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RiteMED Diclofenac

RiteMED Diclofenac Warnings

diclofenac

Manufacturer:

RiteMED

Distributor:

United Lab
Full Prescribing Info
Warnings
Cardiovascular Risk: Diclofenac, particularly at higher doses, is associated with an increased risk of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events, which can be fatal) that is comparable to COX-2 inhibitors. The risk may increase with the dose and duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
For patients with a high risk of developing an adverse cardiovascular event, other management strategies that do not include NSAIDs, particularly COX-2 inhibitors and diclofenac, should be considered first.
Treatment with diclofenac is not recommended in patients with pre-existing cardiovascular disease (congestive heart failure, ischemic heart disease, peripheral arterial disease) cerebrovascular disease, uncontrolled hypertension or patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking). These patients should be treated with diclofenac only after careful consideration.
Use of NSAIDs, such as diclofenac, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure.
Gastrointestinal Risk: NSAIDs, including diclofenac, cause an increased risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious GI events.
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