Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
STAT Rx USA LLC
IBUPROFEN
IBUPROFEN 600 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted. Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patie
Ibuprofen Tablets, USP are available in the following strengths, colors and sizes: 600 mg (white, oval-shaped, biconvex, aqueous film-coated tablets, debossed “IP 465” on obverse and plain on reverse. They are available as follows: Bottles of 30: NDC 42549-517-30 Bottles of 40: NDC 42549-517-40 Bottles of 60: NDC 42549-517-60 Bottles of 90: NDC 42549-517-90 Bottles of 100: NDC 42549-517-00 Bottles of 120: NDC 42549-517-12 Bottles of 140: NDC 42549-517-04 800 mg (white, capsule-shaped, biconvex, aqueous film-coated tablets, debossed “IP 466” on obverse and plain on reverse. They are available as follows: Bottles of 30: NDC 42549-518-30 Bottles of 40: NDC 42549-518-40 Bottles of 60: NDC 42549-518-60 Bottles of 90: NDC 42549-518-90 Bottles of 100: NDC 42549-518-00 Bottles of 120: NDC 42549-518-12 Bottles of 140: NDC 42549-518-04 Store at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Rx only Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501 Rev. 09-2009
Abbreviated New Drug Application
IBUPROFEN - IBUPROFEN TABLET, FILM COATED STAT RX USA LLC ---------- IBUPROFEN TABLETS, USP RX ONLY CARDIOVASCULAR RISK NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS). Ibuprofen tablets are contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see 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 events. (See WARNINGS). DESCRIPTION Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (_p _– isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide. CLINICAL PHARMACOLOGY Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. In clinical studies in patients with rheumatoid arthritis and osteoarthritis, ibuprofen tablets have been shown to be comparable t Prečítajte si celý dokument