ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Հասանելի է:

DirectRX

INN (Միջազգային անվանումը):

ACETAMINOPHEN

Կազմը:

ACETAMINOPHEN 300 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. - Controlled Substance Acetaminophen and codeine phosphate tablets are classified as a Schedule III controlled substance. Abuse and Dependence Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications. Acetaminophen and codeine phosphate tablets are classified as a Schedule III controlled substance. Codeine can produce drug dependence of the morp

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
DIRECTRX
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ACETAMINOPHEN AND CODEINE PHOSPHATE
BOXED WARNING SECTION
BOXED WARNING
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure,
at times resulting in liver
transplant and death. Most of the cases of liver injury are associated
with the use of
acetaminophen at doses that exceed 4000 milligrams per day, and often
involve more than one
acetaminophen-containing product.
WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to
Morphine
Respiratory depression and death have occurred in children who
received codeine following
tonsillectomy and/or adenoidectomy and had evidence of being
ultra-rapid metabolizers of
codeine due to a CYP2D6 polymorphism.
DESCRIPTION SECTION
Acetaminophen and codeine is supplied in tablet form for oral
administration.
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a
non-opiate, non-salicylate analgesic and antipyretic. It has the
following structural formula:
C8H9NO2 M.W. 151.16
Codeine phosphate,
7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate
(1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic
analgesic and antitussive. It has the
following structural formula:
C18H21NO3•H3PO4•1/2H2O M.W. 406.37
Each tablet contains:
acetaminophen...........................300 mg
codeine phosphate.......................15 mg
(Warning: May be habit forming)
OR
acetaminophen...........................300 mg
codeine phosphate....................... 30 mg
(Warning: May be habit forming)
OR
acetaminophen...........................300 mg
codeine phosphate....................... 60 mg
(Warning: May be habit forming)
In addition, each tablet contains the following inactive ingredients:
corn starch, colloidal silicon
dioxide, croscarmellose sodium, magnesium stearate, and
microcrystalline cellulose. The 300
mg/60 mg strength tablets also contain crospovidone, povidone,
pregelatinized starch,