SPRIX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SPRIX (SPRIX).
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.
| Metabolism | Primarily hepatic via conjugation (glucuronidation) and oxidation (CYP2C9 minor). Metabolites are inactive. |
| Excretion | Renal excretion of unchanged drug and metabolites; after intravenous administration, approximately 92% of the dose is recovered in urine (50% as unchanged ketorolac, 40% as glucuronide conjugates) and 6% in feces. |
| Half-life | Terminal elimination half-life is 5-6 hours in adults with normal renal function; may be prolonged to 13-14 hours in elderly patients and 15-20 hours in patients with renal impairment. |
| Protein binding | 99% bound to plasma proteins, primarily albumin (saturable at high concentrations). |
| Volume of Distribution | 0.2-0.3 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | Intranasal: approximately 75-80% relative to intravenous administration. |
| Onset of Action | Intranasal: 30 minutes to first perceptible pain relief, with peak analgesic effect at 1-2 hours. |
| Duration of Action | Duration of analgesic effect is 6-8 hours after intranasal administration; multi-dose studies show sustained efficacy with dosing every 6-8 hours. |
Intranasal: 31.5 mg (1 spray) in one nostril, may repeat after 30 minutes; maximum 63 mg (2 sprays) per dose. Subsequent doses every 6-8 hours as needed; maximum 126 mg (4 sprays) per day.
| Dosage form | SPRAY, METERED |
| Renal impairment | Contraindicated in patients with severe renal impairment (CrCl <30 mL/min). For moderate impairment (CrCl 30-60 mL/min), reduce total daily dose by 50% and monitor for renal toxicity. |
| Liver impairment | Contraindicated in Child-Pugh Class C cirrhosis. For mild to moderate hepatic impairment (Child-Pugh A or B), reduce total daily dose by 50% and monitor for signs of bleeding or hepatic toxicity. |
| Pediatric use | Not recommended for use in pediatric patients (safety and efficacy not established). |
| Geriatric use | Elderly patients may have increased risk of GI bleeding and renal toxicity. Use lowest effective dose and shortest duration; monitor renal function and adjust dose based on estimated glomerular filtration rate (eGFR). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SPRIX (SPRIX).
| Breastfeeding | Excreted in human milk in low amounts. M/P ratio not available. Consider risk of infant NSAID exposure; use with caution, especially in neonates. |
| Teratogenic Risk | Pregnancy Category C. Avoid in third trimester due to risk of premature closure of ductus arteriosus and oligohydramnios. No adequate studies in first two trimesters; use only if potential benefit justifies risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
Risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk is increased with duration of use and in patients with cardiovascular risk factors. Contraindicated for treatment of perioperative pain in coronary artery bypass graft (CABG) surgery.
| Serious Effects |
["Hypersensitivity to ketorolac or any NSAID","Active peptic ulcer disease or GI bleeding","Advanced renal impairment (creatinine clearance <30 mL/min)","Patients at risk for bleeding or receiving anticoagulants","Labor and delivery (risk of fetal harm)","Treatment of perioperative pain in CABG surgery","Concomitant use with other NSAIDs or aspirin","Intrathecal or epidural administration (contains alcohol)"]
| Precautions | ["Cardiovascular risk: May increase risk of serious cardiovascular thrombotic events.","Gastrointestinal risk: Can cause serious GI adverse events including bleeding, ulceration, and perforation.","Renal toxicity: Monitor renal function; avoid in patients with advanced renal disease.","Hepatic effects: Elevations in liver enzymes; discontinue if signs of hepatic injury occur.","Anaphylactoid reactions: Can occur in patients without prior exposure.","Pregnancy: Avoid in late pregnancy due to risk of premature closure of ductus arteriosus."] |
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| Monitor renal function, platelet count, and bleeding times in mother. Fetal ultrasound for oligohydramnios if used beyond 48 hours or after 32 weeks gestation. |
| Fertility Effects | May impair female fertility via inhibition of prostaglandin synthesis affecting ovulation. Reversible upon discontinuation. |