"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
There has been no experience with overdosage of SPRIX. In controlled overdosage studies with IM ketorolac injection, daily doses of 360mg given for five days (approximately 3 times the maximum daily dose of SPRIX)caused abdominal pain and peptic ulcers, which healed after discontinuation of dosing. Single overdoses of ketorolac tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis, and renal dysfunction.
Symptoms and Signs
Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare.
Manage patients using symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Activated charcoal (60 g to 100 g in adults, 1 g/kg to 2 g/kg in children) may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large oral overdose (5 to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis, or hemo perfusion may not be useful due to high protein binding.
- Known hypersensitivity to ketorolac tromethamine [see WARNINGS AND PRECAUTIONS]
- Use in patients with active peptic ulcer disease, inpatients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding [see WARNINGS AND PRECAUTIONS]
- Use in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs [see WARNINGS AND PRECAUTIONS]
- Use as a prophylactic analgesic before any major surgery [seeWARNINGS AND PRECAUTIONS]
- Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS]
- Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion [see WARNINGS AND PRECAUTIONS]
- Use in labor and delivery. Through its prostaglandin synthesis inhibitory effect, ketorolac may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.[see WARNINGS AND PRECAUTIONS, Use In Specific Populations]
- Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS]
- Known hypersensitivity to aspirin or to other NSAIDs [see WARNINGS AND PRECAUTIONS]
- Known hypersensitivity to ethylene diamine tetra acetic acid (EDTA) [see DESCRIPTION]
- Concomitant use with probenecid [see DRUG INTERACTIONS]
- Concomitant use with pentoxifylline [see DRUG INTERACTIONS]
Last reviewed on RxList: 5/12/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Sprix Information
- Sprix Drug Interactions Center: ketorolac nasl
- Sprix Side Effects Center
- Sprix FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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