Odrel 75 Tablet
Clopidogrel
75mg
Beximco Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 12.00 AED |
Indications
Odrel 75 Tablet is used for:
Coronary Artery Disease, Acute coronary syndrome, Myocardial infarction, Peripheral vascular disease, Cerebrovascular disease, Atherosclerosis, Thromboembolic disorders, Unstable angina, Stroke
Adult Dose
Oral
Acute coronary syndrome
Adult: For ST-elevation MI (STEMI):
In combination with aspirin: 75 mg once daily.
<75 years
300 mg loading dose followed by 75 mg for 14 days up to 12 months (if no bleeding)
Concomitant therapy with aspirin: Administer in combination with aspirin 75-325 mg once daily with or without thrombolytic
>75 years
No loading dose
75 mg for 14 days up to 12 months (if no bleeding)
For unstable angina, non-ST-elevation MI: In combination with aspirin:
Initially, 300 mg loading dose, followed by 75 mg once daily for up to 12 mth.
Prophylaxis of thromboembolic disorders, Recent MI, Stroke, or Established Peripheral Arterial Disease, Coronary Artery Disease
Adult: 75 mg once daily orally without a loading dose.
Recommended as an alternative to aspirin or concomitantly with aspirin if patient not at increased risk for bleeding but at high risk for cardiovascular disease
Child Dose
Renal Dose
Renal impairment: Dose adjustment not necessary
Administration
May be taken with or without food.
Contra Indications
Active pathological bleeding, such as a peptic ulcer or an intracranial hemorrhage
Hypersensitivity to clopidogrel or any component of the product
Precautions
Clopidogrel's antiplatelet activity is dependent on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19
Tests are available to identify patients who are CYP2C19 poor metabolizers
Consider the use of another platelet P2Y12 inhibitor in patients identified as CYP2C19 poor metabolizers
CYP2C19 inhibitors: Avoid concomitant use of omeprazole or esomeprazole.
Bleeding: Plavix increases risk of bleeding.
Discontinuation: Premature discontinuation increases risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding.
Thrombotic thrombocytopenic purpura (TTP) has been reported.
Cross-reactivity among thienopyridines has been reported.
Pregnancy-Lactation
Pregnancy
Available data from cases reported over two decades in published literature and postmarketing surveillance have not identified any drug-associated risks for major birth defects or miscarriage; there are risks to pregnant woman and fetus associated with myocardial infarction and stroke
Myocardial infarction and stroke are medical emergencies; therapy for pregnant woman should not be withheld because of potential concerns regarding effects of clopidogrel on the fetus
Labor or delivery
Therapy during labor or delivery will increase risk of maternal bleeding and hemorrhage; avoid neuraxial blockade during clopidogrel use because of risk of spinal hematoma; when possible, discontinue therapy 5-7 days prior to labor, delivery, or neuraxial blockade
There are no data on presence of drug in human milk or effects on milk production; no adverse effects on breastfed infants observed during lactation in a small number of postmarketing cases; studies in rats have shown that clopidogrel and/or its metabolites are present in milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk; consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or underlying maternal condition
Interactions
Opioids: Decreased exposure to clopidogrel. Consider use of parenteral antiplatelet agent.
Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs):
Increases risk of bleeding.
Repaglinide (CYP2C8 substrates): Increases substrate plasma concentrations.
Contraindicated (2)
abrocitinib
ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
Serious (45)
antithrombin alfa
antithrombin III
apixaban
argatroban
aspirin rectal
bivalirudin
cangrelor
caplacizumab
carbamazepine
cimetidine
clarithromycin
dalteparin
efavirenz
erythromycin base
erythromycin ethylsuccinate
erythromycin lactobionate
erythromycin stearate
eslicarbazepine acetate
esomeprazole
etrasimod
etravirine
felbamate
fluconazole
fluoxetine
fluvoxamine
fondaparinux
isoniazid
ketoconazole
levoketoconazole
modafinil
morphine
nefazodone
nirmatrelvir/ritonavir
omeprazole
oxcarbazepine
pacritinib
protamine
rabeprazole
repaglinide
rifabutin
rifampin
St John's Wort
tovorafenib
tucatinib
voriconazole
Adverse Effects
Side effects of Clopidogrel :
1-10%
Upper respiratory tract infection (8.7%),Chest pain (8.3%),Headache (7.6%),Flulike syndrome (7.5%),Arthralgia (6%),Pain (6%),Dizziness (6%),Diarrhea (4.5%),Rash (4.2%),Rhinitis (4.2%),Depression (3.6%),Urinary tract infection (3.1%)
<1%
Severe neutropenia,Thrombotic thrombocytopenic purpura,Acute liver failure,Aplastic anemia,Hypotension,Hepatitis,Myalgia,Eczema,Erythema,Agranulocytosis
Potentially Fatal: Bleeding disorders including GI and intracranial haemorrhage. Blood dyscrasias.
Mechanism of Action
Clopidogrel inhibits adenosine diphosphate (ADP) from binding to its receptor sites on the platelets and subsequent activation of glycoprotein GP IIb/IIIa complex thus preventing fibrinogen binding, platelet adhesion and aggregation.
Note
Odrel 75 75mg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Clopidogrel. Odrel 75 is availble in Bangladesh.
Farmaco BD drug index information on Odrel 75 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.