"July 10, 2015 -- Popular painkillers like ibuprofen and naproxen have carried warnings for years about potential risks of heart attacks and strokes. This week, the FDA decided to strengthen those warnings on the medications, known as nonsteroidal"...
Medication Guide For 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-SteroidalAnti-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 NSAIDmedicines
- 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-SteroidalAnti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain, redness, swelling, and heat (inflammation) from medical conditions such as:
Who should not take aNon-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. Keepa list of your medicines to show to your healthcare provider and pharmacist.
- if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
- if you are breastfeeding. SPRIX® (ketorolac tromethamine) Nasal Spray can pass into your breast milk.
What are the possible side effects of Non-SteroidalAnti-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 NSAIDmedicines.
Call your doctor for medical advice about side effects.You may report side effects to FDA at 1-800-FDA-1088.
Other information about Non-SteroidalAnti-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:
|Generic Name||Trade name|
|Diclofenac||Flector®, Cataflam®, Voltaren®, Arthrotec® (combined with misoprostol), PENNSAID®, Zorvolex, Cambia, Voltaren gel, Zipsor|
|Etodolac||Lodine®, Lodine XL®|
|Fenoprofen||Nalfon®, Nalfon® 200|
|Ibuprofen||Motrin®, Tab-Profen®, Vicoprofen®* (combined with hydrocodone), Combunox™ (combined with oxycodone), Duexis (combined with famotidine)|
|Indomethacin||Indocin®, Indocin SR®, Indo-Lemmon™, Indomethagan™, Tivorbex,|
|Naproxen||Naprosyn®, Anaprox®, Anaprox® DS, EC-Naproxyn®, Naprelan®, Naprapac® (copackaged with lansoprazole), Treximet (combined with sumatriptan succinate) and Vimovo (combined with esomeprazole magnesium)|
|Tolmetin||Tolectin®, Tolectin DS®, Tolectin® 600|
|*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, 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.|
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Instructions for Use
(spriks) (ketorolac tromethamine) Nasal Spray
Read this Instructions for Use before you start using SPRIX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
- SPRIX is for use in your nose only. Do not breathe in (inhale) SPRIX.
- Each SPRIX bottle has enough pain medicine for 1 day.
- Throw away each SPRIX bottle within 24 hours of taking your first dose, even if the bottle still contains unused medicine.
Your healthcare provider has prescribed SPRIX to treat moderate to severe pain.
- Use SPRIX exactly as your healthcare provider tells you to use it.
- Your healthcare provider will tell you how many sprays you should use each time you use SPRIX.
- Do not use SPRIX for more than 5 days. If you still have pain after 5 days, contact your healthcare provider.
- Do not use SPRIX more than every 6 hours.
- It is important that you drink plenty of fluids while you are using SPRIX. Tell your healthcare provider if you urinate less while using SPRIX.
You may have discomfort or irritation in your nose when using SPRIX. This usually lasts for a short time. Do not breathe in (inhale) SPRIX while spraying.
Using SPRIX nasal spray
Parts of your SPRIX bottle
Follow the instructions below to use SPRIX.
Before you use SPRIX for the first time, you will need to prime the bottle. Priming SPRIX:
Step 1. Hold the finger flange with your fingers (See Figure A), and remove the clear plastic cover with your opposite hand. Keep the clear plastic cover for later. Remove and throw away the blue plastic safety clip.
If the clear plastic cover is improperly removed, the tip of the bottle may be pulled off of the glass vial. If this happens, place the tip back onto the glass vial by lining it up carefully and gently pushing it back on until it is back in the correct position (See Figure B). The SPRIX bottle should work properly again.
Step 2. Hold the SPRIX bottle upright 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 C).
Press down on the finger flange and release the pump 5 times. You may not see a spray the first few times you press down.
Now the pump is primed and ready to use. You do not need to prime the pump again if you use more doses from this bottle.
Step 3. Blow your nose to clear your nostrils.
Step 4. Sit up straight or stand.
Step 5. Keep your head tilted downward toward your toes.
Step 6. Place the tip of the SPRIX bottle into your right nostril.
Step 7. Hold the SPRIX bottle upright and aim the tip toward the back of your nose (see Figure D).
Step 8. Hold your breath and spray 1 time into your right nostril, pressing down on both sides of the finger flange (See Figure D).
Step 9. Breathe in gently through your mouth after you use SPRIX. You may also pinch your nose to help keep the medicine in your nose.
Step 10. If your healthcare provider has prescribed only 1 spray per dose for you, you have now finished your dose, skip to Step 12 below.
Step 11. If your healthcare provider has prescribed 2 sprays for you, repeat steps 3 - 9 above for your left nostril. Be sure to point the spray away from the center of your nose. Spray 1 time into your left nostril.
Step 12. When you are finished using SPRIX, put the clear plastic cover back on the SPRIX bottle.
How should I store SPRIX?
- Store unopened SPRIX bottles between 36°F to 46°F (2°C to 8°C).
- Keep opened bottles of SPRIX at room temperature.
- Keep SPRIX out of direct sunlight.
- Do not freeze SPRIX.
- SPRIX does not contain a preservative. Throw away each SPRIX bottle within 24 hours of taking your first dose, even if the bottle still contains unused medicine.
Keep SPRIX and all medicines out of the reach of children.
General information about the safe and effective use of SPRIX.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not give SPRIX to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about SPRIX that is written for health professionals.
What are the ingredients in SPRIX?
Active ingredient: ketorolac tromethamine
Inactive ingredient: edetate disodium (EDTA), mono basic potassium phosphate, sodium hydroxide, and water for injection
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
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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