LEVOFLOXACIN Eye drops, solution Ref.[7252] Active ingredients: Levofloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

Levofloxacin 5mg/ml Eye Drops Solution.

Pharmaceutical Form

Eye drops, solution.

Clear, pale yellow to pale greenish-yellow solution, practically free from visible particles.

The pH of the solution is 6.0-6.8 and the osmolality is 270-320 mOsmol/kg.

Qualitative and quantitative composition

1 ml of eye drops, solution, contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin.

Excipient with known effect: One ml of eye drops, solution contains 0.05 mg benzalkonium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levofloxacin

Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class. As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA – DNA-gyrase complex and topoisomerase IV.

List of Excipients

Benzalkonium chloride (0.05 mg in 1 ml eye drops, solution)
Sodium chloride
Sodium hydroxide or hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

White LDPE 5 ml bottle with a white LDPE dropper and a white high density polyethylene (HDPE)/LDPE tamper-evident seal cap.

Pack size: one bottle in a cardboard box.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/0946

07/03/2016

© 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.