codrix- acetaminophen and codeine phosphate tablet

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:

Andrx Laboratories, Inc.

INN (International Name):

acetaminophen and codeine phosphate

Pharmaceutical form:

TABLET

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CODRIX™ is 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. CODRIX™ is 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.

Product summary:

CODRIX™ (acetaminophen and codeine phosphate tablets, USP), 500 mg/30 mg are oval, light pink tablets with the “” imprinted on one side and "712" imprinted on the other side. Bottles of 100 Tablets       NDC 62022-712-01 Bottles of 500 Tablets       NDC 62022-712-05 Bottles of 1000 Tablets      NDC 62022-712-50 Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP]. Dispense in tight, light-resistant container as defined in the USP. Manufactured by: Andrx Pharmaceuticals, Inc. Fort Lauderdale, FL 33314 Manufactured for: Andrx Laboratories, Inc. Weston, FL 33331 Rev. date: 08/07 7214

Summary of Product characteristics

CODRIX- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
ANDRX LABORATORIES, INC.
----------
CODRIX™
(ACETAMINOPHEN
AND CODEINE PHOSPHATE
TABLETS, USP)
CIII
RX ONLY
DESCRIPTION
Acetaminophen and codeine is supplied in tablet form for oral
administration.
Acetaminophen, 4'-hydroxyacetanalide, 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 tablet contains:
Acetaminophen 500 mg
Codeine phosphate 30 mg
In addition each tablet contains the following inactive ingredients:
Colloidal silicon dioxide,
crospovidone, croscarmellose sodium, FD&C red #40 Aluminium Lake,
magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized starch and
stearic acid.
CLINICAL PHARMACOLOGY
This product combines the analgesic effects of a centrally acting
analgesic, codeine, with the
peripherally acting analgesics, 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