Ketorolac Tromethamine (Page 2 of 2)

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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.

12.3 Pharmacokinetics

One drop of 0.5% ketorolac tromethamine ophthalmic solution was instilled into one eye and one drop of vehicle into the other eye TID in 26 healthy subjects. Five of 26 subjects had detectable concentrations of ketorolac in their plasma (range 11 to 23 ng/mL) at day 10 during topical ocular treatment.
Two drops of 0.5% ketorolac tromethamine ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in the aqueous humor of 8 of 9 eyes tested (range 40 to 170 ng/mL).

14 CLINICAL STUDIES

In two double-masked, multi-centered, parallel-group studies, 313 patients who had undergone photorefractive keratectomy received ketorolac tromethamine ophthalmic solution 0.4% or its vehicle QID for up to 4 days. Significant differences favored ketorolac tromethamine for the reduction of ocular pain and burning/stinging following photorefractive keratectomy surgery.
Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure.
The safety and effectiveness of ketorolac tromethamine in post-cataract surgery patients has not been established.

16 HOW SUPPLIED/STORAGE AND HANDLING

Ketorolac tromethamine ophthalmic solution 0.4% is a clear colorless to slightly yellow solution supplied in white opaque LDPE container with LDPE nozzle and gray color HDPE cap as follows:
5 mL in 10 mL bottle NDC 65862-775-05

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

17 PATIENT COUNSELING INFORMATION

Slow or Delayed Healing

Inform patients of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

Avoiding Contamination of the Product

Instruct patients to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Contact Lens Wear

Advise patients that ketorolac tromethamine ophthalmic solution should not be administered while wearing contact lenses.
Intercurrent Ocular Conditions

Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of ketorolac tromethamine.

Concomitant Topical Ocular Therapy

Advise patients that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.
Distributed by:

Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Eugia Pharma Specialities Limited
Hyderabad — 500032
India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.4% — Container Label

NDC 65862-775-05
Ketorolac
Tromethamine
Ophthalmic Solution
0.4%
For Use in the Eyes Only
Rx only Aurobindo

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.4% — Container-Carton

NDC 65862-775-05
Ketorolac
Tromethamine
Ophthalmic
Solution
0.4%
For Use in the Eyes Only
5 mL
Rx only
AUROBINDO

KETOROLAC TROMETHAMINE ketorolac tromethamine solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-775 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 4 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE EDETATE DISODIUM OCTOXYNOL-40 WATER SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-775-05 1 BOTTLE in 1 CARTON contains a BOTTLE 1 5 mL in 1 BOTTLE This package is contained within the CARTON (65862-775-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205191 11/15/2018

Labeler — Aurobindo Pharma Limited (650082092)

Establishment
Name	Address	ID/FEI	Operations
Eugia Pharma Specialities Limited		650498244	ANALYSIS (65862-775), MANUFACTURE (65862-775), PACK (65862-775)

Revised: 12/2022 Aurobindo Pharma Limited