PHARMACOLOGICAL CLASSIFICATION: A. 15.4 Ophthalmic preparations; Others.
PHARMACOLOGICAL ACTION: Mydriatic and vasoconstrictor.
INDICATIONS: For powerful and rapid dilation of the pupil and reduction of congestion in the capillary bed. Can also be used in uveitis and for the temporary reduction of intraocular tension in certain cases of glaucoma.
In intraocular surgery to obtain a wide dilation of the pupil.
CONTRA-INDICATIONS: Do not use in narrow-angle glaucoma. Use with caution in persons with marked hypertension and arteriosclerotic changes.
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 to two drops as often as required.
One drop of solution may be applied to free recently formed posterior synechia. Repeat next day if necessary. For intraocular surgery apply 30 - 60 minutes before surgery.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Stinging and lacrimation may occur. Discontinue if sensitivity develops. Corneal epithelial changes have been seen with the use of phenylephrine hydrochloride solution.
If the solution becomes discoloured, do not use.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: None.
IDENTIFICATION: Colourless liquid.
PRESENTATION: 7,5 mL in an opaque white dropper bottle with dropper insert and cap.
STORAGE INSTRUCTIONS: Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: F/15.4/11
NAME AND BUSINESS ADDRESS OF THE APPLICANT: Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext. 77
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT: December 1973
New addition to this site: May 2004
Source: Pharmaceutical Industry