Ketorolac (Ketorolac Tromethamine) - Summary

WARNING

Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days) management of moderately severe acute pain that requires analgesia at the opioid level. It is NOT indicated for minor or chronic painful conditions. Ketorolac tromethamine is a potent NSAID analgesic, and its administration carries many risks. The resulting NSAID-related adverse events can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. Increasing the dose of ketorolac tromethamine beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events.

Gastrointestinal Effects

• Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding, and/or perforation. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.

Renal Effects

• Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS).

Risk of Bleeding

• Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding (see WARNINGS and PRECAUTIONS).

• Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery, and is CONTRAINDICATED intraoperatively when hemostasis is critical because of the increased risk of bleeding.

Hypersensitivity

• Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine injection (see CONTRAINDICATIONS and WARNINGS). Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Intrathecal or Epidural Administration

• Ketorolac tromethamine is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.

Labor, Delivery and Nursing

• The use of ketorolac tromethamine in labor and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and inhibit uterine contractions.

• The use of ketorolac tromethamine is CONTRAINDICATED in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.

Concomitant Use with NSAIDs

• Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving ASA or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.

DOSAGE AND ADMINISTRATION

Ketorolac Tromethamine Tablets

• Ketorolac tromethamine tablets are indicated only as continuation therapy to ketorolac tromethamine^IV/IM, and the combined duration of use of ketorolac tromethamine^IV/IM and ketorolac tromethamine tablets is not to exceed 5 (five) days, because of the increased risk of serious adverse events.

• The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine^IV/IM (maximum 120 mg) (see DOSAGE AND ADMINISTRATION).

Special Populations

• Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION), and for patients with moderately elevated serum creatinine (see WARNINGS). IV/IM doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients. Ketorolac tromethamine injection is indicated as a single dose therapy in pediatric patients (see DOSAGE AND ADMINISTRATION); Not to exceed 30 mg for IM administration and 15 mg for IV administration.