Sprix is a nonsteroidal anti inflammatory drug (NSAID). Ketorolac works by reducing substances in the body that cause pain, fever, and inflammation.

Sprix Nasal Spray is used in adult patients for the short-term (5 days or less) treatment of moderate to severe pain.

The safety and effectiveness of Sprix in patients 17 years and younger has not been established. It is not for use in children less than 2 years of age.

You should not use Sprix if you have severe kidney disease, a bleeding or blood clotting disorder, bleeding in your brain, a stomach ulcer or history of stomach bleeding, or if you have ever had a severe allergic reaction after taking aspirin or an NSAID. Do not use Sprix Nasal Spray for longer than 5 days.

Ketorolac can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ketorolac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Pentoxifylline or probenecid can interact with ketorolac and should not be used at the same time.

Use Sprix Nasal Spray exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

Sprix is usually given every 6 to 8 hours. Use only the number of sprays prescribed by your doctor.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not use Sprix for longer than 5 days unless your doctor has told you to.

Each bottle of this medicine contains 8 sprays for use within a 24-hour period. Throw the bottle away 24 hours after your first use, even if there is still medicine left inside.

Store unopened nasal spray bottles in a refrigerator. Do not freeze.

After opening a Sprix Nasal Spray bottle, store it at room temperature in a dry place, out of direct sunlight.

Usual Adult Dose for Pain:
Nasal Spray:
-Weight 50 kg or more: 31.5 mg every 6 to 8 hours (1 spray in each nostril)
-Weight less than 50 kg: 15.75 mg every 6 to 8 hours (1 spray in 1 nostril)
-Maximum dose; weight less than 50 kg: 63 mg
-Maximum dose; weight: 50 kg or more: 126 mg.

Usual Geriatric Dose for Pain:
-Nasal Spray:
-Dose: 15.75 mg every 6 to 8 hours (one spray in 1 nostril)
-Maximum dose: 4 doses per day (63 mg).

Sprix can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ketorolac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use Sprix nasal spray if you are allergic to ketorolac, or if you have:

• severe kidney disease;

• a bleeding or blood clotting disorder;

• a closed head injury or bleeding in your brain;

• a stomach ulcer, perforation, or a history of stomach or intestinal bleeding; or

• if you are breast-feeding a baby; or

• if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Pentoxifylline or probenecid can interact with ketorolac and should not be used at the same time.

Do not use Sprix Nasal Spray if you are already taking aspirin or other NSAIDs, or using other forms of ketorolac (such as injections or pills you take by mouth).

To make sure Sprix nasal spray is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• ulcerative colitis or Crohn's disease;

• asthma;

• liver or kidney disease;

• fluid retention; or

• if you smoke.

If you are pregnant, you should not use Sprix nasal spray unless your doctor tells you to. Using an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Sprix may affect ovulation, which could temporarily affect fertility (your ability to have children).

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Sprix Nasal Spray is not approved for use by anyone younger than 2 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting this medication in your eyes. If this does happen, rinse with water or saline solution. Call your doctor if you have eye irritation for longer than 1 hour.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs while you are using Sprix.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ketorolac (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction to Sprix (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using Sprix and call your doctor at once if you have:

• any skin rash, no matter how mild;

• high blood pressure - severe headache, blurred vision, pounding in your neck or ears;

• heart problems - swelling, rapid weight gain, feeling short of breath;

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• liver problems - nausea, upper stomach pain, itching, tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Sprix side effects may include:

• heartburn, stomach pain, gas, nausea, vomiting;

• diarrhea, constipation;

• slow heartbeats;

• decreased urination;

• abnormal liver function tests;

• increased blood pressure;

• pain or irritation in your nose;

• runny nose;

• watery eyes;

• throat irritation; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Ask your doctor before using Sprix if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• lithium;

• methotrexate;

• a blood thinner - warfarin, Coumadin, Jantoven;

• heart or blood pressure medication, including a diuretic or "water pill"; or

• seizure medicine - carbamazepine, phenytoin.

This list is not complete. Other drugs may interact with ketorolac, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.