FLURBIPROFEN- flurbiprofen tablet, film coated
Mylan Pharmaceuticals Inc.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
? Cardiovascular Thrombotic Events
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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 and Precautions (5.1) ].
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Flurbiprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].
? Gastrointestinal Bleeding, Ulceration, and Perforation
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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 and Precautions (5.2) ].
1 INDICATIONS AND USAGE
Flurbiprofen tablets are indicated:
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For relief of the signs and symptoms of rheumatoid arthritis.
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For relief of the signs and symptoms of osteoarthritis.
2 DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of flurbiprofen tablets and other treatment options before deciding to use flurbiprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ].
After observing the response to initial therapy with flurbiprofen tablets, the dose and frequency should be adjusted to suit an individual patient�s needs.
For relief of the signs and symptoms of rheumatoid arthritis or osteoarthritis, the dosage is 200 mg to 300 mg per day, divided for administration two, three, or four times a day. The largest recommended single dose in a multiple-dose daily regimen is 100 mg.
3 DOSAGE FORMS AND STRENGTHS
Flurbiprofen Tablets, USP are available containing 50 mg or 100 mg of flurbiprofen, USP.
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The 50 mg tablets are beige, film-coated, round, unscored tablets debossed with M over 76 on one side of the tablet and blank on the other side.
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The 100 mg tablets are beige, film-coated, round, unscored tablets debossed with M over 93 on one side of the tablet and blank on the other side.