Application Nr Approved Date Route Status External Links
ANDA074761 1997-05-16 Oral 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 Tablets, Usp 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. Acute Pain In Adult Patients Ketorolac Tromethamine Tablets 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 Ketorolac Tromethamine-Iv Or Im And Ketorolac Tromethamine Tablets Are To Be Used Only As Continuation Treatment, If Necessary. The Total Combined Duration Of Use Of Ketorolac Tromethamine-Iv/im 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 Tablet Therapy Is Not To Exceed 5 Days.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Hypromelloses HYPROMELLOSES Unresolved
6. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

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