ACETAMINOPHEN AND CODEINE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Tilgjengelig fra:

RxChange Co.

INN (International Name):

ACETAMINOPHEN

Sammensetning:

ACETAMINOPHEN 300 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain. Codeine-containing products are contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Acetaminophen and Codeine Phosphate Tablets should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. Controlled Substance Acetaminophen and Codeine Phosphate Tablets are classified as a Schedule III controlled substance. Drug Abuse and Dependence 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.

Produkt oppsummering:

Acetaminophen and Codeine Phosphate Tablets, USP 300 mg /30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse. They are available as follows: Bottles of 100:   NDC 65162-033-10 Bottles of 500:   NDC 65162-033-50 Bottles of 1000: NDC 65162-033-11 Store Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM-5PM EST Manufactured by: Amneal Pharmaceuticals Hauppauge, NY 11788 Rev. 10-2013

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
RXCHANGE CO.
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ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300MG/30MG
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.
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.
DESCRIPTION
Each tablet contains:
Acetaminophen,
USP……………………………………………………..300
mg
Codeine Phosphate,
USP…………………………………………………...30 mg
(Warning: May be habit forming)
Inactive ingredients: croscarmellose sodium, crospovidone, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized starch and
stearic acid.
Acetaminophen and codeine is supplied in tablet form for oral
administration.
Acetaminophen, 4'-hydroxyacetanlllde, IS 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-l7-methylmorphinan-6α-ol
phosphate (1:1)
(salt) hemihydrate, a white crystalline powder, is a narcotic
analgesic and antitussive. It has the
following structural formula:
CLINICAL PHARMACOLOGY
Acetaminophen and Codeine Phosphate Tablets 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 rapidly absorbed from the gastrointestinal tract. It is
rapidly distributed fr