and Drug Administration for the treatment of acute migraine1
acute treatment of migraine. Empty the contents of
one packet into a cup containing 1 to 2 ounces
(30 to 60 mL) of water, mix well and drink
immediately. Do not use liquids other than water.1
Indication and Limitations of Use
CAMBIA® (Diclofenac Potassium for Oral Solution) is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). CAMBIA is not indicated for the prophylactic therapy of migraine. The safety and effectiveness of CAMBIA have not been established for cluster headache.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) 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. CAMBIA is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs increase the risk of serious gastrointestinal (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 gastrointestinal events.