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출처: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
MedVantx, Inc.
IBUPROFEN
IBUPROFEN 400 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: 400 mg (white, round, biconvex, aqueous film-coated tablets, debossed “IP 464” on obverse and plain on reverse. They are available as follows: Bottles of 30: NDC 53746-464-30 Bottles of 60: NDC 53746-464-60 Bottles of 90: NDC 53746-464-90 Bottles of 100: NDC 53746-464-01 Bottles of 500: NDC 53746-464-05 600 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 53746-465-30 Bottles of 50: NDC 53746-465-50 Bottles of 60: NDC 53746-465-60 Bottles of 90: NDC 53746-465-90 Bottles of 100: NDC 53746-465-01 Bottles of 500: NDC 53746-465-05 800 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 53746-466-30 Bottles of 50: NDC 53746-466-50 Bottles of 60: NDC 53746-466-60 Bottles of 90: NDC 53746-466-90 Bottles of 100: NDC 53746-466-01 Bottles of 500: NDC 53746-466-05 Store at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Rx only
Abbreviated New Drug Application
IBUPROFEN- IBUPROFEN TABLET MEDVANTX, INC. ---------- IBUPROFEN TABLETS, USP RX ONLY CARDIOVASCULAR RISK GASTROINTESTINAL RISK 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 to aspirin in controlling pain and inflammation and to be associated with a statistically significant reduction in the milder gastrointestinal side effects (see ADVERSE REACTIONS). Ibuprofen tablets may be well tolerated in some patients who have had gastrointestinal side effects with aspirin, but these patients when treated with ibuprofen tablets should be carefully followed for signs and symptoms of gastrointestinal ulceration and bleeding. Although it is not definitely known whether ibuprofen tablets causes less peptic ulceration than aspirin, in one study involving 885 patients with rheumatoid arthritis treated for up to one year, there were no reports of gastric ulceration with ibuprofen tablets whereas frank ulceration was reported in 13 patients in the aspirin group (statistically signifi 전체 문서 읽기