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In addition to requiring new labeling on these prescript"...
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. [see WARNINGS AND PRECAUTIONS]
- ZORVOLEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. [see CONTRAINDICATIONS]
- NSAIDs cause an increased risk of serious gastrointestinal 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 gastrointestinal events. [see WARNINGS AND PRECAUTIONS]
ZORVOLEX (diclofenac) capsules contain the active ingredient diclofenac which is a benzeneacetic acid based nonsteroidal anti-inflammatory drug (NSAID). ZORVOLEX is available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name of diclofenac is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following structural formula.
The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink.
Last reviewed on RxList: 10/31/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Zorvolex Information
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