Source: FDA, National Drug Code (US) Revision Year: 2019
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 376.40.
Its molecular formula is C19H24N2O6.
Its chemical structure is:
ACUVAIL solution is supplied as a sterile isotonic aqueous 0.45% preservative-free solution, with a pH of approximately 6.8. ACUVAIL solution contains 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 solution is approximately 285 mOsml/kg.
Each mL of ACUVAIL ophthalmic solution contains:
Active:ketorolac tromethamine 0.45%.
Inactives: carboxymethylcellulose sodium; sodium chloride; sodium citrate dihydrate; and purified water with sodium hydroxide and/or hydrochloric acid to adjust pH.
| Dosage Forms and Strengths |
|---|
|
4.5 mg/mL ketorolac tromethamine solution (0.45%) in a single-use vial. |
| How Supplied |
|---|
|
ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is available as a sterile solution supplied in clear, LDPE, single-use vials packaged in 3 foil pouches, 10 vials per pouch: 30 Single-Use Vials 0.4 mL each: NDC 0023-3507-31 Distributed by: Allergan USA, Inc., Madison, NJ 07940 |
| Drug | Countries | |
|---|---|---|
| ACUVAIL | Canada, Singapore, Turkey, United States |
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