ACETAMINOPHEN AND CODEINE PHOSPHATE solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Proficient Rx LP

DCI (Dénomination commune internationale):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 120 mg in 5 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain. 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.

Descriptif du produit:

Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: NDC 63187-291-04 (4 fl. oz. bottles) Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
PROFICIENT RX LP
----------
ACETAMINOPHEN AND CODEINE
PHOSPHATE ORAL SOLUTION USP
CV
RX ONLY
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 oral solution is pharmacologically
classified as an analgesic.
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 5 mL, for oral administration, contains:
Acetaminophen
120 mg
Codeine Phosphate
12 mg
Alcohol
7%
INACTIVE INGREDIENTS: FD&C Red No. 40, FD&C Yellow No. 6 (Sunset
Yellow), flavoring,
glycerin, propylene glycol, purified water, sodium saccharin, 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
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
barrier, and is found in fetal tissue
and breast milk. The plasma concentration does not correlate with
brain concentration or relief of pain;
however, codeine is not bound to plasma proteins and does not
accumulate in body tissues.
The pl