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

Logo SPERSADEX® 0,1 % EYE DROPS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

SPERSADEX® 0,1 % EYE DROPS

COMPOSITION:
Dexamethasone disodium phosphate 0,1 g; Hydroxypropylmethylcellulose 0,2 g; Benzalkonium chloride 0,01% m/v (preservative); Sterile water to 100 mL.

PHARMACOLOGICAL CLASSIFICATION:
A. 15.2 Ophthalmic preparations with corticosteroids.

PHARMACOLOGICAL ACTION:
Dexamethasone is one of the most potent corticosteroids; it is 5 - 14 times more potent than prednisolone and 25 - 75 times more potent than cortisone and hydrocortisone. Of paramount importance with regard to local therapy is the fact that dexamethasone is over 2 000 times more soluble than hydrocortisone or prednisolone.

INDICATIONS:
Vernal conjunctivitis, allergic blepharitis and conjunctivitis, non-specific keratitis, superficial punctate keratitis, disciform keratitis (provided the corneal surface is intact). Affection of the anterior uvea, such as acute or chronic iritis and iridocyclitis (with exception of tuberculous forms), scleritis and episcleritis, sympathetic ophthalmia.

CONTRA-INDICATIONS:
Injuries and ulcerations of the cornea, in particular those of bacterial or viral origin (herpes simplex and herpes zoster), purulent infections of the conjunctiva and eyelids, tuberculosis, mycoses and glaucoma.

WARNINGS:
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological 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 DIRECTIONS FOR USE:
One drop, 4 times daily, into the lower eyelid.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The local use of dexamethasone over a prolonged period may lead in some cases to secondary glaucoma and the development of complicated cataract. To be used, therefore, under strict medical supervision. Because of the possibility of inducing corneal abscess, fungal keratopathy or glaucoma, the patient should be referred to an ophthalmologist if the eye has not responded within 48 hours.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
If a rise of intraocular pressure occurs, the treatment has to be discontinued.

IDENTIFICATION:
Colourless solution.

PRESENTATION:
Plastic dropper bottle of 5 mL.

STORAGE INSTRUCTIONS:
Store in a cool place below 25°C. Discard 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
H1285 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021
Under licence from:
Novartis Pharma AG
® Registered Trade Mark

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17/2/1975

        80971 10/2004

New addition to this site: April 2005
Source: Hospital Pharmacy

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