Ketorolac Tromethamine
Generic Name: ketorolac tromethamine
Brand Names:
Ketorolac Tromethamine
DESCRIPTION Ketorolac Tromethamine Tablets, USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti- inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-benzoyl- 2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3- propanediol (1:1). The structural formula is: C 15 H 13 NO 3 . C 4 H 11 NO 3 M.W. 376.40 Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP.
Overview
DESCRIPTION Ketorolac Tromethamine Tablets, USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti- inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-benzoyl- 2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3- propanediol (1:1). The structural formula is: C 15 H 13 NO 3 . C 4 H 11 NO 3 M.W. 376.40 Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP.
Uses
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets USP are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and Ketorolac Tromethamine Tablets USP are to be used only as continuation treatment, if necessary.
Dosage
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Side Effects
ADVERSE REACTIONS Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING , WARNINGS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.
Interactions
Drug Interactions Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs. Warfarin, Digoxin, Salicylate, and Heparin The in vitro binding of warfarin to plasma proteins is only slightly reduced by ketorolac tromethamine (99.5% control vs 99.3%) when ketorolac plasma concentrations reach 5 to 10 mcg/mL. Ketorolac does not alter digoxin protein binding. In vitro studies indicate that, at therapeutic concentrations of salicylate (300 mcg/mL), the binding of ketorolac was reduced from approximately 99.2% to 97.5%, representing a potential twofold increase in unbound ketorolac plasma levels.
Warnings
BOXED WARNING Ketorolac tromethamine tablets, a nonsteroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days. WARNINGS (See also Boxed WARNING .) The total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine tablets are not indicated for use in pediatric patients. The most serious risks associated with ketorolac tromethamine are: Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation Ketorolac tromethamine is contraindicated in patients with previously documented peptic ulcers and/or GI bleeding. Ketorolac tromethamine can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration and perforation, of the stomach, small intestine, or large intestine, which can be fatal. CONTRAINDICATIONS (See also Boxed WARNING .) Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.
Storage
HOW SUPPLIED Ketorolac Tromethamine Tablets USP are available as follows: 10 mg: White, round, bi-convex, unscored film-coated tablets, debossed "A" on one side and "39" on other side.
Frequently Asked Questions
What is Ketorolac Tromethamine used for?▼
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets USP are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and Ketorolac Tromethamine Tablets USP are to be used only as continuation treatment, if necessary.
What are the side effects of Ketorolac Tromethamine?▼
ADVERSE REACTIONS Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING , WARNINGS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.
What are the important warnings for Ketorolac Tromethamine?▼
BOXED WARNING Ketorolac tromethamine tablets, a nonsteroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days. WARNINGS (See also Boxed WARNING .) The total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine tablets are not indicated for use in pediatric patients. The most serious risks associated with ketorolac tromethamine are: Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation Ketorolac tromethamine is contraindicated in patients with previously documented peptic ulcers and/or GI bleeding. Ketorolac tromethamine can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration and perforation, of the stomach, small intestine, or large intestine, which can be fatal. CONTRAINDICATIONS (See also Boxed WARNING .) Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.