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)

Հասանելի է:

Mckesson Packaging Services a business unit of McKesson Corporation

INN (Միջազգային անվանումը):

ACETAMINOPHEN

Կազմը:

ACETAMINOPHEN 300 mg

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS
CIII
RX ONLY
OCTOBER 2011
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.
DESCRIPTION
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:
Codeine phosphate,
7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate
(1:1)
(salt) hemihydrate, a white crystalline powder, is a narcotic
analgesic and antitussive. It has the
following structural formula:
Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains:
Acetaminophen
......................................................................................................300
mg
Codeine Phosphate
..................................................................................................30
mg
Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains:
Acetaminophen
......................................................................................................300
mg
Codeine Phosphate
..................................................................................................60
mg
CLINICAL PHARMACOLOGY
This product combines the analgesic effects of a centrally acting
analgesic, codeine, with a
peripherally acting analgesic, acetaminophen.
PHARMACOKINETICS :
The behavior on the individual components is described below.
Codeine:
Codeine is readily absorbed from the gastrointestinal tract. It is
rapidly distribute