IBUCODONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROCODONE BITARTRATE; IBUPROFEN

Available from:

PALADIN LABS INC.

ATC code:

N02AJ23

INN (International Name):

HYDROCODONE AND IBUPROFEN

Dosage:

7.5MG; 200MG

Pharmaceutical form:

TABLET

Composition:

HYDROCODONE BITARTRATE 7.5MG; IBUPROFEN 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0240381001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2018-07-17

Summary of Product characteristics

1
PRODUCT MONOGRAPH
N
IBUCODONE
(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 6, 2009
Montreal (QC) Canada
H4P 2T4
Control No.: 128717
2
PRODUCT MONOGRAPH
NAME OF DRUG
N
IBUCODONE
(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.
IBUCODONE combines the analgesic effects of the centrally acting
analgesic hydrocodone with
the peripherally acting NSAID analgesic, ibuprofen.
3
PHARMACOKINETICS
Hydrocodone bitartrate and ibuprofen are well absorbed in the
gastrointestinal tract from oral
IBUCODONE. In a single oral dose study, 31 adult male and female
subjects dosed with two
IBUCODONE 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-
4
was 216 ng/mL*hr. The mean ibuprofen
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-
4
was 136 mcg/mL*hr.
Hydrocodone
exhibits
a
complex
pattern
of
metabolism
including
O-demethylation,
N-