acetaminophen and codeine phosphate- Acetaminophen and Codeine Phosphate tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

UAD LABORATORIES

INN (Nama Internasional):

Acetaminophen and Codeine Phosphate

Bentuk farmasi:

TABLET

Komposisi:

650 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

Acetaminophen and Codeine Phosphate Tablets USP, 650 mg/60 mg are available as a capsule-shaped, white, uncoated, unprinted tablet single-scored on one side, in bottles of 100, NDC 0785-6270-01 and in bottles of 500, NDC 0785-6270-50. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container with a child-resistant closure. CAUTION: Federal law prohibits dispensing without prescription.

Karakteristik produk

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
UAD LABORATORIES
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII
650 MG/60 MG
DESCRIPTION
Acetaminophen and codeine is supplied in tablet form for oral
administration.
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:
C H NO MW = 151.16
Codeine phosphate, 7,8-didehydro-4, 5
α-epoxy-3-methoxy-17-methylmorphinan-6 α-ol phosphate
(1:1)(salt) hemihydrate, a white crystalline powder, is a narcotic
analgesic and antitussive. It has the
following structural formula:
C
H NO H PO ½H O MW = 406.37
Each tablet contains:
Acetaminophen.........................................650 mg
Codeine Phosphate....................................60 mg
(Warning: May be habit forming)
In addition each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, crospovidone, microcrystalline cellulose,
povidone, pregelatinized starch and
stearic acid.
CLINICAL PHARMACOLOGY
This product combines the analgesic effects of a centrally acting
analgesic, codeine, with a
peripherally acting analgesic, acetaminophen.
8
9
2
18
21
3•
3
4•
2
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 kid