Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
FLURBIPROFEN (UNII: 5GRO578KLP) (FLURBIPROFEN - UNII:5GRO578KLP)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Flurbiprofen tablets are indicated: Flurbiprofen tablets are contraindicated in the following patients: Risk Summary Use of NSAIDs, including flurbiprofen tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of flurbiprofen tablets use between about 20 and 30 weeks of gestation, and avoid flurbiprofen tablets use at about 30 weeks of gestation and later in pregnancy [see Clinical Considerations, Data ]. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including flurbiprofen tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
Flurbiprofen Tablets USP, 100 mg are round, convex, blue, film-coated tablets debossed “93” and “711” available in Bottles of 30 (NDC 68788-7341-3) Bottles of 60 (NDC 68788-7341-6) Bottles of 90 (NDC 68788-7341-9) Bottles of 100 (NDC 68788-7341-1) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
Preferred Pharmaceuticals Inc. ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). Dispense with Medication Guide available at: www.tevausa.com/medguides What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs” or “SNRIs” • increasing doses of NSAIDs • longer use of NSAIDs • smoking • • older age • poor health • advanced liver disease • drinking alcohol bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Przeczytaj cały dokument
FLURBIPROFEN- FLURBIPROFEN TABLET, FILM COATED PREFERRED PHARMACEUTICALS INC. ---------- 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._ • • • INDICATIONS AND USAGE Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS Tablets: 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 (1) Relief of the signs and symptoms of osteoarthritis (1) 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, three, or four times a day. The largest recommended single dose in a multiple- dose daily regimen is 100 mg (2) Known hypersensitivity to flurbiprofen or any components of the Przeczytaj cały dokument