CESAMET CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

NABILONE

Tillgänglig från:

BAUSCH HEALTH, CANADA INC.

ATC-kod:

A04AD11

INN (International namn):

NABILONE

Dos:

0.5MG

Läkemedelsform:

CAPSULE

Sammansättning:

NABILONE 0.5MG

Administreringssätt:

ORAL

Enheter i paketet:

15G/50G

Receptbelagda typ:

Narcotic (CDSA II)

Terapiområde:

MISCELLANEOUS ANTIEMETICS

Produktsammanfattning:

Active ingredient group (AIG) number: 0115009002; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2004-09-13

Produktens egenskaper

PRODUCT MONOGRAPH
N
CESAMET
®
Nabilone
Capsules; 1 mg, 0.5 mg, 0.25 mg
ANTIEMETIC
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear West
Laval, Quebec
H7L 4A8
DATE OF REVISION:
May 24, 2019
Submission Control No.: 226983
_N_
_CESAMET_
_®_
_ Product Monograph _
_ Page 2 of 16_
NAME OF DRUG
N
CESAMET
®
capsules
(nabilone)
THERAPEUTIC CLASSIFICATION
Antiemetic Agent
ACTION
N
CESAMET
®
(nabilone) is a synthetic cannabinoid with antiemetic properties which
have been
found to be of value in the management of some patients with nausea
and vomiting associated
with cancer chemotherapy. It also has sedative and psychotropic
effects.
After oral administration, comparable peak plasma levels of nabilone
and of its carbinol
metabolite were attained within 2 hours. The combined plasma
concentrations of nabilone and of
its carbinol metabolite accounted for, at most, 10 to 20% of the total
radiocarbon concentration
in plasma. The plasma half-life of nabilone was approximately 2 hours,
while that of the total
radiocarbon was of the order of 35 hours.
Of the two major possible metabolic pathways, stereo-specific
enzymatic reduction and direct
enzymatic oxidation, the latter appears to be the more important in
man.
The drug and its metabolites are eliminated mainly in the feces
(approximately 65%) and to a
lesser extent in the urine (approximately 20%). The major excretory
pathway is the biliary
system.
INDICATIONS
ADULTS: > 18 YEARS
N
CESAMET
®
(nabilone) is indicated for the management of severe nausea and
vomiting
associated with cancer chemotherapy.
PEDIATRICS: < 18 YEARS
The safety and efficacy of
N
CESAMET
®
in the pediatric population have not been established
and its use is not recommended in this patient population.
GERIATRICS: > 65 YEARS
N
CESAMET
®
should be used with caution in the elderly (see PRECAUTIONS).
_N_
_CESAMET_
_®_
_ Product Monograph Page 3 of 16_
CONTRAINDICATIONS
N
CESAMET
®
(nabilone) is contraindicated in patients with known sensitivity to
marijuana or
other cannabinoid agents, and in those with a histor