KETOROLAC TROMETHAMINE

Manufacturer: Leading Pharma, LLC

Score: 144.0

Quick Summary

Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) used for the short-term management of moderately severe acute pain that requires analgesia at the opioid level. It is contraindicated in patients with active peptic ulcer disease, recent gastrointestinal bleeding or perforation, and history of peptic ulcer disease or gastrointestinal bleeding. The total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine should not exceed 5 days. Elderly patients are at greater risk for serious gastrointestinal events, and dose adjustments are necessary for patients with renal impairment or those who are 65 years or older.

Key Clinical Findings and Indications

Short-term management of moderately severe acute pain
Analgesia at the opioid level
Postoperative pain management

Important Safety Information

Warning

Ketorolac Tromethamine can cause serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

Contraindications

Active peptic ulcer disease
Recent gastrointestinal bleeding or perforation
History of peptic ulcer disease or gastrointestinal bleeding
Aspirin triad
Cerebrovascular bleeding or hemorrhagic diathesis

Adverse Reactions

Gastrointestinal events (bleeding, ulceration, perforation)
Hemorrhage
Renal effects (acute renal failure, interstitial nephritis, nephrotic syndrome)
Anaphylactoid reactions
Cardiovascular events (myocardial infarction, stroke)

Dosing Recommendations

General Guidance

Dose adjustments are necessary for patients with renal impairment or those who are 65 years or older.

Acute pain management

Adult Dose

20 mg PO once, followed by 10 mg q4 to 6 hours prn, not to exceed 40 mg/day

Pediatric Dose

Not indicated for use in pediatric patients

Special Population Considerations

Pregnancy

Use during pregnancy should be avoided, particularly in late pregnancy, due to the potential for premature closure of the ductus arteriosus.

Nursing Mothers

Exercise caution when administering ketorolac to nursing mothers, as low levels of ketorolac have been detected in breast milk.

Pediatric Use

Ketorolac tromethamine tablets are not indicated for use in pediatric patients.

Geriatric Use

Extreme caution and reduced dosages are recommended when treating elderly patients with ketorolac tromethamine due to increased sensitivity to dose-related adverse effects.

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