ACETAMINOPHEN ELIXIR WITH 8MG CODEINE PHOSPHATE SYRUP

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ACETAMINOPHEN; CODEINE PHOSPHATE

Dostupné z:

JAMP PHARMA CORPORATION

ATC kód:

N02AJ06

INN (Medzinárodný Name):

CODEINE AND PARACETAMOL

Dávkovanie:

160MG; 8MG

Forma lieku:

ELIXIR

Zloženie:

ACETAMINOPHEN 160MG; CODEINE PHOSPHATE 8MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

OPIATE AGONISTS

Prehľad produktov:

Active ingredient group (AIG) number: 0211376002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2007-08-14

Súhrn charakteristických

Page 1 of 8
Revised August 13, 2007
Revised September 12, 2013
ACETAMINOPHEN ELIXIR WITH
8 MG CODEINE PHOSPHATE SYRUP
Analgesic-Antipyretic
PRESCRIBING INFORMATION
DESCRIPTION
Each 5 mL of elixir contains 160 mg of acetaminophen and 8 mg of
codeine phosphate in a
slightly viscous clear red liquid that tastes and smells like cherry.
Non-medicinal ingredients: Alcohol, citric acid, D&C red #33, cherry
flavour, polyethylene
glycol, sodium benzoate, sodium cyclamate, sorbitol, sucrose and
purified water.
CLINICAL PHARMACOLOGY
Acetaminophen and codeine phosphate are analgesic, antipyretic agents.
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.
INDICATIONS AND USAGE
Acetaminophen Elixir with 8 mg Codeine Phosphate Syrup is indicated
for the relief of minor
pains, headaches and fever.
CONTRAINDICATIONS
Acetaminophen Elixir with 8 mg Codeine Phosphate Syrup should not be
administered to patients
who have previously exhibited hypersensitivity to acetaminophen or
codeine.
Page 2 of 8
Revised August 13, 2007
Revised September 12, 2013
WARNINGS
As with any other analgesic drug, physicians should be cognizant of
and supervise the use of
acetaminophen in patients with alcoholism, serious kidney or serious
liver disease. Chronic heavy
alcohol abusers may be at increased risk of liver toxicity from
excessive acetaminophen use,
although reports of this event are rare. Reports usually i