Product Overview
[Drug Name]
Generic Name: Clopidogrel Bisulfate Tablets
Trade Name: Taijia
English Name: Clopidogrel Bisulfate Tablets
Chinese Pinyin: Liusuan Lvbigelei Pian
[Ingredients]
The main ingredient of this product is clopidogrel sulfate.
[Properties]
This product is white or off-white tablets.
[Indications]
For the prevention and treatment of circulatory disorders of the heart, brain, and other arteries caused by hyperplatelet aggregation.
[Dosage and Administration]
Oral administration, can be taken with or without food. Two tablets once daily.
[Adverse Reactions]
Occasional gastrointestinal reactions (such as abdominal pain, indigestion, constipation, or diarrhea), rash, and mucocutaneous bleeding may occur. Rarely, leukopenia and granulocytopenia may occur.
[Contraindications]
1. This product is contraindicated in patients with allergies to its ingredients. 2. This product is contraindicated in patients with recent active bleeding (such as peptic ulcers or intracranial hemorrhage). [Precautions] 1. Patients using this drug should inform their surgeon if surgery is required. 2. Use with caution in patients with liver damage or bleeding tendency. 3. No dose adjustment is required for patients with renal insufficiency.
[Special Population Use]
Precautions for Pediatric Use:
The safety and efficacy of this drug in pediatric settings have not been established.
Precautions for Pregnancy and Lactation:
Reproductive studies in rats and rabbits have shown that clopidogrel has no effect on fertilization or the fetus. Similarly, there are no adequate, rigorously controlled studies in pregnant women, so this drug is not recommended for use during pregnancy. Studies in rats have shown that clopidogrel and/or its metabolites are excreted in breast milk, but it is unknown whether this drug is excreted in human breast milk.
Precautions for the Elderly:
Plasma concentrations of the main metabolite in elderly individuals (≥75 years) are significantly higher than in young, healthy volunteers. However, the higher plasma concentrations are not associated with differences in platelet aggregation or bleeding time, so dose adjustment is not necessary for the elderly.
[Drug Interactions]
Aspirin: This product increases the inhibitory effect of aspirin on collagen-induced platelet aggregation. Further studies are lacking regarding the safety of long-term coadministration. Heparin: Studies in healthy volunteers have shown no interaction between this product and heparin. However, caution should be exercised when coadministering these drugs. Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of this product with naproxen in healthy volunteers increased gastrointestinal occult blood loss. Therefore, caution should be exercised when coadministering this product with NSAIDs. Warfarin: No safety studies have been conducted regarding coadministration.
[Pharmacological Actions]
1. This product is a platelet aggregation inhibitor that selectively inhibits the binding of ADP to platelet receptors, subsequently inhibiting the activation of the ADP complex with glycoprotein GPⅡb/Ⅲa, thereby inhibiting platelet aggregation.
2. This product also inhibits platelet aggregation induced by pathways other than ADP without affecting phosphodiesterase activity. This product irreversibly alters platelet ADP receptors, thereby affecting platelet lifespan.
[Storage] Store in a cool, dry place (not exceeding 20°C) in a dark, sealed container.
[Specification] 25mg x 20 tablets
[Packaging] Bottle/box
[Expiry Date] 24 months
[Approval Number] National Medicine Standard H20000542
[Manufacturer] Company Name: Shenzhen Xinlitai Pharmaceutical Co., Ltd.
