ACETAMINOPHEN AND CODEINE- acetaminophen and codeine phosphate tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D), Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J)

Предлага се от:

Mutual Pharmaceutical Company, Inc.

INN (Международно Name):

Acetaminophen

Композиция:

Acetaminophen 300 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. Codeine-containing products are contraindicated for post-operative 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.

Каталог на резюме:

Acetaminophen and codeine phosphate tablets (300 mg/15 mg) white, round, unscored, debossed MP 111 on one side and 2 on the other side. Available as follows: Acetaminophen and codeine phosphate tablets (300 mg/30 mg) white, round, unscored, debossed MP 122 on one side and 3 on the other side. Available as follows: Acetaminophen and codeine phosphate tablets (300 mg/60 mg) white, round, unscored, debossed MP 127 on one side and 4 on the other side. Available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
MUTUAL PHARMACEUTICAL COMPANY, INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII
RX ONLY
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:
C H NO M.W. 151.16
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:
8
9
2
C H NO •H PO •½H O M.W. 4 06.37
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, NF; croscarmellose
sodium, NF; magnesium stearate, NF; microcrystalline cellulose, NF;
polyvinylpyrrolidone; sodium
lauryl sulfate, NF; stearic acid, NF.
CLINICAL PHARMACOLOGY
This product combines the analgesic effects of a centrally acting
analgesic, codeine, with a
peripherally acting analgesic, acetaminophen.
PHARMACOKINETICS
T