Ketorolac Tromethamine Injection and Ketorolac tromethamine tablets

Description

Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40.

Ketorolac tromethamine (Acular), approved in November 1992, is one of the earliest prescription products for treating itch associated with allergic conjunctivitis. Ketorolac, which is a pyrazolone, is a nonsteroidal anti-inflammatory agent. Its primary mechanism of action is on the arachidonic acid cascade, where it binds cyclooxygenase to block the production of prostaglandins. However, it does not inhibit lipoxygenase or the formation of leukotrienes.

Uses

Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, 6.68 mg, 4.35 mg, and 8.70 mg of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow.

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.

Ketorolac tromethamine tablets are not indicated for use in pediatric patients or for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events.

References

[1] labeling.pfizer.com/ShowLabeling.aspx?id=4487 https://labeling.pfizer.com/ShowLabeling.aspx?id=4487

[2] DailyMed - KETOROLAC TROMETHAMINE tablet, film coated https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=688f5dec-a6db-43c6-a1f8-5df99d08d395

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