Riik: Kanada
keel: inglise
Allikas: Health Canada
ACETAMINOPHEN; CODEINE PHOSPHATE
JAMP PHARMA CORPORATION
N02AJ06
CODEINE AND PARACETAMOL
160MG; 8MG
ELIXIR
ACETAMINOPHEN 160MG; CODEINE PHOSPHATE 8MG
ORAL
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0211376002; AHFS:
APPROVED
2007-08-14
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 Lugege kogu dokumenti