Gavix
INFORMATION FOR MEDICAL STAFF
GAVIX
COMPOSITION:
Clopidogrel (as clopidogrel bisulfate) ................................. 75 mg
Excipients q.s .................................................................. 1 tablet
(Mannitol, microcrystalline cellulose M101, povidone K30, low-substituted hydroxypropyl cellulose (L-HPC (LH21)), hydrogenated castor oil, talc, hypromellose 2910 (6cp), hypromellose 2910 (15cp), polyethylene glycol 6000, titanium dioxide, red ferric oxide).
PHARMACEUTICAL FORM: Film coated tablet.
PHARMACODYNAMIC PROPERTIES:
ATC code: B01AC04
Gavix contains clopidogrel which selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptors and the subsequent ADP-medicated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Clopidogrel must be metabolized to produce the active metabolite that inhibits platelet aggregation. Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP. This action is irreversible. Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Platelet aggregation and bleeding time gradually return to baseline values after treatment is discontinued, generally in about 5 days.
PHARMACOKINETIC PROPERTIES:
After repeated oral dose of 75 mg/day, clopidogrel is rapidly absorbed and mainly metabolized by the liver with two forms: active (thiol derivative) and inactive (carboxylic acid derivative). The active thiol metabolite binds rapidly and irreversibly to ADP platelet receptors. This metabolite has not been detected in plasma. The carboxylic acid derivative which presents about 85% of the circulating compound in plasma. The elimination half-life of the main circulating metabolite was 8 hrs after single or repeated administration. Approximately 50% of clopidogrel was excreted in the urine and approximately 46% in the faeces in the 120-hr interval after dosing.
PRESENTATION: Box of 1 blister x 14 film coated tablets.
THERAPEUTIC INDICATIONS:
Gavix 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) and ST segment elevation acute myocardial infarction, in combination with aspirin.
DOSAGE & ADMINISTRATION:
Adult and elderly patients: Gavix should be given as a single daily dose of 1 tablet (75 mg) with or without food. Modification of dosage is not required in the elderly or patients with renopathy.
In patients suffering from non-ST segment elevation acute coronary syndrome: clopidogrel treatment should be initiated with a single 4 tablets (300 mg) loading dose and then continued at 75 mg once a day (with aspirin 75 mg-325 mg daily).
No clopidogrel's safety and efficacy data is showed in patients aged less than 18 years.
CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Active pathological bleeding e.g. gastroduodenal bleeding, retinal or intracranial haemorrhage.
Severe hepatic impairment.
PRECAUTIONS: Clopidogrel should be used with caution in patients who may be risk of increased bleeding from trauma, surgery or other pathological conditions (including ulcer). Clopidogrel should be discontinued 7 days prior to surgery. Patients are warned to stop the drug in case of unusual bleeding and inform a physician. Clopidogrel should be used with caution in patients who suffer from renal impairment, hepatic disease.
Pregnancy and lactation: Clopidogrel should not be recommended during the pregnant period because there are no adequate and well-controlled studies in pregnant women.
It is not known whether clopidogrel is excreted in human milk; thereby, the drug should not be used in nursing mothers.
Effects on works: Clopidogrel has no or negligible influence on the ability to drive, use machines, work at height, and other cases.
INTERACTIONS: Clopidogrel and aspirin, NSAIDs, heparin, thrombolytic drugs should be co-administered with caution.
No concurrent use of clopidogrel and warfarin is recommended.
UNDESIRABLE EFFECTS: Gastrointestinal bleeding, intracranial bleeding, haematoma, epistaxis, urina cruenta, eye bleeding, colic, anorexia, diarrhea, constipation, vomiting, rash, itching.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSE:
No adverse effects were reported after single oral administration of 600 mg of clopidogrel. The bleeding time was prolonged by a factor of 1.7, which is similar to that typically observed with the therapeutic dose of 75 mg/ day. No antidote to clopidogrel has been found. Platelet transfusion may reverse the effects of clopidogrel.
Read the directions carefully before use.
This drug is for prescription only.
SHELF-LIFE: 36 months from the manufacturing date.
STORAGE CONDITIONS:
Store in dry places, not exceeding 30oC, protect from light.
DATE OF REVISION OF THE TEXT: April 16, 2018
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
Keep out of reach of children.
Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.
This drug is for prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Clopidogrel (as clopidogrel bisulfate) .............................. 75 mg
Excipients q.s .............................................................. 1 tablet
(Mannitol, microcrystalline cellulose M101, povidone K30, low-substituted hydroxypropyl cellulose (L-HPC (LH21)), hydrogenated castor oil, talc, hypromellose 2910 (6cp), hypromellose 2910 (15cp), polyethylene glycol 6000, titanium dioxide, red ferric oxide).
PRODUCT DESCRIPTION: Round, light pink, film-coated tablets engraved a heart shape on one side, smooth on the other, intact edges.
PRESENTATION: Box of 1 blister x 14 film coated tablets.
WHAT THE DRUG IS USED FOR: Gavix 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) and ST segment elevation acute myocardial infarction, in combination with aspirin.
HOW TO TAKE THIS MEDICINE: For oral use.
Adult and elderly patients: Gavix should be given as a single daily dose of 1 tablet (75 mg) with or without food. Modification of dosage is not required in the elderly or patients with renopathy.
In patients suffering from non-ST segment elevation acute coronary syndrome: clopidogrel treatment should be initiated with a single 4 tablets (300 mg) loading dose and then continued at 75 mg once a day (with aspirin 75 mg-325 mg daily).
No clopidogrel's safety and efficacy data is showed in patients aged less than 18 years.
Or as directed by the physician.
WHEN SHOULD YOU NOT TAKE THIS MEDICINE:
Hypersensitivity to any components of the drug. Active pathological bleeding e.g. gastroduodenal bleeding, retinal or intracranial haemorrhage.
Severe hepatic impairment.
UNDESIRABLE EFFECTS:
Gastrointestinal bleeding, intracranial bleeding, haematoma, epistaxis, urina cruenta, eye bleeding, colic, anorexia, diarrhea, constipation, vomiting, rash, itching.
Inform your physician about any adverse effects occur during the treatment.
WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:
Clopidogrel and aspirin, NSAIDs, heparin, thrombolytic drugs should be co-administered with caution.
No concurrent use of clopidogrel and warfarin is recommended.
WHAT SHOULD YOU DO IF YOU MISS A DOSE:
The next dose should be taken as directed. Do not take extra medicine to make up the missed dose to avoid overdose.
HOW TO STORE THIS MEDICINE:
Store in dry places, not exceeding 30oC, protect from light.
SIGNS AND SYMPTOMS OF DRUG OVERDOSE:
No adverse effects were reported after single oral administration of 600 mg of clopidogrel. The bleeding time was prolonged by a factor of 1.7, which is similar to that typically observed with the therapeutic dose of 75 mg/ day.
WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE:
No antidote to clopidogrel has been found. Platelet transfusion may reverse the effects of clopidogrel.
WHAT ARE THE PRECAUTIONS WHEN TAKING THIS MEDICINE:
Clopidogrel should be used with caution in patients who may be risk of increased bleeding from trauma, surgery or other pathological conditions (including ulcer). Clopidogrel should be discontinued 7 days prior to surgery. Patients are warned to stop the drug in case of unusual bleeding and inform a physician. Clopidogrel should be used with caution in patients who suffer from renal impairment, hepatic disease.
Pregnancy and lactation: Clopidogrel should not be recommended during the pregnant period because there are no adequate and well-controlled studies in pregnant women.
It is not known whether clopidogrel is excreted in human milk; thereby, the drug should not be used in nursing mothers.
Effects on works:
Clopidogrel has no or negligible influence on the ability to drive, use machines, work at height, and other cases.
WHEN SHOULD YOU CONSULT YOUR DOCTOR, PHARMACIST: If you need further information, please consult your doctor or pharmacist.
SHELF-LIFE: 36 months from the manufacturing date.
DATE OF REVISION OF THE TEXT: April 16, 2018