ACETAMINOPHEN AND CODEINE PHOSPHATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520)

Available from:

RedPharm Drug Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 120 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Acetaminophen and Codeine Phosphate Oral Solution, USP is an amber colored, cherry flavored syrup containing 120 mg acetaminophen and 12 mg codeine phosphate/5 mL supplied in 16 fl oz bottles. Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not refrigerate. Dispense in tight, light-resistant container as defined in the official compendium. Rx only Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev. 079:03 4/09 MG #11092

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE - ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
REDPHARM DRUG INC.
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ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP
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:
Citric acid, propylene glycol, sodium benzoate, saccharin sodium,
sucrose, artificial cherry flavor, FD
and C Yellow No. 6 and purified water.
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 co