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Logo IOPIDINE™ Apraclonidine 1%, sterile ophthalmic solution

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

IOPIDINE™ Apraclonidine 1%, sterile ophthalmic solution

COMPOSITION:
IOPIDINE™ contains per mL:
11,5 mg
apraclonidine hydrochloride (equivalent to 10 mg apraclonidine) and 0,01% benzalkonium chloride as a preservative in a sterile, buffered, isotonic solution.

PHARMACOLOGICAL CLASSIFICATION:
A.15.4 Ophthalmic preparations, other.

PHARMACOLOGICAL ACTION:
Apraclonidine is a potent alpha-adrenergic agonist which is relatively selective to alpha-2 receptors, although it does have some affinity for alpha-1 receptors. Apraclonidine is more highly ionized than clonidine at physiological pH due to its higher pKa and its polar structure reduces blood/brain permeability.
Apraclonidine has been shown to lower intraocular pressure (IOP) when administered by the topical ocular route.
Ophthalmic apraclonidine (IOPIDINE) does not have significant membrane stabilizing (local anaesthetic) activity.
The mechanism of the ocular hypotensive action of IOPIDINE is by a reduction of aqueous flow and not by an effect on the facility of aqueous outflow.

INDICATIONS:
IOPIDINE is indicated for the control or prevention of postsurgical elevations in intraocular pressure that occur in patients following anterior segment laser surgery.

CONTRA-INDICATIONS:
IOPIDINE is contra-indicated in patients receiving monoamine oxidase inhibitor therapy and in patients with hypersensitivity to any component of the preparation or to clonidine.

WARNINGS:
NOT FOR INJECTION.
Since apraclonidine is a potent depressor of intraocular pressure, patients that develop exaggerated reduction in intraocular pressure should be closely monitored.
Caution should be exercised when transferring a patient from IOPIDINE. The withdrawal of IOPIDINE may result in the release of large amounts of catecholamines which may give rise to a hypertensive crisis. If beta-blockers are administered in these circumstances, the unopposed alpha receptor stimulation may potentiate this effect.
Patients scheduled for anterior segment laser surgery and IOPIDINE administration should be withdrawn from all beta-blocker administration 24 hours prior to surgery and remain free from beta-blocker administration until 24 hours postsurgery.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants.
IOPIDINE should be used with caution in patients with cerebral, or coronary insufficiency, Raynaud's disease or thromboangiitis obliterans or with a history of depression.

DOSAGE AND DIRECTIONS FOR USE:
One drop of IOPIDINE should be instilled in the eye scheduled for operation one hour before initiating anterior segment laser surgery. A second drop should be instilled into the same eye immediately upon completion of the laser surgical procedure.
The safety and effectiveness of IOPIDINE in children have not been established and therefore IOPIDINE is not recommended for use in children.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The following side-effects were reported following topical, ocular administration: injection, lid retraction, conjunctival blanching, possible mydriasis.
Precautions: Caution should be observed in treating patients with cardiovascular disease, including hypertension. The possibility of a vasovagal attack occurring during laser surgery should be considered and
caution should be exercised in patients with a history of such episodes.
Pregnancy: Safety in pregnancy and lactation has not been established.
Drug interactions: The hypotensive effect of IOPIDINE may be antagonised by tricyclic antidepressants, and enhanced by thiazide diuretics.
The concurrent use of beta-blockers or tricyclic antidepressants, or the sudden withdrawal of a systemic alpha-agonist have the potential to precipitate a sudden severe rebound hypertension.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS:
Symptomatology in the event of ingestion is unknown. A topical overdosage may be flushed from the eye with warm tap water.

IDENTIFICATION:
A clear, colourless to pale yellow solution.

PRESENTATION:
Two low density polyethylene containers each containing 0,1 mL IOPIDINE ophthalmic solution enclosed in a foil pouch and presented in cartons of 12 pouches.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C), protect from light. Discard container immediately after use.

REGISTRATION NUMBER:
X/15.4/178

NAME AND ADDRESS OF APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd/(Edms) Bpk
Surrey Avenue
RANDBURG 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 February 1990
347741

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