PREDNISOLONE/SULFACETAMIDE SUSPENSION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE

Disponible depuis:

PHARMA STULLN INC.

Code ATC:

S01CA02

DCI (Dénomination commune internationale):

PREDNISOLONE AND ANTIINFECTIVES

Dosage:

10%; 0.5%

forme pharmaceutique:

SUSPENSION

Composition:

SULFACETAMIDE SODIUM 10%; PREDNISOLONE ACETATE 0.5%

Mode d'administration:

OPHTHALMIC

Unités en paquet:

250ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SULFONAMIDES

Descriptif du produit:

Active ingredient group (AIG) number: 0206094002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-05-15

Résumé des caractéristiques du produit

PRESCRIBING
INFORMATION
PR
PREDNISOLONE/SULFACETAMIDE
SULFACETAMIDE SODIUM AND PREDNISOLONE
ACETATE OPHTHALMIC SUSPENSION, USP
CORTICOSTEROID / ANTIBACTERIAL
PHARMA STULLN INC.
6500 TransCanada Highway, Suite 400
Pointe-Claire, Québec
H9R 0A5
SUBMISSION CONTROL NO.: 236530
DATE OF REVISION:
April 16, 2020
2
PRESCRIBING INFORMATION
PR
PREDNISOLONE/SULFACETAMIDE
SULFACETAMIDE SODIUM AND PREDNISOLONE
ACETATE OPHTHALMIC SUSPENSION, USP
CORTICOSTEROID / ANTIBACTERIAL
ACTION AND CLINICAL PHARMACOLOGY
Prednisolone acetate is a potent synthetic corticosteroid with
anti-inflammatory properties, useful in the treatment
of inflammatory conditions of the eye, particularly the anterior
segment. Corticosteroids suppress the inflammatory
response to a variety of agents. Since they may inhibit the body’s
defense mechanism against infection. A
concomitant antibacterial drug may be used when there is the risk of
ocular infection. Corticosteroids probably
also delay healing.
Sulfacetamide sodium is a sulfonamide with bacteriostatic action,
except at very high concentrations as may
occur with ophthalmic use, when it may be bactericidal. It interferes
with the utilization of para-aminobenzoic acid
by bacteria, thus preventing the essential biosynthesis of folic acid,
and inhibiting growth of a wide variety of gram-
negative and gram-positive bacteria. It is particularly suited to the
eye because it is freely soluble in water and
less alkaline, and therefore less irritating to the eye, than other
sulfonamides.
NON-MEDICINAL INGREDIENTS
Benzalkonium Chloride 0.025%, Disodium Edetate. Hydroxypropyl
Methylcellulose, Polysorbate 80, Sodium
Phosphate Dibasic, Sodium Phosphate Monobasic, Sodium Thiosulphate and
Purified Water.
INDICATIONS
For steroid-responsive inflammatory ocular conditions for which a
corticosteroid is indicated and where bacterial
infection or risk of bacterial infection exists.
Ocular steroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva, cornea, and
anterior segment of the globe s