国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
McKesson Packaging Services a business unit of McKesson Corporation
HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE 7.5 mg
ORAL
PRESCRIPTION DRUG
Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term (generally less than 10 days) management of acute pain. Hydrocodone Bitartrate and ibuprofen are not indicated for the treatment of such conditions as ostearthritis or rheumatoid arthritis. Hydrocodone bitartrate and ibuprofen tablets should not be administered to patients who previously have exhibited hypersensitivity to hydrocodone or ibuprofen. Hydrocodone bitartrate and ibuprofen should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or the NSAIDs. Severe, rarely fatal, anaphylactoid-like reactions to NSAIDs have been reported in such patients (see WARNINGS-Anaphylactoid Reactions, and PRECAUTIONS-Pre-existing Asthma). Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Controlled Substance : Hydrocodone bitartrate and ibuprofen tablets are a Schedule III controlled substance. Abuse : Psychic dependence, physical depen
Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg / 200 mg are available as: White film-coated, round, biconvex tablets, debossed with “IP” over “145” on one side and plain on the other side. Boxes of 10x10 UD 100 NDC 63739-557-10 Storage : Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND IBUPROFEN TABLET MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION ---------- HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MG DESCRIPTION Hydrocodone bitartrate and ibuprofen tablets are supplied in a fixed combination tablet form for oral administration. Hydrocodone bitartrate and ibuprofen tablets combine the opioid analgesic agent, hydrocodone bitartrate, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen. Hydrocodone bitartrate is a semisynthetic and centrally acting opioid analgesic. Its chemical name is: 4, 5 α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its chemical formula is: C H NO •C H O •21/2 H O, and the molecular weight is 494.50. Its structural formula is: Ibuprofen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties. Its chemical name is: (±)-2-(p-isobutylphenyl) propionic acid. Its chemical formula is C H O , and the molecular weight is: 206.29. Its structural formula is: silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, pregelatinized starch, and titanium dioxide. CLINICAL PHARMACOLOGY _HYDROCODONE COMPONENT:_ Hydrocodone is a semisynthetic opioid analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opioids is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, opioids may produce drowsiness, changes in mood, and mental clouding. _IBUPROFEN COMPONENT_: Ibuprofen is a non-steroidal anti-inflammatory agent that possesses analgesic and 18 21 3 4 6 6 2 13 18 2 antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to inhibition of cyclo 完全なドキュメントを読む