ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Tersedia dari:

McKesson Contract Packaging

INN (Nama Internasional):

ACETAMINOPHEN

Komposisi:

ACETAMINOPHEN 300 mg

Jenis Resep:

PRESCRIPTION DRUG

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
MCKESSON CONTRACT PACKAGING
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
0050
0150
0350
RX ONLY
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 M.W. 151.16
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:
C
H NO •H PO •1/2H O M.W. 406.37
Each tablet contains:
acetaminophen...........................300 mg
codeine phosphate.......................15 mg
(Warning: May be habit forming)
OR
acetaminophen...........................300 mg
codeine phosphate....................... 30 mg
(Warning: May be habit forming)
8
9
2
18
21
3
3
4
2
OR
acetaminophen...........................300 mg
codeine phosphate....................... 60 mg
(Warning: May be habit forming)
In addition, each tablet contains the following inactive ingredients:
corn starch, colloidal silicon
dioxide, croscarmellose sodium, magnesium stearate, and
microcrystalline cellulose. The 300 mg/60
mg strength tablets also contain crospovidone, 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.
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