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Ketorolac (Nasal route)

Pronunciation:

kee-toe-ROLE-ak

Brand Names:

  • Sprix

Dosage Forms:

  • Spray

Warnings:

Nasal route(Spray)

For short term use only (up to 5 days total duration, including oral, IV, or IM formulations in adults). Indicated for moderate to moderately severe pain that requires analgesia at the opioid level. Not for use in pediatric patients and not indicated for minor or chronic pain. The risk for serious and potentially fatal cardiovascular thrombotic events may increase with use, duration of use, and in patients with cardiovascular disease, or risk factors for cardiovascular disease. Contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG). Contraindicated in patients with active or history of peptic ulcer disease, recent gastrointestinal bleeding or perforation, history of gastrointestinal bleeding, advanced renal impairment, in patients at risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high-risk of bleeding. Use caution with elderly patients due to high risk of gastrointestinal adverse events .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

NSAID

Chemical—

Acetic Acid (class)

Uses of This Medicine:

Ketorolac nasal spray is used to relieve moderate to moderately severe pain, such as pain that occurs after an operation or other painful procedure. It is a nonsteroidal anti-inflammatory drug (NSAID) that will reduce pain and inflammation.

Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the amount that is used and the length of time it is used. Ketorolac should not be used for more than 5 days in a row. Before using this medicine, you should discuss with your doctor the benefits that this medicine can do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ketorolac nasal spray in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ketorolac nasal spray in the elderly. However, because of this medicine's toxicity, it should be used with caution in the elderly, after less toxic alternatives have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment. In addition, elderly patients are more likely to have age-related heart, kidney, liver, stomach, or bowel problems, which may require caution and an adjustment in the dose for patients receiving ketorolac nasal spray.

Pregnancy—

Pregnancy CategoryExplanation
1st TrimesterCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd TrimesterCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Aspirin
  • Bromfenac
  • Bufexamac
  • Celecoxib
  • Choline Salicylate
  • Clonixin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Ibuprofen
  • Ibuprofen Lysine
  • Indomethacin
  • Ketoprofen
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pentoxifylline
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Pranoprofen
  • Probenecid
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Apixaban
  • Ardeparin
  • Argatroban
  • Beclamide
  • Beta Glucan
  • Bivalirudin
  • Caramiphen
  • Carbamazepine
  • Certoparin
  • Cilostazol
  • Citalopram
  • Clomethiazole
  • Clopidogrel
  • Clovoxamine
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Diazepam
  • Dipyridamole
  • Duloxetine
  • Enoxaparin
  • Eptifibatide
  • Erlotinib
  • Escitalopram
  • Ethotoin
  • Felbamate
  • Femoxetine
  • Feverfew
  • Flesinoxan
  • Fluoxetine
  • Fondaparinux
  • Fosphenytoin
  • Gabapentin
  • Ginkgo
  • Gossypol
  • Heparin
  • Lacosamide
  • Lepirudin
  • Levetiracetam
  • Levomilnacipran
  • Meadowsweet
  • Mephenytoin
  • Mephobarbital
  • Methotrexate
  • Milnacipran
  • Nadroparin
  • Nefazodone
  • Oxcarbazepine
  • Paraldehyde
  • Paramethadione
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Phenacemide
  • Phenobarbital
  • Phenytoin
  • Piracetam
  • Pralatrexate
  • Prasugrel
  • Pregabalin
  • Protein C
  • Reviparin
  • Rivaroxaban
  • Rufinamide
  • Sibutramine
  • Stiripentol
  • Tacrolimus
  • Tiagabine
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Topiramate
  • Trimethadione
  • Valproic Acid
  • Venlafaxine
  • Vigabatrin
  • Vilazodone
  • Vortioxetine
  • Zimeldine
  • Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Acetohexamide
  • Alacepril
  • Alprenolol
  • Amiloride
  • Amlodipine
  • Arotinolol
  • Atenolol
  • Azilsartan Medoxomil
  • Azosemide
  • Befunolol
  • Bemetizide
  • Benazepril
  • Bendroflumethiazide
  • Benzthiazide
  • Bepridil
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Bucindolol
  • Bumetanide
  • Bupranolol
  • Buthiazide
  • Candesartan Cilexetil
  • Canrenoate
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Chlorothiazide
  • Chlorpropamide
  • Chlorthalidone
  • Cilazapril
  • Clopamide
  • Cyclopenthiazide
  • Delapril
  • Desvenlafaxine
  • Dilevalol
  • Diltiazem
  • Enalaprilat
  • Enalapril Maleate
  • Eprosartan
  • Esmolol
  • Ethacrynic Acid
  • Felodipine
  • Flunarizine
  • Fosinopril
  • Furosemide
  • Gallopamil
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Imidapril
  • Indapamide
  • Irbesartan
  • Isradipine
  • Labetalol
  • Lacidipine
  • Landiolol
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Lithium
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Olmesartan Medoxomil
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Piretanide
  • Polythiazide
  • Pranidipine
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Spironolactone
  • Talinolol
  • Tasosartan
  • Telmisartan
  • Temocapril
  • Tertatolol
  • Timolol
  • Tolazamide
  • Tolbutamide
  • Torsemide
  • Trandolapril
  • Triamterene
  • Trichlormethiazide
  • Valsartan
  • Verapamil
  • Xipamide
  • Zofenopril

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to ethylenediamine tetraacetic acid (EDTA) or
  • Allergy to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs) or
  • Aspirin-sensitive asthma, history of or
  • Bleeding problems or
  • Kidney disease, severe or
  • Major surgery, prior to or
  • Stomach ulcers or bleeding or perforation, or history of
  • Use for pain relief of labor or childbirth—Should not be used in patients with these conditions.
  • Anemia or
  • Blood clotting problems or
  • Congestive heart failure or
  • Crohn's disease, history of or
  • Edema (fluid retention or body swelling) or
  • Heart attack, history of or
  • Heart disease or
  • Hypertension (high blood pressure) or
  • Kidney disease, or history of or
  • Liver disease, or history of or
  • Stroke, history of or
  • Ulcerative colitis, history of—Use with caution. May make these conditions worse.
  • Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor to benefit your condition as much as possible. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not use it for more than 5 days in a row. The total number of days also includes any doses of ketorolac that may be given in a hospital or clinic setting. Using too much of this medicine increases the chance of side effects, especially in elderly patients.

This medicine should come with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not breathe in (inhale) this medicine while spraying. Do not get any of it in your eyes. If it does get in the eyes, rinse them with water or saline right away and call your doctor.

Drink extra fluids while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

To use:

  • If you are using the nasal spray for the first time, you will need to prime the spray. To do this, pump the bottle 5 times until some of the medicine sprays out. Now it is ready to use.
  • Gently blow your nose to clear the nostrils.
  • Sit or stand up straight and tilt your head slightly forward.
  • Insert the tip of the bottle into your right nostril. Point the bottle away from the center of your nose.
  • Hold your breath and spray once into your right nostril. Slowly breathe in through your mouth. You may want to pinch your nose, to allow the medicine to be absorbed in through the skin in your nose.
  • If your dose is 2 sprays, spray once into your left nostril the same way.
  • After using the spray, wipe the tip of the bottle with a clean tissue and put the clear plastic cover back on.
  • Do not use the bottle for more than 24 hours after your first dose. Throw the bottle away after 24 hours even if it still has liquid in it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For nasal dosage form (spray):
    • For pain:
      • Adults weighing 50 kilograms (kg) or more—31.5 milligrams (mg) or 1 spray in each nostril every 6 to 8 hours. Your doctor may adjust your dose if needed. However, the dose is usually not more than 126 mg (a total of 8 sprays) per day.
      • Older adults and adults weighing less than 50 kg—15.75 mg or 1 spray in only one nostril every 6 to 8 hours. However, the dose is usually not more than 63 mg (a total of 4 sprays) per day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the unopened bottle in the refrigerator. Protect it from light and freezing. Once opened, store the bottle at room temperature, away from heat and direct sunlight. Throw away any unused medicine 24 hours after you opened the bottle and used your first dose.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Do not use any other form of ketorolac (such as injection or tablets) or other NSAIDs, unless your doctor says it is okay. Some examples of NSAIDs are aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, or Voltaren®. Also, you should not use this medicine together with pentoxifylline (Trental®) or probenecid (Benemid®).

Ketorolac may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). Call your doctor right away if you have bloody or black, tarry stools, severe stomach pain or heartburn, or vomiting of blood or material that looks like coffee grounds.

This medicine may cause a serious allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Ketorolac may increase your risk of having blood clots, heart attack, or stroke. This is more likely in people who already have heart disease. Call your doctor right away if you have chest pain or discomfort, an irregular or fast heartbeat, severe indigestion or heartburn, nausea, sweating, or troubled breathing with exertion.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. Do not use this medicine during the latter part of a pregnancy unless your doctor tells you to.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Abdominal or stomach pain, cramping, or burning
bloody or black, tarry stools
dizziness
fast, irregular, pounding, or racing heartbeat or pulse
headache
nausea
nervousness
pale skin
pounding in the ears
severe stomach pain
sweating
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
Less common
Burning feeling in the chest or stomach
chest pain or discomfort
decrease in the amount or frequency of urine
difficult or labored breathing
frequent urination
lightheadedness, dizziness, or fainting
rapid or shallow breathing
wheezing
Rare
Bloody, cloudy, or dark urine
clay-colored stools
confusion
difficult, burning, or painful urination
difficulty with swallowing
extreme fatigue
hives, itching, or rash
lower back or side pain
nosebleeds
swelling of the face, fingers, feet, or lower legs
swollen glands
tightness in the chest
unpleasant breath odor
upper right abdominal pain
vomiting
weight gain or loss
yellow eyes or skin
Incidence not known
Blistering, peeling, or loosening of the skin
difficulty with moving
difficulty with speaking
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
general body swelling
joint or muscle pain
pain or discomfort in the arms, jaw, back, or neck
pains in the stomach, side, or abdomen, possibly radiating to the back
pale or blue lips, fingernails, or skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness, soreness, or itching skin
severe mood or mental changes
sneezing
sores, welting, or blisters
swollen, painful, or tender lymph glands in the neck, armpit, or groin
weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Acid or sour stomach
belching
continuing ringing or buzzing or other unexplained noise in the ears
drowsiness
full feeling
hearing loss
nasal discomfort
passing gas
swelling or inflammation of the mouth
Less common
Runny nose
stuffy nose
watering of the eyes
Rare
Abnormal dreams
abnormal taste
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
excessive thirst
inability to concentrate
irritability or restlessness
muscle trembling, jerking, or stiffness
redness, swelling, or soreness of the tongue
seeing, hearing, or feeling things that are not there
sensation of spinning
shakiness in the legs, arms, hands, or feet
trouble concentrating
trouble sleeping
uncontrolled movements, especially of the face, neck, and back
Incidence not known
Burning, dry, or itching eyes
eye discharge or excessive tearing
redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
stiff neck or back

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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