ACETAMINOPHEN AND CODEINE PHOSPHATE solution

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:

ATLANTIC BIOLOGICALS COPR.

INN (International Name):

ACETAMINOPHEN

Sammensetning:

ACETAMINOPHEN 120 mg in 5 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate 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 oral solution is classified as a Schedule V 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:

NDC:17856-0079-1 in a CUP of 12.5 SOLUTIONS NDC:17856-0079-2 in a CUP of 10 SOLUTIONS NDC:17856-0079-4 in a CUP of 12 SOLUTIONS NDC:17856-0079-5 in a CUP of 5 SOLUTIONS

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
ATLANTIC BIOLOGICALS COPR.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP 120 MG/12 MG
PER 5 ML
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 phosphate oral solution is pharmacologically
classified as an analgesic.
Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a non-
opiate, nonsalicylate 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 5 mL, for oral administration, contains:
Acetaminophen 120 mg
Codeine Phosphate 12 mg
(Warning: May be habit forming)
Alcohol 7%
In addition the following inactive ingredients are present: artificial
cherry flavor, citric acid, FD&C
Yellow No. 6, propylene glycol, purified water, saccharin sodium,
sodium benzoate, and sucrose.
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
intrava