Sprix nasal

Ketorolac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

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 ketorolac nasal, especially in older adults.

You should not use this medicine 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;

• 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 nasal and should not be used at the same time.

Do not use ketorolac nasal 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 ketorolac nasal is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

• a history of heart attack, stroke, or blood clot;

• a history of stomach ulcers or bleeding;

• ulcerative colitis or Crohn's disease;

• asthma;

• liver or kidney disease;

• fluid retention; or

• if you have recently had surgery.

Using ketorolac nasal during the last 3 months of pregnancy may harm the unborn baby. Ketorolac may also increase the risk of uterine bleeding and is not for use during labor and delivery. Tell your doctor if you are pregnant.

Ketorolac nasal can pass into breast milk and may harm a nursing baby. Do not breast-feed while using this medicine.

Ketorolac nasal is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Do not use this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Ketorolac nasal is usually given every 6 to 8 hours. Follow your doctor's instructions.

To use the ketorolac nasal spray:

• Gently blow your nose before using the nasal spray.

• The first time you use a new bottle, remove the clip and plastic cover and prime the unit by pumping 5 sprays into the air, away from your face, until a fine mist appears.

• Tilt your head forward slightly and insert the tip of bottle into your nostril, pointing it away from the center of your nose. Breathe through your mouth while spraying gently into your nostril. Do not inhale or sniff while spraying. If your nose runs, gently sniff to keep the nasal spray from leaking out.

• Use only the number of sprays prescribed by your doctor.

• Put the plastic cap back on the bottle and store it in a dry place, out of direct sunlight.

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.

Do not use this medication 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 within 24 hours after your first use, even if there is still some medicine left in the bottle.

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

After opening a bottle, store it at room temperature away from moisture, heat, and light.

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

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

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• the first sign of any skin rash, no matter how mild;

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

• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

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

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• pain or irritation in your nose;

• runny nose;

• watery eyes;

• throat irritation; or

• mild 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.

Ask your doctor before using ketorolac if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• lithium;

• methotrexate;

• heparin or warfarin (Coumadin, Jantoven);

• antipsychotic medicine;

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

• seizure medicine (carbamazepine, phenytoin); or

• steroid medicine (such as prednisone).

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

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, probenecid, corticosteroids (such as prednisone), "water pills" (diuretics such as furosemide).

This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, pentoxifylline, among others.

Do not use this medication with other forms of ketorolac, high doses of aspirin, or other NSAIDs.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to ketorolac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Get emergency medical help if you have signs of an allergic reaction to Sprix: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

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

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• the first sign of any skin rash, no matter how mild;

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

• liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

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

• low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Sprix side effects may include:

• pain or irritation in your nose;

• runny nose;

• watery eyes;

• throat irritation; or

• mild 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.

Applies to ketorolac: injectable, solution, tablet

Other dosage forms:

• nasal spray

Along with its needed effects, ketorolac (the active ingredient contained in Sprix) 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 while taking ketorolac:

• Swelling of face, fingers, lower legs, ankles, and/or feet
• weight gain (unusual)

• Bruising (not at place of injection)
• high blood pressure
• skin rash or itching
• small, red spots on skin
• sores, ulcers, or white spots on lips or in mouth

• Abdominal or stomach pain, cramping, or burning that is severe
• bleeding from the rectum or bloody or black, tarry stools
• bloody or cloudy urine
• blue lips and fingernails
• blurred vision of other vision change
• burning, red, tender, thick, scaly, or peeling skin
• chest pain
• convulsions
• cough or hoarseness
• dark urine
• decrease in amount of urine that is sudden
• fainting
• fast, irregular, noisy, or troubled breathing
• fever with severe headache, drowsiness, confusion, and stiff neck or back
• fever with or without chills or sore throat
• hallucinations (seeing, hearing, or feeling things that are not there)
• hearing loss
• hives
• increase in amount of urine or urinating often
• light-colored stools
• loss of appetite
• low blood pressure
• mood changes or unusual behavior
• muscle cramps or pain
• nausea, heartburn, or indigestion that is severe and continues
• nosebleeds
• pain in lower back and/or side
• pain, tenderness, or swelling in the upper stomach area
• painful or difficult urination
• pale skin
• puffiness or swelling of the eyelids or eyes
• ringing or buzzing in ears
• runny nose
• severe restlessness
• shortness of breath
• swollen or painful glands
• swollen tongue
• thirst that continues
• tightness in the chest with or without wheezing
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

Some side effects of ketorolac 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:

• Abdominal or stomach pain (mild or moderate)
• bruising at place of injection
• diarrhea
• dizziness
• drowsiness
• headache
• indigestion
• nausea

• Bloating or gas
• burning or pain at place of injection
• constipation
• feeling of fullness in abdominal or stomach area
• increased sweating
• vomiting

Applies to ketorolac: injectable solution, nasal spray, oral tablet

General

The most common adverse reactions among patients treated with ketorolac (the active ingredient contained in Sprix) include abdominal pain, nausea, dyspepsia, and headaches. For patients receiving the nasal spray, nasal discomfort, rhinalgia, increased lacrimation, throat irritation, and rhinitis were reported.[Ref]

Gastrointestinal

A large postmarketing observational study (n=10,000) revealed the incidence of clinically serious gastrointestinal (GI) bleeding was dose dependent and more than double in patients 65 years or older. The incidence of clinically serious GI bleeding after up to 5 days of treatment with doses of 60 mg or less, greater than 60 to 90 mg, greater than 90 to 120 mg, or greater than 120 mg, respectively was 0.4%, 0.4%, 0.9%, and 4.6% in those less than 65 years compared with 1.2%, 2.8%, 2.2%, and 7.7% in those 65 years or older. Among patients with a history of GI perforation, ulcer, or bleeding, these numbers were 2.1%, 4.6%, 7.8%, and 15.4% compared with 4.7%, 3.7%, 2.8%, and 25%, in younger and older patients, respectively.[Ref]

Very common (10% or more): Abdominal pain, dyspepsia, nausea
Common (1% to 10%): Constipation, diarrhea, flatulence, gastrointestinal (GI) fullness, GI ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, stomatitis, vomiting, throat irritation (nasal spray)
Frequency not reported: Anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, melena, rectal bleeding, increased appetite, peptic ulcers, ulcers, hematemesis, gastritis
Postmarketing reports: Acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease), eructation[Ref]

Hematologic

Common (1% to 10%): Anemia, increased bleeding time
Frequency not reported: Bleeding, hematoma, postoperative wound hemorrhage
Postmarketing reports: Agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, thrombocytopenia purpura, thrombocytopenia, neutropenia, postoperative wound hemorrhage (rarely requiring blood transfusion)[Ref]

Serious events of bleeding (n=4) or hematoma (n=3) at the operative site were reported in controlled clinical trials in patients (n=455) undergoing major surgeries (primarily knee and hip replacements, and abdominal hysterectomies) receiving ketorolac nasal spray compared with 1 patient in the placebo group (hematoma).

In pediatric patients, an increased risk of bleeding was observed following tonsillectomy. In a retrospective analysis, risk of bleeding following a tonsillectomy with or without adenoidectomy was 10.1% in patients receiving this drug compared with 2.2% in those receiving opioids. The postoperative hemorrhage rate in patients 12 years and younger was 6.5% with ketorolac treatment versus 3.3% without. In a prospective study in patients 3 to 9 years undergoing tonsillectomy with or without adenoidectomy, the overall incidence of bleeding in patients receiving this drug was 16.3% compared with 17% in children receiving morphine. However, during the first 24 hours after surgery, bleeding was observed in 14.3% of the ketorolac group versus 4.2% of the morphine group.[Ref]

Cardiovascular

Common (1% to 10%): Edema, hypertension, bradycardia
Frequency not reported: Congestive heart failure, palpitations, pallor, tachycardia, syncope, cardiac failure
Postmarketing reports: Arrhythmia, chest pain, flushing, hypotension, myocardial infarction, vasculitis[Ref]

Clinical trials of several cyclooxygenase (COX)-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs appear to have a similar risk. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk and may be associated with an increased risk of serious gastrointestinal events.[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, purpura, sweating
Very rare (less than 0.01%):
Frequency not reported: Alopecia, photosensitivity, urticaria
Postmarketing reports: Angioedema, exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reactions
Postmarketing reports: Laryngeal edema, tongue edema[Ref]

Renal

Common (1% to 10%): Abnormal renal function, oliguria
Postmarketing reports: Acute renal failure, nephrotic syndrome[Ref]

Hepatic

Common (1% to 10%): Elevated liver enzymes
Frequency not reported: Hepatitis, jaundice, liver failure[Ref]

Metabolic

Frequency not reported: Weight change
Postmarketing reports: Hyperglycemia, hyperkalemia, hyponatremia[Ref]

Respiratory

Very common (10% or more): Nasal discomfort (15%, nasal spray), rhinalgia (13%, nasal spray)
Common (1% to 10%): Rhinitis (nasal spray)
Frequency not reported: Epistaxis, pulmonary edema, asthma
Postmarketing reports: Bronchospasm, respiratory depression, pneumonia[Ref]

Nervous system

Very common (10% or more): Headaches
Common (1% to 10%): Drowsiness, dizziness
Frequency not reported: Extrapyramidal symptoms, hyperkinesis, inability to concentrate, insomnia, paresthesia, somnolence, stupor, tremors
Postmarketing reports: Aseptic meningitis, convulsions, coma, taste abnormality[Ref]

Local

Common (1% to 10%): Injection site pain[Ref]

Ocular

Common (1% to 10%): Lacrimation increased (nasal spray)
Postmarketing reports: Conjunctivitis, optic neuritis, visual disturbances, abnormal vision[Ref]

Psychiatric

Frequency not reported: Anxiety, depression, euphoria, hallucinations, abnormal dreams, abnormal thinking
Postmarketing reports: Psychosis[Ref]

Other

Common (1% to 10%): Tinnitus
Frequency not reported: Fever, asthenia, malaise, vertigo, hearing loss[Ref]

Endocrine

Frequency not reported: Female infertility[Ref]

Genitourinary

Postmarketing reports: Flank pain with or without hematuria and/or azotemia, hemolytic uremia syndrome, increased urinary frequency, oliguria, interstitial nephritis, urinary retention[Ref]

Immunologic

Frequency not reported: Infections, sepsis[Ref]

Musculoskeletal

Postmarketing reports: Myalgia[Ref]

Some side effects of Sprix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.