Acuvail

DRUG DESCRIPTION

ACUVAIL™ (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2,3- dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and its molecular weight is 376.41. Its molecular formula is C19H24N2O6. Its chemical structure is:

ACUVAIL™ (ketorolac tromethamine) Structural Formula Illustration

ACUVAIL™ (ketorolac tromethamine ophthalmic solution) solution is supplied as a sterile isotonic aqueous 0.45% preservative-free solution, with a pH of approximately 6.8. ACUVAIL™ 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 ACUVAIL™ (ketorolac tromethamine ophthalmic solution) solution is approximately 285 mOsml/kg.

Contains: Active: ketorolac tromethamine 0.45%. Inactives: Carboxymethylcellulose; sodium chloride; sodium citrate dihydrate; and purified water with sodium hydroxide and/or hydrochloric acid to adjust pH.



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