Ketorolac nasal

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

Ketorolac nasal (for the nose) is used short-term (5 days or less) to treat moderate to severe pain.

Ketorolac may also be used for purposes not listed in this medication guide.

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

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.

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 ketorolac, you should discuss with your doctor the benefits that ketorolac can do as well as the risks of using it.

ketorolac is available only with your doctor's prescription.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad swelling or pain of hands or feet.
• Very loose stools (diarrhea).
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

• Ketorolac Tromethamine

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

Ketorolac 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.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nose pain, rhinitis or pharyngitis. Have patient report immediately to prescriber signs of abdominal ulcers (severe abdominal or back pain; black, tarry, or bloody stools; vomiting blood or vomit that looks like coffee grounds; or weight gain or abnormal swelling), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weak, shortness of breath, numbness or tingling feeling), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), severe headache, severe dizziness, passing out, vision changes, angina, shortness of breath, excessive weight gain, swelling of arms or legs, severe diarrhea, severe swelling or pain of hands or feet, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

The combined duration of use of parenteral, oral, and intranasal ketorolac should not exceed 5 days; the oral formulation is only to be used as continuation to IV or IM therapy.

Intranasal:
-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: 4 doses per day

Parenteral:
Single-Dose Treatment:
-Weight 50 kg or more: 60 mg IM or 30 mg IV
-Weight less than 50 kg: 30 mg IM or 15 mg IV
Multiple-Dose Treatment:
-Weight 50 kg or more: 30 mg IM/IV every 6 hours as needed
Maximum dose: 120 mg/day
-Weight less than 50 kg: 15 mg IM/IV every 6 hours as needed
Maximum dose: 60 mg/day

Oral, as continuation to parenteral therapy:
Weight 50 kg or more: 20 mg orally once followed by 10 mg every 4 to 6 hours as needed
Weight less than 50 kg: 10 mg orally once followed by 10 mg every 4 to 6 hours as needed
Maximum dose: 40 mg/day

Comments:
-Do not increase the dose or frequency for breakthrough pain; consider supplementing with low dose opioids as needed, if appropriate.
-Use minimum effective dose, and switch to alternative analgesics as soon as possible

Use: For the short-term (5 days or less) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.

US BOXED WARNINGS: This drug is a NSAID indicated for the short term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. It is NOT indicated for minor or chronic painful conditions. This drug is a potent NSAID analgesic, and its administration carries many risks. The resulting NSAID-related adverse events can be serious in certain patients for whom it is indicated, especially when the drug is used inappropriately. Increasing the dose beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events.
-GASTROINTESTINAL (GI) EFFECTS: This drug can cause peptic ulcers, GI bleeding and/or perforation. Therefore, this drug is contraindicated in patients with active peptic ulcer disease, in patients with recent GI bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.
-RENAL EFFECTS: This drug is contraindicated in patients with advance renal impairment and in patients at risk for renal failure due to volume depletion.
-RISK OF BLEEDING: This drug inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding.
SURGERY: This drug is contraindicated as prophylactic analgesic before any major surgery and is contraindicated intraoperatively when hemostasis is critical because of the increased risk of bleeding. This drug is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
HYPERSENSITIVITY: Reactions ranging from bronchospasm to anaphylactic shock have occurred; appropriate counteractive measures must be available when administering the first dose. This drug is contraindicated in patients with previously demonstrated hypersensitivity to this drug or allergic manifestations to aspirin or other NSAIDs.
INTRATHECAL OR EPIDURAL ADMINISTRATION: Contraindicated due to its alcohol content.
LABOR, DELIVERY, AND NURSING: Contraindicated in labor and delivery because it may adversely affect fetal circulation and inhibit uterine contractions; contraindicated in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.
CONCOMITANT USE WITH NSAIDS: Due to the cumulative risk of inducing serious NSAID-related side effects, this drug is contraindicated in patients currently receiving aspirin or NSAIDs.
DOSAGE AND ADMINISTRATION: Tablets are only indicated as continuation therapy to injection, and the combined duration of use is not to exceed 5 days because of the increased risk of serious adverse events. The recommended total daily dose of tablets (maximum 40 mg/day) is significantly lower than for the injection (maximum 120 mg/day).
SPECIAL POPULATIONS: Dosage should be adjusted for patients 65 year or older, for patients under 50 kg, and for patients with moderately elevated serum creatinine. Do not exceed a total daily injection dose of 60 mg in these patients.
PEDIATRIC PATIENTS: This drug is indicated as single dose therapy only, not to exceed 30 mg IM or 15 mg IV.

Safety and efficacy have not been established in patients younger than 2 years.
Safety and efficacy of the intranasal and oral product have not been established in patients younger than 17 years.

Consult WARNINGS section for additional precautions.

• Ketorolac helps to relieve pain and inflammation by blocking the effects of the enzymes cyclooxygenase (COX)-1 and COX-2.
• Ketorolac belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs).

• Peak concentrations of ketorolac are reached within two to three hours. The effects of oral ketorolac may last for four to six hours.

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