KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE DIRECT RX FDA Approved Ketorolac tromethamine ophthalmic solution 0.5% 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: Ketorolac tromethamine ophthalmic solution 0.5% is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution 0.5% 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 ketorolac tromethamine ophthalmic solution 0.5% is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH.
FunFoxMeds bottle
Route
OPHTHALMIC
Applications
ANDA203410
Package NDC

Drug Facts

Composition & Profile

Strengths
0.5 % 3 ml 5 ml 10 ml
Quantities
3 ml 5 ml 10 ml
Treats Conditions
Before You Use Ketorolac Tromethamine Ophthalmic Solution 0 5 For The First Time 1 Check To Make Sure That The Tamper Evident Ring Between The Bottle And The Cap Is Not Broken See Figure A If The Tamper Evident Ring Is Broken Or Missing Contact Your Pharmacist Img Fig A 2 Tear Off The Tamper Evident Ring See Figure B Img Fig B 3 To Open The Bottle Remove The Cap By Turning It In The Counterclockwise Direction See Figure C Img Fig C This Instructions For Use Has Been Approved By The U S Food And Drug Administration Rev 10 2021 Ketorolac Tromethamine Ophthalmic Solution 0 5 Is Indicated For The Temporary Relief Of Ocular Itching Due To Seasonal Allergic Conjunctivitis Ketorolac Tromethamine Ophthalmic Solution 0 5 Is Also Indicated For The Treatment Of Postoperative Inflammation In Patients Who Have Undergone Cataract Extraction

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
4EVE5946BQ
Packaging

Ketorolac Tromethamine Ophthalmic solution 0.5% is supplied sterile, in white opaque LDPE bottles with white opaque LDPE Nozzles with HDPE grey caps as follows. 3 mL in 5 mL bottle NDC 42571-137-31 5 mL in 5 mL bottle NDC 42571-137-25 10 mL in 10 mL bottle NDC 42571-137-26 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; fhtyfgh

Package Descriptions
  • Ketorolac Tromethamine Ophthalmic solution 0.5% is supplied sterile, in white opaque LDPE bottles with white opaque LDPE Nozzles with HDPE grey caps as follows. 3 mL in 5 mL bottle NDC 42571-137-31 5 mL in 5 mL bottle NDC 42571-137-25 10 mL in 10 mL bottle NDC 42571-137-26 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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Overview

Ketorolac tromethamine ophthalmic solution 0.5% 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: Ketorolac tromethamine ophthalmic solution 0.5% is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution 0.5% 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 ketorolac tromethamine ophthalmic solution 0.5% is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH.

Indications & Usage

Before you use Ketorolac Tromethamine Ophthalmic solution 0.5% for the first time: 1.Check to make sure that the tamper evident ring between the bottle and the cap is not broken ( See Figure A). If the tamper evident ring is broken or missing, contact your pharmacist. [Img-fig-a] 2.Tear off the tamper evident ring ( See Figure B). [Img-fig-b] 3.To open the bottle, remove the cap by turning it in the counterclockwise direction ( See Figure C). [Img-fig-c] This Instructions for Use has been approved by the U.S. Food and Drug Administration. Rev.10/2021 Ketorolac tromethamine ophthalmic solution 0.5% is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution 0.5% is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Dosage & Administration

Not available

Warnings & Precautions
No warnings available yet.

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