Item nanme:Clopidogrel Sulfate Tablets Item character:This product is white
Indication: Prevention of atherothrombotic events in the following patients:
·Patients with myocardial infarction (from a few days to less than 35 days), ischemic stroke (from 7 days to less than 6 months), or peripheral arterial disease.
·Patients with acute coronary syndrome
-Patients with non ST elevation acute coronary syndrome (including unstable angina or non-Q-wave myocardial infarction), including stent implantation after percutaneous coronary intervention, are treated with aspirin.
-For patients with ST segment elevation acute coronary syndrome, combined with aspirin, can be combined in thrombolytic therapy.
Item specifications:75mg*7tab/box
Usage and dosage:Prevention of atherothrombotic events in the following patients:
·Patients with myocardial infarction (from a few days to less than 35 days), ischemic stroke (from 7 days to less than 6 months), or peripheral arterial disease.
·Patients with acute coronary syndrome
-Patients with non ST elevation acute coronary syndrome (including unstable angina or non-Q-wave myocardial infarction), including stent implantation after percutaneous coronary intervention, are treated with aspirin.
-For patients with ST segment elevation acute coronary syndrome, combined with aspirin, can be combined in thrombolytic therapy.
Adverse reactions Clinical research experience: the safety of clopidogrel has been evaluated in more than 42000 patients, of which 9000 patients have been treated for no less than 1 year. Data on clinical related adverse reactions observed in CAPRIE, cure, registry, and commit were included. In CAPRIE study, clopidogrel 75mg/ day was more tolerable than aspirin 325mg/ day. In this study, clopidogrel was similar in overall tolerance to aspirin, regardless of age, gender and race.
From the clinical research abroad, the incidence of adverse reactions ≥ 0.1%, all serious adverse reactions and drug-related adverse reactions are listed in the following categories according to the World Health Organization. The incidence of adverse reactions was defined as: common (>1/100, 10); uncommon (>1/1000100); rare (>1/10000, < 1/1000).
In each frequency group, adverse effects were ranked in decreasing severity.
Central and peripheral nervous system abnormality:
- unusual: headache, dizziness and sensory abnormalities
- rare: Vertigo
Gastrointestinal system abnormality:
- common: diarrhea, abdominal pain and indigestion
- unusual: gastric ulcer, duodenal ulcer, gastritis, vomiting, nausea, constipation, gastrointestinal flatulence.
Platelet, bleeding and coagulation abnormalities:
- unusual: prolonged bleeding time and thrombocytopenia
Abnormal skin and appendages:
- unusual: rash and itch
Leukocytes and res (reticuloendothelial system) were abnormal:
- unusual: leucopenia, neutrophil reduction and eosinophil increase
Post IPO experience:
In post market reports, bleeding is the most common adverse effect and most often occurs within the first month of treatment.
Bleeding: some bleeding patients have been reported with fatal consequences (especially intracranial, gastrointestinal and retroperitoneal bleeding); severe skin bleeding (purpura), musculoskeletal hemorrhage (hematoma), eye hemorrhage (conjunctiva, intraocular, retina), nasal bleeding, respiratory tract hemorrhage (hemoptysis, pulmonary hemorrhage), hematuria and surgical wound bleeding have been reported; there are already reports of patients Serious bleeding caused by clopidogrel + aspirin, or clopidogrel + aspirin + heparin.
The following adverse reactions have been reported in the post market report. "Very rare" means the occurrence rate is less than 1 / 10000. In each frequency group, adverse reactions were sorted by their severity.
Abnormal blood and lymph system:
- very rare: thrombocytopenic purpura (1/200000), severe thrombocytopenia (platelet count ≤ 30 × 109/l), granulocytopenia, granulocytopenia, aplastic anemia / whole blood cell reduction and anemia.
Immune system abnormality:
- very rare: allergic reactions, serologic diseases
Mental abnormality:
- very rare: confusion of consciousness, illusion
Abnormal nervous system:
- very rare: taste disorder
Vascular abnormality:
- very rare: vasculitis, hypotension
Abnormal breathing, chest and mediastinum:
- very rare: bronchospasm, interstitial pneumonia
Gastrointestinal abnormalities:
- very rare: pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Abnormal liver and gall:
- very rare: acute liver failure, hepatitis.
Abnormal skin and subcutaneous tissue:
- very rare: vascular (neurotic) edema, foaming dermatitis (erythema multiforme), erythema, urticaria, eczema, lichen planus.
Skeletal muscle, connective tissue and bone abnormality:
- very rare: joint pain, arthritis, myalgia
Renal and urinary tract abnormalities:
- very rare: glomerulonephritis.
General situation:
- very rare: fever.
Laboratory examination:
- very rare: abnormal liver function test, increased serum creatinine level
Taboo: 1. it is forbidden to be allergic to the active substances or any components of the product.
2. serious liver damage.
3. active pathological hemorrhage, such as peptic ulcer or pathological hemorrhage.
4. nursing.
Matters needing attention: Due to the risk of bleeding and hematological adverse reactions, blood cell count and / or other appropriate examinations should be performed immediately in case of clinical symptoms of bleeding during treatment. Like other antiplatelet drugs, clopidogrel should be used with caution in patients with increased risk of bleeding due to trauma, surgery or other pathological conditions, and in patients receiving aspirin, non steroidal anti-inflammatory drugs, heparin, platelet glycoprotein B / a (GP B / a) antagonists or thrombolytic drugs. Patients should be closely followed up and pay attention to any signs of bleeding, including occult bleeding Especially in the first few weeks of treatment and / or after cardiac intervention or surgery. Clopidogrel combined with warfarin is not recommended because it may aggravate the bleeding.
If antiplatelet therapy is not necessary, clopidogrel should be stopped more than 7 days before operation. Clopidogrel can prolong the bleeding time. Patients with bleeding diseases (especially gastrointestinal and intraocular diseases) should use it with caution. Patients should be told that when they take clopidogrel (alone or in combination with aspirin), the hemostasis time may be longer than usual, and patients should report abnormal bleeding (location and bleeding time) to their doctor. Patients should inform their doctors that they are taking clopidogrel before scheduling any surgery and before taking any new drugs.
Thrombotic thrombocytopenic purpura (TTP) rarely occurs after clopidogrel treatment, sometimes in a short time after treatment. It is characterized by thrombocytopenia, microangiopathic hemolytic anemia, accompanied by neurological manifestations, renal dysfunction or fever. TTP may threaten the patient's life and need immediate emergency treatment such as plasma exchange.
Clopidogrel is not recommended for patients with acute ischemic stroke (within 7 days) due to lack of relevant research data.
The experience of clopidogrel in patients with renal impairment is limited. Therefore, these patients should be cautious in the use of clopidogrel.
Clopidogrel should be used with caution in patients with moderate liver disease who may have bleeding tendency due to their limited experience in the use of clopidogrel.
Patients with a rare genetic disease galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption should not use this drug.
After taking clopidogrel, there was no effect on driving or mechanical operation.
Medication for pregnant and lactating women: Pregnancy
Because there is no clinical data of taking clopidogrel during pregnancy, we should avoid using clopidogrel for pregnant women. Indirect or inter laboratory evidence suggests that clopidogrel has harmful effects on pregnancy, embryonic / fetal development, delivery or postnatal growth.
·Lactation
Studies in rats have shown that clopidogrel and / or other metabolites can be excreted from milk, but it is not clear whether the drug is excreted from human milk.
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Our Manufacture Factory Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.
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At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.
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