ACETAMINOPHEN AND CODEINE- acetaminophen and codeine phosphate tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Liberty Pharmaceuticals, Inc.

INN (International Nazwa):

CODEINE PHOSPHATE

Skład:

CODEINE PHOSPHATE 30 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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. Acetaminophen and Codeine Phosphate tablets are classified as a Schedule III controlled substance. 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.

Podsumowanie produktu:

Acetaminophen and Codeine Phosphate Tablets 300 mg/30 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2064" and "V" on one side and debossed "3" on the reverse side. They are supplied in bottles of 30 and 40. Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2065" and "V" on one side and debossed "4" on the reverse side. They are supplied in bottles of 30 and 40.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
LIBERTY PHARMACEUTICALS, INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP
300 MG/30 MG AND 300 MG/60 MG
CIII
RX ONLY
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
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
In addition each tablet contains the following inactive ingredients:
magn