MYLAN-BROMAZEPAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BROMAZEPAM

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

N05BA08

INN (International Name):

BROMAZEPAM

Dosage:

1.5MG

Pharmaceutical form:

TABLET

Composition:

BROMAZEPAM 1.5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0114488002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2012-10-19

Summary of Product characteristics

PRODUCT MONOGRAPH
MYLAN-BROMAZEPAM
(Bromazepam Tablets)
1.5 mg
ANXIOLYTIC - SEDATIVE
Mylan Pharmaceuticals ULC
Date of Preparation:
85 Advance Road
August 19, 2010
Etobicoke, Ontario
Date of Revision
M8Z 2S6
Submission#: 140828
PRODUCT MONOGRAPH
MYLAN-BROMAZEPAM
(Bromazepam Tablets)
1.5 mg
THERAPEUTIC CLASSIFICATION
Anxiolytic - Sedative
ACTION AND CLINICAL PHARMACOLOGY
Bromazepam is a benzodiazepine with anxiolytic and sedative properties
which are of value in
the symptomatic relief of pathological anxiety in psychoneurotic
patients.
Orally administered bromazepam is completely absorbed and peak blood
levels are achieved 1
to 4 hours after administration. Bromazepam has a mean serum half-life
of 12 hours (8 to 19
hours). Over a 72 hour interval, 69% of a 12 mg oral dose was
recovered in the urine, in the
form
of
conjugated
3-hydroxybromazepam
and
conjugated
2-(2-amino-5-bromo-3-
hydroxybenzoyl)-pyridine.
A
comparative
two-way
bioavailability
study
was
conducted
to
compare
MYLAN-
BROMAZEPAM (bromazepam) 6 mg tablets against a Canadian Reference
Brand Product of
bromazepam
6
mg
tablets.
The
pharmacokinetic
data
calculated
for
the
MYLAN-
BROMAZEPAM and Reference product tablet formulations is tabulated
below:
PARAMETER
TEST PRODUCT
REFERENCE
PRODUCT
RATIO OF
GEOMETRIC MEANS
(%)
AUC
t
(ng.h/mL)
3714.50*
3904.77 (1136.48)**
3640.95*
3798.62 (1145.35)**
102.48
AUC
i
(ng.h/mL)
4023.87*
4213.14 (1275.81)**
3944.19*
4186.73 (1430.72)**
101.12
C
max
(ng/mL)
183.09*
190.24 (52.82)**
175.92*
179.01 (37.26)**
104.17
T
max
(h)
1.43 (0.98)**
1.43 (1.18)**
---
T
1/2
(h)
20.27 (6.74)**
23.01 (10.29)**
---
*
Geometric Mean
**
Arithmetic Mean (CV)
2
INDICATIONS AND CLINICAL USE
MYLAN-BROMAZEPAM (bromazepam) is useful for the short-term,
symptomatic relief of
manifestations of excessive anxiety in patients with anxiety neurosis.
CONTRAINDICATIONS
MYLAN-BROMAZEPAM
(bromazepam)
is
contraindicated
in
patients
with
known
hypersensitivity to benzodiazepines and in patients with myasthenia
gravis.
WARNINGS
MYLAN-BROMAZEPAM
(bromazepam)
i