国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)
PD-Rx Pharmaceuticals, Inc.
KETOPROFEN
KETOPROFEN 75 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
KETOPROFEN- KETOPROFEN CAPSULE PD-RX PHARMACEUTICALS, INC. ---------- KETOPROFEN CAPSULES USP 3195 RX ONLY 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 WARNINGSand PRECAUTIONS). Ketoprofen capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). GASTROINTESTINAL RISK NSAIDs cause an increased risk of serious gastrointestinal 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 (GI) events (see WARNINGS). DESCRIPTION Ketoprofen capsules USP are a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen, USP is 2-(3-benzoylphenyl)-propionic acid with the following structural formula: C H O M.W. 254.29 It has a pKa of 5.94 in methanol: water (3:1) and an n-octanol: water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen, USP is a white or practically white, crystalline powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Ketoprofen capsules USP contain 50 mg or 75 mg of ketoprofen, USP for oral administration. INACTIVE INGREDIENTS CLINICAL PHARMACOLOGY 16 14 3 CLINICAL PHARMACOLOGY Ketoprofen is a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties. The anti-inflammatory, analgesic and antipyretic properties of ketoprofen have been demonstrated in classical animal and _in vitro_ test systems. In anti-inflammatory models ketoprofen has been shown to have inhibitory effects on prostaglandin and leukotriene synthesis, to have antibrad 完全なドキュメントを読む