ACETAMINOPHEN WITH CODEINE- acetaminophen, codeine phosphate tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

PharmPak, Inc.

DCI (Dénomination commune internationale):

CODEINE PHOSPHATE

Composition:

CODEINE PHOSPHATE 30 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

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, 50, 60, 90, 100, 120, 180, 500 and 1000.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ACETAMINOPHEN WITH CODEINE - ACETAMINOPHEN, CODEINE PHOSPHATE TABLET
PHARMPAK, INC.
----------
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.
CONTROLLED SUBSTANCE SECTION
CIII
Rx only
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
INACTIVE INGREDIENTS
In addition each tablet contains the following inactive ingredients:
magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized corn starch, sodium metabisulfite,
sodium starch glycolate and
stearic acid.
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 compo