Plavix
Plavix
Plavix (Clopidogrel)Pharmacological action
Inhibitor of aggregation of thrombocytes. Plavix also inhibits the aggregation of thrombocytes caused by other agonists, by blockade of rising of activity of thrombocytes. Plavix is irreversible contacts thrombocyte ADF-RECEPTORS. Hence, the thrombocytes which have entered with it in interaction, are unreceptive to stimulation ADF during all term of their life, and normal function of thrombocytes is restored with the rate corresponding to rate of updating of thrombocytes.
From the first day of application of a preparation appreciable inhibition of aggregation of thrombocytes becomes perceptible. Inhibition of aggregation of thrombocytes amplifies also a stable condition is reached in 3-7 days. Thus the average level of suppression of aggregation of thrombocytes at application of a daily dose of 75 mg makes 40-60 %. Aggregation of thrombocytes and a bleeding time come back to initial level on the average in 5 days after the treatment termination.
The preparation has coronarodilator an effect.
Indications
Preventive maintenance of ischemic disturbances at patients with the expressed atherosclerosis, including:
- After the transferred myocardial infarction, an ischemic stroke or recently diagnosed disease of peripheric arteries;
- At an acute coronary syndrome without lifting of segment ST (an astable stenocardia or a myocardial infarction without pathological tooth Q) in a combination with Acidum acetylsalicylicum.
Dosage regimen
For preventive maintenance of ischemic disturbances at patients after the transferred myocardial infarction, an ischemic stroke and recently diagnosed disease of peripheric arteries adult (including to elderly patients) prescribe 75 mg of 1 times/sut irrespective of food intake.
At an acute coronary syndrome without lifting of segment ST (an astable stenocardia or a myocardial infarction without tooth Q) treatment should be begun with appointment of a unitary loading dose of 300 mg, and then is continued in a dose of 1 times/sut of 75 mg (with simultaneous appointment of Acidum acetylsalicylicum). As Acidum acetylsalicylicum application in the big doses is bound to the big risk of the bleedings, the recommended dose should be not above 100
Course of treatment - till 1 year.
Side effect
From coagulating system of blood: gastroenteric bleedings (2 %), in 0.7 % of cases demanded hospitalisation; less often - hematomas, a hematuria and hemorrhages in a conjunctiva.
From the alimentary system: abdominal pains, a dyspepsia (a constipation, a diarrhoeia, a nausea), a gastritis; seldom - changes of hepatic assays.
From party TSNS and peripheric nervous system: a headache, giddiness, paresthesias.
Dermatological reactions: a dermal eruption, an itch.
Allergic reactions: extremely seldom - a bronchospasm, a Quincke's disease, anaphylactic reactions.
The other: a Werlhof's disease (1/200 000).
From coagulating system of blood: infrequently - bleeding time elongation.
From hemopoiesis system: infrequently - a leukopenia, depression of number of neutrophils and an eosinophilia, depression of number of thrombocytes.
Dermatological reactions: infrequently - an eruption and an itch.
Postmarketing data
From coagulating system of blood: reports on bleedings were the most frequent (the majority of cases occurred within the first month of treatment). Some cases with a lethal outcome (intracranial, gastroenteric and retroperitoneal bleedings) Are known; there are reports on serious cases of dermal bleedings (purple), skeletno-muscular bleedings (a hemarthrosis, a hematoma), eye bleedings (conjunctival, ocular, retinal), nasal bleedings, a pneumorrhagia, pulmonary bleedings, a hematuria and bleedings from an operational wound; at the patients accepting Plavix simultaneously with Acidum acetylsalicylicum or with Acidum acetylsalicylicum and a heparin, cases of serious bleedings also became perceptible.
From party TSNS: very seldom - confusion of consciousness, hallucination.
From cardiovascular system: very seldom - a vasculitis, BP depression.
From respiratory system: very seldom - a bronchospasm.
From the alimentary system: very seldom - a colitis (including an ulcerative or lymphocytic colitis), a pancreatitis, change of gustatory sensations, a hepatitis, disturbances of function of a liver.
From osteomuscular system: very seldom - an arthralgia, an arthritis.
From urinary system: very seldom - a glomerulonephritis.
Dermatological reactions: very seldom - a violent eruption, an erythematic eruption, an eczema, flat deprive.
Allergic reactions: very seldom - a Quincke's disease, an urticaria, anaphylactoid reactions.
The other: very seldom - rise in temperature, augmentation of a creatinine of blood.
Contraindications
- Hepatic insufficiency of serious degree;
- An acute bleeding, for example, at a round ulcer or intracraneal hemorrhage;
- Pregnancy;
- The lactemia period (thoracal feeding);
- Children's age till 18 years (safety and efficiency of application are not established);
- A hypersensibility to preparation components.
With care it is necessary to prescribe a preparation at diseases of a liver and kidneys (including moderate hepatic and-or renal insufficiency), traumas, before operations.
Pregnancy and lactemia
In view of absence of data it is not recommended to prescribe Plavix at pregnancy and in a lactemia (thoracal feeding).
Special indicatings
At Plavix application the blood analysis should be spent within the first week of treatment in case of a combination of a preparation with Acidum acetylsalicylicum, a heparin, inhibitors Iib/IiIa and also at the patients subject to raised risk of a bleeding, bound to a trauma, surgical interventions or other pathological conditions.
In connection with risk of development of a bleeding and hematological side-effects, in case of occurrence during treatment of clinical symptoms specifying in it, it is necessary to carry out immediately the blood analysis (quantity of thrombocytes, tests of functional activity of thrombocytes) and functional activity of a liver.
At planned surgical interventions course of Plavix treatment should be stopped 7 days prior to operation.
Plavix should be applied with care at patients with risk of bleedings (especially gastroenteric and intraocular).
Patients should be warned that they should inform the doctor on each case of a bleeding.
Because of insufficient data on Plavix application at patients with an acute myocardial infarction (with tooth Q) treatment by a preparation should not be begun within first several days after an infarct.
Because of insufficient data Plavix is not necessary to prescribe in the acute period of an ischemic stroke (in the first 7 days).
The preparation should be prescribed with care at patients with the broken function of kidneys.
Plavix is necessary to prescribe with care the patient with moderate disturbances of function of a liver at which occurrence of a hemorrhagic diathesis is possible.
Influence on ability to driving of motor transport and to management of mechanisms
Influence of Plavix reception on ability to driving of motor transport and to management of mechanisms is not established.
Overdosage
At single Plavix intake in a dose of 600 mg (the quantity equivalent to 8 standard tablets on 75 mg) by healthy volunteers side-effects are noted. The bleeding time has been extended in 1.7 times that corresponds to the size registered after reception of a therapeutic dose (75 mg/24h).
Treatment: platelet concentrate transfusion. The specific antidote does not exist.
Medicinal interaction
Acidum acetylsalicylicum does not change inhibiting Plavix effect to the ADF-INDUCED aggregation of thrombocytes, but Plavix strengthens Acidum acetylsalicylicum action on collagen-induced aggregation of thrombocytes. Joint application of these preparations demands care. However at an acute coronary syndrome without lifting of segment ST joint plavix application and Acidum acetylsalicylicum is recommended. Safety of long simultaneous application of Acidum acetylsalicylicum and Plavix is not established yet.
At simultaneous application with a heparin according to the clinical test spent on healthy volunteers, Plavix does not change neither the general requirement for a heparin, nor heparin action to blood coagulation. Simultaneous application of a heparin did not change inhibiting Plavix action to aggregation of thrombocytes. However safety of such combination is not established till now, and simultaneous application of these preparations demands care.
Conditions and periods of storage
B.Preparat's list should be stored in a place inaccessible to children at temperature not above 25 C. The Period of validity - 3 years.
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