Platelex | Iberica Verheilen Pharmaceuticals

OUR PRODUCTS

ANTIBIOTICS

GASTRO-INTESTINAL PRODUCTS

ANTI-HISTAMINE

ANTI-HYPERTENSIVE

ANTI-EPILEPTIC/NEUROPATHIC PAIN

ANTI-PLATELET

ANTI-CHOLESTEROL

MULTIVITAMINS

FORMULATION

Each film-coated tablet contains: Clopidogrel Bisulfate USP eq. to Clopidogret, 75 mg.

DOSAGE AND ADMINISTRATION

Clopidogrel should be taken once a day with or without food. Recent MI, Recent Stroke or Estabished Peripheral Arterial Disease: The recommended daily dose of Clopidogrel is 75 mg once daily. Acute Coronary Syndrome: For patients with Acute Coronary Syndrome (unstable agina/non Q-Wave MI) Clopidogrel should be initiated with a single 300 mg loading dose and continued at 75 mg once daily. Aspirin (75 mg-325 mg oncr daily) should be initiated and continued in combination with Clopidogrel. Safety and efficacy in subject below the age of 18 years have not been established. No dosage adjustment is necessary for elderly patients or patients with renal disease.

INDICATION

1. Recent MI, Recent Stroke or Established Peripheral Arterial Disease: For patient with a history of recent myocardial infarction (MI), recent stroke or established peripheral arterial disease, Clopidogrel has been shown to reduce the rate of a combined endpoint of new ischaemic stroke (fatal or not), new MI (fatal or not) 2. Acute Coronary Syndrome: For patients with Acute Coronary Syndrome (unstable angina/non Q-Wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG. Clopidogrel has been shown to decrease the rate of combined endpoint of cardiovascular death, MI or stroke or refractory ischaemia.

CONTRAINDICATION

Hypersensitivity to Clopidogrel or any of the excipients. Severe liver impairment. Active pathological bleeding such as peptic ulcer and intracranial haemorrhage. Pregnancy and lactation.

SPEACIAL PRECAUTIONS

General: As with the other anti-platelet agents, Clopidogrel prolongs bleeding time and should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological condition as follows: 1.) If a patient is to undergo elective surgery anti-platelet effect is not desired, Clopidogrel should be discontinued at least 5 days prior to surgery. 2.) If the patient is at high risk of ophthalmic bleeding due to intraocular lesions, Clopidogrel should be used with extra caution. 3.) Although Clopidogrel has shown a lower incidence of gastrointestinal bleeding compared to aspirin in a large clinical trial (CAPRIE), the drug should be used with caution in patients who have lesions with a propensity to bleed. Drugs that might induce such lesions (such as Apirin and Non-steroidal anti-inflammatory drug) should be used in caution in patients taking Clopidogrel. 4.) Patients should be told that it may take longer than usual for bleeding to stop when they take Clopidogrel (alone or in combination with Aspirin) and that they should report any unusual bleeding (site and/or duration) to their physician. Patients should inform physicians and dentists that they are taking Clopidogrel before.