Generic Name: ketorolac tromethamine nasal spray
Date of Approval: May 14, 2010
Company: Roxro Pharma, Inc.
Treatment for: Pain
FDA Approves Sprix
The U.S. Food and Drug Administration (FDA) has approved Sprix (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.
Sprix is a prescription intranasal formulation of the analgesic ketorolac, a non-steroidal anti-inflammatory drug (NSAID), designed to provide ambulatory patients with a convenient, potent, and fast-acting option for acute moderate to moderately severe pain relief.
Ketorolac tromethamine is a frequently administered non-narcotic injectable analgesic for moderately severe pain in U.S. hospitals today. The approval of Sprix provides acute pain outpatients with a non-narcotic and easy-to-administer alternative to commonly prescribed opioids.
Highlights of Sprix Prescribing Information
These highlights do not include all of the information needed to use Sprix safely and effectively. See full prescribing information for Sprix.
Warning: Limitations of Use, Gastrointestinal, Bleeding, Cardiovascular, and Renal Risk
See full prescribing information for complete boxed warning.
- Limitations of Use: The total duration of use of Sprix and other ketorolac formulations should not exceed 5 days.
- Gastrointestinal (GI) Risk: Ketorolac can cause peptic ulcers, GI bleeding, and/or perforation of the stomach or intestines, which can be fatal.
- Sprix is contraindicated in patients with peptic ulcer disease or history of GI bleeding.
- Bleeding Risk: Sprix inhibits platelet function and is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding.
- Cardiovascular (CV) Risk: NSAIDs may cause an increased risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.
- Sprix is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- Renal risk: Sprix is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
Sprix Indications and Usage
Sprix is indicated for short term (up to 5 days) management of moderate to moderately severe pain.
Dosage and Administration
- For adult patients < 65 years of age: 31.5 mg (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg.
- For patients ≥ 65 years of age, renally impaired patients, and patients less than 50 kg (110 lbs): 15.75 mg (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg.
- Sprix has not been shown to be safe and effective in pediatric patients.
- Sprix nasal spray should be discarded within 24 hours of taking the first dose, even if the bottle still contains some medication.
Dosage Form and Strengths
Nasal spray: 15.75 mg of ketorolac tromethamine in each 100 µL spray. Each 1.7 g bottle contains 8 sprays.
- Known hypersensitivity to ketorolac, aspirin, other NSAIDs, or EDTA
- Use in patients with active peptic ulcer disease, recent GI bleeding or perforation, or a history of peptic ulcers or GI bleeding
- Use in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- Use as a prophylactic analgesic before any major surgery
- Use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery
- Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion
- Use in labor and delivery
- Use in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding
Warnings and Precautions
- Sprix should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs.
- Ketorolac can cause serious GI adverse events including bleeding, ulceration, and perforation. Sprix should be prescribed with caution in patients with a prior history of ulcer disease or GI bleeding. Elderly patients are at greater risk for serious GI events.
- NSAIDs affect platelet aggregation and may cause bleeding complications. Sprix should be used with caution in patients who have coagulation disorders or are on therapy that affects hemostasis. Do not use Sprix in patients for whom hemostasis is critical.
- Ketorolac can cause renal injury. Sprix should not be used in patients with advanced renal disease or patients at risk for renal failure due to volume depletion, and should be used with caution in patients taking diuretics or ACE inhibitors.
- Anaphylactoid reactions may occur in patients with or without a history of allergic reactions to aspirin or NSAIDs. Sprix should be discontinued immediately in patients with allergic reactions.
- Serious and potentially fatal cardiovascular thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment.
- Fluid retention and edema have been observed in patients taking NSAIDs. Sprix should be used with caution in patients with cardiac decompensation or similar conditions.
- NSAIDs can cause serious dermatologic adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Sprix should be discontinued immediately in patients with skin reactions.
- During pregnancy, use of Sprix beyond 30 weeks gestation can cause premature closure of the ductus arteriosus, resulting in fetal harm.
Sprix Side Effects
The most common adverse reactions (incidence > 2%) in patients treated with Sprix and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch
See also: Sprix side effects (in more detail)
- Concomitant use with anticoagulants may increase the risk of serious GI bleeding.
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:
- with longer use of NSAID medicines
- in people who have heart disease
NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
- can happen without warning symptoms
- may cause death
The chance of a person getting an ulcer or bleeding increases with:
- taking medicines called "corticosteroids" and "anticoagulants"
- longer use
- drinking alcohol
- older age
- having poor health
NSAID medicines should only be used:
- exactly as prescribed
- at the lowest dose possible for your treatment
- for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs?
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as
- different types of arthritis
- menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug?
Do not take an NSAID medicine
- if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
- for pain right before or after heart bypass surgery
Tell your health care provider
- about all of your medical conditions
- about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your health care provider and pharmacist
- if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy
- if you are breastfeeding. Talk to your health care provider
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs?
Serious side effects include
- heart attack
- high blood pressure
- heart failure from body swelling (fluid retention)
- kidney problems including kidney failure
- bleeding and ulcers in the stomach and intestine
- low red blood cells (anemia)
- life-threatening skin reactions
- life-threatening allergic reactions
- liver problems including liver failure
- asthma attacks in people who have asthma
Other side effects include
- stomach pain
Get emergency help right away if you have any of the following symptoms
- shortness of breath or trouble breathing
- chest pain
- weakness in one part or side of your body
- slurred speech
- swelling of the face or throat
Stop your NSAID medicine and call your health care provider right away if you have any of the following symptoms
- more tired or weaker than usual
- your skin or eyes look yellow
- stomach pain
- flu-like symptoms
- vomit blood
- there is blood in your bowel movement or it is black and sticky like tar
- skin rash or blisters with fever
- unusual weight gain
- swelling of the arms and legs, hands and feet These are not all of the possible side effects with NSAID medicines. Talk to your health care provider or pharmacist for more information about NSAID medicines. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines
- Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your health care provider before using over-the-counter NSAIDs for more than 10 days NSAID medicines that need a prescription
|Generic Name||Trade Name|
|diclofenac||Cataflam, Voltaren, Arthrotec (combined with misoprostol) Voltaren|
|etodolac||Lodine, Lodine XL|
|fenoprofen||Nalfon, Nalfon 200|
|ibuprofen||Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)|
|indomethacin||Indocin, Indocin SR, Indo-Lemmon, Indomethagan|
|naproxen||Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Vimovo|
|tolmetin||Tolectin, Tolectin DS, Tolectin 600|
* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long-term, continuous use may increase the risk of heart attack or stroke.
Patient Instructions for Sprix
Guide to Proper Use of Sprix (ketorolac tromethamine) Nasal Spray
Each Nasal Spray Bottle Contains 1 Day's Supply of Pain Medication
Discard each nasal spray bottle within 24 hours of taking your first dose, even if the bottle still contains some unused medication.
Please read this leaflet carefully before you start to take your medicine. It is important that you use Sprix properly to achieve the desired results.
For further information ask your doctor or pharmacist.
Use of Sprix For Acute Moderate to Moderately Severe Pain
Your doctor has prescribed Sprix to treat pain. It is important that you use Sprix only as prescribed by your doctor. Do not use Sprix for more than 5 days in a row. If you are still experiencing pain after 5 days, please contact your doctor or healthcare provider.
Sprix contains ketorolac, a potent non-steroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain. For more information about NSAID products, please see the NSAID Medication Guide above.
As with all pain medications, it is important that you drink plenty of fluids while you are taking Sprix.
Using Your Nasal Spray
Always follow your doctor’s instructions about how often to use Sprix. The doctor will tell you how many sprays you should use each time you take Sprix. These instructions will provide you with information on how to use the spray bottle.
Some patients experience discomfort or irritation in the nose when using Sprix. Generally, this lasts only a few minutes and does not worsen when you use Sprix again. Some people experience a brief sensation in the throat. If this happens, you may want to take a sip of water after using Sprix.
Instructions for Use
- First hold the finger flange with your fingers and remove the clear plastic cover with your opposite hand; then remove the blue plastic safety clip. Keep the clear plastic cover; you may throw away the blue plastic safety clip.
- Before using the bottle for the FIRST time, you must activate the pump. To activate the pump, hold the bottle at arm’s length away from you with your index finger and middle finger resting on the top of the finger flange and your thumb supporting the base. Press down evenly and release the pump 5 times. Note: you may not see a spray the first few times you press down. The bottle is now ready to use. There is no need to activate the pump again if you use more doses from this bottle.
- It’s important to get the medication to the correct place in your nose so it will be most effective. Here’s the simple way to do this. Blow your nose gently to clear your nostrils. Sit up straight or stand. Tilt your head slightly forward. Insert the tip of the container into your right nostril. Point the container away from the center of your nose. Spray once into your right nostril, pressing down evenly on both sides. If your doctor has prescribed only one spray per dose for you, you have now completed administration; skip to Step 5 below.
- If your doctor has prescribed a dose of 2 sprays for you, repeat the process for your left nostril. Again, be sure to point the spray away from the center of your nose. Spray once into your left nostril.
- Replace the clear plastic cover and place the bottle in a cool, dry location out of direct sunlight, such as inside a medication cabinet. Keep out of reach of children.
Dosing and Administration
- For adults under 65 years of age, the usual recommended dose is one dose every 6-8 hours, as needed for relief of pain. One dose consists of one spray into each nostril (two sprays in total).
- For adults 65 years of age or older, the usual recommended dose is one dose every 6-8 hours, as needed. One dose consists of one spray into either nostril (one spray in total).
- Do not use more than the prescribed amount, and do not use more frequently than once every 6 hours.
Storing and Discarding Your Containers
- Keep Sprix upright in a cool, dry location out of direct sunlight.
- Sprix does not contain a preservative. It is important that you throw away each bottle of Sprix within 24 hours of administering the first dose. Once a bottle has been used, do not keep it for more than 24 hours.
- Always keep Sprix out of the reach of children. -Do not allow Sprix to become frozen. -Discard in the trash (non-recyclable).
If the clear plastic cover is improperly removed, the top portion of the nasal spray may be pulled off of the glass vial. If this happens, reinsert the top portion back onto the glass vial by lining it up carefully and softly pushing it back on until it is back in the correct position. The nasal spray bottle will now work properly again.
If you have any questions about Sprix, or are unsure about something, you should ask your doctor or pharmacist.