ACET CODEINE 30 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACETAMINOPHEN; CODEINE PHOSPHATE

Available from:

PHARMASCIENCE INC

ATC code:

N02AJ06

INN (International Name):

CODEINE AND PARACETAMOL

Dosage:

300MG; 30MG

Pharmaceutical form:

TABLET

Composition:

ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG

Administration route:

ORAL

Units in package:

4 X 25 (CONTROL PACK), 100 & 500 TABLETS

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0211376003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-11-13

Summary of Product characteristics

PRESCRIBING INFORMATION
N
ACET-CODEINE 30
N
ACET-CODEINE 60
(ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP)
300 MG/30 MG
300 MG/60 MG
Analgesic-Antipyretic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Revision:
April 16, 2014
SUBMISSION CONTROL NO.: 172009
_ _
_ACET-CODEINE Prescribing Information _
_Page 2 of 13_
PRESCRIBING INFORMATION
N
ACET-CODEINE 30
N
ACET-CODEINE 60
Acetaminophen and Codeine Phosphate Tablets, USP
Analgesic-Antipyretic
CLINICAL PHARMACOLOGY
Acetaminophen and codeine phosphate are analgesic, antipyretic agents.
ACTION
Acetaminophen, and codeine phosphate combine the analgesic effects of
the centrally acting
analgesic codeine, with a peripherally acting analgesic,
acetaminophen.
Acetaminophen, and codeine phosphate are well absorbed orally.
Acetaminophen is distributed throughout most tissues of the body.
Acetaminophen is metabolized
primarily in the liver. Little unchanged drug is excreted in the
urine, but most metabolic products
appear in the urine within 24 hours.
Codeine retains at least one-half of its analgesic activity when
administered orally. A reduced first-
pass metabolism of codeine by the liver accounts for the greater oral
potency of codeine when
compared to most other morphine-like narcotics. Following absorption,
codeine is metabolized by
the liver and metabolic products are excreted in the urine.
Approximately 10% of the administered
codeine is demethylated to morphine, which may account for its
analgesic activity.
PHARMACOKINETICS
Following oral administration of acetaminophen in combination with
codeine, both drugs are rapidly
absorbed with peak plasma levels occurring within 60 minutes.
The plasma elimination half-life (t
1/2
) ranges from 1.5 to 3.5 hours for acetaminophen, and 1.5 to 4
hours for codeine. Metabolism is rapid; the principal metabolites are
conjugates of glucuronic acid
which are excreted in the urine. Less than 1% of an administered dose
of codeine, and less than 4%
of an administered dose