Application Nr Approved Date Route Status External Links
ANDA074802 1997-06-05 Intramuscular RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Carefully Consider The Potential Benefits And Risks Of Ketorolac Tromethamine And Other Treatment Options Before Deciding To Use Ketorolac. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Acute Pain In 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 Intravenous Or Intramuscular Dosing Of Ketorolac Tromethamine, And Oral Ketorolac Tromethamine Is To Be Used Only As Continuation Treatment, If Necessary. The Total Combined Duration Of Use Of Ketorolac Tromethamine Injection And Oral Ketorolac Tromethamine 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. 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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