ACETAMINOPHEN AND CODEINE PHOSPHATE solution

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 ANHYDROUS - UNII:UX6OWY2V7J)

Sẵn có từ:

Apotheca Inc.

INN (Tên quốc tế):

ACETAMINOPHEN

Thành phần:

ACETAMINOPHEN 120 mg in 5 mL

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain. Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. Acetaminophen and codeine phosphate oral solution is classified as a Schedule V 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 Oral Solution, USP is an amber colored, cherry flavored solution containing 120 mg acetaminophen and 12 mg codeine phosphate/5 mL supplied in 180mL bottles. Store at15° to 30°C (59° to 86°F) [see Controlled Room Temperature]. Protect from light. Do not refrigerate. Dispense in tight, light-resistant container as defined in the official compendium. Rx only Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Repacked by Apotheca, Inc Phoenix, AZ 85006

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
APOTHECA INC.
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ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP
120 MG/12 MG PER 5 ML
BOXED WARNING
HEPATOTOXICITY
Acetaminophen has been associated with cases of acute liver failure,
at times resulting in liver
transplant and death. Most of the cases of liver injury are associated
with the use of
acetaminophen at doses that exceed 4000 milligrams per day, and often
involve more than one
acetaminophen-containing product.
WARNING: DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO
MORPHINE
RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO
RECEIVED CODEINE
FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY AND HAD EVIDENCE OF BEING
ULTRA-RAPID
METABOLIZERS OF CODEINE DUE TO A CYP2D6 POLYMORPHISM.
DESCRIPTION
Acetaminophen and codeine phosphate oral solution is pharmacologically
classified as an analgesic.
Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a non-
opiate, nonsalicylate 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 5 mL, for oral administration, contains:
Acetaminophen 120 mg
Codeine Phosphate 12 mg
(Warning: May be habit forming)
Alcohol 7%
In addition the following inactive ingredients are present: artificial
cherry flavor, citric acid, FD&C
Yellow No. 6, propylene glycol, purified water, saccharin sodium,
sodium benzoate, and sucrose.
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