Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
FLURBIPROFEN (UNII: 5GRO578KLP) (FLURBIPROFEN - UNII:5GRO578KLP)
Bryant Ranch Prepack
FLURBIPROFEN
FLURBIPROFEN 100 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
FLURBIPROFEN- FLURBIPROFEN TABLET, FILM COATED BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLURBIPROFEN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLURBIPROFEN TABLETS. FLURBIPROFEN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1988 WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • RECENT MAJOR CHANGES Boxed Warning 5/2016 Warnings and Precautions, Cardiovascular Thrombotic Events (5.1) 5/2016 Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016 INDICATIONS AND USAGE Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for (1) • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS Flurbiprofen tablet USP, 100 mg (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • 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 (5.1) FLURBIPROFEN TABLETS ARE CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (4, 5.1) 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 (5.2) Relief of the signs and symptoms of rheumatoid arthritis Relief of the signs and symptoms of osteoarthritis Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2) The recommended starting dose of flurbiprofen tablets is 200 to 300 mg per day, divided for administration two, t Olvassa el a teljes dokumentumot