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:

Physicians Total Care, 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. 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:

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg. It is available as a round, white to off-white tablet debossed with "3" on one side and an on the other side. Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with "4" on one side and an  on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.   is a trademark of Mallinckrodt Inc. Mallinckrodt Inc. Hazelwood, MO 63042 USA Rev 06/2011 Mallinckrodt COVIDIEN™ Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ACETAMINOPHEN AND CODEINE PHOSPHATE - ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP
(300 MG/15 MG, 300 MG/30 MG, 300 MG/60 MG)
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.
DESCRIPTION
Acetaminophen and codeine phosphate 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-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:
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg)
contains:
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg)
contains:
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg)
contains:
In addition, each Acetaminophen and Codeine Phosphate Tablet USP
contains the following inactive
ingredients: crospovidone, magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized
starch, 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 of the individual components is described below.
CODEINE – Codeine is readily absorbed from the gastrointestinal
tract. It is rapidly distributed from the
intravascular spaces to the various body tissues, with preferential
uptake by parenchymatous organs
such as the liver, spleen and kidney. Codeine crosses the blood-brain
b