ACULAR LS™
(ketorolac tromethamine ophthalmic solution) 0.4%
Sterile
DESCRIPTION
ACULAR LS™ (ketorolac tromethamine ophthalmic solution) 0.4% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use.
Structural and Molecular Formula:
Chemical Name:
(±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
Contains
Active: ketorolac tromethamine 0.4%. Preservative: benzalkonium chloride 0.006%. Inactives: sodium chloride; edetate disodium 0.015%; octoxynol 40; purified water; and hydrochloric acid and/or sodium hydroxide to adjust the pH.
ACULAR LS™ ophthalmic solution is supplied as a sterile isotonic aqueous 0.4% solution, with a pH of approximately 7.4. ACULAR LS™ ophthalmic solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The osmolality of ACULAR LS™ ophthalmic solution is approximately 290 mOsml/kg.
|
