ACETAMINOPHEN AND CODEINE- codeine phosphate and apap tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Northwind Pharmaceuticals, LLC

INN (Международно Name):

ACETAMINOPHEN

Композиция:

ACETAMINOPHEN 300 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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. Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine-containing products are contraindicated for post-operative pain management in all pediatric patients u

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ACETAMINOPHEN AND CODEINE- CODEINE PHOSPHATE AND APAP TABLET
NORTHWIND PHARMACEUTICALS, LLC
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ACETAMINOPHEN AND CODEINE
WARNING
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.
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 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 milk. The plasma concentration does not correlate with
brain concentration or relief of pain:
however, codeine is not bound to plasma proteins and does not
accumulate in body tissues. The plasma
half-life is about 2.9 hours. The elimination of codeine is primarily
via the kidneys, and about 90% of
an oral dose is excreted by the kidneys within 24 hours of dosing. The
urinary secretion products
consist of free and glucuronide (about 70%). free and conjugated
morphine (about 10%), normorphine
(4%) and hydrocodone (1%). The remainder of the dose is excreted in
the feces.
At therapeutic doses, the analgesic effect reaches a peak within 2
hours and persists between 4 and 6
hours.
See OVERDOSAGE for