IMPORTANT SAFETY INFORMATION ABOUT SPRIX
What is the most important information I should know about SPRIX and prescription Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
Sprix (ketorolac tromethamine) Nasal Spray is an NSAID. NSAIDs can cause serious side effects including, increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase with increasing doses of NSAIDs and with longer use of NSAIDs.
NSAIDs can also cause increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines which may occur anytime during use, without warning symptoms, and may cause death.
See the Boxed Warning: Risk of Serious Cardiovascular and Gastrointestinal Events
Do not take SPRIX right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
Do not take SPRIX after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
The risk of getting an ulcer or bleeding also increases with:
SPRIX should only be used:
What is SPRIX®? SPRIX® (ketorolac tromethamine) is used 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.
Limitations of Use
Do not use SPRIX®:
Before taking SPRIX or any NSAID, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. SPRIX and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.
What are the possible side effects of SPRIX? See “What is the most important information I should know about SPRIX and prescription Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”
Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Most common side effects with SPRIX include: discomfort in the nose; pain in the nose; increased tears; throat irritation; decreased amount of urine; rash; slow heart rate; increased liver enzymes; high blood pressure; stuffy nose. Keep SPRIX away from your eyes. If you get SPRIX in your eyes, wash out the eye with water or saline, and call a doctor if irritation persists for more than an hour.
Get emergency help right away if you get any of the following symptoms:
Stop taking SPRIX and call your healthcare provider right away if you get any of the following symptoms:
If you take too much SPRIX, call your healthcare provider or get medical help right away. These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning and patient Medication Guide, at www.sprix.com/PI.