TYLENOL WITH CODEINE acetaminophen and phosphate tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

제공처:

PD-Rx Pharmaceuticals, Inc.

INN (국제 이름):

ACETAMINOPHEN

구성:

ACETAMINOPHEN 300 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

TYLENOL WITH CODEINE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
TYLENOL
WITH CODEINE
CIII
(ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLETS
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 4,000 MILLIGRAMS PER DAY, AND OFTEN
INVOLVE MORE THAN
ONE ACETAMINOPHEN-CONTAINING PRODUCT (SEE WARNINGS).
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
TYLENOL
with 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-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:
®
®
Tylenol with Codeine No. 3 tablets contain:
Acetaminophen
300 mg
Codeine Phosphate
30 mg
(Warning: May be habit forming)
Tylenol with Codeine No. 4 tablets contain:
Acetaminophen
300 mg
Codeine Phosphate
60 mg
(Warning: May be habit forming)
In addition, each tablet contains the following inactive ingredients:
TYLENOL
with Codeine No. 3 contains powdered cellulose, magnesium stearate,
sodium
metabisulfite
, pregelatinized starch (corn), and modified starch (corn).
TYLENOL
with Codeine No. 4 contains powdered cellulose, magnesium stearate,
sodium
metabisulfite
, pregelatinized starch (corn), and corn starch.
1
CLINICAL PHARMACOLOGY
This product combines the analgesic effects of a centrally acting
analgesic, codeine, wit