País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
DIRECTRX
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets 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 patients . Ibuprofen tablets are contraindicated in the s
Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white, round shaped, film-coated tablets engraved "IBU" over "400" on one side). Bottles of 100 NDC 64380-809-06 Bottles of 500 NDC 64380-809-07 600 mg (white, oval shaped, biconvex film-coated tablets engraved "IBU" over "600" on one side) Bottles of 100 NDC 64380-808-06 Bottles of 500 NDC 64380-808-07 800 mg (white, capsule shaped, film-coated tablets engraved "IBU" over "800" on one side) Bottles of 100 NDC 64380-807-06 Bottles of 500 NDC 64380-807-07 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only Manufactured by: Strides Shasun Limited Puducherry-605 014, India. Distributed by: Strides Pharma lnc. East Brunswick, NJ 08816 Revised: 04/2018
Abbreviated New Drug Application
IBUPROFEN- IBUPROFEN TABLET, FILM COATED DIRECTRX ---------- Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white, round shaped, film-coated tablets engraved "IBU" over "400" on one side). Bottles of 100 NDC 64380-809-06 Bottles of 500 NDC 64380-809-07 600 mg (white, oval shaped, biconvex film-coated tablets engraved "IBU" over "600" on one side) Bottles of 100 NDC 64380-808-06 Bottles of 500 NDC 64380-808-07 800 mg (white, capsule shaped, film-coated tablets engraved "IBU" over "800" on one side) Bottles of 100 NDC 64380-807-06 Bottles of 500 NDC 64380-807-07 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only Manufactured by: Strides Shasun Limited Puducherry-605 014, India. Distributed by: Strides Pharma lnc. East Brunswick, NJ 08816 Revised: 04/2018 Revised: 10/2023 Document Id: 08653794-2b9e-eeab-e063-6394a90aef1f 34391-3 Set id: 82f8f9fd-7ae8-f0f4-e053-2a91aa0a7b8a Version: 7 Effective Time: 20231023 DIRECTRX Leer el documento completo
IBUPROFEN- IBUPROFEN TABLET, FILM COATED DIRECTRX ---------- IBUPROFEN 800 MG Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 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: [chem structure] Ibuprofen tablets, 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, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide. 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 . 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 significant p<.001). Gastroscopic studies at varying doses show an incr Leer el documento completo