ACULAR Eye drops, solution Ref.[7563] Active ingredients: Ketorolac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK

Product name and form

Acular.

Pharmaceutical Form

Eye drops, solution.

Clear, colourless to pale yellow aqueous solution.

Qualitative and quantitative composition

Ketorolac trometamol 5 mg/ml.

Excipient(s) with known effect: benzalkonium chloride 0.1 mg/ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ketorolac

Ketorolac is a non-steroidal anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity. Ketorolac inhibits the cyclo-oxygenase enzyme essential for biosynthesis of prostaglandins. Ketorolac has been shown to reduce prostaglandin levels in the aqueous humour after topical ophthalmic administration.

List of Excipients

Sodium chloride
Benzalkonium chloride
Disodium edetate
Octoxinol 40
1N Sodium hydroxide or 1N Hydrochloric acid, to adjust pH
Purified water

Pack sizes and marketing

Low density polyethylene dropper bottles (with LDPE dropper tips) containing 3 ml, 5 ml or 10 ml of solution. The drop size is 35 microlitres. Each bottle has a medium impact polystyrene (MIPS) screw-cap.

Not all pack sizes may be marketed.

Marketing authorization holder

AbbVie Ltd., Maidenhead, SL6 4UB, UK

Marketing authorization dates and numbers

PL 41042/0051

27th July 2006

Drugs

Drug Countries
ACULAR Austria, Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States

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