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

Logo MYDRIACYL® 1% ophthalmic solution

SCHEDULING STATUS:
3

PROPRIETARY NAME
(and dosage form):

MYDRIACYL® 1% ophthalmic solution

COMPOSITION
Each mL contains:
  Tropicamide 10,0 mg
  Preservative: Benzalkonium chloride 0,01%.

PHARMACOLOGICAL CLASSIFICATION:
A.15.4 Ophthalmic preparations, other.

PHARMACOLOGICAL ACTION:
A mydriatic-cycloplegic. Maximum mydriasis and cycloplegia are obtained within 20 to 25 minutes following instillation in the eye. Complete recovery occurs within 5 to 6 hours without the use of a miotic.

INDICATIONS:
For mydriasis and cycloplegia for diagnostic purposes.

CONTRA-INDICATIONS:
Contra-indicated in narrow angle or closed angle 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:
For refraction 1 or 2 drops in eye(s) repeated in 5 minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of the fundus, 1 drop 15 to 20 minutes prior to examination.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Transient stinging may occur when drops are instilled. Hypersensitivity may occur eg. conjunctivitis. As with any mydriatic, caution should be used when intraocular pressure is high or unknown or when anterior chamber is shallow. In refractions where prolongation of cycloplegia is desirable, one additional drop only is recommended.
CAUTION: Systemic reactions have followed the absorption of tropicamide through the lachrymal ducts.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS:
Dilation of the pupils with loss of accommodation and photophobia. Increased intra-ocular pressure. Physostigmine eye drops can be instilled to reverse the action.

IDENTIFICATION:
A clear, colourless to pale yellow solution.

PRESENTATION:
Drop-Tainer™ dispenser containing 15 mL.

STORAGE INSTRUCTIONS:
Store in a cool place, below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H.1154 (Act 101.1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd
Surrey Avenue
RANDBURG 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 February 1974

1093                34295-E

Updated on this site: November 2000

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