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

Logo ISOPTO® ATROPINE Ophthalmic Solution

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ISOPTO® ATROPINE Ophthalmic Solution

COMPOSITION:
Atropine sulphate 10 mg per mL.
Preservative: Benzalkonium chloride 0,01% (m/v).

PHARMACOLOGICAL CLASSIFICATION:
A.15.4 Ophthalmic preparations, other.

PHARMACOLOGICAL ACTION:
Atropine sulphate blocks the action of certain parasympathetic nerves and cholinergic drugs. In ophthalmology atropine is used for mydriatic and cycloplegic effects. Dilation of the pupil occurs in half an hour following its local application and lasts for a week or more. Accommodation is paralysed in 2 hours, with recovery in 2 or 3 days.

INDICATIONS:
For use as long acting mydriatic and cycloplegic.

CONTRA-INDICATIONS:
ISOPTO
® ATROPINE is contra-indicated in patients with closed-angle glaucoma or with a narrow angle between the iris and the cornea. Hypersensitivity to belladonna alkaloids.

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 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:
Place one drop twice daily in the eye(s) for 1-2 days before examination, and 1 drop 1 hour before examination.

For uveitis: Place 1 drop in the eye(s) 3 times daily. Care should be taken to avoid contact between the dropper tip and the eye, eyelashes or any other surface. The cap should be replaced tightly after use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity to atropine is not uncommon and occurs as conjunctivitis. Systemic toxicity may be produced by the instillation of anti-cholinergic ophthalmic solution particularly in infants. Systemic absorption may be minimised by compressing the lacrimal sac for a minute or two during the following instillation. It may increase intra-ocular pressure, therefore in elderly and others where an increase may be encountered mydriatics and cycloplegics should be used with caution. Tonometric examination prior to drop instillation is advisable.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may cause systemic effects such as ataxia, incoherent speech, restlessness, hallucinations, disorientation, failure to recognize people, and tachycardia. Psychotic reactions and behavioural disturbances have been encountered in children.

Physostigmine salicylate 1 to 2 mg subcutaneously, I.M. or I.V. will control central and peripheral effects. Excitement may be controlled by small doses of a short-acting barbiturate such as thiopentone sodium 100 mg.

IDENTIFICATION:
A clear, colourless liquid.

PRESENTATION:
Natural low density polyethylene bottle containing 5 mL with red polypropylene cap.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep the container tightly closed.
KEEP OUT OF REACH OF CHILDREN.
DO NOT USE MORE THAN 30 DAYS AFTER OPENING.

REFERENCE NUMBER:
H.1135 (Act 101/1965)

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1981

Rev. 05/95

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