| Dossier: | Ctd |
|---|---|
| Transport Package: | Free |
| Specification: | 200mg |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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| Generic Name | Celecoxib Capsules 200mg |
| Strength | 200mg |
| Packing | 10caps/blister,2blister/box |
| Origin | China |
This product is a capsule with white powder content.
The potential benefits and risks of this and other treatment options should be carefully considered before deciding to use this product. According to the treatment goals of each patient, the lowest effective dose is used for the shortest duration of treatment (see [Precautions]- Warnings).
1) Used to relieve the signs and symptoms of osteoarthritis.
2) Used to relieve the signs and symptoms of rheumatoid arthritis in adults.
3) For the treatment of acute pain in adults. (See [Clinical trials])
Matters needing attention:
Cardiovascular thrombotic events
Long-term use of this product may cause serious cardiovascular thrombotic adverse events and an increased risk of myocardial infarction and stroke, the risks of which may be fatal, and in the APC trial, the relative risk (RR) of the composite endpoint of cardiac death, myocardial infarction or stroke was 3.4 (95%CI: 1.4-8.5), the relative risk of 200mg twice daily was 2.5 (95%CI: 1.0-6.4) (see Special Study - Adenomatous Polyps Study).
All non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2-selective and non-selective drugs, may have similar risks, and the risk may be greater in patients with known cardiovascular disease or risk factors for cardiovascular disease. In order to minimize the potential risk of adverse cardiovascular events in patients treated with Celebrex, the lowest effective dose should be used for the shortest possible course of treatment, and physicians and patients should be vigilant about the occurrence of such events even if there are no prior cardiovascular symptoms. Patients should be informed of the symptoms and/or signs of serious cardiovascular safety and the steps to take if they occur. Patients should be alert to signs and symptoms such as chest pain, shortness of breath, weakness, and slurred speech, and seek medical help as soon as any of these signs or symptoms occur.
There is no consistent evidence that the increased risk of serious cardiovascular thrombotic events associated with the use of an NSAID is mitigated by the concurrent use of aspirin, and that the concurrent use of aspirin and NSAID increases the risk of serious gastrointestinal events (Wind gastrointestinal Warning).
In two large, controlled clinical trials using other COX-2-selective NSaids for pain in the first 10-14 days after CABG surgery, an increased incidence of myocardial infarction and stroke was found (see [contraindications]).
hypertension
As with all non-steroidal anti-inflammatory drugs (NSAIDs), this product can cause new hypertension or aggravate existing hypertension, any of which can lead to an increased incidence of cardiovascular events, and patients taking thiazines or pulpodiuretics taking NSAIDs may affect the effectiveness of these treatments. Patients with hypertension should use non-steroidal anti-gunpowder (NSAIDs) with caution, including this product. Blood pressure should be monitored closely at the beginning of treatment and throughout the course of treatment. In the CLASS trial, the incidence of hypertension in patients treated with ibuprofen and diclofenac was 2.4%, 4.5% and 2.5%, respectively (see Special Study -CLASS).
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