ALLERGAN EYE ITCH RELIEF SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CROMOLYN SODIUM

Available from:

ALLERGAN INC

ATC code:

S01GX01

INN (International Name):

CROMOGLICIC ACID

Dosage:

2%

Pharmaceutical form:

SOLUTION

Composition:

CROMOLYN SODIUM 2%

Administration route:

OPHTHALMIC

Units in package:

100

Prescription type:

OTC

Therapeutic area:

MAST-CELL STABILIZERS

Product summary:

Active ingredient group (AIG) number: 0108810004; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2017-08-05

Summary of Product characteristics

PRODUCT MONOGRAPH
ALLERGAN EYE ITCH RELIEF™
Sodium Cromoglycate Ophthalmic Solution 2% w/v
ANTI-ALLERGIC
Allergan Inc.
Date of Preparation: November 27, 2007
Markham, Ontario
L3R 9S1
Control: 117435
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PRODUCT MONOGRAPH
ALLERGAN EYE ITCH RELIEF™
Sodium Cromoglycate Ophthalmic Solution 2% w/v
Allergan Standard
THERAPEUTIC CLASSIFICATION:
ANTI-ALLERGIC
ACTIONS AND CLINICAL PHARMACOLOGY
In the immediate allergic reaction (Type I), the union of antigen with
reaginic antibody leads to
the formation and release of mediators of the local anaphylactic
reaction. The principal effect of
sodium cromoglycate is its specific ability to stabilize the membrane
of the mast cell and thus
prevent the release of mediators of anaphylaxis. The action appears to
be specific for reaginic
(immediate type) antigen/antibody reactions. No direct effect has been
demonstrated on other
types of immune reactions (Type II, III, and IV).
Sodium cromoglycate has no vasoconstriction, anti-histaminic or
anti-inflammatory activity.
Within 2-3 days of commencing treatment one can expect improvement in
the signs and
symptoms of seasonal allergic conjunctivitis (itching, tearing,
congestion, etc.) in most patients.
Continued therapy will usually keep the patient free from ophthalmic
allergy symptoms during
the challenge period.
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3
INDICATIONS AND CLINICAL USE
ALLERGAN EYE ITCH RELIEF™ (sodium cromoglycate) Ophthalmic Solution
2% is indicated
to help relieve and prevent symptoms associated with allergic
conjunctivitis or hay fever
conjunctivitis.
CONTRAINDICATIONS
ALLERGAN
EYE
ITCH
RELIEF™
(sodium
cromoglycate)
Ophthalmic
Solution
2%
is
contraindicated in those patients who have shown hypersensitivity to
sodium cromoglycate or to
benzalkonium chloride.
WARNINGS
The recommended frequency of administration should not be exceeded.
ALLERGAN EYE ITCH RELIEF™ should only be used for allergic
conditions of the eye. In
some instances irritation or redness may be due to serious eye
conditions such as infection,
foreign body in the eye, or other mecha