PRED FORTE STERILE EYE SUSPENSION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbvie (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

SUSPENSION

Composition:

EACH 1 ml SUSPENSION CONTAINS PREDNISOLONE ACETATE 10 mg

Authorization status:

Registered

Authorization date:

1977-11-12

Patient Information leaflet

AbbVie (Pty) Ltd
Pred Forte
®
Sterile Eye Suspension
Prednisolone acetate 10 mg/ml
1.3.2 Patient Information Leaflet
Page 1 of 3
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
PRED FORTE STERILE EYE SUSPENSION, PREDNISOLONE ACETATE 10 mg/ml
sterile eye
suspension
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING PRED FORTE
STERILE EYE
SUSPENSION

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

PRED FORTE has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
1.
WHAT PRED FORTE CONTAINS

The active substance in PRED FORTE is prednisolone acetate 10 mg/ml.

The other ingredients are benzalkonium chloride 0,004 % m/v as a
preservative, disodium
edetate, hypromellose, sodium chloride, sodium citrate dihydrate,
sodium metabisulphite,
polysorbate 80 and purified water.
2.
WHAT PRED FORTE IS USED FOR
PRED FORTE belongs to a group of medicines known as steroids. PRED
FORTE is used in
adults for the short-term treatment of eye inflammation.
3.
BEFORE YOU USE PRED FORTE
DO NOT USE PRED FORTE:

If you are hypersensitive (allergic) to prednisolone acetate,
benzalkonium chloride or any
of the other ingredients of PRED FORTE;

If you have viral, fungal or bacterial eye infections;

If you have a mycobacterial infection or tuberculosis of the eye;

If you have injuries to or ulcers on the cornea;
AbbVie (Pty) Ltd
Pred Forte
®
Sterile Eye Suspension
Prednisolone acetate 10 mg/ml
1.3.2 Patient Information Leaflet
Page 2 of 3

If you have glaucoma;

If you have previously had herpes simplex.
TAKE SPECIAL CARE WITH PRED FORTE
Talk to your doctor before using PRED FORTE if you suffer from, or
have in the past
suffered from:

Eye ulcers or have had a disease or treatment to the eye that caused
the tissue of the
cornea (the see-through layer coverin

Summary of Product characteristics

AbbVie (Pty) Ltd
Pred Forte
®
Sterile Eye Suspension
Prednisolone acetate 10 mg/ml
1.3.1.1 Professional Information
Page 1 of 3
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME AND DOSAGE FORM
PRED FORTE Sterile Eye Suspension
COMPOSITION
PRED FORTE Sterile Eye Suspension contains: Prednisolone acetate 10
mg/ml
Preservative: Benzalkonium chloride 0,004 % m/v
Excipients included in the formulation: Boric acid, disodium edetate,
hypromellose, sodium
chloride, sodium citrate dihydrate, sodium metabisulphite, polysorbate
80, purified water.
PHARMACOLOGICAL CLASSIFICATION
A 15.2 Ophthalmic preparations with corticosteroids.
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Prednisolone
acetate
is
a
synthetic
corticosteroid
with
anti-inflammatory
properties.
Prednisolone acetate has, on a weight to weight basis, an
anti-inflammatory potency three to
five times that of hydrocortisone.
PHARMACOKINETIC PROPERTIES
The pharmacokinetic profile following topical ocular administration of
1 % prednisolone
acetate
has
been
evaluated
in
human
volunteers
undergoing
cataract
surgery;
peak
concentration of prednisolone in aqueous humour was found to occur
within two hours after
instillation, and the half-life in aqueous humour was estimated to be
approximately 30
minutes.
Prednisolone is mainly metabolised in the liver. After intravenous
administration of 14C-
prednisolone, greater than 90 % of the administered radioactivity was
excreted in the urine,
and approximately 10 - 30 % of the dose was excreted unchanged in
urine.
INDICATIONS
For steroid responsive inflammation of the palpebral and bulbar
conjunctiva, cornea, and
anterior segment of the eye globe.
AbbVie (Pty) Ltd
Pred Forte
®
Sterile Eye Suspension
Prednisolone acetate 10 mg/ml
1.3.1.1 Professional Information
Page 2 of 3
CONTRA-INDICATIONS
Acute, untreated purulent ocular infections, superficial herpes
simplex (dendritic keratitis),
vaccinia, varicella and other viral diseases of the cornea and
conjunctiva, mycobacterial
infection of the eye, fungal diseases of the ocular