Mobic

Meloxicam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• gas
• sore throat

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately. Do not take any more meloxicam until you speak to your doctor:

• fever
• blisters
• rash
• skin blisters or peeling
• hives
• itching
• swelling of the eyes, face, tongue, lips, or throat
• difficulty breathing or swallowing
• hoarseness
• pale skin
• fast heartbeat
• shortness of breath or difficulty breathing
• unexplained weight gain,
• swelling in the abdomen, ankles, feet, or legs
• nausea
• excessive tiredness
• lack of energy
• yellowing of the skin or eyes
• pain in the right upper part of the stomach
• flu-like symptoms
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination

Meloxicam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Yes

: Meloxicam may increase the blood levels of lithium (Eskalith, Lithobid) by reducing the excretion of lithium by the kidneys. Increased levels of lithium may lead to lithium toxicity.

Meloxicam may reduce the blood pressure-lowering effects of drugs given to reduce blood pressure. This may occur because prostaglandins play a role in the regulation of blood pressure.

When meloxicam is used in combination with methotrexate (Rheumatrex, Trexall) or aminoglycosides (for example, gentamicin) the blood levels of the methotrexate or aminoglycoside may increase, presumably because their elimination from the body is reduced. This may lead to more methotrexate or aminoglycoside-related side effects.

Meloxicam increases the negative effect of cyclosporine on kidney function and reduces the effect of furosemide (Lasix) and thiazide diuretics because of prostaglandin inhibition.

Individuals taking oral blood thinners, for example, warfarin (Coumadin), should avoid meloxicam because meloxicam also thins the blood, and excessive blood thinning may lead to bleeding.

Meloxicam should be avoided by patients with a history of asthma attacks, hives, or other allergic reactions to aspirin or other NSAIDs. If aspirin is taken with meloxicam there may be an increased risk for developing a gastrointestinal ulcer.

Persons who have more than three alcoholic beverages per day may be at increased risk of developing stomach ulcers when taking meloxicam or other NSAIDs.

Cholestyramine (Questran), colestipol (Colestid), and colesevelam (Welchol) may decrease the effectiveness of meloxicam by preventing its absorption from the intestine.

Meloxicam oral suspension contains sorbitol. Combining sodium polystyrene sulfonate (Kayexalate) with sorbitol may cause fatal intestinal necrosis. Therefore, meloxicam oral solution should not be combined with Kayexalate.

Osteoarthritis (OA)

MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies].

Rheumatoid Arthritis (RA)

MOBIC is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies].

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular And Polyarticular Course

MOBIC is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥ 60 kg [see DOSAGE AND ADMINISTRATION and Clinical Studies].

Dosage Forms And Strengths

• 7.5 mg: pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg. Impressed with the Boehringer Ingelheim logo on one side and the letter “M” on the other.
• 15 mg: pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. Impressed with the tablet code “15” on one side and the letter “M” on the other.

Storage And Handling

MOBIC is available as a pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg or as a pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. The 7.5 mg tablet is impressed with the Boehringer Ingelheim logo on one side, and on the other side, the letter “M”. The 15 mg tablet is impressed with the tablet code “15” on one side and the letter “M” on the other.

MOBIC (meloxicam) tablets 7.5 mg: NDC 0597-0029-01; Bottles of 100
MOBIC (meloxicam) tablets 15 mg: NDC 0597-0030-01; Bottles of 100

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep MOBIC tablets in a dry place.

Dispense tablets in a tight container.

Keep this and all medications out of the reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: May 2016

Since meloxicam is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Serious side effects have been reported with Mobic including:

• Cardiovascular thrombotic events. Mobic can increase your risk of cardiovascular and heart diseases such as strokes and myocardial infarctions, which can lead to death. Tell your doctor if you have a history of heart disease.
• Gastrointestinal effects. Mobic can cause digestive tract problems such as ulcers, bleeding, inflammation, and perforations (small holes). Tell your doctor if you have a history of digestive problems, or if you smoke or frequently drink alcohol. Alert your doctor if you take anticoagulants (blood-thinners) or corticosteroids such as prednisone.
• Hepatic events. Mobic c­­an cause damage to the liver and increase liver tests. Tell your doctor if you have a history of liver disease.
• Hypertension. Mobic may raise your blood pressure. Tell your doctor if you have a history of high blood pressure or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Congestive heart failure and edema. Mobic can increase the chance of congestive heart failure, fluid retention, and weight gain.
• Renal effects. Kidney damage can result from the use of Mobic. Tell your doctor if you have a history of kidney disease or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Hypersensitivity reaction. An allergic reaction to Mobic can occur. Symptoms of a hypersensitivity reaction include:
  • hives
  • rash
  • difficulty breathing or swallowing
  • itching
  • swelling
• Adverse skin reactions. Mobic can lead to dangerous skin reactions. Symptoms of a skin reaction include:
  • rash
  • red, itchy, or scaly skin
  • blisters
  • fever
• Pregnancy. Mobic should not be taken past the 30th week of pregnancy.

Mobic can cause dizziness. Do not drive or operate heavy machinery until you know how Mobic affects you.

Do not take Mobic if you:

• are allergic to Mobic
• will have or have recently had coronary (heart) surgery

Take Mobic exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your doctor will prescribe the appropriate dose of Mobic depending on the severity of your arthritis and your response to the medication. The dosage range of Mobic is between 7.5 and 15 mg per day for adults. The maximum daily dose of Mobic is 15 mg for adults.

For the treatment of children over two years old with juvenile rheumatoid arthritis, the child’s body weight will determine the dosage of the medication. The maximum daily dose in children is 7.5 mg.

Contraindications

• Known hypersensitivity to meloxicam or any ingredient in the formulation.1

• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.1

• In the setting of CABG surgery.508

Warnings/Precautions

Warnings

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.500 502 508

Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information500 501 502 indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.500

Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.500 502 506 508

Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.500 502 505 506 508

In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.508

In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.505 508

Increased 1-year mortality rate observed in patients receiving NSAIAs following MI;500 508 511 absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.508 511

Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs.26 27 28 30 500 501 502 503 506 FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.500

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.1 500 508

Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease.505 511 512 516 Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia.508 Contraindicated in the setting of CABG surgery.508

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.1 502 508 (See Specific Drugs under Interactions.)

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.1

Lower incidence of adverse GI effects compared with other prototypical NSAIAs (e.g., diclofenac, naproxen, piroxicam) in some studies.16 17

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.1 Use with caution in patients with hypertension; monitor BP.1

Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur.1 508 (See Specific Drugs under Interactions.)

Fluid retention and edema reported.1 508

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.500 501 504 507 508

NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema.508 (See Specific Drugs under Interactions.)

Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.508

Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.507

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.1

Potential for overt renal decompensation.1 Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in patients with volume depletion, in geriatric patients, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.1 20 29 (See Renal Impairment under Cautions.)

Correct dehydration before initiating meloxicam therapy.1

Sensitivity Reactions

Anaphylactoid reactions reported.1

Immediate medical intervention and discontinuance for anaphylaxis.1

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.1

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.1 Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).1

General Precautions

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.1

Elevations of serum ALT or AST reported.1

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.1 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.1

Anemia reported rarely.1 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.1

Notable effects on platelets or bleeding times not observed.3 8 9

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.1

May mask certain signs of infection.1

Obtain CBC and chemistry profile periodically during long-term use.1

Specific Populations

Category C.1 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.1

Distributed into milk in rats; not known whether distributed into milk in humans.1 Discontinue nursing or the drug.1

Safety and efficacy not established in children <2 years of age.1

Safety and efficacy in pediatric patients 2–17 years of age with juvenile rheumatoid arthritis supported by evidence from controlled studies.1 23

Abdominal pain, vomiting, diarrhea, headache, and pyrexia reported more frequently in children than adults.1

Caution advised.1 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.1

Not studied in patients with severe hepatic impairment (Child-Pugh class III).1

Use with caution in renal disease.1 Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.1

Common Adverse Effects

Abdominal pain, diarrhea, dizziness, dyspepsia, edema, flatulence, headache, nausea, rash, upper respiratory tract infection, influenza-like illness, musculoskeletal and connective tissue signs and symptoms (back pain, muscle spasms, musculoskeletal pain).1

Metabolized by CYP isoenzymes, mainly by CYP2C9 and to a lesser extent by CYP3A4.1

Specific Drugs

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5- and 2.6-times, respectively, the maximum recommended human dose [MRHD] of 15 mg/day Mobic based on body surface area [BSA] comparison).

Mutagenesis

Meloxicam was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.

Impairment of Fertility

Meloxicam did not impair male and female fertility in rats at oral doses up to 9 mg/kg/day in males and 5 mg/kg/day in females (up to 5.8- and 3.2-times greater, respectively, than the MRHD based on BSA comparison).

Mobic is available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.

Mobic (meloxicam) oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mL

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep oral suspension container tightly closed.

Keep this and all medications out of the reach of children.

Mobic can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Mobic may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Mobic, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Medicines similar to meloxicam are contained in many combination medicines. Check the label to see if a medicine contains an NSAID (non-steroidal anti-inflammatory drug) such as aspirin, ibuprofen, ketoprofen, or naproxen.

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

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Mobic may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Mobic, especially in older adults.

You should not use Mobic if you are allergic to meloxicam, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Mobic is safe for you, tell your doctor if you have:

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

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

• a history of stomach ulcers or bleeding;

• asthma;

• kidney disease (or if you are on dialysis);

• liver disease; or

• fluid retention.

Taking Mobic during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Mobic may cause a delay in ovulation (the release of an egg from an ovary). You should not take Mobic if you are undergoing fertility treatment, or are otherwise trying to get pregnant.

Meloxicam can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Mobic is not approved for use by anyone younger than 2 years old.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking Mobic.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to Mobic. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

More frequent side effects include: abdominal pain, anemia, and edema. See below for a comprehensive list of adverse effects.