombosis of the vessels, lesion of the arteries of the lower extremities);
• in individuals with acute coronary syndrome: without elevation of S — T (non-Q-infarction, unstable angina), incl. in individuals who have undergone bypass surgery during coronary angioplasty; with the rise of S — T (in combination with acetylsalicylic acid).

Trombonet is also indicated for the prevention of thromboembolic, atherothrombotic events in atrial fibrillation.

Contraindications

You cannot use Trombonet coated tablets:

• with liver failure;
• if you are allergic to clopidogrel;
• with intolerance to auxiliary components;
• with acute bleeding;
• children.
• Trombonet is prescribed with caution to patients with chronic renal dysfunction, risk of bleeding, hereditary decrease in the function of the isoenzyme CYP2C19, as well as to patients receiving acetylsalicylic acid, heparin, non-steroidal anti-inflammatory, glycoprotein IIb / IIIa inhibitors.

Application during pregnancy and lactation

During these periods, Trombonet coated tablets is not prescribed.

Method of administration and dosage

Trombonet coated tablets is administered orally, regardless of food.
The standard dose is 75 mg once a day.
With ACS without elevation of the S — T segment, a single loading dose of 300 mg is started once, and then 75 mg once a day. When used with acetylsalicylic acid, the risk of bleeding increases, so it is not recommended to exceed the dose of 100 mg. The maximum effect was usually achieved after 3 months of treatment.
With ACS with an increase in the S — T segment, 75 mg / day is prescribed, starting with a single loading dose of 300 mg. Treatment of persons over 75 years old begins without a loading dose.
For atrial fibrillation, a single dose of 75 mg is used.

Overdose

Overdose signs: prolongation of bleeding time, development of hemorrhagic complications.
Treatment: stopping bleeding, platelet transfusion.

Side effects:

• Changes in blood counts: eosinophilia, neutropenia, leukopenia, thrombocytopenic purpura, granulocytopenia, pancytopenia, aplastic anemia, agranulocytosis, severe thrombocytopenia, anemia.
  Immune disorders: serum sickness, cross-hypersensitivity with thienopyridines (prasugrel, ticlopidine), anaphylactoid reactions.
• Mental disorders: confusion, hallucinations.
• Neurological disorders: paresthesias, intracranial bleeding, headache, dizziness, change in taste.
• Ophthalmic disorders: ocular, conjunctival, retinal bleeding.
• Otolaryngological disorders: vertigo.
• Cardiovascular disorders: hematoma, significant hemorrhage, vasculitis, bleeding from the surgical wound, arterial hypotension.
• Respiratory disorders: interstitial pneumonitis, epistaxis, pulmonary bleeding, hemoptysis, bronchospasm, eosinophilic pneumonia.
• Digestive disorders: gastrointestinal bleeding, abdominal pain, diarrhea, ulcerative lesions, gastritis, nausea, flatulence, constipation, retroperitoneal hemorrhage, retroperitoneal or gastrointestinal bleeding, pancreatitis, ulcerative or lymphocytic colitis, hepatitis, stomatitis, abnormal results liver, acute liver failure.
• Dermatological disorders: subcutaneous hemorrhage, pruritus, bullous dermatitis, rash, purpura, angioedema, exfoliative rash, drug-induced hypersensitivity syndrome, urticaria, DRESS syndrome, lichen planus, eczema.
• Musculoskeletal disorders: arthralgia, arthritis, hemarthrosis, myalgia.
• Urinary disorders: glomerulonephritis, hematuria, increased blood creatinine levels.
• General: fever.