Country: United States
Language: English
Source: NLM (National Library of Medicine)
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)
Rebel Distributors Corp.
KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE 5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
INDICATIONS AND USAGE ACULAR® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. CONTRAINDICATIONS ACULAR® ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
HOW SUPPLIED ACULAR® (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 21695-463-05 Store at 15°C - 25°C (59°F- 77°F) with protection from light. Rx Only © 2004 Allergan, Inc. Irvine, CA 92612, U.S.A. ACULAR® (a registered trademark of Roche Palo Alto L.L.C.) is manufactured and distributed by Allergan under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A. ® Marks owned by Allergan, Inc. U.S. Pat. 5,110,493 8344X 71590US11P Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320
New Drug Application
ACULAR- KETOROLAC TROMETHAMINE SOLUTION REBEL DISTRIBUTORS CORP. ---------- DESCRIPTION ACULAR (ketorolac tromethamine ophthalmic solution) 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 it has the following structure: ACULAR ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. ACULAR 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 molecular weight of ketorolac tromethamine is 376. 41. The osmolality of ACULAR ophthalmic solution is 290 mOsml/kg. Each mL of ACULAR ophthalmic solution contains: ACTIVE: ketorolac tromethamine 0.5%. PRESERVATIVE: benzalkonium chloride 0.01%. INACTIVES: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; and hydrochloric acid and/or sodium hydroxide to adjust the pH CLINICAL PHARMACOLOGY Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis. Ketorolac tromethamine given systemically does not cause pupil constriction. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery b Read the complete document