SPRIX® (ketorolac tromethamine) is:

  • Prescribed for adult patients who require opioid-strength pain relief for up to 5 days
  • The first and only Nonsteroidal Anti-inflammatory Drug (NSAID) pain-relieving nasal spray
  • A medicine that contains a potent pain reliever

SPRIX is not:

  • An opioid narcotic pill
  • A patch or injection
  • A controlled substance

SPRIX Nasal Spray can be used for short-term treatment of moderate to severe pain for up to 5 days in adult patients who require opioid-strength pain relief.

SPRIX® (ketorolac tromethamine) comes in a carton with 5 pre-filled bottles

SPRIX is delivered through a nasal spray. Each carton contains 5 bottles, with each bottle containing 8 precisely metered doses.

SPRIX is intended for use:

Every 6-8 hours*

Up to 4 times a day

For up to 5 days

*For adult patients < 65 years of age, ≥ 110 lbs, and normal kidney function, the recommended dose is 1 spray in each nostril every 6-8 hours up to 4 times a day. For adult patients ≥ 65 years of age, renally impaired patients, and adult patients < 110 lbs, the recommended dose is 1 spray in 1 nostril every 6-8 hours up to 4 times per day.

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

Instructions for use of sprix® (ketorolac tromethamine) nasal spray

SPRIX is for use in the nose only. Do not breathe in (inhale) SPRIX.

Before you use SPRIX for the first time, you will need to prime the bottle. 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.

Hold the SPRIX bottle upright at arm’s length away from you with your index finger on 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 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.

Blow your nose to clear your nostrils. Sit up straight or stand. Keep your head tilted downward toward your toes. Place the tip of the SPRIX bottle into your right nostril. Hold the SPRIX bottle upright and aim the tip toward the back of your nose (see Figure D).

Hold your breath and spray 1 time into your right nostril, pressing down on both sides of the finger flange (see Figure D). Breathe in gently through your mouth after you use SPRIX. You may also pinch your nose to help keep the medicine in your nose.

SPRIX is for use in the nose only. Do not breathe in (inhale) SPRIX.

If your healthcare provider has prescribed only 1 spray per dose for you, you have now finished your dose. However, if your healthcare provider has prescribed 2 sprays for you, repeat the above steps for your left nostril. Be sure to point the spray away from the center of your nose. Spray 1 time into your left nostril. When you are finished using SPRIX, put the clear plastic cover back on the SPRIX bottle.

SPRIX® Patient Use Video

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDS) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • SPRIX® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDS cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

Sprix (ketorolac tromethamine) Nasal Spray is an NSAID.

See the Boxed Warning: Risk of Serious Cardiovascular and Gastrointestinal Events.

Do not take NSAIDs 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:

  • Taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
  • Increasing doses of NSAIDs
  • Longer use of NSAIDs
  • Smoking
  • Drinking alcohol
  • Poor health
  • Advanced liver disease
  • Bleeding problems

NSAIDs should only be used:

  • Exactly as prescribed
  • At the lowest dose possible for your treatment
  • For the shortest time needed

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.

Do not use SPRIX®:

  • If you are allergic to ketorolac or any components of the drug product
  • If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs
  • Right before or after heart bypass surgery
  • If you have active ulcer disease or any history of bleeding in the stomach or intestines
  • If you have had bleeding in the brain, a tendency to bleed, or have decreased ability for your blood to clot
  • If you have kidney disease
  • If you are taking probenecid or pentoxifylline
  • For more than 5 days or with other formulations of ketorolac or with other NSAIDs

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems
  • have high blood pressure or heart failure
  • have asthma
  • have bleeding problems
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy
  • Are breastfeeding or plan to breastfeed. Some SPRIX can pass into your breast milk

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs 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 NSAIDs?

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

NSAIDs can cause serious side effects, including:

  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions

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:

  • 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 taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or 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, legs, hands and feet

If you take too much of your NSAID, 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.

    Important Safety Information

    Important Safety Information

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Thrombotic Events

    • Nonsteroidal anti-inflammatory drugs (NSAIDS) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
    • SPRIX® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    Gastrointestinal Bleeding, Ulceration, and Perforation

    • NSAIDS cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

    What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

    Sprix (ketorolac tromethamine) Nasal Spray is an NSAID.

    See the Boxed Warning: Risk of Serious Cardiovascular and Gastrointestinal Events.

    Do not take NSAIDs 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:

    • Taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
    • Increasing doses of NSAIDs
    • Longer use of NSAIDs
    • Smoking
    • Drinking alcohol
    • Poor health
    • Advanced liver disease
    • Bleeding problems

    NSAIDs should only be used:

    • Exactly as prescribed
    • At the lowest dose possible for your treatment
    • For the shortest time needed

    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.

    Do not use SPRIX®:

    • If you are allergic to ketorolac or any components of the drug product
    • If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs
    • Right before or after heart bypass surgery
    • If you have active ulcer disease or any history of bleeding in the stomach or intestines
    • If you have had bleeding in the brain, a tendency to bleed, or have decreased ability for your blood to clot
    • If you have kidney disease
    • If you are taking probenecid or pentoxifylline
    • For more than 5 days or with other formulations of ketorolac or with other NSAIDs

    Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

    • have liver or kidney problems
    • have high blood pressure or heart failure
    • have asthma
    • have bleeding problems
    • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy
    • Are breastfeeding or plan to breastfeed. Some SPRIX can pass into your breast milk

    Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs 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 NSAIDs?

    See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

    NSAIDs can cause serious side effects, including:

    • new or worse high blood pressure
    • heart failure
    • liver problems including liver failure
    • kidney problems including kidney failure
    • low red blood cells (anemia)
    • life-threatening skin reactions
    • life-threatening allergic reactions

    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:

    • 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 taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

    • nausea
    • more tired or weaker than usual
    • diarrhea
    • itching
    • your skin or eyes look yellow
    • indigestion or 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, legs, hands and feet

    If you take too much of your NSAID, 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.