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

Logo DIPIVEFRIN HCl 0.1%, Alcon® ophthalmic solution

        44069-A

SCHEDULING STATUS:
3

PROPRIETARY NAME
(and dosage form):

DIPIVEFRIN HCl 0.1%, Alcon® ophthalmic solution

COMPOSITION:
Each mL of
Dipivefrin HCl 0.1%, Alcon ophthalmic solution contains dipivefrin hydrochloride 1.0 mg, preserved with benzalkonium chloride 0.005% (m/v).

PHARMACOLOGICAL CLASSIFICATION:
A.15.4 Ophthalmic preparations, other.

PHARMACOLOGICAL ACTION:
Dipivefrin hydrochloride is a prodrug of adrenaline formed by the diesterification of adrenaline and pivalic acid. The addition of pivaloyl groups to the adrenaline molecule enhances its lipophilic character and as a consequence, its penetration into the anterior chamber. Dipivefrin hydrochloride is converted to adrenaline inside the human eye by enzyme hydrolysis. The liberated adrenaline, an adrenergic agonist, appears to exert its action by decreasing aqueous production and by enhancing outflow, thus lowering intra-ocular pressure.
The onset of action with one drop of Dipivefrin HCl 0.1%, Alcon occurs about 30 minutes after treatment, with maximum effect seen at about one hour.

INDICATIONS:
Dipivefrin HCl 0.1%, Alcon is indicated as therapy for the control of intraocular pressure in chronic open-angle glaucoma and ocular hypertensive patients. Patients responding inadequately to other antiglaucoma therapy may respond to replacement with or addition of Dipivefrin HCl 0.1%, Alcon.

CONTRA-INDICATIONS:
Dipivefrin HCl 0.1%, Alcon should not be used in patients with narrow angles since any dilation of the pupil may predispose the patient to an attack of angle-closure glaucoma. This product is contra-indicated in patients who are hypersensitive to any of its components. Not recommended for use in children and during pregnancy.

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:
Initial glaucoma therapy:
The usual dosage of Dipivefrin HCl 0.1%, Alcon is one drop in the eye(s) every 12 hours.
Replacement with Dipivefrin HCl 0.1%, Alcon:
When patients are being transferred to Dipivefrin HCl 0.1%, Alcon from antiglaucoma agents other than adrenaline, on the first day continue the previous medication and add one drop of Dipivefrin HCl 0.1%, Alcon in each eye every 12 hours. On the following day, discontinue the previously used antiglaucoma agent and continue with Dipivefrin HCl 0.1%, Alcon. In transferring patients from conventional adrenaline therapy to Dipivefrin HCl 0.1%, Alcon, simply discontinue the adrenaline medication and institute the Dipivefrin HCl 0.1%, Alcon regimen.
Addition of Dipivefrin HCl 0.1%, Alcon:
When patients on other antiglaucoma agents require additional therapy, add one drop of Dipivefrin HCl 0.1%, Alcon every 12 hours.
Concomitant Therapy:
For difficult to control patients, the addition of other agents such as pilocarpine, betablockers, carbachol, echothiopate iodide or acetazolamide to Dipivefrin HCl therapy has been shown to be effective.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
For external use only.
Side effects include conjunctival hyperaemia, lid oedema, conjunctival chemosis, follicular hypertrophy, blepharoconjunctivitis, itching, pain, tearing, browache or headache.
Aphakic patients:
Macular oedema has been shown to occur in up to 30% of aphakic patients treated with adrenaline. Discontinuation of adrenaline generally results in reversal of the maculopathy.
The possibility of macular oedema must be considered in aphakic patients treated with Dipivefrin HCl 0.1%, Alcon.
Adrenochrome deposits:
Adrenaline therapy has led to adrenochrome deposits in the conjunctiva and cornea, these have been reported following the use of Dipivefrin HCl 0.1%, Alcon.
Cardiovascular effects:
Other side-effects such as tachycardia, arrhythmia and hypertension may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Due to the fact that Dipivefrin HCl 0.1%, Alcon is a topical ophthalmic product, overdosage is negligible. However, recommended treatment is as follows:
In the eye: Flush eye with water or normal saline
Accidental oral ingestion: Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, colourless solution.

PRESENTATION:
Available in 5 mL and 10 mL white or natural low density polyethylene DROPTAINER
® bottles.

STORAGE INSTRUCTIONS:
Keep tightly closed.
Store below 25°C away from light.
KEEP OUT OF REACH OF CHILDREN.
DO NOT USE LONGER THAN 30 DAYS AFTER OPENING.

REGISTRATION NUMBER:
30/15.4/0172

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 February 1996

1096        44069-A

Updated on this site: November 1999

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