Meloxicam (Lexi-Drugs)

ALERT: US Boxed Warning
  Serious cardiovascular thrombotic events:
  Serious gastrointestinal bleeding, ulcerations, and perforation:
Pronunciation

(mel OKS i kam)

Brand Names: US

Mobic; Qmiiz ODT; Vivlodex

Brand Names: Canada

ACT Meloxicam; APO-Meloxicam; Auro-Meloxicam; DOM-Meloxicam; Mobicox [DSC]; MYLAN-Meloxicam [DSC]; PHL-Meloxicam [DSC]; PMS-Meloxicam; TEVA-Meloxicam

Dosing: Adult

Note: Capsules are not interchangeable with other formulations of oral meloxicam even if the total milligram strength is the same. Do not substitute similar dose strengths of other meloxicam products.

Gout, acute flares (alternative agent) (off-label use): Oral: 15 mg once daily (Cheng 2004); initiate within 24 to 48 hours of flare onset preferably; discontinue 2 to 3 days after resolution of clinical signs; usual duration: 5 to 7 days (ACR [Khanna 2012]; Becker 2018)

Osteoarthritis: Capsule: Oral: Initial: 5 mg once daily; some patients may receive additional benefit from increasing dose to 10 mg once daily; maximum dose: 10 mg/day

Osteoarthritis, rheumatoid arthritis: Tablet/Suspension: Oral: Initial: 7.5 mg once daily; some patients may receive additional benefit from increasing dose to 15 mg once daily; maximum dose: 15 mg/day

Dosing: Geriatric

Refer to adult dosing. Use with caution; initiate dose at lower end of the dosing range.

Dosing: Renal Impairment: Adult

CrCl ≥20 mL/minute: No dosage adjustment necessary.

CrCl <20 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use is not recommended.

Hemodialysis (not dialyzable): Use with caution and monitor closely. Maximum dose: 7.5 mg/day (tablet/suspension); 5 mg/day (capsule). Note: Additional dose not necessary after hemodialysis.

KDIGO 2012 guidelines provide the following recommendations for NSAIDs:

eGFR 30 to <60 mL/minute/1.73 m2: Temporarily discontinue in patients with intercurrent disease that increases risk of acute kidney injury.

eGFR <30 mL/minute/1.73 m2: Avoid use.

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.

Dosing: Pediatric

Note: Capsules are not interchangeable with other formulations of oral meloxicam even if the total milligram strength is the same; do not substitute similar dose strengths of other meloxicam products.

Juvenile idiopathic arthritis (JIA): Children ≥2 years and Adolescents: Oral suspension, tablets (limited data available with tablets): Oral: 0.125 mg/kg once daily; maximum daily dose: 7.5 mg/day; higher doses (up to 0.375 mg/kg/day) have not demonstrated additional benefit in clinical trials (American Pain Society 2016). Note: To reduce the risk of adverse cardiovascular and GI effects, use the lowest effective dose for the shortest period of time; adjust dose to specific patient’s clinical needs.

Dosing: Renal Impairment: Pediatric

Children ≥2 years and Adolescents:

Manufacturer’s labeling:

Mild to moderate impairment: No dosage adjustments are recommended.

Significant impairment (CrCl <20 mL/minute): Use is not recommended (has not been studied).

Hemodialysis: Not dialyzable; additional doses are not required after dialysis

KDIGO 2012 guidelines provide the following recommendations for NSAIDs (KDIGO 2013):

eGFR 30 to <60 mL/minute/1.73 m2: Temporarily discontinue in patients with intercurrent disease that increases risk of acute kidney injury

eGFR <30 mL/minute/1.73 m2: Avoid use

Dosing: Hepatic Impairment: Pediatric

Children ≥2 years and Adolescents:

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustments are recommended.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution; meloxicam is significantly metabolized in the liver.

Use: Labeled Indications

Osteoarthritis: Relief of the signs and symptoms of osteoarthritis (OA); management of OA pain.

Rheumatoid arthritis (tablet and suspension only): Relief of signs and symptoms of rheumatoid arthritis (RA); relief of the signs and symptoms of pauciarticular or polyarticular course juvenile RA in patients ≥2 years (suspension) and in patients weighing ≥60 kg (tablet).

Use: Off-Label: Adult

  Gout, acute flaresLevel of Evidence [B, G]

Data from a single-blind, randomized, controlled trial supports the efficacy of meloxicam in the treatment of acute gout flares Ref. Clinical experience also suggests the utility of meloxicam as an alternative agent option for acute gout flares Ref.

Based on the 2012 American College of Rheumatology guidelines for management of gout, NSAIDS are effective and recommended agents in the treatment of acute gout flares.

Clinical Practice Guidelines

Ankylosing Spondylitis:

ACR/SAA/SPARTAN, “Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis,” 2016

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Juvenile Idiopathic Arthritis:

American College of Rheumatology, “2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis,” 2013

Osteoarthritis:

American College of Rheumatology, “Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” 2012

Surgery:

STS, “2012 Update to the Society of Thoracic Surgeons Guideline on Use of Antiplatelet Drugs in Patients Having Cardiac and Noncardiac Operations,” November 2012

Other:

“The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” 2011

Administration: Oral

Administer with or without meals; administer with food or milk to minimize GI irritation. Shake oral suspension gently prior to use.

Administration: Pediatric

Oral: May be taken with or without meals; administer with food or milk to minimize gastrointestinal irritation.

Oral suspension: Shake gently prior to use.

Dietary Considerations

May be taken with food or milk to minimize gastrointestinal irritation.

Storage/Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect tablets and capsules from moisture.

Medication Patient Education with HCAHPS Considerations

• 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 heartburn, nausea, vomiting, common cold symptoms, diarrhea, constipation, or flatulence. 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 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 liver problems (dark urine, fatigue, lack of appetite, nausea, severe abdominal pain, light-colored stools, vomiting, or jaundice), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weak, shortness of breath, numbness or tingling feeling), shortness of breath, excessive weight gain, swelling of arms or legs, angina, severe headache, severe dizziness, passing out, vision changes, severe loss of strength and energy, severe abdominal pain, flu-like signs, 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.

Medication Safety Issues
  Geriatric Patients: High-Risk Medication:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf, must be dispensed with this medication.

Contraindications

Hypersensitivity to meloxicam or any component of the formulation; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; use in the setting of coronary artery bypass graft (CABG) surgery.

Canadian labeling: Additional contraindications (not in US labeling): Pregnancy (third trimester); breastfeeding; severe uncontrolled heart failure; active or recent GI/gastric/duodenal/peptic ulceration/perforation; active GI bleeding; cerebrovascular bleeding or other bleeding disorders; inflammatory bowel disease (Crohn disease or ulcerative colitis); severe liver impairment or active liver disease; severe renal impairment (creatinine clearance [CrCl] <30 mL/minute or 0.5 mL/second) or deteriorating renal disease; known hyperkalemia; pediatric patients <18 years; rare hereditary conditions that may be incompatible with an excipient of the product.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid reactions: Even in patients without prior exposure anaphylactoid reactions may occur; patients with “aspirin triad” (bronchial asthma, aspirin intolerance, rhinitis) may be at increased risk. Contraindicated in patients who experience bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy.

• Cardiovascular events: [US Boxed Warning]: NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including MI and stroke. Risk may occur early during treatment and may increase with duration of use. Relative risk appears to be similar in those with and without known cardiovascular disease or risk factors for cardiovascular disease; however, absolute incidence of serious cardiovascular thrombotic events (which may occur early during treatment) was higher in patients with known cardiovascular disease or risk factors. New onset hypertension or exacerbation of hypertension may occur (NSAIDs may also impair response to ACE inhibitors, thiazide diuretics, or loop diuretics); may contribute to cardiovascular events; monitor blood pressure; use with caution in patients with hypertension. May cause sodium and fluid retention, use with caution in patients with edema. Avoid use in patients with heart failure (ACCF/AHA [Yancy 2013]). Avoid use in patients with recent MI unless benefits outweigh risk of cardiovascular thrombotic events. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of cardiovascular events; alternate therapies should be considered for patients at high risk.

• CNS effects: May cause drowsiness, dizziness, blurred vision, and other neurologic effects which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• GI events: [US Boxed Warning]: NSAIDs cause an increased risk of serious GI inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. These events may occur at any time during therapy and without warning. Avoid use in patients with active GI bleeding. In patients with a history of acute lower GI bleeding, avoid use of non-aspirin NSAIDs, especially if due to angioectasia or diverticulosis (Strate 2016). Use caution with a history of GI ulcers, concurrent therapy known to increase the risk of GI bleeding (eg, aspirin, anticoagulants and/or corticosteroids, selective serotonin reuptake inhibitors), advanced hepatic disease, coagulopathy, smoking, use of alcohol, or in elderly or debilitated patients. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of GI adverse events; alternate therapies should be considered for patients at high risk. When used concomitantly with aspirin, a substantial increase in the risk of GI complications (eg, ulcer) occurs; concomitant gastroprotective therapy (eg, proton pump inhibitors) is recommended (Bhatt 2008).

• Hematologic effects: Platelet adhesion and aggregation may be decreased; may prolong bleeding time; patients with coagulation disorders or who are receiving anticoagulants should be monitored closely. Anemia may occur; patients on long-term NSAID therapy should be monitored for anemia. Rarely, NSAID use has been associated with potentially severe blood dyscrasias (eg, agranulocytosis, thrombocytopenia, aplastic anemia).

• Hepatic effects: Transaminase elevations have been reported with use; closely monitor patients with any abnormal LFT. Rare (sometimes fatal) severe hepatic reactions (eg, fulminant hepatitis, liver necrosis, hepatic failure) have occurred with NSAID use; discontinue immediately if signs or symptoms of hepatic disease develop or if systemic manifestations occur.

• Hyperkalemia: NSAID use may increase the risk of hyperkalemia, particularly in the elderly, diabetics, renal disease, and with concomitant use of other agents capable of inducing hyperkalemia (eg, angiotensin-converting enzyme [ACE] inhibitors). Monitor potassium closely.

• Ophthalmic effects: Blurred and/or diminished vision has been reported; discontinue use and refer for ophthalmologic evaluation if such symptoms occur.

• Renal effects: NSAID use may compromise existing renal function; dose-dependent decreases in prostaglandin synthesis may result from NSAID use, reducing renal blood flow, which may cause renal decompensation (usually reversible). Patients with impaired renal function, dehydration, hypovolemia, heart failure, hepatic impairment, those taking diuretics and ACE inhibitors or ARBs, and the elderly are at greater risk of renal toxicity. Rehydrate patient before starting therapy; monitor renal function closely. Long-term NSAID use may result in renal papillary necrosis and other renal injury.

• Skin reactions: NSAIDs may cause potentially fatal serious skin adverse events including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN); may occur without warning; discontinue use at first appearance of skin rash (or any other sign of hypersensitivity).

Disease-related concerns:

• Asthma: Contraindicated in patients with aspirin-sensitive asthma; severe potentially fatal bronchospasm may occur. Use caution in patients with other forms of asthma.

• Coronary artery bypass graft surgery: [US Boxed Warning]: Use is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Risk of MI and stroke may be increased with use within the first 10 to 14 days following CABG surgery.

• Hepatic impairment: Use with caution in patients with hepatic impairment; patients with hepatic impairment may require reduced doses due to extensive hepatic metabolism. Patients with advanced hepatic disease are at an increased risk of GI bleeding with NSAIDs.

• Renal impairment: Avoid use in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function; monitor closely if therapy must be initiated.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Elderly patients are at greater risk for serious GI, cardiovascular, and/or renal adverse events. Use with caution; initiate dose at the lower end of the dosing range.

Dosage form specific issues:

• Sorbitol: Oral suspension formulation may contain sorbitol. Concomitant use of sorbitol-containing products and sodium polystyrene sulfonate (Kayexalate) may cause intestinal necrosis (including fatal cases); combined use should be avoided.

Other warnings/precautions:

• Surgical/dental procedures: Withhold for at least 4 to 6 half-lives prior to surgical or dental procedures.

Geriatric Considerations

Men ≥65 years of age exhibited steady-state plasma concentrations and pharmacokinetics similar to younger men. Elderly women (≥65 years of age) had nearly a 50% greater AUC and 32% higher Cmax compared to younger women.

Elderly patients are at high risk for adverse effects from NSAIDs. Up to 60% of elderly patients can develop an asymptomatic peptic ulcer and/or hemorrhage. Using the lowest effective dose for the shortest period possible is recommended. Use of NSAIDs can compromise existing renal function, especially when CrCl is <30 mL/minute. CNS adverse effects such as confusion, agitation, and hallucination may occur even with lower doses in elderly patients.

Warnings: Additional Pediatric Considerations

Pediatric patients ≥2 years may experience a higher frequency of some adverse effects than adults, including the following: Abdominal pain, diarrhea, fever, headache, and vomiting.

Pregnancy Considerations

Birth defects have been observed following in utero NSAID exposure in some studies; however, data is conflicting (Bloor 2013). Nonteratogenic effects, including prenatal constriction of the ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, necrotizing enterocolitis, renal dysfunction or failure, and intracranial hemorrhage have been observed in the fetus/neonate following in utero NSAID exposure. In addition, non-closure of the ductus arteriosus postnatally may occur and be resistant to medical management (Bermas 2014; Bloor 2013). Because NSAIDs may cause premature closure of the ductus arteriosus, product labeling for meloxicam specifically states use should be avoided starting at 30-weeks gestation.

Use of NSAIDs can be considered for the treatment of mild rheumatoid arthritis flares in pregnant women; however, use should be minimized or avoided early and late in pregnancy (Bermas 2014; Saavedra Salinas 2015).

The chronic use of NSAIDs in women of reproductive age may be associated with infertility that is reversible upon discontinuation of the medication. Consider discontinuing use in women having difficulty conceiving or those undergoing investigation of fertility. The use of NSAIDs close to conception may be associated with an increased risk of miscarriage (Bermas 2014; Bloor 2013).

Breast-Feeding Considerations

It is not known if meloxicam is present in breast milk. In general, NSAIDs may be used in postpartum women who wish to breastfeed; however, agents other than meloxicam are preferred (Montgomery 2012) and use should be avoided in women breastfeeding infants with platelet dysfunction or thrombocytopenia (Bloor 2013; Sammaritano 2014). According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Percentages reported in adult patients. Reactions similar in pediatric patients; abdominal pain, diarrhea, fever, headache, pyrexia, and vomiting were reported more commonly than in adult patients.

1% to 10%:

Cardiovascular: Edema (≤5%), angina pectoris (<2%), cardiac arrhythmia (<2%), cardiac failure (<2%), facial edema (<2%), hypertension (<2%), hypotension (<2%), myocardial infarction (<2%), palpitations (<2%), paresthesia (<2%), syncope (<2%), tachycardia (<2%), vasculitis (<2%)

Central nervous system: Pain (≤5%), headache (2% to 4%), dizziness (1% to 4%), insomnia (≤4%), falling (1% to 3%), abnormal dreams (<2%), anxiety (<2%), confusion (<2%), convulsions (<2%), depression (<2%), drowsiness (<2%), fatigue (<2%), malaise (<2%), nervousness (<2%), vertigo (<2%)

Dermatologic: Skin rash (≤3%), pruritus (≤2%), bullous rash (<2%), diaphoresis (<2%), skin photosensitivity (<2%), urticaria (<2%)

Endocrine & metabolic: Albuminuria (<2%), dehydration (<2%), hot flash (<2%), increased gamma-glutamyl transferase (<2%), weight gain (<2%), weight loss (<2%)

Gastrointestinal: Dyspepsia (4% to 10%), diarrhea (2% to 8%), nausea (2% to 7%), abdominal pain (2% to 5%), constipation (≤3%), flatulence (≤3%), vomiting (≤3%), aphthous stomatitis (<2%), colitis (<2%), duodenal ulcer (<2%), dysgeusia (<2%), eructation (<2%), esophagitis (<2%), gastrointestinal perforation (<2%; including duodenal, gastric), gastric ulcer (<2%), gastritis (<2%), gastroesophageal reflux disease (<2%), gastrointestinal hemorrhage (<2%), hematemesis (<2%), increased appetite (<2%), intestinal perforation (<2%), melena (<2%), pancreatitis (<2%), xerostomia (<2%)

Genitourinary: Urinary tract infection (≤7%), urinary frequency (≤2%), hematuria (<2%)

Hematologic & oncologic: Anemia (≤4%), leukopenia (<2%), purpura (<2%), thrombocytopenia (<2%)

Hepatic: Hepatitis (<2%), hyperbilirubinemia (<2%), increased serum ALT (<2%), increased serum AST (<2%)

Hypersensitivity: Angioedema (<2%), hypersensitivity reaction (<2%)

Neuromuscular & skeletal: Arthralgia (≤5%), back pain (≤3%), tremor (<2%)

Ophthalmic: Conjunctivitis (<2%), visual disturbance (<2%)

Otic: Tinnitus (<2%)

Renal: Increased blood urea nitrogen (<2%), increased serum creatinine (<2%), renal failure (<2%)

Respiratory: Upper respiratory tract infection (≤8%), flu-like symptoms (3% to 6%), pharyngitis (3%), cough (≤2%), asthma (<2%)

Miscellaneous: Fever (<2%)

<1%, postmarketing, and/or case reports: Acute urinary retention, agranulocytosis, alopecia, anaphylactoid reaction, anaphylaxis, bronchospasm, dyspnea, erythema multiforme, exfoliative dermatitis, hepatic failure, hepatotoxicity (idiosyncratic) (Chalasani 2014), interstitial nephritis, jaundice, mood changes, renal insufficiency, renal papillary necrosis, shock, Stevens-Johnson syndrome, toxic epidermal necrolysis

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2C9 (major), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

5-Aminosalicylic Acid Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of 5-Aminosalicylic Acid Derivatives. Risk C: Monitor therapy

Acemetacin: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Risk C: Monitor therapy

Alcohol (Ethyl): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of GI bleeding may be increased with this combination. Risk C: Monitor therapy

Aliskiren: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Aliskiren. Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Aliskiren. Management: Monitor renal function periodically in patients receiving aliskiren and any nonsteroidal anti-inflammatory agent. Patients at elevated risk of renal dysfunction include those who are elderly, are volume depleted, or have pre-existing renal dysfunction. Risk C: Monitor therapy

Aminoglycosides: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of Aminoglycosides. Data only in premature infants. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Angiotensin II Receptor Blockers: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Anticoagulants: Nonsteroidal Anti-Inflammatory Agents may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Apixaban: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Apixaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of apixaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Beta-Blockers. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Nonsteroidal Anti-Inflammatory Agents. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Both an increased risk of gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern. Risk C: Monitor therapy

Calcium Polystyrene Sulfonate: Meloxicam may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. More specifically, concomitant use of meloxicam oral suspension (which contains sorbitol) may increase the risk for intestinal necrosis. Risk X: Avoid combination

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Risk C: Monitor therapy

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

CycloSPORINE (Systemic): Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider alternatives to nonsteroidal anti-inflammatory agents (NSAIDs). Monitor for evidence of nephrotoxicity, as well as increased serum cyclosporine concentrations and systemic effects (eg, hypertension) during concomitant therapy with NSAIDs. Risk D: Consider therapy modification

CYP2C9 Inducers (Moderate): May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP2C9 Inhibitors (Moderate): May decrease the metabolism of CYP2C9 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Dabigatran Etexilate: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Dabigatran Etexilate. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of dabigatran and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C9 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Deferasirox: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Risk C: Monitor therapy

Desmopressin: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy

Dexibuprofen: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Dexibuprofen. Risk X: Avoid combination

Dexketoprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Diclofenac (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Management: Seek alternatives to the combined use of diclofenac with other nonsteroidal anti-inflammatory agents (NSAIDs). Avoid the use of diclofenac/misoprostol with other NSAIDs. Risk D: Consider therapy modification

Digoxin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Digoxin. Risk C: Monitor therapy

Drospirenone: Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Drospirenone. Risk C: Monitor therapy

Edoxaban: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of edoxaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP2C9 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C9 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Eplerenone: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Eplerenone. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Eplerenone. Risk C: Monitor therapy

Fat Emulsion (Fish Oil Based): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Felbinac: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Floctafenine: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Haloperidol: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Haloperidol. Specifically including drowsiness and confusion. Risk C: Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Risk D: Consider therapy modification

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Bleeding may occur. Management: Concomitant treatment with these agents should generally be avoided. If used concomitantly, increased diligence in monitoring for adverse effects (eg, bleeding, bruising, altered mental status due to CNS bleeds) must be employed. Risk D: Consider therapy modification

HydrALAZINE: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of HydrALAZINE. Risk C: Monitor therapy

Ibritumomab Tiuxetan: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Inotersen: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Itraconazole: May decrease the serum concentration of Meloxicam. Risk C: Monitor therapy

Ketorolac (Nasal): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Ketorolac (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Lithium: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Lithium. Risk D: Consider therapy modification

Loop Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the diuretic effect of Loop Diuretics. Loop Diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Management: Monitor for evidence of kidney injury or decreased therapeutic effects of loop diuretics with concurrent use of an NSAID. Consider avoiding concurrent use in CHF or cirrhosis. Concomitant use of bumetanide with indomethacin is not recommended. Risk D: Consider therapy modification

Lumacaftor: May decrease the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor may increase the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor therapy

Macimorelin: Nonsteroidal Anti-Inflammatory Agents may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Methotrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Methotrexate. Management: Alternative anti-inflammatory therapy should be considered whenever possible, especially if the patient is receiving higher, antineoplastic doses of methotrexate. Risk D: Consider therapy modification

Mifamurtide: Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Mifamurtide. Risk X: Avoid combination

MiFEPRIStone: May increase the serum concentration of CYP2C9 Substrates (High risk with Inhibitors). Management: Use CYP2C9 substrates at the lowest recommended dose, and monitor closely for adverse effects, during and in the 2 weeks following mifepristone treatment. Risk D: Consider therapy modification

Morniflumate: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Naftazone: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk X: Avoid combination

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased.Risk C: Monitor therapy

Omacetaxine: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of nonsteroidal antiinflammatory drugs (NSAIDs) with omacetaxine in patients with a platelet count of less than 50,000/uL. Risk X: Avoid combination

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Pelubiprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Risk C: Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Phenylbutazone: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Potassium-Sparing Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Potassium-Sparing Diuretics. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

PRALAtrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of PRALAtrexate. More specifically, NSAIDS may decrease the renal excretion of pralatrexate. Management: Closely monitor for increased pralatrexate serum levels and/or toxicity if used concomitantly with an NSAID. Monitor for decreased pralatrexate serum levels with NSAID discontinuation. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Quinolones: Nonsteroidal Anti-Inflammatory Agents may enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Risk C: Monitor therapy

Rifapentine: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

Rivaroxaban: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Rivaroxaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of rivaroxaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Salicylates: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination. Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Exceptions: Choline Magnesium Trisalicylate. Risk D: Consider therapy modification

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Management: Consider using alternative analgesics, when appropriate, and/or addition of a gastroprotective agent. Monitor patients closely for signs/symptoms of bleeding, and for evidence of diminished SSRI effectiveness with concurrent use. Risk D: Consider therapy modification

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Sodium Phosphates: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of acute phosphate nephropathy may be enhanced. Management: Consider avoiding this combination by temporarily suspending treatment with NSAIDs, or seeking alternatives to oral sodium phosphate bowel preparation. If the combination cannot be avoided, maintain adequate hydration and monitor renal function closely. Risk D: Consider therapy modification

Sodium Polystyrene Sulfonate: Meloxicam may enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of meloxicam oral suspension (which contains sorbitol) may increase the risk for intestinal necrosis. Risk X: Avoid combination

Tacrolimus (Systemic): Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

Talniflumate: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Tenofovir Products: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. Risk D: Consider therapy modification

Tenoxicam: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Tolperisone: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Tolperisone. Specifically, the risk of hypersensitivity reactions may be increased. Tolperisone may enhance the therapeutic effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Tricyclic Antidepressants (Tertiary Amine): May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Risk X: Avoid combination

Vancomycin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Vancomycin. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification

Voriconazole: May increase the serum concentration of Meloxicam. Risk C: Monitor therapy

Zaltoprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Test Interactions

May lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016)

Monitoring Parameters

Complete blood cell count (CBC) and chemistry profile; occult blood loss, and periodic liver function tests; renal function (urine output, serum BUN and creatinine); signs or symptoms of GI bleeding; blood pressure; periodic ophthalmologic exam with long term therapy.

Advanced Practitioners Physical Assessment/Monitoring

Evaluate cardiac risk and potential for GI bleeding prior to prescribing this medication. Monitor blood pressure at the beginning of therapy and periodically during use.

Nursing Physical Assessment/Monitoring

Monitor blood pressure at the beginning of therapy and periodically during use. Monitor for gastrointestinal effects and ototoxicity at beginning of therapy and periodically throughout.

Product Availability

Qmiiz ODT (meloxicam orally disintegrating tablet): FDA approved October 2018; anticipated availability is currently unknown. Information pertaining to this product within the monograph is pending revision. Consult the prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Vivlodex: 5 mg, 10 mg [contains fd&c blue #2 (indigotine), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Suspension, Oral:

Mobic: 7.5 mg/5 mL (100 mL [DSC]) [contains saccharin sodium, sodium benzoate; raspberry flavor]

Generic: 7.5 mg/5 mL (100 mL [DSC])

Tablet, Oral:

Mobic: 7.5 mg, 15 mg

Generic: 7.5 mg, 15 mg, 15 mg

Tablet Disintegrating, Oral:

Qmiiz ODT: 7.5 mg, 15 mg [contains aspartame]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Mobicox: 7.5 mg [DSC], 15 mg [DSC]

Generic: 7.5 mg, 15 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • M01AC06
Generic Available (US)

May be product dependent

Pricing: US

Capsules (Vivlodex Oral)

5 mg (per each): $31.39

10 mg (per each): $31.39

Tablets (Meloxicam Oral)

7.5 mg (per each): $0.17 – $3.17

15 mg (per each): $4.26 – $4.85

Tablets (Mobic Oral)

7.5 mg (per each): $10.13

15 mg (per each): $15.48

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties

Other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.

Pharmacodynamics/Kinetics

Distribution:

Children 2 to 6 years (n=7): Apparent Vd: 0.19 L/kg (Burgos-Vargas 2004)

Children and Adolescents 7 to 16 years (n=11): Apparent Vd: 0.13 L/kg (Burgos-Vargas 2004)

Adults: Vdss~10 L

Protein binding: ~99%, primarily to albumin; Note: Free fraction was higher in adult patients with renal failure who were receiving chronic dialysis.

Metabolism: Hepatic via CYP2C9 and CYP3A4 (minor); forms 4 metabolites (inactive)

Bioavailability: 89% (capsule); suspension is bioequivalent to tablets

Half-life elimination:

Children 2 to 6 years (n=7): 13.4 hours (Burgos-Vargas 2004)

Children and Adolescents 7 to 16 years (n=11): 12.7 hours (Burgos-Vargas 2004)

Adults: ~15 to 22 hours

Time to peak:

Children and Adolescents 2 to 16 years (n=18): Suspension: Initial: 1 to 3 hours; secondary: 6 to 12 hours (Burgos-Vargas 2004)

Adults: Initial: Within 2 hours (capsule); 4 to 5 hours (tablet); Secondary: ~8 hours (capsule); 12 to 14 hours (tablet)

Excretion: Urine and feces (as inactive metabolites); <1% excreted unchanged in urine

Clearance:

Children 2 to 6 years (n=7): 0.17 mL/minute/kg (Burgos-Vargas 2004)

Children and Adolescents 7 to 16 years (n=11): 0.12 mL/minute/kg (Burgos-Vargas 2004)

Adults: 7 to 9 mL/minute

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Meloxicam plasma concentration is decreased and total clearance increased in patients with renal impairment.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Taste perversion, ulcerative stomatitis, and xerostomia (normal salivary flow resumes upon discontinuation). The dentist should be aware of the potential of abnormal coagulation. Caution should also be exercised in the use of NSAIDs in patients already on anticoagulant therapy with drugs such as warfarin (Coumadin®). See Effects on Bleeding.

Effects on Bleeding

Nonselective NSAIDs such as meloxicam inhibit platelet aggregation and prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible.

Index Terms

Qmiiz ODT

FDA Approval Date
April 14, 2000
References

American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi:10.1111/jgs.13702.[PubMed 26446832]

Becker MA. Treatment of gout flares. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 6, 2018.

Bell AD, Roussin A, Cartier R, et al, “The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” Can J Cardiol, 2011, 27(Suppl A):1-59.[PubMed 21640290]

Bermas BL. Non-steroidal anti inflammatory drugs, glucocorticoids and disease modifying anti-rheumatic drugs for the management of rheumatoid arthritis before and during pregnancy. Curr Opin Rheumatol. 2014;26(3):334-340. doi: 10.1097/BOR.0000000000000054.[PubMed 24663106]10.1097/BOR.0000000000000054

Bhatt DL, Scheiman J, Abraham NS, et al, “ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risk of Antiplatelet Therapy and NSAID Use. A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents,” J Am Coll Cardiol, 2008, 52(18):1502-17.[PubMed 19017521]

Bloor M, Paech M. Nonsteroidal anti-inflammatory drugs during pregnancy and the initiation of lactation. Anesth Analg. 2013;116(5):1063-1075. doi: 10.1213/ANE.0b013e31828a4b54.[PubMed 23558845]10.1213/ANE.0b013e31828a4b54

Burgos-Vargas R, Foeldvari I, Thon A, et al. Pharmacokinetics of meloxicam in patients with juvenile rheumatoid arthritis,” J Clin Pharmacol. 2004;44(8):866-872.[PubMed 15286090]

Chalasani NP, Hayashi PH, Bonkovsky HL, et al. ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury. Am J Gastroenterol. 2014;109(7):950-966.[PubMed 24935270]

Cheng TT, Lai HM, Chiu CK, et al. A single-blind, randomized, controlled trial to assess the efficacy and tolerability of rofecoxib, diclofenac sodium, and meloxicam in patients with acute gouty arthritis. Clin Ther. 2004;26(3):399-406.[PubMed 15110132]

Ferraris VA, Saha SP, Oestreich JH, et al, “2012 Update to the Society of Thoracic Surgeons Guideline on Use of Antiplatelet Drugs in Patients Having Cardiac and Noncardiac Operations,” Ann Thorac Surg, 2012, 94(5):1761-81.[PubMed 23098967]

Funder JW, Carey RM, Mantero F, et al. The management of primary aldosteronism: case detection, diagnosis, and treatment: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016;101(5):1889-1916. doi: 10.1210/jc.2015-4061.[PubMed 26934393]

Hochberg MC, Altman RD, April KT, et al, “American College of Rheumatology 2012 Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” Arthritis Care Res (Hoboken), 2012, 64(4):465-74.[PubMed 22563589]

KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2013;3(1):i-150.

Khanna D, Khanna PP, Fitzgerald JD, et al; American College of Rheumatology. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012;64(10):1447-1461. doi: 10.1002/acr.21773.[PubMed 23024029]

Mobic (meloxicam) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim; October 2018.

Mobicox (meloxicam) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd; November 2014.

Montgomery A, Hale TW; Academy Of Breastfeeding Medicine. ABM clinical protocol #15: analgesia and anesthesia for the breastfeeding mother, revised 2012. Breastfeed Med. 2012;7(6):547-553.[PubMed 23215911]

Morgan TO, Anderson A, and Bertram D, “Effect of Indomethacin on Blood Pressure in Elderly People With Essential Hypertension Well Controlled on Amlodipine or Enalapril,” Am J Hypertens, 2000, 13(11):1161-7.[PubMed 11078175]

Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain. 7th ed. Glenview, IL: American Pain Society; 2016.

Saavedra Salinas MÁ, Barrera Cruz A, Cabral Castañeda AR, et al. Clinical practice guidelines for the management of pregnancy in women with autoimmune rheumatic diseases of the Mexican College of Rheumatology. Part II. Reumatol Clin. 2015;11(5):305-315.[PubMed 25683368]

Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014;26(3):354-360. doi: 10.1097/BOR.0000000000000055.[PubMed 24614280]10.1097/BOR.0000000000000055

Strate LL, Gralnek IM. ACG clinical guideline: management of patients with acute lower gastrointestinal bleeding. Am J Gastroenterol. 2016;111(4):459-474. doi: 10.1038/ajg.2016.41.[PubMed 26925883]

Vivlodex (meloxicam) [prescribing information]. Philadelphia, PA: Iroko Pharmaceuticals LLC; October 2015.

Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128(16):e240-e327.[PubMed 23741058]

Brand Names: International

Acticam (CR, DO, GT, HN, NI, PA, SV); Aflamid (MX); Afloxx (PE); Areloger (IE); Aroxicam (ET); Arrox (HK, MY); Artriclox (CO); Aspicam (UA); Atrocox (ID); Avegesic (MY); Bexxam (PH); Bienex (CR, DO, EC, GT, HN, NI, PA, SV); Cambic-15 (TH); Camrox (KR); Caxlem (PH); Cloxim (PH); Coxicam (EC, QA); Dormelox (BR); Ecax (CL); Exel (MX); Flamoxi (ID); Flexicam (AE, ET); Flodin (PE); Friart (ID); Hyflex (PY); Ilacox (CR, DO, GT, HN, NI, PA, SV); Koniflam (ID); Letex (PY); Loxaid (PH); Loxibest (MX); Loxicam (JO); Loxikam (BD); Loxil (ID); M-Cam (TZ); Mebilax (VN); Mecaron (KR); Mecasel (VN); Mecon (TW); Mecox (ID); Medoxicam (AE); Mel-OD (IN, MY, TH); Melart (PH); Melcam (BD, HK, IE, TH); Melcox (KR); Melflam (HK); Meliam (HR); Melicam (TW); Melocam (AE, CO, CY, EG, IL, IQ, IR, JO, KR, KW, LY, MY, OM, SA, SY, YE); Melocid (MT); Melocox (KR, PH); Melodyn (AT); Meloflam (PH, VN); Melonax (ET); Melosteral (MX); Melox (AE, BH, CY, IL, IQ, IR, JO, KR, KW, LV, LY, MT, MY, OM, QA, RO, SA, SG, SY, TH, TW, YE); Meloxibell (AU); Meloxin (ID); Memovic (KR); Merapiran (AR); Mevamox (BR); Mexicam (EG); Mexolan (LV); Mexpharm (ID); Mexx (PH); Miloxam (AE, CY, IL, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Miovalis (AU); Mobec (DE); Mobex (KR); Mobic (AE, AR, AU, BB, BE, BF, BH, BJ, BM, BS, BZ, CI, CN, CO, CY, DK, EC, EG, ET, FI, FR, GB, GH, GM, GN, GY, HK, IE, IL, IQ, IR, IT, JM, JO, KE, KR, KW, LB, LR, LU, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, NZ, OM, PE, PH, PY, QA, SA, SC, SD, SE, SG, SL, SN, SR, SY, TH, TN, TR, TT, TW, TZ, UG, UY, VE, VN, YE, ZA, ZM, ZW); Mobicox (CH, CR, CU, DO, GT, HN, MX, NI, PA, SV); Mobiflex (ID); Mobiglan (IE); Mobitil (ET); Mobix (PK); Moov (VN); Mopik (TW); Motion (LB); Movalis (BG, CZ, EE, ES, HR, IS, LT, LV, PL, PT, RO, RU, SI, SK, UA); Moven (BH, LB, QA); Movi-Cox (ID); Moxalid (GR); Moxicam (AU, KR); Muvera (IN); Muvik (LK); Neoxicam (BH, QA); Nulox (ID, SG); Nulox Forte (ID); Ostelox (ID, LK); Osteoflam (PH); Oxichem (LK); Oximal (LB); Parocin (ES); Paxicam (ID); Quicktra (HR); Rafree (PH); Recoxa (LV); Selektine (LB, SA); Troxicam (KR); Xiarax (EC); Xobix (LK); Zeloxim (ET)

Meloxicam (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(mel OKS i kam)

Brand Names: US

Mobic; Qmiiz ODT; Vivlodex

Brand Names: Canada

Mobicox

Warning
  • This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if you have heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not use this drug right before or after bypass heart surgery.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
What is this drug used for?
  • It is used to treat arthritis.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • All products:
  • If you have an allergy to meloxicam or any other part of this drug.
  • If you have an allergy to aspirin or NSAIDs.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
  • If you have had a recent heart attack.
  • If you are having trouble getting pregnant or you are having your fertility checked.
  • If you are pregnant or may be pregnant. Do not take this drug if you are in the third trimester of pregnancy. You may also need to avoid this drug at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this drug during pregnancy.
  • If you are taking any other NSAID.
  • If you are taking a salicylate drug like aspirin.
  • If you are taking pemetrexed.
  • If the patient is a child who weighs less than 132 pounds (60 kilograms).
  • Suspension:
  • If you are taking sodium polystyrene sulfonate.
  • Oral-disintegrating tablet:
  • If you have phenylketonuria (PKU). This drug has phenylalanine in it.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • If you have asthma, talk with your doctor. You may be more sensitive to this drug.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If you are taking aspirin to help prevent a heart attack, talk with your doctor.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug may affect being able to father a child. Talk with the doctor.
  • NSAIDs like this drug may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when this drug is stopped. Talk with your doctor.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • 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 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 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.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling very tired or weak.
  • Very bad belly pain.
  • Flu-like signs.
  • 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.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Constipation.
  • Gas.
  • Dizziness.
  • Signs of a common cold.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this drug for longer than you were told by your doctor.
  • Suspension:
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Oral-disintegrating tablet:
  • Do not take this drug out of the blister pack until you are ready to take it. Take this drug right away after opening the blister pack. Do not store the removed drug for future use.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it dissolve. Water is not needed. Do not chew, break, or crush the tablet.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Capsules, tablets, and suspension:
  • Keep lid tightly closed.
  • Capsules:
  • Store in original container.
  • Oral-disintegrating tablet:
  • Protect from heat.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Meloxicam (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(mel OKS i kam)

Brand Names: US

Mobic; Qmiiz ODT; Vivlodex

Brand Names: Canada

Mobicox

Warning
  • This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if your child has heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not give this drug to your child right before or after bypass heart surgery.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
What is this drug used for?
  • It is used to treat arthritis.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child has an allergy to aspirin or NSAIDs.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has kidney disease.
  • If your child has GI (gastrointestinal) bleeding.
  • If your child has had a recent heart attack.
  • If your child is having her fertility checked.
  • If your child is taking any other NSAID.
  • If your child is taking a salicylate drug like aspirin.
  • If your child is taking pemetrexed.
  • If the patient is a child who weighs less than 132 pounds (60 kilograms).
  • If your child is pregnant:
  • Do not give this drug to your child if she is in the third trimester of pregnancy. You may also need to avoid giving this drug to your child at other times during pregnancy. Talk with your child’s doctor to see when you need to avoid giving this drug to your child during pregnancy.
  • Suspension:
  • If your child is taking sodium polystyrene sulfonate.
  • Oral-disintegrating tablet:
  • If your child has phenylketonuria (PKU). This drug has phenylalanine in it.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • High blood pressure has happened with drugs like this one. Have your child’s blood pressure checked as you have been told by the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child smokes, talk with the doctor.
  • Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
  • Do not have your child use longer than you have been told by your child’s doctor.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • If your child has asthma, talk with the doctor. He/she may be more sensitive to this drug.
  • Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If your child is taking aspirin to help prevent a heart attack, talk with the doctor.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • If your child is or may be sexually active:
  • This drug may affect being able to father a child. Talk with the doctor.
  • NSAIDs like this drug may affect egg release (ovulation) in females. This may affect being able to get pregnant. This goes back to normal when this drug is stopped. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • 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 child’s doctor or get medical help right away if your child has 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • 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 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 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.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling very tired or weak.
  • Very bad belly pain.
  • Flu-like signs.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • 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 your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Headache.
  • Constipation.
  • Gas.
  • Dizziness.
  • Signs of a common cold.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Suspension:
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Oral-disintegrating tablet:
  • Do not take this drug out of the blister pack until you are ready to give this drug to your child. Give this drug right away after opening the blister pack. Do not store the removed drug for future use.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your child’s tongue and have your child let it dissolve. Water is not needed. Do not let your child chew, break, or crush it.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Capsules, tablets, and suspension:
  • Keep lid tightly closed.
  • Capsules:
  • Store in original container.
  • Oral-disintegrating tablet:
  • Protect from heat.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.