Ointment
Non-proprietary name: Dibromopropamidine isethionate Structural formula Chemical formula: 3,3'-dibromo-4,4'-(propane-1,3-diybisoxy)dibenzimidine bis(2- hydroxyethanesulphonate) Molecular formula: C17H18Br2N4O2.2C2H6O4S Molecular weight: 722 CAS number: 614-87-9
Drops
Non-proprietary name: Propamidine isethionate Chemical formula: 1,3-di-(4-aminophenoxy)propone di-(2-hydroxyethene-sulfate) Molecular formula: C17H20N4O2.2C2H6O4S Molecular weight: 564.6 CAS number: 140-63-6
Ointment
Dibromopropamidine isethionate 1.5mg/g in an eye ointment base. Excipients include phenethyl alcohol 5mg/g as preservative, paraffin-soft yellow, paraffin-liquid and lanolin.
Drops
Propamidine isethionate 1mg/mL in a sterile (aqueous) vehicle, isotonic with the lacrimal secretion. Excipients include benzalkonium chloride 0.05mg/mL as preservative, ammonium chloride, sodium chloride and sodium hydroxide.
Propamidine and dibromopropamidine possess inhibitory activity against a range of organisms, mainly gram-positive, as well as acanthamoeba.
Treatment of mild acute conjunctivitis.
Acanthamoeba keratitis (for use under medical supervision).
Hypersensitivity to propamidine or any other component of the preparation.
The drops should be discarded 4 weeks after first opening for domiciliary use or 7 days after opening for hospital use. Seek medical advice if infection does not improve within 24-48 hours or clear completely in 7 days. There is always the possibility, although rare, of a sensitisation reaction resulting from the use of Brolene preparations; in such an event, treatment should be immediately discontinued. Do not use Brolene eye drops when wearing soft or gas permeable contact lenses. Not to be used in eye infections in infants except on medical advice.
Use in pregnancy
Safety of use in pregnancy has not been established. Use only if considered essential by a physician.
Use in lactation
Use during lactation only if considered essential by a physician.
Effects on ability to drive or operate machinery
Brolene may cause blurring on instillation. If blurring occurs, patients should not drive or operate hazardous machinery until vision is clear.
Hypersensitivity may occur. Eye pain or irritation, usually in the form of a stinging or burning sensation, may also occur. In such cases, use should be discontinued immediately and a physician should be consulted.
Before the application of Brolene, it is advisable to cleanse the affected eye with warm water or saline solution which has previously been boiled. The ointment should be applied to the conjunctival sacs 2 or 3 times daily for not more than 1 week. The drops should be instilled into the affected eye at the rate of 1 or 2 drops 3 or 4 times daily, for not more than 1 week. A suggested method is to use the ointment at bedtime and the eye drops during the day. If Brolene is effective, there will be an obvious improvement within 2 days. If this has not occurred, further medical advice should be obtained.
Contact the Poisons Information Centre on 13 11 26 for advice.
Eye ointment: 5 g Eye drops (plastic dropper bottle): 10 mL * Store below 25degC
sanofi-aventis australia pty ltd 12-24 Talavera Road Macquarie Park NSW 2113 AUSTRALIA
S2 Date of TGA approval: 12 September 1997 Date of most recent amendment: 10 February 2010 *marketed presentation