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(diclofenac potassium) Immediate-release Tablets 50 mg
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. (see WARNINGS.)
- CATAFLAM® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS, WARNINGS).
Gastrointestinal Bleeding, Ulceration, and Perforation
- NSAIDs cause an increased 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. (see WARNINGS.)
CATAFLAM® (diclofenac potassium immediate-release tablets) is a benzeneacetic acid derivative. CATAFLAM is available as immediate-release tablets of 50 mg (light brown) for oral administration. Diclofenac potassium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structural formula
The inactive ingredients in CATAFLAM include: calcium phosphate, colloidal silicon dioxide, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, maize starch, sucrose, talc, titanium dioxide.
What are the possible side effects of diclofenac (Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using diclofenac and call your doctor at once if you have a serious side effect such as:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain, urinating less than usual or not at...
What are the precautions when taking diclofenac potassium immediate-release tablets (Cataflam)?
See also Warning section.
Before taking diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring...
Last reviewed on RxList: 6/7/2016
This monograph has been modified to include the generic and brand name in many instances.
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