What Are the Common Clopidogrel Side Effects?

Clopidogrel bisulfate is suitable for patients with recent stroke, myocardial infarction, and diagnosed peripheral arterial disease.

Clopidogrel

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Clopidogrel hydrogen sulfate is suitable for those who have had recent episodes

[Drug Name] Common Name: Clopidogrel Hydrogen Sulfate Tablets Trade Name: Polyvig English Name: ClopidogrelHydrogenShlfateTablets English Trade Name: PLAVIX Chinese Pinyin: Liusuanqinglubigeleipian Main Ingredients and Chemical Name of this Product

[Character] Oral agent is a pink, round, biconvex, scored film-coated tablet with 75 on one side and 1171 on the other, containing 97.875 mg of clopidogrel hydrogen sulfate, equivalent to 75 mg of chlorine Pigreline.

[Pharmacology and toxicology] Pharmacodynamic properties:

After repeated oral clopidogrel 75mg, clopidogrel is absorbed

Bolivar is suitable for patients who have had a recent stroke, myocardial infarction, and diagnosed peripheral arterial disease. The drug reduces the incidence of atherosclerotic events (such as myocardial infarction, stroke, and vascular death.)

The recommended dose of Polyvi is 75 mg per day, with or without food. No dose adjustment is necessary for elderly patients.

The safety of clopidogrel was evaluated by treating more than 11,300 patients, of which more than 7,000 patients received treatment for one year or more. In a large clinical study (CAPRIE), taking 75 mg / day of clopidogrel was well tolerated compared with 325 mg / day of aspirin. Regardless of age, gender, and race, clopidogrel's overall tolerance is similar to aspirin. The main clinical adverse reactions in the CAPRIE trial are discussed below:

Bleeding:

The overall incidence of bleeding in patients receiving clopidogrel or aspirin was 9.3%. The incidence of severe bleeding events with clopidogrel and aspirin was 1.4% and 1.6%, respectively.

The incidence of gastrointestinal bleeding was 2.0% in patients receiving clopidogrel, 0.7% required hospitalization, and aspirin was 2.7% and 1.1%, respectively.

Compared with aspirin, patients taking clopidogrel had a higher incidence of other bleeding events (7.3% vs 6.5%), but the incidence of serious events was similar in the two treatment groups (0.6% vs 0.4%). Two treatments The most common adverse events in the group were purpura / bruise / hematoma, and nosebleeds, others were hematoma, hematuria, and eye bleeding (mainly conjunctival bleeding).

The incidence of intracranial hemorrhage was 0.4% for clopidogrel and 0.5% for aspirin.

Blood disease:

Severe neutrality in 6 patients

1. Allergic to medicine or any component of this product.

2.Severe liver damage

3. Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage.

In patients with acute myocardial infarction, clopidogrel is not recommended for the first few days of acute myocardial infarction.

Due to lack of relevant data, clopidogrel is not actively recommended for unstable angina pectoris, PTCA (with stent), CABG, and acute ischemic stroke (less than 7 days).

Concomitant with other antiplatelet drugs, clopidogrel should be used with caution in patients who may cause increased bleeding due to trauma, surgery or other pathological reasons. Patients underwent elective surgery and did not require antiplatelet therapy. Clopidogrel was discontinued one week before surgery.

Clopidogrel prolongs bleeding time and should be used with caution in patients with wounds (especially in the gastrointestinal tract and eyes).

Patients should be aware that clopidogrel may take longer to stop bleeding than usual. At the same time, patients should report abnormal bleeding to their doctors. Patients should inform their doctors before taking clopidogrel and before taking other new drugs.

Because patients with kidney damage have very limited experience with clopidogrel, they should be used with caution.

Patients with severe liver disease may have a tendency to bleed. Such patients have very limited experience with this drug and should be used with caution and clopidogrel.

Since warfarin also has a tendency to bleed, it is not recommended to use warfarin simultaneously with this medicine.

Because concurrent use of aspirin, non-steroidal antipyretic analgesics, heparin, and thrombolytic agents can increase the risk of bleeding, simultaneous use is not recommended ([see Drug Interactions]).

Clopidogrel should be used with caution in patients who are taking drugs that are prone to gastrointestinal damage (such as non-steroidal antipyretic analgesics) (see [Drug Interactions]).

No effect on driving or psychological testing after using this drug.

[Medication for pregnant and lactating women]

Reproductive studies in rats and rabbits have shown that clopidogrel has no effect on fertilization and the fetus. As there are not enough rigorous controlled studies in pregnant women, this drug is not recommended during pregnancy.

Studies in rats have shown that clopidogrel and / or its metabolites are excreted from milk, but it is not clear whether this drug is excreted from human milk.

[Children's medication] The safety and effectiveness of this product in pediatric use have not been determined.

[Medication for elderly patients]

The concentration of major metabolites in the elderly (not less than 75 years old) is significantly higher in plasma than young healthy volunteers, but higher plasma concentrations are not related to differences in platelet aggregation and bleeding time, so it is not necessary to adjust the dose for the elderly.

medicine interactions

Warfarin: See notes.

Aspirin (ASA)

Aspirin does not change the inhibitory effect of clopidogrel on platelet aggregation induced by ADP, but clopidogrel enhances the effect of aspirin on collagen-induced platelet aggregation. The use of aspirin 500mg with clopidogrel, taken twice a day and once, does not significantly increase the prolonged bleeding time caused by clopidogrel, and the safety of long-term simultaneous use of aspirin and clopidogrel has not been determined. (See [Notes]).

heparin:

In studies of healthy volunteers, clopidogrel did not change the effect of heparin on coagulation, and did not need to change the dose of heparin. Taking heparin at the same time did not affect the inhibitory effect of clopidogrel on platelet aggregation. Since the safety of simultaneous administration is not known, it should be used with caution.

Thrombolytic agents:

Patients with recent-onset myocardial infarction were evaluated for safety with clopidogrel, rt-PA, and heparin. The incidence of clinical bleeding was similar to the incidence of simultaneous administration of rt-PA and heparin with aspirin. Because clopidogrel has not been established for safety with other thrombolytic agents, caution should be used when using it. ([Precautions])

Nonsteroidal Antipyretic and Analgesics (NSALDS)

Healthy volunteers taking naproxen and clopidogrel at the same time are related to potential gastrointestinal bleeding. Due to the lack of studies on the interaction of clopidogrel with other nonsteroidal antipyretic analgesics, whether it is antipyretic with all nonsteroidal Both analgesia and simultaneous administration will increase gastrointestinal bleeding events without clearing. Therefore, caution should be exercised when nonsteroidal antipyretic analgesics and clopidogrel are taken orally. ([Precautions])

Other combination therapies:

Through a large number of clinical trials, the pharmacodynamic and pharmacokinetic interactions of clopidogrel have been studied. There was no significant clinical pharmacodynamic interaction between clopidogrel, atenolol and nifedipine alone or in combination, and clopidogrel and phenobarbital, cimetidine or The combination of estradiol did not significantly affect the pharmacodynamic activity of clopidogrel.

In combination with clopidogrel, the pharmacokinetic properties of digoxin and theophylline have not changed. Simultaneous use of antacids did not change clopidogrel absorption.

Human liver microsomal enzyme studies have shown that clopidogrel carboxyl metabolites can inhibit P450 (2C9) activity. Therefore, clopidogrel may increase the blood concentrations of certain drugs such as phenytoin, tolbutamide, and other nonsteroidal antipyretic and analgesic drugs that are metabolized by P450 (2C9). CAPRIE studies show that phenytoin and tolbutamide are safe in combination with clopidogrel.

[Drug overdose]

One case of overdose of Bolivar has been reported. A 34-year-old woman took 1,050 mg of clopidogrel at a time (equivalent to 14 tablets of 75 mg / tablet) without associated side effects and did not receive special treatment. The patient recovered without sequelae.

Healthy volunteers took 600 mg (equivalent to 8 tablets of 75 mg / tablet) clopidogrel at one time without any adverse reactions. The bleeding time extension factor was 1.7, which was the same as that observed with conventional doses (75 mg / day).

There is no antidote for clopidogrel. If a rapid return to normal bleeding time is required, platelet transfusion can be performed to antagonize the pharmacological effects of clopidogrel.

[Specifications] 75mg / tablet

[Packing] Double aluminum film packaging, 7 pieces / box, 14 pieces / box, 28 pieces / box

[Storage] No special storage requirements.

[Validity] 3 years

[Packaging enterprise] Hangzhou Sanofi Shengdebao Minsheng Pharmaceutical Co., Ltd.