Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)
Avera McKennan Hospital
KETOPROFEN
KETOPROFEN 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
KETOPROFEN- KETOPROFEN CAPSULE AVERA MCKENNAN HOSPITAL ---------- KETOPROFEN CAPSULES USP RX ONLY CARDIOVASCULAR THROMBOTIC EVENTS • • GASTROINTESTINAL RISK • 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 Drug Product Lactose, magnesium stearate, and sodium starch glycolate. 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). 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). 16 14 3 Capsule Shell Constituents Gelatin, printing ink, sodium lauryl sulfate, titanium dioxide, D&C Red #28, and FD&C Blue #1. 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 ani Perskaitykite visą dokumentą