ACETAMINOPHEN AND CODEINE- acetaminophen and codeine phosphate tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

STAT RX USA LLC

INN (Tên quốc tế):

ACETAMINOPHEN

Thành phần:

ACETAMINOPHEN 300 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

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 30, 50, 60, 90, 100, 120, 180, 500 and 1000. Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2065" and "V" on one side and debossed "4" on the reverse side. They are supplied in bottles of 100, 500 and 1000.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

ACETAMINOPHEN AND CODEINE - ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
STAT RX USA LLC
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP
300 MG/30 MG AND 300 MG/60 MG
CIII
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:
Codeine phosphate,
7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate
(1:1)
(salt) hemihydrate, a white crystalline powder, is a narcotic
analgesic and antitussive. It has the
following structural formula:
Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains:
Acetaminophen
......................................................................................................300
mg
Codeine Phosphate
..................................................................................................30
mg
Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains:
Acetaminophen
......................................................................................................300
mg
Codeine Phosphate
..................................................................................................60
mg
In addition each tablet contains the following inactive ingredients:
magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized corn starch, sodium metabisulfite,
sodium starch glycolate 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 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 cro