PMS-SODIUM CROMOGLYCATE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CROMOLYN SODIUM

Available from:

PHARMASCIENCE INC

ATC code:

R03BC01

INN (International Name):

CROMOGLICIC ACID

Dosage:

1%

Pharmaceutical form:

SOLUTION

Composition:

CROMOLYN SODIUM 1%

Administration route:

INHALATION

Units in package:

2ML

Prescription type:

Prescription

Therapeutic area:

MAST-CELL STABILIZERS

Product summary:

Active ingredient group (AIG) number: 0108810003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2023-03-31

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
PMS-SODIUM CROMOGLYCATE
(Cromolyn Sodium Inhalation Solution, USP)
1% W/V
(in 2 mL polynebs)
Asthma Prophylaxis
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave. Suite #100
February 14, 2012
Montreal, Quebec
H4P 2T4
Control # 152019
2
NAME OF DRUG
PR
PMS-SODIUM CROMOGLYCATE
(Cromolyn Sodium Inhalation Solution, USP)
1% W/V
THERAPEUTIC CLASSIFICATION
Asthma Prophylaxis
ACTION & CLINICAL PHARMACOLOGY
In
vitro
and
in
vivo
animal
studies
have
shown
that
sodium
cromoglycate
inhibits
the
degranulation of sensitized mast cells occurring after exposure to
specific antigens. Sodium
cromoglycate acts by inhibiting the release of mediators from mast
cells. Studies show that
sodium cromoglycate indirectly blocks calcium ions from
entering
the
mast cell,
thereby
preventing mediator release.
Sodium
cromoglycate
has
no
intrinsic
bronchodilator,
antihistaminic
or
anti-inflammatory
activity.
Sodium cromoglycate is poorly absorbed from the gastrointestinal tract
but is rapidly absorbed
following inhalation or intranasal administration. Once absorbed
sodium cromoglycate is rapidly
cleared by the liver and kidneys prior to excretion in the bile and
urine. Apart from the liver and
kidneys there is no significant accumulation in any tissues.
Sodium cromoglycate is not metabolized and is excreted unchanged.
INDICATIONS AND CLINICAL USE
pms-SODIUM
CROMOGLYCATE
nebulizer
solution
is
indicated
as
an
adjunct
in
the
management of intrinsic and extrinsic asthma, including
exercise-induced asthma, cold air
3
induced
asthma
and
occupational
asthma
and
are
used
on
a
continuous
basis
to
prevent
symptoms of these conditions.
CONTRAINDICATIONS
pms-SODIUM CROMOGLYCATE nebulizer solution is contraindicated in those
patients who
have shown hypersensitivity to any of its ingredients.
WARNINGS
The patient should be instructed on the number of pms-SODIUM
CROMOGLYCATE nebulizer
solution polynebs to be inhaled per day. Regular dosage is important.
Treatment with pms-SODIUM CROMOGLYCATE nebulizer solution must not be
disconti