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

Logo SPERSADEX COMP® EYE DROPS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

SPERSADEX COMP® EYE DROPS

COMPOSITION:
Dexamethasone Disodium Phosphate 0,1 g; Chloramphenicol 0,5 g; Hydroxypropylmethylcellulose 0,2 g;
Preservative: Thiomersal 0,002% m/v; sterile water to 100 mL.

PHARMACOLOGICAL CLASSIFICATION:
A.15.3 Opthalmic preparations - Combination antibiotics and/or sulphonamides and corticoids.

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 2000 times more soluble than hydrocortisone or prednisolone. Thanks to the addition of chloramphenicol, a broad-spectrum antibiotic, this combination yields excellent results in inflammation of the anterior uvea (iritis, iridocyclitis).

INDICATIONS:
Acute purulent conjunctivitis; fresh inflammation of the superficial and deeper corneal layers and corneal ulceration. Keratitis disciformis and the more deep-seated forms of post-herpetic keratitis (possibly together with HERPIDU). Allergic conjunctivitis, allergic blepharitis. Acute and chronic iritis and iridocyclitis.

CONTRA-INDICATIONS:
Fresh herpes simplex cornealis, tubercular processes involving the conjunctiva, the cornea and the anterior uvea.

DOSAGE AND DIRECTIONS FOR USE:
One drop, 1 to 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 INSTRUCTION:
Store at 2-8°C. Discard 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
H1278 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

Under licence from Novartis Ophthalmics Ltd.
® Registered Trade Mark

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12/3/81

        80968-11/2001
                Pro-Print

Updated on this site: January 2005
Source: Hospital Pharmacy

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