CLOPIDOGREL 75MG TAB BT90

Name: CLOPIDOGREL 75MG TAB BT90
Brand: Dr Reddys Laboratories
SKU: 10104816

Product Details

Manufacturer: Dr Reddys Laboratories

MFG#: 55111-0196-90

NDC: 55111-0196-90

PID: 417917

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Additional Information

Product Name	Clopidogrel 75 mg Tablet (Bottle of 90 tablets)
Active Ingredient	Clopidogrel
Mechanism of Action	Inhibits ADP-induced platelet aggregation by binding to P2Y12 receptor.
Dosage Form	Oral tablet
Strength	75 mg per tablet
Recommended Dose	1 tablet daily
Side Effects	Bleeding, bruising, gastrointestinal discomfort
Precautions	Caution in bleeding disorders, liver disease, and before surgeries.
Contraindications	Active bleeding, history of hemorrhagic stroke.
Onset of Action	Typically within 2 hours after oral administration.
Half-life	7-8 hours
Metabolism	Primarily metabolized in the liver by CYP450 enzymes.
Excretion	Excreted mainly in the urine (50%) and feces (46%).
Pregnancy Category	Category B (no proven risk in humans).
Lactation	Caution advised; may be excreted in breast milk.
Packaging	Bottle of 90 tablets
Uses	Prevention of thrombotic events like stroke, MI, and PAD.

Description

Clopidogrel 75 mg is an antiplatelet medication that helps prevent blood clots by inhibiting platelet aggregation. It works by irreversibly blocking the adenosine diphosphate (ADP) receptor on platelets, thus preventing the activation of the glycoprotein IIb/IIIa complex, which is crucial for platelet aggregation. This action reduces the risk of thrombotic events such as stroke, myocardial infarction, and peripheral artery disease.

The primary indication for Clopidogrel 75 mg is the prevention of atherothrombotic events in patients with a history of myocardial infarction, stroke, or established peripheral vascular disease. It is often prescribed for use in combination with aspirin in patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Clopidogrel 75 mg tablets are typically taken orally, once daily, with or without food. Common side effects include bleeding, bruising, and gastrointestinal disturbances such as nausea or diarrhea. It is important to monitor for signs of bleeding or bruising and consult a healthcare provider if these occur.

Product Properties:

Description	-
Description	-
DESI Drug Ind	-
DESI Drug Ind	-
DESI2 Drug Ind	AB
DESI2 Drug Ind	-
Drug Category	N
Drug Category	NJ
Drug Type Code	N
Drug Type Code	1
FDA Approval Date	01/14/2008
FDA Approval Date	05/17/2012
FDA Therap Equiv	TAB
FDA Therap Equiv	AB
HCPCS	-
HCPCS	-
Market Entry Date	-
Market Entry Date	05/17/2012
Medical Coverage	-
Medical Coverage	-
Termination Date	1
Termination Date	-
Unit	TAB
Unit	1
Units Per Pkg	01/14/2008
Units Per Pkg	1
Active Ingredients	7364 clopidogrel bisulfate 120202666
Active Ingredients	7364 clopidogrel bisulfate 120202666
AHFS Class	20121800 PLATELET-AGGREGATION INHIBITORS
AHFS Class	20121800 PLATELET-AGGREGATION INHIBITORS
DEA Class	NC
DEA Class	NC
Dose Form	TABLET
Dose Form	TABLET
Fine Line Class	850085008510 All Rx Products
Fine Line Class	850085008510 All Rx Products
Gen Code and Des	38164 clopidogrel bisulfate ORAL TABLET 75 MG
Gen Code and Des	38164 clopidogrel bisulfate ORAL TABLET 75 MG
Inactive Ingredients	2272 mannitol 69658
Inactive Ingredients	2272 mannitol 69658
OMP Family	-
OMP Family	-
Product Category	RX Pharmaceuticals
Product Category	RX Pharmaceuticals
Strength	75MG
Strength	75MG
Common Brand Name	COMMON BRAND NAME(S): Plavix
Common Brand Name	COMMON BRAND NAME(S): Plavix
Drug Interaction	DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: tipranavir. If you are currently taking aspirin, consult your doctor promptly and ask whether to continue or stop taking it with this medication for your specific condition (aspirin and clopidogrel may be used in combination after a coronary stent procedure, or for some heart conditions). If you are not currently taking aspirin, consult your doctor before starting it for any medical condition. Other medications can affect the removal of clopidogrel from your body, which may affect how clopidogrel works. Examples include certain acid reducers (proton pump inhibitors/PPIs such as omeprazole, esomeprazole), cimetidine, etravirine, felbamate, fluconazole, fluoxetine, fluvoxamine, ketoconazole, rifampin, ticlopidine, voriconazole, among others. Clopidogrel can slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include repaglinide, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin). These drugs may increase the risk of bleeding/antiplatelet effect when used with clopidogrel. Ask your pharmacist about using these products safely.
Drug Interaction	DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: tipranavir. If you are currently taking aspirin, consult your doctor promptly and ask whether to continue or stop taking it with this medication for your specific condition (aspirin and clopidogrel may be used in combination after a coronary stent procedure, or for some heart conditions). If you are not currently taking aspirin, consult your doctor before starting it for any medical condition. Other medications can affect the removal of clopidogrel from your body, which may affect how clopidogrel works. Examples include certain acid reducers (proton pump inhibitors/PPIs such as omeprazole, esomeprazole), cimetidine, etravirine, felbamate, fluconazole, fluoxetine, fluvoxamine, ketoconazole, rifampin, ticlopidine, voriconazole, among others. Clopidogrel can slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include repaglinide, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin). These drugs may increase the risk of bleeding/antiplatelet effect when used with clopidogrel. Ask your pharmacist about using these products safely.
Allocation Period	-
Allocation Period	-
Case Quantity	24
Case Quantity	24
Drug Form Pack Size	90
Drug Form Pack Size	90
Form	TABLET
Form	TABLET
Hazard Code	-
Hazard Code	-
Listed Chemical	-
Listed Chemical	-
NIOSH Code	-
NIOSH Code	-
Orange Book	AB Products meeting necessary bioequivalence requirements.
Orange Book	AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity	1
Retail Pack Quantity	1
Returnable Status	Returnable
Returnable Status	Returnable
Special Storage Cond	00 None
Special Storage Cond	00 None
Temp Zone	10 Room Temperature
Temp Zone	10 Room Temperature
Unit	EA
Unit	EA
Unit Size	90
Unit Size	90
How to Use	HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking clopidogrel and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. The dosage and length of treatment are based on your medical condition and response to treatment. If you are taking this medication to prevent clots after a stent implant or other procedure, take this medication with aspirin for many months to years after the procedure (depending on the procedure/type of stent) as directed by your doctor. Consult your doctor for more details and about the risks of stopping early. Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. Get medical help right away if you have any signs that this medication is not working, such as symptoms of a new heart attack or stroke (such as chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, trouble speaking, sudden vision changes, confusion).
How to Use	HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking clopidogrel and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. The dosage and length of treatment are based on your medical condition and response to treatment. If you are taking this medication to prevent clots after a stent implant or other procedure, take this medication with aspirin for many months to years after the procedure (depending on the procedure/type of stent) as directed by your doctor. Consult your doctor for more details and about the risks of stopping early. Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. Get medical help right away if you have any signs that this medication is not working, such as symptoms of a new heart attack or stroke (such as chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, trouble speaking, sudden vision changes, confusion).
Missed Dose	MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Missed Dose	MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes	NOTES: Do not share this medication with others. Lab and/or medical tests (such as complete blood count) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes	NOTES: Do not share this medication with others. Lab and/or medical tests (such as complete blood count) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose	OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose	OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation	(kloe-PID-oh-grel)
Phonetic Pronunciation	(kloe-PID-oh-grel)
Precautions	PRECAUTIONS: Before taking clopidogrel, tell your doctor or pharmacist if you are allergic to it; or to similar antiplatelet drugs (thienopyridines such as prasugrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding conditions (such as stomach ulcers, bleeding in the brain/eye), recent surgery, serious injury/trauma, liver disease, bleeding disease (such as hemophilia). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may instruct you to stop clopidogrel for at least 5 days before surgery. Do not stop taking clopidogrel without talking with your heart doctor (cardiologist) first. This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions	PRECAUTIONS: Before taking clopidogrel, tell your doctor or pharmacist if you are allergic to it; or to similar antiplatelet drugs (thienopyridines such as prasugrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding conditions (such as stomach ulcers, bleeding in the brain/eye), recent surgery, serious injury/trauma, liver disease, bleeding disease (such as hemophilia). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may instruct you to stop clopidogrel for at least 5 days before surgery. Do not stop taking clopidogrel without talking with your heart doctor (cardiologist) first. This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects	SIDE EFFECTS: Easy bleeding/bruising, stomach upset/pain, diarrhea, and constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Although unlikely, serious bleeding in the stomach, gut, eyes, or brain may occur. Also, clopidogrel can rarely cause a very serious blood disorder (thrombotic thrombocytopenic purpura-TTP). Symptoms may appear any time after starting this medication. Get medical help right away if any of these symptoms occur: severe stomach/abdominal pain, uncontrolled bleeding from gums or nose, bloody/black stools, confusion, fever, extreme skin paleness, purple skin patches, fainting, fast heartbeat, sudden severe headache, unusual weakness/tiredness, vomit with blood or that looks like coffee grounds, trouble speaking, vision changes, seizures, yellowing eyes/skin, bloody/red/pink/dark urine, signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects	SIDE EFFECTS: Easy bleeding/bruising, stomach upset/pain, diarrhea, and constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Although unlikely, serious bleeding in the stomach, gut, eyes, or brain may occur. Also, clopidogrel can rarely cause a very serious blood disorder (thrombotic thrombocytopenic purpura-TTP). Symptoms may appear any time after starting this medication. Get medical help right away if any of these symptoms occur: severe stomach/abdominal pain, uncontrolled bleeding from gums or nose, bloody/black stools, confusion, fever, extreme skin paleness, purple skin patches, fainting, fast heartbeat, sudden severe headache, unusual weakness/tiredness, vomit with blood or that looks like coffee grounds, trouble speaking, vision changes, seizures, yellowing eyes/skin, bloody/red/pink/dark urine, signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage	STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage	STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses	USES: Clopidogrel is used to prevent heart attacks and strokes in persons with heart disease (recent heart attack), recent stroke, or blood circulation disease (peripheral vascular disease). It is also used with aspirin to treat new/worsening chest pain (new heart attack, unstable angina) and to keep blood vessels open and prevent blood clots after certain procedures (such as cardiac stent). Clopidogrel works by blocking platelets from sticking together and prevents them from forming harmful clots. It is an antiplatelet drug. It helps keep blood flowing smoothly in your body.
Uses	USES: Clopidogrel is used to prevent heart attacks and strokes in persons with heart disease (recent heart attack), recent stroke, or blood circulation disease (peripheral vascular disease). It is also used with aspirin to treat new/worsening chest pain (new heart attack, unstable angina) and to keep blood vessels open and prevent blood clots after certain procedures (such as cardiac stent). Clopidogrel works by blocking platelets from sticking together and prevents them from forming harmful clots. It is an antiplatelet drug. It helps keep blood flowing smoothly in your body.

Product Details