ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Quality Care Products, LLC

INN (International Name):

ACETAMINOPHEN

Sammensetning:

ACETAMINOPHEN 300 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg. It is available as a round, white to off-white tablet debossed with "2" on one side and an M on the other side. 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 M on the other side. 49999-060-06 49999-060-15 49999-060-12 49999-060-10 49999-060-20 49999-060-24 49999-060-30 49999-060-50 49999-060-60 49999-060-90 49999-060-00 49999-060-01 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 M 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™

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
QUALITY CARE PRODUCTS, LLC
----------
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/30 mg)
contains:
Acetaminophen USP . . . . . . . . . . . . . 300 mgCodeine Phosphate
USP . . . . . . . . . . . . .
30 mg
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg)
contains:
Acetaminophen USP . . . . . . . . . . . . . 300 mgCodeine Phosphate
USP . . . . . . . . . . . . .
60 mg
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 ti