Ketorolac, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which may result in hospitalization and even death. Although serious skin reactions may occur without warning, instruct patients to be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash, and contact their physicians as soon as possible [see Warnings and Precautions (5.7)].
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop therapy and seek immediate medical therapy [see Warnings and Precautions (5.9)].
Inform patients of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, instruct patients to seek immediate emergency help [see Contraindications (4), Warnings and Precautions (5.5, 5.11)].
Instruct patients not to use any single bottle of SPRIX for more than one day [see Dosage and Administration (2.4)].
Advise patients that they may experience transient, mild to moderate nasal irritation or discomfort upon dosing.
American Regent, Inc.
Shirley, NY 11967
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
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:
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:
The chance of a person getting an ulcer or bleeding increases with:
NSAID medicines should only be used:
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
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 (NSAID)?
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 healthcare 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 healthcare provider and pharmacist.
- if you are pregnant. Use of NSAID medicines (at or after 30 weeks of pregnancy) can harm your baby.
- if you are breastfeeding. Some SPRIX® (ketorolac tromethamine) Nasal Spray may pass into your breast milk.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
| Serious side effects include: || Other side effects include: |
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 healthcare 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
- unusual weight gain
- skin rash or blisters with fever
- swelling of the arms and legs, hands and feet
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.
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 healthcare provider before using over-the-counter NSAIDs for more than 10 days.
NSAID medicines that need a prescription:
|Diclofenac||Flector, Cataflam, Voltaren, Arthrotec (combined with misoprostol)|
|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, Naprapac (copackaged with lansoprazole)|
|Tolmetin||Tolectin, Tolectin DS, Tolectin 600|
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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 separate NSAID Medication Guide.
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.
FOLLOW THESE SIMPLE INSTRUCTIONS
- First hold the finger flange with your fingers (See Figure 1), 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 (see Figure 2).
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 (see Figure 3).
Spray once into your right nostril, pressing down evenly on both sides, as shown in Figure 3.
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 (See Figure 4). The nasal spray bottle will now work properly again.
FOR MORE INFORMATION
If you have any questions about SPRIX, or are unsure about something, you should ask your doctor or pharmacist.
Do not throw this leaflet away, so you may read it again when you administer additional doses or begin using a new bottle of SPRIX Nasal Spray.
American Regent, Inc.Shirley, NY 11967
Principal Display Panel – 5 Day Carton Label
15.75 mg per spray
For Intranasal Use Only
Dispense the accompanying Medication Guide to each patient.
Discard each bottle 24 hours after first dose, even if drug product remains.
|SPRIX ketorolac tromethamine spray, metered|
|Labeler — Physicians Total Care, Inc. (194123980)|
|Physicians Total Care, Inc.||194123980||relabel, repack|
Revised: 01/2011 Physicians Total Care, Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.