LOTEMAX Eye-drops, suspension Ref.[9454] Active ingredients: Loteprednol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Bausch & Lomb GmbH, Brunsbรผtteler Damm 165-173, 13581, Berlin, Germany

Product name and form

Lotemax 0.5% w/v Eye Drops, Suspension.

Pharmaceutical Form

Eye-drops, suspension.

Milky-white.

Qualitative and quantitative composition

The suspension contains 0.5%w/v loteprednol etabonate (5 mg/ml).

Each drop contains 0.19 mg loteprednol etabonate.

Excipient with known effect: Benzalkonium Chloride (0.01%).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Loteprednol

Loteprednol etabonate is a new class of corticosteroid with potent antiinflammatory activity designed to be active at the site of action. Its antiinflammatory activity is similar to the most powerful steroid used in ophthalmology but with less intraocular pressure.

List of Excipients

Disodium edetate
Glycerol
Povidone
Purified water
Tyloxapol
Hydrochloric acid (pH adjuster)
Sodium hydroxide (pH adjuster)
Benzalkonium chloride

Pack sizes and marketing

Lotemax is available in the following packaging configurations:

2.5 mL and 5 mL supplied in a white low density polyethylene bottle (7.5 mL) with a white control drop tip and a pink polypropylene cap.

10 mL supplied in a white low density polyethylene bottle (10 mL) with a white control drop tip and a pink polypropylene cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Bausch & Lomb GmbH, Brunsbรผtteler Damm 165-173, 13581, Berlin, Germany

Marketing authorization dates and numbers

PL 17947/0001

31/03/2008

Drugs

Drug Countries
LOTEMAX Austria, Canada, Cyprus, Estonia, Hong Kong, Ireland, Israel, Lithuania, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

ยฉ All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.