SPRIX - ketorolac tromethamine spray, metered
Physicians Total Care, Inc.
WARNING; LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK
Limitations of Use
SPRIX (ketorolac tromethamine), a nonsteroidal anti-inflammatory drug (NSAID), is indicated for short-term (up to 5 days in adults) management of moderate to moderately severe pain that requires analgesia at the opioid level. Do not exceed a total combined duration of use of SPRIX and other ketorolac formulations (IM/IV or oral) of 5 days [see Dosage and Administration, (2.1) and Warnings and Precautions (5.1)].
SPRIX is not indicated for use in pediatric patients and it is not indicated for minor or chronic painful conditions.
Gastrointestinal Risk
Ketorolac tromethamine, including SPRIX, can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, SPRIX 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. Elderly patients are at greater risk for serious gastrointestinal events [see Contraindications (4), Warnings and Precautions (5.2)].
Bleeding Risk
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 Contraindications (4), Warnings and Precautions (5.3)].
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.6)].
SPRIX Nasal spray is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4)].
Renal Risk
SPRIX is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion [see Contraindications (4), Warnings and Precautions (5.4)].
1 INDICATIONS AND USAGE
SPRIX is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.
2 DOSAGE AND ADMINISTRATION
2.1 Limitations of Use
The total duration of use of SPRIX alone or sequentially with other formulations of ketorolac (IM/IV or oral) must not exceed 5 days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses [see Warnings and Precautions (5.1)]. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX.
Do not use SPRIX concomitantly with other formulations of ketorolac or other NSAIDs [see Warnings and Precautions (5.1)].
SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.
2.2 Adult Patients < 65 Years of Age
The recommended dose is 31.5 mg SPRIX (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg (four doses).
2.3 Reduced Doses for Special Populations
For patients ≥ 65 years of age, renally impaired patients, and adult patients less than 50 kg (110 lbs), the recommended dose is 15.75 mg SPRIX (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg (four doses) [see Warnings and Precautions (5.2, 5.4)].
2.4 Discard Used SPRIX Bottle after 24 Hours
Do not use any single SPRIX bottle for more than one day as it will not deliver the intended dose after 24 hours. Therefore, the bottle must be discarded no more than 24 hours after taking the first dose, even if the bottle still contains some liquid.
3 DOSAGE FORMS AND STRENGTHS
Nasal spray: 15.75 mg of ketorolac tromethamine in each 100 μL spray. Each 1.7 g bottle contains 8 sprays.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
SPRIX contains ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID). Ketorolac is an analgesic that inhibits the enzyme cyclooxygenase (COX), an early component of the arachidonic acid cascade, resulting in the reduced synthesis of prostaglandins, thromboxanes, and prostacyclin.
Ketorolac does not bind to the opiate receptor subtypes (mu, kappa, delta), but a 30 mg dose of ketorolac tromethamine IM has demonstrated an overall analgesic effect between that obtained with morphine 6 mg and 12 mg. Ketorolac possesses no sedative or anxiolytic properties, and has no effect on gut motility
