SPRIX SPRIX SPRIX

SPRIX® (ketorolac tromethamine) Nasal Spray is a novel formulation of ketorolac tromethamine and a proven pain reliever. SPRIX® combines the potency of non-narcotic ketorolac with the convenience of a patient-administered nasal spray.

References:

  1. SPRIX® [package insert]. Wayne, PA : Egalet US Inc. 2016.
  2. Vadivelu N, Gowda AM, Urman RD, et al. Ketorolac tromethamine – routes and clinical implications. Prain Pract. 2014;15(2):175-193
  3. Boyer KC, McDonald P, Zoetis T. A novel formulation of ketorolac tromethamine for intranasal administration: Preclinical safety evaluation. Int J Toxicol. 2010;29(5):467-478
  4. McAleer SD, Majid O, Venables, E, Polak T, Sheikh MS. Pharmacokinetics and safety of ketorolac following single intranasal and intramuscular administration in healthy volunteers. J Cin Pharmacol. 2007;47(1):13-18
  5. Brown C, Moodie J, Bisley E, Bynum L. Intranasal ketorolac for postoperative pain: a phase 3, double-blind, randomized study. Pain Med. 2009;10(6):1106-1114.
  6. Singla N, Singla S, Minkowtiz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010:26(8):1915-1923.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS SIDE EFFECTS

See full prescribing information for complete boxed warning

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including heart attack and stroke, which can lead to death. This risk may happen early in treatment and may increase with increasing doses of NSAIDs or with longer use of NSAIDs.
  • Do not take SPRIX® right before or after heart surgery called a "coronary artery bypass graft (CABG)".
  • Do not take NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines, which can lead to death. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of stomach ulcers, or stomach or intestinal bleeding are at greater risk for serious GI events.
    The risk of getting an ulcer or bleeding also increases with:
    • Taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
    • Increasing doses of NSAIDs
    • Longer use of NSAIDs
    • Smoking
    • Drinking alcohol
    • Poor health
    • Advanced liver disease
    • Bleeding problems

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

See the Boxed Warning: Risk of Serious Side Effects

NSAIDs should only be used:

  • Exactly as prescribed
  • At the lowest dose possible for your treatment
  • For the shortest time needed

What is SPRIX®?

SPRIX® (ketorolac tromethamine) is used in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Do not use SPRIX®:

  • If you are allergic to ketorolac or any components of the drug product.
  • If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • Right before or after heart bypass surgery
  • If you have active ulcer disease or any history of bleeding in the stomach or intestines
  • If you have had bleeding in the brain, a tendency to bleed, or have decreased ability for your blood to clot
  • For more than 5 days or with other NSAIDs

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems
  • have high blood pressure
  • have asthma
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
  • are breastfeeding or plan to breast feed. Some SPRIX can pass into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

NSAIDs can cause serious side effects, including:

  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Most common side effects with SPRIX include: discomfort in the nose; pain in the nose; increased tears; throat irritation; decreased amount of urine; rash; slow heart rate; increased liver enzymes; high blood pressure; stuffy nose.

Keep SPRIX away from your eyes. If you get SPRIX in your eyes, wash out the eye with water or saline, and call a doctor if irritation persists for more than an hour.

Get emergency help right away if you get any of the following symptoms:

  • Shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms, legs, hands and feet

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

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

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

Please see Important Safety Information and complete Prescribing Information, including Boxed Warning, at www.sprix.com.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning

  • 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
  • SPRIX® 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

Indications and Usage

SPRIX® (ketorolac tromethamine) is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Contraindications

    SPRIX® is contraindicated in the following patients:

  • Known hypersensitivity to ketorolac or any components of the drug product.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
  • In the setting of coronary artery bypass graft (CABG) surgery.
  • Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.
  • Use as a prophylactic analgesic before any major surgery.
  • Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.
  • Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
  • Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical.
  • Concomitant use with probenecid.

Warnings and Precautions

Cardiovascular Thrombotic Events: increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Contraindicated in the setting of CABG. Patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.

Gastrointestinal Bleeding, Ulceration, and Perforation: contraindicated in patients with active peptic ulcers and/or GI bleeding and in patients with recent gastrointestinal bleeding or perforation. Can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms. Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Hypertension: NSAIDs, including SPRIX®, can lead to new onset or worsening of preexisting hypertension. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: Avoid use of SPRIX® in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of SPRIX® in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

Exacerbation of Asthma Related to Aspirin Sensitivity: Contraindicated in patients with aspirinsensitive asthma. Monitor patients with preexisting asthma (without known aspirin sensitivity).

Serious Skin Reactions: NSAIDs, including SPRIX®, can cause serious skin reactions, which can be fatal. Discontinue SPRIX® at first appearance of skin rash or other signs of hypersensitivity.

Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.

Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Do not use SPRIX® in patients for whom hemostasis is critical.

Limitations of Use: SPRIX® should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs.

Adverse Reactions

Serious adverse reactions include: cardiovascular thrombotic events; GI bleeding, ulceration and perforation; hepatotoxicity; hypertension; heart failure and edema; renal toxicity and hyperkalemia; anaphylactic reactions; serious skin reactions; hematologic toxicity.

The most common adverse reactions (incidence ≥2%) in patients treated with SPRIX® and occurring at a rate at least twice that with placebo include: nasal discomfort rhinalgia; increased lacrimation; throat irritation; oliguria; rash; bradycardia; decreased urine output; increased ALT and/or AST; hypertension; rhinitis.

In controlled clinical trials in major surgery, primarily knee and hip replacements and abdominal hysterectomies, 1.5% of patients treated with SPRIX® experienced serious adverse events of bleeding or hematoma at the operative site versus 0.4% of patients treated with placebo who experienced hematoma.

In patients taking ketorolac or other NSAIDs in clinical trials, the most frequently reported adverse reactions in approximately 1% to 10% of patients are:

  • Gastrointestinal (GI): abdominal pain, constipation/diarrhea, dyspepsia, flatulence, GI fullness, GI ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, nausea (incidence >10%), stomatitis, vomiting.
  • Other: abnormal renal function, anemia, dizziness, drowsiness, edema, elevated liver enzymes, headache (incidence >10%), hypertension, increased bleeding time, injection site pain, pruritus, purpura, rash, tinnitus, sweating.

Drug Interactions

Drugs that interfere with hemostasis: increased risk of serious bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs); concomitant use with pentoxifylline is contraindicated.

ACE inhibitors, angiotensin receptor blockers (ARBs), and beta-blockers: may diminish the antihypertensive effect of these drugs; monitor blood pressure.

ACE Inhibitors and ARBs: In elderly, volume depleted, or those with renal impairment may result in deterioration of renal function; monitor for signs of worsening renal function.

Diuretics: reduces the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

Digoxin: has been reported to increase the serum concentration and prolong the half-life of digoxin.

Use in Specific Populations

Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of SPRIX® in women who have difficulties conceiving.

Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS SIDE EFFECTS

See full prescribing information for complete boxed warning

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including heart attack and stroke, which can lead to death. This risk may happen early in treatment and may increase with increasing doses of NSAIDs or with longer use of NSAIDs.
  • Do not take SPRIX® right before or after heart surgery called a "coronary artery bypass graft (CABG)".
  • Do not take NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines, which can lead to death. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of stomach ulcers, or stomach or intestinal bleeding are at greater risk for serious GI events.
    The risk of getting an ulcer or bleeding also increases with:
    • Taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
    • Increasing doses of NSAIDs
    • Longer use of NSAIDs
    • Smoking
    • Drinking alcohol
    • Poor health
    • Advanced liver disease
    • Bleeding problems

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

See the Boxed Warning: Risk of Serious Side Effects

NSAIDs should only be used:

  • Exactly as prescribed
  • At the lowest dose possible for your treatment
  • For the shortest time needed

What is SPRIX®?

SPRIX® (ketorolac tromethamine) is used in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Do not use SPRIX®:

  • If you are allergic to ketorolac or any components of the drug product.
  • If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • Right before or after heart bypass surgery
  • If you have active ulcer disease or any history of bleeding in the stomach or intestines
  • If you have had bleeding in the brain, a tendency to bleed, or have decreased ability for your blood to clot
  • For more than 5 days or with other NSAIDs

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems
  • have high blood pressure
  • have asthma
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
  • are breastfeeding or plan to breast feed. Some SPRIX can pass into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

NSAIDs can cause serious side effects, including:

  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Most common side effects with SPRIX include: discomfort in the nose; pain in the nose; increased tears; throat irritation; decreased amount of urine; rash; slow heart rate; increased liver enzymes; high blood pressure; stuffy nose.

Keep SPRIX away from your eyes. If you get SPRIX in your eyes, wash out the eye with water or saline, and call a doctor if irritation persists for more than an hour.

Get emergency help right away if you get any of the following symptoms:

  • Shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms, legs, hands and feet

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

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

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

Please see Important Safety Information and complete Prescribing Information, including Boxed Warning, at www.sprix.com.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning

  • 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
  • SPRIX® 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

Indications and Usage

SPRIX® (ketorolac tromethamine) is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Contraindications

    SPRIX® is contraindicated in the following patients:

  • Known hypersensitivity to ketorolac or any components of the drug product.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
  • In the setting of coronary artery bypass graft (CABG) surgery.
  • Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.
  • Use as a prophylactic analgesic before any major surgery.
  • Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.
  • Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
  • Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical.
  • Concomitant use with probenecid.

Warnings and Precautions

Cardiovascular Thrombotic Events: increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Contraindicated in the setting of CABG. Patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.

Gastrointestinal Bleeding, Ulceration, and Perforation: contraindicated in patients with active peptic ulcers and/or GI bleeding and in patients with recent gastrointestinal bleeding or perforation. Can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms. Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Hypertension: NSAIDs, including SPRIX®, can lead to new onset or worsening of preexisting hypertension. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: Avoid use of SPRIX® in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of SPRIX® in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

Exacerbation of Asthma Related to Aspirin Sensitivity: Contraindicated in patients with aspirinsensitive asthma. Monitor patients with preexisting asthma (without known aspirin sensitivity).

Serious Skin Reactions: NSAIDs, including SPRIX®, can cause serious skin reactions, which can be fatal. Discontinue SPRIX® at first appearance of skin rash or other signs of hypersensitivity.

Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.

Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Do not use SPRIX® in patients for whom hemostasis is critical.

Limitations of Use: SPRIX® should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs.

Adverse Reactions

Serious adverse reactions include: cardiovascular thrombotic events; GI bleeding, ulceration and perforation; hepatotoxicity; hypertension; heart failure and edema; renal toxicity and hyperkalemia; anaphylactic reactions; serious skin reactions; hematologic toxicity.

The most common adverse reactions (incidence ≥2%) in patients treated with SPRIX® and occurring at a rate at least twice that with placebo include: nasal discomfort rhinalgia; increased lacrimation; throat irritation; oliguria; rash; bradycardia; decreased urine output; increased ALT and/or AST; hypertension; rhinitis.

In controlled clinical trials in major surgery, primarily knee and hip replacements and abdominal hysterectomies, 1.5% of patients treated with SPRIX® experienced serious adverse events of bleeding or hematoma at the operative site versus 0.4% of patients treated with placebo who experienced hematoma.

In patients taking ketorolac or other NSAIDs in clinical trials, the most frequently reported adverse reactions in approximately 1% to 10% of patients are:

  • Gastrointestinal (GI): abdominal pain, constipation/diarrhea, dyspepsia, flatulence, GI fullness, GI ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, nausea (incidence >10%), stomatitis, vomiting.
  • Other: abnormal renal function, anemia, dizziness, drowsiness, edema, elevated liver enzymes, headache (incidence >10%), hypertension, increased bleeding time, injection site pain, pruritus, purpura, rash, tinnitus, sweating.

Drug Interactions

Drugs that interfere with hemostasis: increased risk of serious bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs); concomitant use with pentoxifylline is contraindicated.

ACE inhibitors, angiotensin receptor blockers (ARBs), and beta-blockers: may diminish the antihypertensive effect of these drugs; monitor blood pressure.

ACE Inhibitors and ARBs: In elderly, volume depleted, or those with renal impairment may result in deterioration of renal function; monitor for signs of worsening renal function.

Diuretics: reduces the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

Digoxin: has been reported to increase the serum concentration and prolong the half-life of digoxin.

Use in Specific Populations

Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of SPRIX® in women who have difficulties conceiving.

Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare.

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