Acular

ACULAR is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. ACULAR is a nonsteroidal anti-inflammatory drug (NSAID) indicated for: The temporary relief of ocular itching due to seasonal allergic conjunctivitis. (1) The treatment of inflammation following cataract surgery. (1)

For temporary relief of ocular itching due to seasonal allergic conjunctivitis, apply one drop of ACULAR to the affected eye(s) four times a day. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, apply one drop of ACULAR to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. (2.1)

2.1Recommended Dosage Temporary

Relief o f Ocular Itching D ue t o Seasonal Allergic Conjunctivitis The recommended dosage of ACULAR is one drop four times a day to the affected eye(s) for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Treatment o f Postoperative Inflammation i n Patients Who Have Undergone Cataract Extraction Apply one drop of ACULAR to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period for the treatment of postoperative inflammation in patients who have undergone cataract extraction. 2.2 Use with Other Topical Ophthalmic Medications ACULAR has been safely administered in conjunction with other ophthalmic medications such as antibiotics, alpha-agonists, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

10 mL size bottle filled with 5 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL). Ophthalmic solution containing 0.5% (5 mg/mL) ketorolac tromethamine. (3) 10 mL size bottle filled with 5 mL of solution

ACULAR solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions (6.1)]. Hypersensitivity to any component of this product. (4)

8.1Pregnancy Risk Summary

There are no adequate and well-controlled studies with ACULAR in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ACULAR at clinically relevant doses. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ACULAR during late pregnancy should be avoided. 8.2 Lactation Risk Summary It is not known whether ketorolac when given topically is present in human milk. Because many drugs are excreted in human milk, caution should be exercised when ACULAR is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of ACULAR have not been established in pediatric patients younger than 2 years old. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Risk Summary There are no adequate and well-controlled studies with ACULAR in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ACULAR at clinically relevant doses. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ACULAR during late pregnancy should be avoided.

The safety and effectiveness of ACULAR have not been established in pediatric patients younger than 2 years old.

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

ACULAR (ketorolac tromethamine ophthalmic solution) 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1 H -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 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 molecular weight of ketorolac tromethamine is 376.41. The osmolality of ACULAR ophthalmic solution is 290 mOsmol/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; hydrochloric acid and/or sodium hydroxide to adjust pH. Chemical Structure

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.

ACULAR (ketorolac tromethamine ophthalmic solution) 0.5% is supplied sterile, in white opaque plastic (LDPE) bottles with white droppers, with gray high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 0023-2181-05 Storage: Store at 15°C to 25°C (59°F to 77°F). Protect from light.