Clodovix® Film coated tablet 75 mg, each film coated tablet contains : Clopidogrel bisulfate equivalent to Clopidogrel 75 mg.
Clodovix® containing Clopidogrel bisulfate (equivalent to Clopidogrel) is available in 75 mg film coated tablet.
Clodovix® is indicated for the prevention of atherothrombotic events in :
- Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
- Patients suffering from acute coronary syndrome :
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction). In combination with Acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction. In combination with ASA in medically treated patients eligible for thrombotic therapy.
DOSAGE AND ADMINISTRATION :
Adults and elderly :
Clodovix® should be given as a single daily dose of 75 mg with or without food. In patients suffering from acute coronary syndrome :
- Non-ST segment elevation (unstable angina or non-Q wave myocardial infarction) : Clodovix® treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with Acetylsalicylic acid (ASA) 75 – 325 mg daily). Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months and the maximum benefit was seen at 3 months.
- ST segment elevation acute myocardial infarction : Clodovix® should be given as a single daily dose of 75 mg initiated with or without a loading dose in combination with ASA and with or without thrombolytics. For patients greater than 75 years of age Clodovix® should be initiated without a loading dose. Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. The benefit of the combination of Clodovix® with ASA beyond four weeks has not been studied in this setting.
Children and adolescents :
There is no experience in children.
Overdose following Clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. Appropriate therapy should be considered if bleedings are observed.
No antidote to the pharmacological activity of Clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reversed the effects of Clopidogrel.
- Hypersensitivity to the active substance or to any of the excipients of the medical product.
- Severe liver impairment.
- Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
WARNINGS AND PRECAUTIONS :
- Due to the risk of bleeding and haematological undesirable effects, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment.
- As with other antiplatelet agents, Clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors, heparin or glycoprotein IIb/IIIa inhibitors. Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of the treatment and/or after invasive cardiac procedures or surgery. The concomitant administration of Clopidogrel with warfarin is not recommended since it may increase the intensity of bleedings.
- If a patient is to undergo elective surgery and antiplatelet effect is not necessary, Clopidogrel should be discontinued 7 days prior to surgery. Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular).
- Patients should be told that it might take longer than usual to stop bleeding when they take Clopidogrel (alone or in combination with ASA) and that they should report any unusual bleeding (site or duration) to their physician. Patients should inform physicians and dentist that they are taking Clopidogrel before any surgery is scheduled and before any new drug is taken. Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of Clopidogrel, sometimes after a short exposure. It is characterized by thrombocytopenia and microangiopathic hemolytic anemia associated with either neurological findings, renal dysfunction or fever. TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
- In view of the lack of data, Clopidogrel cannot be recommended in acute ischeamic stroke (less than 7 days).
- Therapeutic experience with Clopidogrel is limited in patients with renal impairment. Therefore Clopidogrel should be used with caution in these patients.
- Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. Clopidogrel should therefore be used with caution in this population.
- Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiencies or glucose galactose malabsorption should not take this medicine.
- Pregnancy : As no clinical data on exposed pregnancies are available, it is preferable not to use Clopidogrel during pregnancy as a precautionary measure. Animal studies do not indicate direct or indirect harmful effects, with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
- Lactation : Studies in rats have shown that Clopidogrel and/or its metabolites are excreted in the milk. It is not known whether this medicinal product is excreted in human milk. Clopidogrel should not be administered in nursing mother.
|Clodovix® Film coated tablet 75 mg
Reg. No. DKL1702354317A1
|Box, 3 blisters @ 10 film coated tablets|
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Sidoarjo – Indonesia