SPRIX

The half-lives of ketorolac by the IN and IM routes were similar. The bioavailability of ketorolac by the IN route of administration of a 31.5 mg dose was approximately 60% compared to IM administration. (See Table 3 ).

Table 3Pharmacokinetic Parameters of Ketorolac Tromethamine after Intramuscular (IM) and Intranasal (IN) Administration C max = maximum plasma concentration; t max = time of C max ; AUC 0-∞ = complete area under the concentration-time curve; T ½ = half-life; SD = standard devia...

14.1 Postoperative Pain The effect of SPRIX on acute pain was evaluated in two multi-center, randomized, double-blind, placebo-controlled studies. In a study of adults who had undergone elective abdominal or orthopedic surgery, 300 patients were randomized and treated with SPRIX or placebo administered every 8 hours and morphine administered via patient controlled analgesia on an as needed basis. Efficacy was demonstrated as a statistically significant greater reduction in the summed pain intensity difference over 48 hours in patients who received SPRIX as compared to those receiving placebo. ...

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [see Warnings and Precautions ( 5.3 ) ] Hypertension [see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ...

SPRIX is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ketorolac or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been ...

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of SPRIX in patients with severe heart failure unless benefits are expected to outweigh risk ...

7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with ketorolac.

Table 2Clinically Significant Drug Interactions with Ketorolac Drugs that Interfere with Hemostasis Clinical Impact: Ketorolac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ketorolac and anticoagulants have an increased risk of serious bleeding compared...