Плавикс

Плавикс – an antiagregant.

Form of release and structure

Dosage form – tablets, film coated: pink color, on round slightly biconvex tablets the engraving "is applied to I 171" on one party and "75" – on another, on oblong tablets – number "1332" on one party and "300" – on another (on 75 mg: on 7, 10 or 14 pieces in the blister, in a cardboard pack 1, 2 or 3 blisters; on 300 mg: on 10 pieces in the blister, in a cardboard pack 1 or 3 blisters).

– klopidogret active ingredient of Plaviks hydrosulphate (form II), in 1 tablet – 97,875 mg (it is equivalent to the content of 75 mg of klopidogrel) or 391,5 mg (it is equivalent to the content of 300 mg of klopidogrel).

Auxiliary components: a macrogoal 6000, Mannitolum, cellulose microcrystallic (with low the content of water, 90 microns), the castor oil hydrogenated the hypro rod low-replaced.

Structure of a film cover: wax of karnaubskiya, опадрай pink (triacetin, lactoses monohydrate, titanium dioxide (E171), dye ferrous oxide red (E172), gipromelloz).

Indications to use

Plaviks's use is shown for prevention of aterotrombotichesky complications at the following pathologies:

• Myocardial infarction in the period of a disease from several days to 35 days, an ischemic stroke (with prescription from 7 days to 6 months), the diagnosed occlusal disease of peripheral arteries;
• Myocardial infarction without tooth Q or unstable stenocardia (an acute coronary syndrome without raising of a segment of ST), including when performing stenting at transdermal coronary intervention (in combination with acetylsalicylic acid);
• Acute myocardial infarction (an acute coronary syndrome with raising of a segment of ST) at medicamentous therapy and a possibility of a thrombolysis (in combination with acetylsalicylic acid).

Besides, drug is appointed for prevention of tromboembolic and aterotrombotichesky episodes (including a stroke) at patients with a ciliary arrhythmia (fibrillation of auricles) which cannot accept indirect anticoagulants, have at least one risk factor of development of vascular complications and insignificant probability of development of bleeding (in combination with acetylsalicylic acid).

Tablets with the maintenance of a klopidogrel of 300 mg are intended only for reception as a load dose at treatment of an acute coronary syndrome.

Contraindications

• Age up to 18 years;
• Acute bleeding, including intracraneal hemorrhage, round ulcer;
• The expressed liver failure;
• Intolerance of a galactose, syndrome of glyukozo-galaktozny malabsorption, deficit of lactase;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to a klopidogrel and other components of drug.

With care it is recommended to appoint Plaviks the patient with a moderate liver failure (because of risk of bleeding), a renal failure, predisposed to development of bleedings by pathologies (including intraocular, gastrointestinal), the instruction in the anamnesis on hematologic and allergic reactions on тиклопидин, prazugret also other thienopyridines.

Extra care should be observed at the accompanying therapy by the medicines capable to cause damages of a mucous membrane of digestive tract (non-steroidal anti-inflammatory drugs (NPVS) and drugs of acetylsalicylic acid (ASK) concern to them), at injuries, surgical intervention and other morbid conditions with the increased risk of development of bleedings, at simultaneous use of inhibitors of a glycoprotein of IIb/IIIa, warfarin, heparin, NPVS (including the selection TsOG-2 inhibitors, selective serotonin reuptake inhibitors), of ASK, at low activity of an isoenzyme of CYP2C19, after an ischemic stroke or passing disturbance of cerebral circulation postponed recently.

Route of administration and dosage

Плавикс accept orally, irrespective of meal.

The recommended dosing for adults and patients of advanced age with normal activity of an isoenzyme of CYP2C19:

• Ischemic stroke, myocardial infarction, the diagnosed occlusal disease of peripheral arteries: on 75 mg of 1 times a day;
• Unstable stenocardia, myocardial infarction without Q tooth (an acute coronary syndrome without raising of a segment of ST): an initial load dose – 300 mg once, then on 75 mg of 1 times a day with a concomitant use of acetylsalicylic acid in a dose of 75-325 mg a day. As reception of higher doses of acetylsalicylic acid is accompanied by risk of bleedings, the patient should appoint up to 100 mg of acetylsalicylic acid a day. Treatment duration – 3-12 months, depending on individual dynamics of treatment;
• Acute myocardial infarction with raising of a segment of ST (an acute coronary syndrome with raising of a segment of ST): an initial load dose – 300 mg once, in combination with acetylsalicylic acid and trombolitika or without them, then on 75 mg of 1 times a day. The patient 75 years are aged more senior it is recommended to carry out therapy without load dose. The combined treatment should be begun with the moment of emergence of the first symptoms of a disease and to continue within 4 weeks. Efficiency of longer therapy klopidogrely in combination with acetylsalicylic acid is not established;
• Ciliary arrhythmia (fibrillation of auricles): 75 mg of 1 times a day in a combination from 75-100 mg of acetylsalicylic acid.

Плавикс it is necessary to accept always in at one time days. In case of delay of reception of the next dose till 12 o'clock the pill should be taken immediately, and following – at the scheduled time. As the double dose of drug cannot be accepted if delay made more than 12 hours, the patient has to accept the following dose in usual time.

The optimum mode of dosing of a klopidogrel for patients with genetically caused reduced activity of an isoenzyme of CYP2C19 is not set therefore for this category of patients the usual dose of drug is recommended to be doubled, it will allow to increase antiagregantny action of a klopidogrel. A load dose – 600 mg, then on 150 mg of 1 times a day daily.

Dose adjustment for patients of advanced age is not required.

Side effects

Clinically significant side effects established at conduct of clinical trials:

• Hemorrhagic disturbances: often – a purpura or bruises, nasal bleeding; seldom – hematomas, a hamaturia, eye hemorrhages (conjunctival are more often); perhaps (including with a lethal outcome) – intracraneal hemorrhage, a hemorrhagic stroke, gastrointestinal bleedings, not cerebral and cerebral bleedings;
• System of a hemopoiesis: perhaps – aplastic anemia, a neutropenia, thrombocytopenia; infrequently – a leukopenia, reduction in the amount of thrombocytes in peripheral blood, an eosinophilia, decrease in neutrophils in peripheral blood;
• Alimentary system: often – diarrhea, an abdominal pain, dyspepsia; infrequently – abdominal distention, nausea, gastritis, vomiting, a lock, stomach ulcer and/or a duodenum;
• Nervous system: infrequently – a headache, paresthesia, dizziness; seldom – вертиго;
• Dermatological reactions: infrequently – a skin itch, rash;
• Coagulant system of blood: infrequently – increase in the period of bleeding.

Post-marketing data of the undesirable phenomena from Plaviks's use:

• Hemorrhagic disturbances: frequency is unknown – serious bleedings (hypodermic, skeletal and muscular, eye hemorrhages (conjunctival, in a retina and tissues of an eye)), pulmonary bleeding, a pneumorrhagia, nasal bleeding are more often, than a hamaturia and bleeding from postoperative wounds, intracraneal hemorrhages, gastrointestinal bleedings, retroperitoneal hemorrhages (including with a lethal outcome);
• System of a hemopoiesis: frequency is unknown – an agranulocytosis, aplastic anemia or a pancytopenia, a granulocytopenia, the acquired hemophilia And, a trombotichesky Werlhof's disease;
• Nervous system: frequency is unknown – disturbances of flavoring perception;
• Mental disturbances: frequency is unknown – hallucinations, confusion of consciousness;
• Respiratory system: frequency is unknown – a bronchospasm, eosinophilic pneumonia, intersticial pneumonia;
• Cardiovascular system: frequency is unknown – a lowering of arterial pressure, a vasculitis;
• Alimentary system: frequency is unknown – colitis (including ulcer colitis, lymphocytic colitis), stomatitis, pancreatitis, an acute liver failure, hepatitis (noninfectious);
• Musculoskeletal system: frequency is unknown – arthritis, an arthralgia, a mialgiya;
• Allergic reactions: frequency is unknown – a serum disease, anaphylactoid reactions, cross hematologic and allergic reactions with other thienopyridines (including prazugret, тиклопидин);
• Dermatological reactions: frequency is unknown – a skin itch, makulopapulezny, exfoliative or erythematic rash, a small tortoiseshell, a Quincke's disease, a syndrome of medicinal hypersensitivity, violent dermatitis (Stephens-Johnson's syndrome, a mnogoformny erythema, a toxic epidermal necrolysis), medicinal rash with system DRESS syndrome and an eosinophilia, flat deprive, eczema;
• Urinary system: frequency is unknown – a glomerulonephritis;
• Laboratory researches: frequency is unknown – disturbance of indicators of function of a liver, increase in level of concentration of creatinine in blood;
• General frustration: frequency is unknown – fever.

Special instructions

Plaviks's use should be accompanied with careful control of possible emergence of symptoms of bleeding (including hidden), especially during the first weeks of treatment, and also after carrying out surgeries and cardiological invasive procedures.

At emergence of clinical symptoms of bleeding it is required to carry out urgently the general blood test, to define indicators of functional activity of thrombocytes and their quantity, the activated partial tromboplastinovy time, other necessary researches.

As drug extends a bleeding time, extra care is recommended to be shown at treatment of patients with the increased risk of development of bleeding, especially at diseases with predisposition to development of bleedings.

The patient has to be informed on need of the immediate address to the attending physician at emergence unusual on duration or localization of bleeding.

Use of any new medicine can be begun only after consultation of the doctor.

Reception of a klopidogrel should be cancelled in 5-7 days prior to carrying out the planned surgery which is not demanding antithrombocytic effect.

Before operation, at visit of the stomatologist the patient has to report to the doctor about Plaviks's reception.

Against the background of use of drug there is a risk of development of a trombotichesky Werlhof's disease – the life-threatening state demanding urgent measures including a plasma exchange.

The combination therapy klopidogrely and ASK at patients after recently had passing disturbance of cerebral circulation or a stroke raises rice of development of big bleedings therefore it should be seen off with care and at the confirmed potential advantage for the patient.

Use of a klopidogrel in the recommended doses with low activity of an isoenzyme of CYP2C19 at transdermal coronary intervention or an acute coronary syndrome can cause higher frequency of development of cardiovascular complications in patients.

At purpose of drug it is necessary to study carefully the anamnesis of the patient regarding the available hematologic and/or allergic reactions on тиклопидин, prazugret also other thienopyridines as there is a risk of cross moderate and heavy allergic and/or hematologic reactions between thienopyridines.

At the confirmed diagnosis of the acquired hemophilia use of a klopidogrel should be stopped.

During therapy control of functional activity of a liver is required, in case of severe damages of a liver it is necessary to consider a possibility of development of hemorrhagic diathesis.

Use of a klopidogrel at an acute stroke with prescription to 7 days is not recommended.

Плавикс does not exert impact on ability of the patient to control of vehicles and mechanisms.

Medicinal interaction

For the purpose of prevention of development of undesirable side effects during Plaviks's use, it is recommended to get advice of the attending physician before reception of any medicines.

Terms and storage conditions

To protect from children.

To store at a temperature up to 30 °C.

Period of validity – 3 years.