TENUATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIETHYLPROPION HYDROCHLORIDE

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

A08AA03

INN (International Name):

AMFEPRAMONE

Dosage:

25MG

Pharmaceutical form:

TABLET

Composition:

DIETHYLPROPION HYDROCHLORIDE 25MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Schedule G (CDSA IV)

Therapeutic area:

Amphetamine Derivatives

Product summary:

Active ingredient group (AIG) number: 0102499002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2009-03-24

Summary of Product characteristics

PRODUCT MONOGRAPH
TENUATE
®
(diethylpropion hydrochloride)
Tablets, 25 mg
TENUATE
®
DOSPAN
®
(diethylpropion hydrochloride)
Continuous Release Tablets, 75 mg
Anorexiant
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
March 23, 2006
Laval, Quebec H7L 4A8
Submission Control No. 104730
s-a Version 1.0 dated
1
PRODUCT MONOGRAPH
TENUATE
®
(diethylpropion hydrochloride)
Tablets, 25 mg
TENUATE
®
DOSPAN
®
(diethylpropion hydrochloride)
Continuous Release Tablets, 75 mg
THERAPEUTIC CLASSIFICATION
Anorexiant
ACTION
TENUATE
®
(diethylpropion hydrochloride) is a psychomotor stimulant with
anorectic,
sympathomimetic and other effects similar to those of amphetamines. As
with all other
drugs of this class in which the phenomenon has been studied, the
initial rate of weight loss
decreases until a plateau is reached; a regain of weight thereafter
even though drug
administration is continued has been reported. As with similar drugs,
rebound weight gain
also may occur after discontinuation of TENUATE
®
.
INDICATIONS AND CLINICAL USE
A psychomotor stimulant used as an adjunct in the short-term (i.e. a
few weeks) to
continued dietary treatment in the medical management of obesity, in
patients who have
not responded to an appropriate weight reducing regimen (diet and/or
exercise) alone.
TENUATE
®
is recommended only for obese patients with an initial body mass index
$
30
kg/m
2
, or
$
27 kg/m
2
in the presence of other risk factors (e.g. hypertension, diabetes,
hyperlipidaemia).
Below is a chart of Body Mass Index (BMI) based on various heights and
weights. BMI is
calculated by taking the patient’s weight, in kilograms, divided by
the patient’s height in
meters and squared. Metric conversions are as follows:
2
S
Pounds(lbs)/2.2 = kilograms (kg)
S
Feet (ft) x 0.3048 = meters (m)
S
Inches x 0.0254 = meters (m)
BODY MASS INDEX (BMI), kg/m
2
Height (feet, inches)
Weight
(pounds)
5'0"
5'3"
5'6"
5'9"
6'0"
6'3"
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180