RAN-NABILONE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NABILONE

Available from:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC code:

A04AD11

INN (International Name):

NABILONE

Dosage:

0.25MG

Pharmaceutical form:

CAPSULE

Composition:

NABILONE 0.25MG

Administration route:

ORAL

Units in package:

50

Prescription type:

Narcotic (CDSA II)

Therapeutic area:

MISCELLANEOUS ANTIEMETICS

Product summary:

Active ingredient group (AIG) number: 0115009003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-10-26

Summary of Product characteristics

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_Page 1 of 22_
PRODUCT MONOGRAPH
N
RAN-NABILONE
(nabilone)
Capsules; 1mg, 0.5 mg, 0.25 mg
Antiemetic
Ranbaxy Pharmaceuticals Canada Inc
Mississauga, Ontario L5R 3Y4
Date of Preparation:
October 18, 2010
Submission Control No: 141934
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_Page 2 of 22_
NAME OF DRUG
N
RAN-NABILONE
capsules
(nabilone)
THERAPEUTIC CLASSIFICATION
Antiemetic Agent
ACTION
N
RAN-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.
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_Page 3 of 22_
INDICATIONS
ADULTS: > 18 YEARS
N
RAN-NABILONE (nabilone) is indicated for the management of severe
nausea and vomiting
associated with cancer chemotherapy.
PEDIATRICS: < 18 YEARS
The safety and efficacy of
N
RAN-NABILONE (nabilone) in the pediatric population have not
been established and its use is not recommended in this patient
population.
GERIATRICS: > 65 YEARS
N
RAN-NABILONE (nabilone) should be used with caution in the elderly.
(See
PRECAUTIONS).
CONTRAINDICATIONS
N
RAN-NABILONE (nabilone) is contraindicated in patients with known
sensitivity to marijuana
or other cannabinoid agents, and in those with a history o