Ketorolac (Nasal route)
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. Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. 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 .
Acetic Acid (class)
Uses of This Medicine:
Ketorolac nasal spray is used to relieve moderate to moderately severe pain (eg, pain that occurs after an operation or other painful procedure) for a short time only. It is a nonsteroidal anti-inflammatory drug (NSAID) which lessens pain and inflammation.
Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the amount 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 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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of ketorolac nasal spray in the pediatric population. Use is not recommended in children younger than 2 years of age. Safety and efficacy have not been established.
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, or stomach or bowel problems, which may require caution and an adjustment in the dose for patients receiving ketorolac nasal spray.
|1st Trimester||C||Animal 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 Trimester||C||Animal 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 Trimester||D||Studies 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.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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.
- Amtolmetin Guacil
- Choline Salicylate
- Flufenamic Acid
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
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.
- Dabigatran Etexilate
- Ethacrynic Acid
- Pentosan Polysulfate Sodium
- Protein C
- Tenofovir Disoproxil Fumarate
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.
- Azilsartan Medoxomil
- Candesartan Cilexetil
- Olmesartan Medoxomil
- Perindopril Erbumine
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 (including kidney failure) or
- Major surgery, prior to or
- Stomach ulcers, bleeding, or perforation, active or recent or
- 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, recent or history of or
- Heart disease or
- Hyperkalemia (high potassium in the blood) 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. 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 into your eyes. If it does get into 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.
- 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 through the skin inside 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 inside it.
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 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.
- For pain:
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.
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 (eg, injection or tablets) or other NSAIDs, unless your doctor says it is okay. Some examples of NSAIDs are aspirin, diclofenac, ibuprofen, or 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 bowels. 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.
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.
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.
Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur, such as chest pain, fast or irregular heartbeat, tightness in the chest, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor right away if you notice any of these warning signs.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or non-steroidal 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, 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.
Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the 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.
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:
- More common
- Bloody or black, tarry stools
- fast, irregular, pounding, or racing heartbeat or pulse
- pale skin
- pounding in the ears
- severe stomach pain
- stomach cramping or burning
- 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
- Bloody, cloudy, or dark urine
- clay-colored stools
- difficult, burning, or painful urination
- difficulty with swallowing
- extreme tiredness or weakness
- hives, itching, or skin rash
- lower back or side pain
- swelling of the face, fingers, feet, or lower legs
- swollen glands
- tightness in the chest
- unpleasant breath odor
- upper right abdominal or stomach pain
- 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
- sores, welts, or blisters
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- weakness or heaviness of the legs
- More common
- continuing ringing or buzzing or other unexplained noise in the ears
- feeling of fullness
- hearing loss
- nasal discomfort
- passing gas
- swelling or inflammation of the mouth
- Less common
- Runny nose
- stuffy nose
- watering of the eyes
- 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
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:
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:
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: 6/18/2019