Ketorolac Tromethamine Solution

Ketorolac Tromethamine Solution

Ketorolac Tromethamine Solution Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Ketorolac Tromethamine Ophthalmic Solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac Tromethamine Ophthalmic Solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

History

There is currently no drug history available for this drug.

Other Information

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)-l,3-propanediol(1:1) and it has the following structural formula:

Structural Formula

The molecular formula of Ketorolac Tromethamine Ophthalmic Solution is C15H13NO3•C4H11NO3.

Ketorolac Tromethamine Ophthalmic Solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4.

Ketorolac Tromethamine 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 Ketorolac Ophthalmic Solution is 290 mOsml/kg.

Each mL of Ketorolac Tromethamine Ophthalmic Solution contains:

Active: ketorolac tromethamine 0.5%

Inactives: edetate disodium 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.8 to 7.4) and purified water.

Preservative: benzalkonium chloride 0.01%

Ketorolac Tromethamine Solution Manufacturers


  • Preferred Pharmaceuticals, Inc.
    Ketorolac Tromethamine Solution [Preferred Pharmaceuticals, Inc.]
  • Falcon Pharmaceuticals, Ltd.
    Ketorolac Tromethamine Solution [Falcon Pharmaceuticals, Ltd.]
  • Rebel Distributors Corp
    Ketorolac Tromethamine Solution [Rebel Distributors Corp]
  • Stat Rx Usa Llc
    Ketorolac Tromethamine Solution [Stat Rx Usa Llc]
  • Rebel Distributors Corp
    Ketorolac Tromethamine Solution [Rebel Distributors Corp]
  • Physicians Total Care, Inc.
    Ketorolac Tromethamine Solution [Physicians Total Care, Inc.]
  • Remedyrepack Inc.
    Ketorolac Tromethamine Solution [Remedyrepack Inc. ]
  • Apotex Corp.
    Ketorolac Tromethamine Solution [Apotex Corp.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ketorolac Tromethamine Solution [Lake Erie Medical Dba Quality Care Products Llc]
  • Sandoz Inc
    Ketorolac Tromethamine Solution [Sandoz Inc]

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