Active ingredients: Betaxolol
BETOPTIC 0.25% w/v Eye Drops, Suspension.
Eye Drops, Suspension.
Betaxolol 0.25% w/v (as hydrochloride).
Excipients with known effect: 1ml of suspension contains 0.1mg benzalkonium chloride.
For a full list of excipients see Section 6.1.
Betaxolol is a cardioselective Beta1 receptor blocker which, when applied topically to the eye, lowers intraocular pressure. It is thought to produce this effect by reducing the rate of production of aqueous humour.
Benzalkonium chloride
Poly (styrene divinylbenzene) sulphonic acid
Carbomer
Boric acid
Mannitol
Disodium edetate
N-Lauroylsarcosine
Hydrochloric acid and/or sodium hydroxide
Purified water
BETOPTIC SUSPENSION is packaged as a 5 ml label fill in a 5 ml and a 10 ml label fill in a 10 ml natural low density polyethylene (LDPE), DROP-TAINER with a LDPE dispensing plug and a 15 mm white polypropylene closure. The DROP-TAINER utilizes a tamper evident closure with a breakaway ring.
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
PL 00101/0990
Date of first authorisation: 27 August 1997
Date of renewal: 27 August 2002