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Logo VISINE
Tetrahydrozoline hydrochloride

STERILE
EYE DROPS

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

VISINE
EYE DROPS

COMPOSITION:
Visine Eye Drops contain tetrahydrozoline hydrochloride 7,5 mg/15 mL; sodium chloride; boric acid; sodium borate; with benzalkonium chloride 0,01% and disodium ethylenediamine tetra-acetate 0,1% added as preservatives.

PHARMACOLOGICAL CLASSIFICATION:
A15.4 Ophthalmic Preparations - Other.

PHARMACOLOGICAL ACTION:
Visine Eye Drops is a sterile, stable, non-irritating solution. Its sympathomimetic action promotes decongestion.

INDICATIONS:
Visine Eye Drops provides relief from burning, itching eye irritation accompanying fatigue, and excessive watering of the eye in a variety of allergic and eye irritating conditions.

IMPORTANT:
Visine Eye Drops should be used only in minor eye irritation. It relief is not obtained within 48 hours, or irritation persists or increases, discontinue use and consult your physician. Infection, pus, the presence of a foreign body in the eye and any mechanical, chemical, heat or other injury to the eye requires the immediate attention of your physician.

CONTRA-INDICATIONS:
Visine Eye Drops should not be used by individuals with glaucoma or other serious eye disease.
It should not be used with monoamine oxidase inhibitors or within 10 days of their discontinuation, since hypertensive crisis may result.

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:
Instil one or two drops of Visine Eye Drops in each eye two or three times a day.
Visine Eye Drops should be used sparingly in children. Its use in children under 2 years of age is not recommended.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Do not let the applicator tip touch the eye or any other surface, since this may contaminate the eye drops.
Visine Eye Drops must be used with caution in patients with hypertension and hyperthyroidism.
Dilation of the pupil of the eye and recurrence of the irritation have rarely been observed with the use of Visine Eye Drops. In rare instances a slight burning or stinging, of short duration, may occur.

IDENTIFICATION:
Visine Eye Drops is a clear, colourless solution.

PRESENTATION:
Visine Eye Drops are available in 15 mL plastic dropper bottles.

STORAGE INSTRUCTIONS:
Store in a cool place below 25°C and protect from light.
Parents: Keep this and all other medications out of the reach of children.

APPLICATION NUMBER:
H1180 (Act 101/1965).

EXPORT REGISTRATION DETAILS
Botswana:         R990435
Tanzania:         TAN 00,1669S0 D PF1
Uganda:         1097/21/97
Zambia:         050/001
Zimbabwe:         79/19.9/612
Ethiopia:         PFZ/SA/001

NAME OF APPLICANT:
Pfizer Consumer Healthcare, Division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION:
22 December 1981.

Updated on this site: February 2005
Source: Pharmaceutical Industry

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