Gastrointestinal and Renal Effects, Risk of Bleeding, Hypersensitivity

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.

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. Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery and is CONTRAINDICATED intra-operatively 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. 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 the uterus.
• 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 Injection, and the combined duration of use of Ketorolac Tromethamine Injection and ketorolac tromethamine tablets is not to exceed five (5) days because of the increased risk of serious adverse events. The recommended total dose of ketorolas tromethamine tablets (Maxium 40 mg) is significantly lower than for ketorolac tromethamine injection (maxium 120 mg.

Special Populations

• Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight and for patients with moderately elevated serum creatinine. Doses of Ketorolac Tromethamine Injection are not to exceed 60 mg (total dose per day) in these patients.