acetaminophen and codeine phosphate- Acetaminophen and Codeine Phosphate solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D), Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520)

Commercializzato da:

Pharmaceutical Associates, Inc.

INN (Nome Internazionale):

Acetaminophen and Codeine Phosphate

Forma farmaceutica:

SOLUTION

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: NDC 0121-0504-04 (4 fl. oz. bottles), NDC 0121-0504-16 (16 fl. oz. bottles), NDC 0121-0504-05 (unit dose cups of 5 mL, 10 x 10's), NDC 0121-0504-10 (unit dose cups of 10 mL, 10 x 10's), NDC 0121-0504-12 (unit dose cups of 12.5 mL, 10 x 10's), and NDC 0121-0504-15 (unit dose cups of 15 mL, 10 x 10's).

Scheda tecnica

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
----------
RX ONLY
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
Glycerin, propylene glycol, sodium saccharin, and sucrose, NF. Also
FD&C Red No. 40, FD&C
Yellow No. 6 (Sunset Yellow), flavoring, and purified water USP.
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 plasma half-life is about 2.9 hours. The elimination of codeine is
primarily via the kidneys, and
about 90% of an oral dose is excreted by the kidneys within 24 hours
of dosing. The urinary secretion
products consist of free and glucuronide conjugated codeine (about
70%), free and conjugated
norcodeine (about 10%), free and conjugated morphine (about