HYDROCODONE BITARTRATE AND IBUPROFEN tablet film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)

Доступно од:

St Marys Medical Park Pharmacy

INN (Међународно име):

HYDROCODONE BITARTRATE

Састав:

HYDROCODONE BITARTRATE 7.5 mg

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

HYDROCODONE BITARTRATE AND IBUPROFEN - HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET, FILM COATED
ST MARYS MEDICAL PARK PHARMACY
----------
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS
7.5 MG/200 MG
CIII
RX ONLY
DESCRIPTION
Each hydrocodone bitartrate and ibuprofen tablet 7.5 mg/200 mg
contains:
Hydrocodone Bitartrate, USP ................................ 7.5 mg
Ibuprofen, USP ......................................................
200 mg
Hydrocodone bitartrate and ibuprofen is supplied in a fixed
combination tablet form for oral
administration. Hydrocodone bitartrate and ibuprofen combines 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
4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate
(2:5). Its chemical formula is
C
H NO •C H O •2½H O, and the molecular weight is 494.50. Its
structural formula is:
Ibuprofen is a nonsteroidal anti-inflammatory agent [nonselective COX
inhibitor] 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:
18
21
3
4
6
6
2
13
18
2
Inactive ingredients include: colloidal silicon dioxide, hypromellose,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
povidone, pregelatinized starch,
sodium starch glycolate, 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