Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
HYDROCODONE BITARTRATE; IBUPROFEN
PALADIN LABS INC.
N02AJ23
HYDROCODONE AND IBUPROFEN
7.5MG; 200MG
TABLET
HYDROCODONE BITARTRATE 7.5MG; IBUPROFEN 200MG
ORAL
25/100/500
Narcotic (CDSA I)
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0240381001; AHFS:
CANCELLED PRE MARKET
2018-07-17
PRODUCT MONOGRAPH N CODOFEN ® (Hydrocodone bitartrate 7.5 mg-Ibuprofen 200 mg) Tablets _Opioid/NSAID combination analgesic_ Paladin Labs Inc. DATE OF PREPARATION: 6111 Royalmount Avenue, Suite 102 April 14, 2009 Montreal (QC) Canada H4P 2T4 Control No: 128830 − 1 − PRODUCT MONOGRAPH NAME OF DRUG N CODOFEN ® (Hydrocodone bitartrate 7.5 mg-Ibuprofen 200 mg ) Tablets THERAPEUTIC CLASSIFICATION Opioid/NSAID combination analgesic ACTION AND CLINICAL PHARMACOLOGY HYDROCODONE COMPONENT Hydrocodone is a centrally acting semisynthetic opioid antitussive and analgesic. The precise mechanism of analgesic action of hydrocodone and other opioids is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, opioids may produce drowsiness, changes in mood, mental clouding, constipation and, in overdose, respiratory depression. IBUPROFEN COMPONENT Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that possesses analgesic and antipyretic activities. The mode of action, like that of other NSAIDs, is not completely understood, but may be related to inhibition of cyclooxygenase activity and prostaglandin synthesis. Ibuprofen is a peripherally acting analgesic. Ibuprofen does not have any known effects on opiate receptors. CODOFEN combines the analgesic effects of the centrally acting analgesic hydrocodone with the peripherally acting NSAID analgesic, ibuprofen. PHARMACOKINETICS Hydrocodone bitartrate and ibuprofen are well absorbed in the gastrointestinal tract from oral CODOFEN. In a single oral dose study, 31 adult male and female subjects dosed with two CODOFEN tablets gave a mean hydrocodone C max of 27.3 ng/mL occurring at T max 1.7 hours; the mean half-life was 4.5 hours and the mean AUC 0- ∞ was 216 ng/mL*hr. The mean ibuprofen − 2 − C max was 30.2 mcg/mL occurring at T max 1.8 hours; the mean half-life was 2.2 hours and the mean AUC 0- ∞ was 136 mcg/mL*hr. Hydrocodone exhibits a complex pattern of metabolism including O-dem Izlasiet visu dokumentu