ACETAMINOPHEN AND CODEINE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

DIRECT RX

INN (Kansainvälinen yleisnimi):

ACETAMINOPHEN

Koostumus:

ACETAMINOPHEN 300 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
DIRECT RX
----------
ACETAMINOPHEN AND CODEINE
BOXED WARNING SECTION
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 SECTION
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 SECTION
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.
The behavior on the individual components is described below.
Codeine
Codeine is rapidly absorbed