APO-NABILONE CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

NABILONE

Tilgængelig fra:

APOTEX INC

ATC-kode:

A04AD11

INN (International Name):

NABILONE

Dosering:

0.5MG

Lægemiddelform:

CAPSULE

Sammensætning:

NABILONE 0.5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

50

Recept type:

Narcotic (CDSA II)

Terapeutisk område:

MISCELLANEOUS ANTIEMETICS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2015-05-20

Produktets egenskaber

_Page 1 of 22_
PRODUCT MONOGRAPH
N
APO-NABILONE
Nabilone Capsules
0.25 mg, 0.5 mg and 1 mg
Antiemetic
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Preparation:
May 15, 2015
Submission Control No: 172451
_Page 2 of 22_
N
APO-NABILONE
Nabilone Capsules
THERAPEUTIC CLASSIFICATION
Antiemetic Agent
ACTION
APO-NABILONE (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 bilary
system.
CLINICAL TRIALS
Comparative Bioavailability Studies
A randomized, single dose, 2-way crossover comparative bioavailability
study, conducted under
fasting conditions, was performed on healthy male and female
volunteers. The rate and extent of
_Page 3 of 22_
absorption of nabilone was measured and compared following a single
oral dose (1 x 1 mg
capsules) of Apo-Nabilone 1 mg capsules (Apotex Inc.) and
N
Cesamet
®
(nabilone) 1 mg
capsules (Valeant Canada Ltd.). The results obtained from 21
volunteers who completed the
study are summarized in the following table.
Nabilone
(1 x 1 mg)
From Measured Data
Geometric Mean
Arithmetic Mean (CV%)
Parameter
Test*
Reference
†
Ratio of
Geometric
Mea