HYDROCODONE BITARTRATE AND IBUPROFEN tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Saatavilla:

McKesson Packaging Services a business unit of McKesson Corporation

INN (Kansainvälinen yleisnimi):

HYDROCODONE BITARTRATE

Koostumus:

HYDROCODONE BITARTRATE 7.5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET
MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION
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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