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

Logo ISOPTO®HOMATROPINE 2% ophthalmic solution

        35641-A

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ISOPTO®HOMATROPINE 2% ophthalmic solution

COMPOSITION:
Homatropine hydrobromide 20 mg per mL.
Preservative: Benzalkonium chloride 0,01% (m/v).

PHARMACOLOGICAL CLASSIFICATION:
A.15.4 Ophthalmic preparations, other.

PHARMACOLOGICAL ACTION:
ISOPTO
® HOMATROPINE contains homatropine hydrobromide which blocks the action of certain parasympathetic nerves and cholinergic drugs. In ophthalmology, homatropine is used for its mydriatic and cycloplegic effects. Its peripheral effects are much weaker than those of atropine. It is preferred to atropine for diagnostic purposes because its action is more rapid, less prolonged and is readily controlled by physostigmine. The effect is exerted in 15 to 30 minutes and passes off in 12 to 24 hours. In children homatropine does not usually produce complete paralysis of accommodation.

INDICATIONS:
For use as a mydriatic and cycloplegic.

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.

CONTRA-INDICATIONS:
ISOPTO HOMATROPINE is contra-indicated in patients with closed-angle glaucoma or with a narrow angle between the iris and the cornea.

DOSAGE AND DIRECTIONS FOR USE:
For refraction:
Place two drops in the eye(s) and repeat two to three times at 5 to 10 minute intervals.
For therapy: Place 1-2 drops in the eye(s) every 3 - 4 hours. 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 is not uncommon and appears as conjunctivitis. Systemic reactions have followed the absorption of anticholinergics from eye drops, particularly in children. Systemic absorption may be minimised by compressing the lacrimal sac for a minute or two during and following instillation of the drops. Mydriatics and cycloplegics may increase intra-ocular pressure, therefore it should be used with caution in the elderly and others where an increase may be encountered. Tonometric examination prior to drop instillation is advisable.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may cause systemic reactions, 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:
Plastic Drop-Tainer™ dispenser with a red screw on cap, containing 5 mL.

STORAGE INSTRUCTION:
Store in a cool place 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.1131(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:
1 October 1993

0694/JV                35641-A

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998