INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PRED MILD Sterile Eye Suspension
SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME
(and dosage form):

PRED MILD Sterile Eye Suspension

COMPOSITION:
PRED MILD Sterile Eye Suspension contains:
Prednisolone acetate 1,2 mg/mL
Preservative:
Benzalkonium chloride 0,004% m/v

PHARMACOLOGICAL CLASSIFICATION
A 15.2 Ophthalmic preparations with corticosteroids.

PHARMACOLOGICAL ACTION
Prednisolone acetate is a glucocorticoid. Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation and phagocytic migration of the acute inflammatory responses as well as capillary proliferation, deposition of collagen and scar formation.

INDICATIONS
Mild to moderate non-infectious allergic and inflammatory disorders of the lid, conjunctiva, cornea and sclera (including chemical and thermal burns).

CONTRA-INDICATIONS
Acute, untreated purulent ocular infections, superficial herpes simplex (dendritic keratitis), vaccinia, varicella and other viral diseases of the cornea and conjunctiva, ocular tuberculosis and fungal diseases of the eye, and sensitivity to any components of the formulation.

WARNINGS
As the possibility of adverse effects on the corneal permeability and danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTION FOR USE
1 to 2 drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosage may safely be increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely. Shake well before using.

SIDE-EFFECTS AND SPECIAL PRECAUTION
Posterior subcapsular cataract formation has been reported after heavy or protracted use of the topical ophthalmic corticosteroids. Patients with histories of herpes simplex should be treated with caution. In those diseases causing thinning of the cornea, perforation has been reported with the use of topical steroids. Since PRED MILD contains no antimicrobial agent, if infection is present, appropriate measures must be taken to counteract the organism involved. Acute purulent infections of the eye may be masked or enhanced by the use of topical steroids. Use of steroid medication in the presence of stromal herpes simplex requires caution and should be followed by frequent mandatory slit-lamp microscopy. As fungal infections of the cornea have been reported coincidentally with long-term local steroid applications, fungal invasion may be suspected in any persistent corneal ulceration where a steroid has been used or is in use. Use of topical corticosterioids may cause increased intraocular pressure in certain individuals. This may result in damage to the optic nerve with defects in the visual fields. It is advisable that the intraocular pressure be checked frequently. Because of the possibility of inducing corneal abscess, fungal keratopathy of glaucoma, the patient should be referred to an ophthalmologist if the eye has not responded within 48 hours.
Use in pregnancy:
Safety of intensive or protracted use of topical steroids during pregnancy has not been substantiated.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Refer to Side Effects and Special Precaution listed above.

IDENTIFICATION
A milky suspension.

PRESENTATION
PRED MILD Sterile Eye Suspension is supplied in sterile plastic dropper bottles containing 5 mL suspension.
For topical use only, under supervision of a medical practitioner.

STORAGE INSTRUCTIONS
Store below 25°C. Do not freeze. Do not use more than 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
J/15.2/73

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Allergan Pharmaceuticals (Pty) Ltd
Mount Royal Industrial Park
James Crescent
Halfway House
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
22 December 1976

Updated on this site: Aug 2007
Source: Pharmaceutical Industry

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