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Plavix is used for:
For what do you use Plavix?
Plavix is indicated for the prevention of aterotrombotici events (problems caused by blood clots and hardening of the arteries) in adults. Plavix can be administered to groups of patients:
patients coming from myocardial infarction (heart attack). Treatment with Plavix may be initiated during the period between a few days and 35 days after heart attack;
patients suffering from ischemic stroke (caused by insufficient attachment blood supply to an area of the brain). Treatment with Plavix may be initiated during the period between seven days and six months after stroke;
patients with peripheral artery disease (problems of blood circulation in arteries);
patients suffering from a disorder known as "acute coronary syndrome", in which the medication is administered with aspirin (another medicine to prevent the formation of blood clots), including patients which was implanted a stent (a tube inserted into an artery to prevent the filling). Plavix may be used in patients who suffer a heart attack with "raising ST" (an abnormal reading in electrocardiogram or ECG) when the doctor considers that the treatment may be beneficial. It can also be used in patients who do not have such an abnormal reading on ECG, if suffering from unstable angina (severe chest pain) or myocardial infarction without Q wave ".
The medicinal product can be obtained only with a prescription.
How do you use Plavix?
The standard dose of Plavix is 75 mg one tablet once a day during or between meals. In acute coronary syndrome, Plavix is used in conjunction with aspirin and treatment usually begins with a loading dose of one tablet from 300 mg or 75 mg tablets four. This dose is then followed by the standard dose of 75 mg once daily for at least four weeks (in myocardial infarction with ST segment elevation) or up to 12 months (in the presence of syndrome without ST segment elevation).
Within your body Plavix is converted to the active form. For genetic reasons, certain subjects are not able to convert Plavix just as effectively as compared to other patients, this could lower the degree of response to the medicinal product. The most appropriate dose for this type of patients has not yet been identified.
How does Plavix?
The active ingredient of Plavix, clopidogrel, is a platelet aggregation inhibitor, i.e. it helps prevent the formation of blood clots. Blood clotting occurs due to the action of special blood cells, platelets, which aggregate (they stick to each other). Clopidogrel blocks platelet aggregation by preventing a substance called ADP to bind to a specific receptor on their surface. This prevents platelets to become "sticky", reducing the risk of blood clots and helping to prevent another heart attack or stroke.
Such studies were carried out on Plavix?
Plavix with aspirin was compared in a study called CAPRIE conducted on approximately 19000 patients who had suffered recently from heart attack or ischemic stroke or who were suffering from peripheral artery disease. The primary measure of effect was the number of patients who suffered an "ischemic event" (heart attack, stroke or ischemic death) in a period of one to three years.
Per quanto concerne la sindrome coronarica acuta, Plavix è stato posto a confronto con un placebo (trattamento fittizio) nell'ambito di uno studio condotto su 12 000 pazienti con sindrome senza innalzamento del tratto ST, di cui 2 172 sono stati sottoposti ad impianto di stent nel corso dello studio (studio CURE, durato fino ad un anno). Plavix è stato altresì confrontato con un placebo in due studi riguardanti pazienti con innalzamento del tratto ST: lo studio CLARITY ha interessato oltre 3 000 pazienti ed è durato fino a otto giorni; lo studio COMMIT, che ha interessato circa 46 000 pazienti, durante il quale ai pazienti è stato somministrato Plavix con o senza metoprolol (un altro farmaco utilizzato per problemi di cuore o di pressione sanguigna elevata) durato fino a quattro settimane. Negli studi sulla sindrome coronarica acuta, tutti i pazienti hanno inoltre assunto aspirina e il principale indicatore di efficacia era basato sul numero di soggetti che attraversano un "evento", ad esempio un blocco arterioso o un altro infarto, oppure che erano deceduti nel corso dello studio.
04.0 CLINICAL INFORMATION of Plavix
04.1 indications
Reduction of atherosclerotic events (myocardial infarction, stroke, vascular causes death) in patients with symptomatic atherosclerosis disease earlier, defined by ischemic stroke (which occurred from 7 days to less than 6 months), myocardial infarction (which occurred from a few days to less than 35 days) or device proven arteriopathy obliterans.
This indication is based on the results of the study which compared clopidogrel CAPRIE with acetylsalicylic acid (ASA). The slight, but statistically significant difference in clopidogrel than ASA was mainly related to patients enrolled for peripheral arterial disease obliterans.
For more information, see the section "Special warnings and precautions for use" and the paragraph "pharmacodynamic properties".
04.2 Posology and method of administration of Plavix
Adults and elderly
Clopidogrel should be given as a single daily dose of 75 mg during or outside meals.
Children and adolescents
The safety and efficacy of clopidogrel in patients under 18 years has not yet been determined.
04.3 Contraindications of Plavix
Hypersensitivity to the active substance or to any component of the product.
Severe hepatic insufficiency.
Pathological bleeding in place e.g. There are peptic ulcer or intracranial hemorrhage.
Breastfeeding (see section "pregnancy and breast-feeding").
04.4 Special warnings and precautions for use of Plavix
In patients with acute myocardial infarction with clopidogrel therapy should not be initiated in the first days following myocardial infarction.
Due to the lack of data, clopidogrel may not be recommended in unstable angina in percutaneous coronary angioplasty (stenting), bypass aorto-coronary and in acute ischemic stroke (which occurred less than 7 days).
As with other platelet anti-platelet agents clopidogrel, is used with caution in patients who have an increased risk of bleeding due to trauma, surgery or other pathological conditions. If a patient must undergo elective surgery and platelet antiaggregante activity is not desired, you must discontinue use of clopidogrel 7 days before the surgery.
Clopidogrel prolongs bleeding time and should be used with caution in patients with injuries to hemorrhagic tendency (particularly gastrointestinal and intraocular).
Patients should be advised that use of clopidogrel may prolong any bleeding and they should inform the doctor of any bleeding that may manifest.
Before you undergo any surgery and before taking a new drug patients need to alert the doctor and the dentist who are in treatment with clopidogrel.
Treatment with clopidogrel experience is limited in patients with renal insufficiency. Clopidogrel must therefore be used with caution in these patients.
Treatment with clopidogrel experience is limited in patients with mild hepatic dysfunction that may have a haemorrhagic Diathesis. Clopidogrel must therefore be used with caution in these patients.
Simultaneous administration of clopidogrel and warfarin is not recommended since it may lead to increased intensity of bleeding.
For the possible increased risk of bleeding the contemporary administration of clopidogrel and ASA, nonsteroidal anti-inflammatory drugs, heparin or trombolitici should be undertaken with caution (see paragraph "interactions with other drugs and interactions of any kind").
Drugs that can cause gastrointestinal lesions (such as nonsteroidal anti-inflammatory drugs) should be used with caution in patients treated with clopidogrel (see paragraph 04.5 interactions with other drugs and interactions of any kind).
Drawbacks of Plavix
Hypersensitivity to the active substance or to any component of the product.
Severe hepatic insufficiency.
Pathological bleeding in place e.g. There are peptic ulcer or intracranial hemorrhage.
Special warnings and precautions for use of Plavix
In patients with acute myocardial infarction with clopidogrel therapy should not be initiated in the first days following myocardial infarction.
Due to the lack of data, clopidogrel may not be recommended in unstable angina in percutaneous coronary angioplasty (stenting), bypass aorto-coronary and in acute ischemic stroke (which occurred less than 7 days).
As with other platelet anti-platelet agents clopidogrel, is used with caution in patients who have an increased risk of bleeding due to trauma, surgery or other pathological conditions. If a patient must undergo elective surgery and platelet antiaggregante activity is not desired, you must discontinue use of clopidogrel 7 days before the surgery.
Clopidogrel prolongs bleeding time and should be used with caution in patients with injuries to hemorrhagic tendency (particularly gastrointestinal and intraocular).
Patients should be advised that use of clopidogrel may prolong any bleeding and they should inform the doctor of any bleeding that may manifest.
For the possible increased risk of bleeding the contemporary administration of clopidogrel and ASA, nonsteroidal anti-inflammatory drugs, heparin or trombolitici should be undertaken with caution.
Plavix drug interactions
Trombolitici: the security administration of clopidogrel, rt-PA and heparin has been studied in patients with recent myocardial infarction. The incidence of clinically significant bleeding was similar to that observed when rt-PA and heparin were administered together with ASA. The safety administration of clopidogrel with other drugs trombolitici has not been determined and therefore this should be undertaken with caution.
Nonsteroidal anti-inflammatory drugs (NSAIDs): in a clinical trial conducted on healthy volunteers, coadministration of clopidogrel and naproxen has resulted in an increased occult gastrointestinal bleeding. However due to the lack of interaction with other FANS, currently it is not clear if there is an increased risk of gastrointestinal bleeding with all FANS. As a result, the administration of NSAIDS and clopidogrel should be performed with caution.
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