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

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

OCULOSAN^®
Eye Drops

COMPOSITION:
Each mL contains:

Zinc sulphate	0,2 mg
Naphazoline nitrate	0,05 mg
Preservative:
Benzoxonium chloride	0,01% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations - Other.

PHARMACOLOGICAL ACTION:
Zinc sulphate displays marked astringent properties. Astringents produce a very fine scurf on the surface of the conjunctiva. Secretion is reduced, slight contraction of the tissue occurs and the capillaries are sealed off, with the result that growth of any bacteria that may be present, is inhibited.
Naphazoline is a vasoconstrictor, and reduces inflammation and swelling of the conjunctiva. The effect of Naphazoline is due to direct binding to alpha-adrenergic receptor sites on unstriated muscle cells in the blood vessels. Naphazoline is systemically absorbed through blood vessels, however the extent of absorption is unknown as no data is available.

INDICATIONS:
Acute and chronic non-infectious conjunctivitis.
Unspecific conjunctival irritations, including allergies.
After successful treatment of bacterial and viral infections.
Irrigation of the tear duct.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
In patients suffering from narrow-angle glaucoma, dry eye and keratoconjunctivitis sicca.
Not to be used in infants.
Not to be administered during Monoamine oxidase inhibitors or within 14 days of termination of such treatment.
In pregnancy and lactation as safety has not been established.

WARNINGS:
Uncontrolled use of Oculosan over extended periods of time should be avoided, due to the rebound effect.
Use with caution in patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes mellitus or hyperglycemia and eye disease, infection or injury.
Contact lens to be removed before instillation and are not to be worn for at least 15 minutes after application of Oculosan.
Results of ocular tonometry may be affected by previous application of Oculosan.

DOSAGE AND DIRECTIONS FOR USE:
Use only as directed.
One drop into the lower eyelid four times per day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
A slight and transient burning sensation may occur after instillation.
Less frequent local effects are mydriasis, blurred vision and a slight increase in intra-ocular pressure.
Long term use may result in reactive redness of the eye (rebound effect).
If eye pain or change in vision occurs or if redness or irritation of the eye continues, worsens or lasts for more than 72 hours, discontinue treatment and consult with the physician.
Systemic absorption, especially in children and the elderly has been reported following ocular application of naphazoline containing solutions. Symptoms of naphazoline being absorbed into the body are dizziness, headache, increased sweating, nausea, nervousness and weakness.
Caution should be exercised with concurrent use of tricyclic antidepressants, as this will potentiate the pressor effect of naphazoline, should systemic absorption of naphazoline take place following ocular administration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage or accidental oral ingestion may cause depression of the central nervous system, with marked reduction in body temperature and bradycardia, sweating, drowsiness and coma, particularly in children. Hypertension may be followed by rebound hypotension. Treatment should be symptomatic.

IDENTIFICATION:
A clear, colourless to pale yellowish aqueous solution, with a characteristic odour.

PRESENTATION:
10 mL transparent, plastic dropper bottle.

STORAGE INSTRUCTIONS:
Store at room temperature (below 30°C), in well closed, non-metallic containers, protected from light.
Keep out of reach of children.
Discard contents 30 days after opening.

REFERENCE NUMBER:
H 1272 (Act 101/1965)

NAME & BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X 69, Bryanston, 2021

Under licence from: Ciba Vision Ltd
Hettlingen, Switzerland
® Registered Trademark

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17/02/75

New addition to this site: April 2004
Source: Pharmaceutical Industry
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