PMS-MOMETASONE OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MOMETASONE FUROATE

Available from:

PHARMASCIENCE INC

ATC code:

D07AC13

INN (International Name):

MOMETASONE

Dosage:

0.1%

Pharmaceutical form:

OINTMENT

Composition:

MOMETASONE FUROATE 0.1%

Administration route:

TOPICAL

Units in package:

15/50

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0121732001; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-09-02

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
pms -MOMETASONE
(Mometasone Furoate 0.1% Ointment USP)
Topical Corticosteroid
PHARMASCIENCE INC. Date of Preparation
6111 Royalmount, suite #100 August 24, 2005
Montréal, Canada
H4P 2T4
Control # : 100707
1
PRODUCT MONOGRAPH
Pr
pms -MOMETASONE
(Mometasone Furoate 0.1% Ointment USP)
THERAPEUTIC CLASSIFICATION
Topical Corticosteroid
ACTIONS AND CLINICAL PHARMACOLOGY
Mometasone furoate is a medium potency topical corticosteroid. Topical
corticosteroids are
synthetic derivatives of cortisone which are effective when applied
locally to control many
types of inflammatory, allergic and pruritic dermatoses. Modifications
to the chemical
structure such as fluorination, generally enhances both
anti-inflammatory activity and
increases the likelihood of adverse effects. The mechanism of
anti-inflammatory activity of
topical corticosteroids is generally unclear. However, corticosteroids
are thought to induce
phospholipase
A2
inhibitor
proteins,
preventing
arachidonic
acid
release
and
the
biosynthesis of potent mediators of inflammation. Topical
corticosteroids are primarily
effective because of their anti-inflammatory, anti-pruritic and
vasoconstrictive actions.
Pharmacokinetics:
While the mechanism of the anti-inflammatory effect is unclear, it is
recognized that there
is a correlation between the therapeutic anti-inflammatory activity of
corticosteroids and
their vasoconstrictor potencies. Vasoconstrictor assays have therefore
been used to compare
and predict the relative therapeutic potencies of this class of
compounds, which are applied
topically and are not absorbed into the blood stream.
In a comparative bioequivalence study between pms-MOMETASONE 0.1%
Ointment and
the Canadian reference product, the relative potency of each product
was measured using a
ChromaMeter. This device measures the degree of local vasoconstrictor
response by
measuring the degree of skin blanching produced by each drug.
The following table reveals the results of the skin blanching
measurements. Both products
demonstrated co