Application Nr Approved Date Route Status External Links
ANDA075772 2004-07-21 Intramuscular DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Adult Patients Ketorolac Tromethamine Is 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 Ketorolac Tromethamine Injection And Ketorolac Tromethamine Tablets Are To Be Used Only As Continuation Treatment, If Necessary. Combined Use Of Ketorolac Tromethamine Injection And Ketorolac Tromethamine Tablets Is Not To Exceed 5 Days Of Use Because Of The Potential Of Increasing The Frequency And Severity Of Adverse Reactions Associated With The Recommended Doses (see Warnings , Precautions , Dosage And Administration And Adverse Reactions ). Patients Should Be Switched To Alternative Analgesics As Soon As Possible, But Ketorolac Tromethamine Therapy Is Not To Exceed 5 Days. Pediatric Patients The Safety And Effectiveness Of Single Doses Of Ketorolac Tromethamine Injection Have Been Established In Pediatric Patients Between The Ages Of 2 And 16 Years. Ketorolac Tromethamine, As A Single Injectable Dose, Has Been Shown To Be Effective In The Management Of Moderately Severe Acute Pain That Requires Analgesia At The Opioid Level, Usually In The Postoperative Setting. There Is Limited Data Available To Support The Use Of Multiple Doses Of Ketorolac Tromethamine In Pediatric Patients. Safety And Effectiveness Have Not Been Established In Pediatric Patients Below The Age Of 2 Years. Use Of Ketorolac Tromethamine In Pediatric Patients Is Supported By Evidence From Adequate And Well-Controlled Studies Of Ketorolac Tromethamine In Adults With Additional Pharmacokinetic, Efficacy And Safety Data On Its Use In Pediatric Patients Available In The Published Literature (see Clinical Pharmacology, Clinical Studies , Warnings , And Precautions ). Ketorolac Tromethamine Injection Has Been Used Concomitantly With Morphine And Meperidine And Has Shown An Opioid-Sparing Effect. For Breakthrough Pain, It Is Recommended To Supplement The Lower End Of The Ketorolac Tromethamine Injection Dosage Range With Low Doses Of Narcotics Prn, Unless Otherwise Contraindicated. Ketorolac Tromethamine Injection And Narcotics Should Not Be Administered In The Same Syringe (see Dosage And Administration - Pharmaceutical Information For Ketorolac Tromethamine Injection ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ketorolac Tromethamine KETOROLAC TROMETHAMINE ZINC2279

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