BETOPTIC Eye drops, suspension

Active ingredients: Betaxolol

Product name and form

BETOPTIC 0.25% w/v Eye Drops, Suspension.

Pharmaceutical Form

Eye Drops, Suspension.

Qualitative and quantitative composition

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.

Active Ingredient
Description

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.

List of Excipients

Benzalkonium chloride
Poly (styrene divinylbenzene) sulphonic acid
Carbomer
Boric acid
Mannitol
Disodium edetate
N-Lauroylsarcosine
Hydrochloric acid and/or sodium hydroxide
Purified water

Pack sizes and marketing

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.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 00101/0990

Date of first authorisation: 27 August 1997

Date of renewal: 27 August 2002

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Spain, Finland, France, Hong Kong, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, United States, South Africa