ACETAMINOPHEN AND CODEINE- 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 ANHYDROUS - UNII:UX6OWY2V7J)

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen and codeine phosphate tablets are 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. Acetaminophen and Codeine Phosphate tablets are 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:

Acetaminophen and Codeine Phosphate Tablets 300 mg/30 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2064" and "V" on one side and debossed "3" on the reverse side. They are supplied in bottles of 10, 15 and 20.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
BLENHEIM PHARMACAL, INC.
----------
CIII
RX ONLY
CLINICAL PHARMACOLOGY
This product combines the analgesic effects of a centrally acting
analgesic, codeine, with a
peripherally acting analgesic, acetaminophen.
PHARMACOKINETICS :
The behavior on 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 10%),
normorphine (4%), and
hydrocodone (1%). The remainder of the dose is excreted in the feces.
At therapeutic doses, the analgesic effect reaches a peak within 2
hours and persists between 4 and 6
hours.
See OVERDOSAGE for toxicity information.
ACETAMINOPHEN:
Acetaminophen is rapidly absorbed from the gastrointestinal tract and
is distributed throughout most
body tissues. The plasma half-life is 1.25 to 3 hours, but may be
increased by liver damage and
following overdosage. Elimination of acetaminophen is principally by
liver metabolism (conjugation)
and subsequent renal excretion of metabolites. Approximately 85% of an
oral dose appears in the urine
within 24 hours of administration, most as the glucuronide conjugate,
with small amounts of other
conjugates and unchanged drug.
See OVERDOSAGE for toxicity inf