BLEPHAMIDE DROPS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE

Available from:

ALLERGAN INC

ATC code:

S01CA02

INN (International Name):

PREDNISOLONE AND ANTIINFECTIVES

Dosage:

10%; 0.2%

Pharmaceutical form:

DROPS

Composition:

SULFACETAMIDE SODIUM 10%; PREDNISOLONE ACETATE 0.2%

Administration route:

OPHTHALMIC

Units in package:

5/10ML

Prescription type:

Prescription

Therapeutic area:

SULFONAMIDES

Product summary:

Active ingredient group (AIG) number: 0206094001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-01-21

Summary of Product characteristics

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_Page 1 of 12_
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BLEPHAMIDE®
Sulfacetamide sodium 10.0% w/v and prednisolone acetate 0.2% w/v
Sterile ophthalmic suspension
Anti-inflammatory / Antibacterial
Allergan Inc.
Markham, ON
L6G 0B5
Date of Preparation:
May 22, 2019
Date of revision:
September 18, 2019
Submission Control No: 230905
_ _
_Page 2 of 12_
PRESCRIBING INFORMATION
NAME OF DRUG
Pr
BLEPHAMIDE®
Sulfacetamide sodium 10.0% w/v and prednisolone acetate 0.2% w/v
THERAPEUTIC CLASSIFICATION
Anti-inflammatory / Antibacterial
MECHANISM OF ACTION
BLEPHAMIDE® (sulfacetamide sodium 10.0% w/v and prednisolone acetate
0.2% w/v) is an anti-
bacterial (effective against a broad range of pathogens, including
staphylococci). The prednisolone
component effectively counters allergic and inflammatory
manifestations.
INDICATIONS
BLEPHAMIDE® is indicated for the treatment of nonpurulent blepharitis
and blepharoconjunctivitis
(seborrheal, staphylococcal, allergic); nonpurulent conjunctivitis
(allergic and bacterial).
BLEPHAMIDE® contains an antibacterial ingredient, sulfacetamide
sodium. To reduce the
development of drug-resistant bacteria and maintain the effectiveness
of sulfacetamide sodium,
BLEPHAMIDE® should only be used for the authorized indication.
CONTRAINDICATIONS
Do not use BLEPHAMIDE® if you have:

viral diseases of the cornea and conjunctiva, including superficial
(or epithelial), acute herpes
simplex, varicella, and vaccinia

mycobacterial infection of the eye

acute purulent untreated infections of the eye, which like other
diseases caused by
microorganisms, may be masked or enhanced by the presence of the
steroid

tuberculosis of the eye; fungal disease of the eye; patients with a
history of hypersensitivity to
any of the components of the product
WARNINGS AND PRECAUTIONS
As with all corticosteroids, BLEPHAMIDE® may mask, activate or
enhance infection. If the infection
does not respond promptly, BLEPHAMIDE® should be discontinued until
the infection has been
contr