Indicated for:

Osteoarthritis (OA):

• For the relief of the signs and symptoms of osteoarthritis.

Rheumatoid Arthritis (RA):

• For relief of the signs and symptoms of rheumatoid arthritis.

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course:

• For relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg.

MOBIC tablets should not be used in children who weigh <60 kg.

In adults, the maximum recommended daily oral dose of MOBIC is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended.

In patients on hemodialysis, the maximum dosage of MOBIC is 7.5 mg per day.

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

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Strategies to Minimize the GI Risks in NSAID-treated patients:

• Use the lowest effective dosage for the shortest possible duration
• Avoid administration of more than one NSAID at a time
• Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs
• Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy
• If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue MOBIC until a serious GI adverse event is ruled out
• In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding

MOBIC is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery and in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

Avoid the use of MOBIC in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If MOBIC is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Avoid the use of MOBIC in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.

The use of MOBIC in subjects with severe renal impairment is not recommended.

Long-term administration of NSAIDs, including MOBIC, has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury.

Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.

Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.

NSAIDs, including MOBIC, can lead to new onset or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs.

NSAIDs, including meloxicam, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as MOBIC. Some of these events have been fatal or life-threatening.

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.

A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, MOBIC is contraindicated in patients with this form of aspirin sensitivity.

The concurrent use of aspirin and an NSAID, such as meloxicam, increases the risk of serious gastrointestinal (GI) events

NSAIDs, including MOBIC, may increase the risk of bleeding events. Comorbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).

NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

During concomitant use of MOBIC and lithium, monitor patients for signs of lithium toxicity.

Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).

Concomitant use of MOBIC and cyclosporine may increase cyclosporine nephrotoxicity.

Concomitant use of meloxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.

Concomitant use of MOBIC and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Patients taking meloxicam should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. In patients with creatinine clearance below 45 mL/min, the concomitant administration of meloxicam with pemetrexed is not recommended.

NSAIDs are associated with reversible infertility. Consider withdrawal of MOBIC in women who have difficulties conceiving. 

Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.There are no adequate and well-controlled studies of MOBIC in pregnant women. Data from observational studies regarding potential embryo-fetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors, such as meloxicam, resulted in increased pre- and post-implantation loss.

There are no human data available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production. Meloxicam was present in the milk of lactating rats at concentrations higher than those in plasma.

GoToSource

• Use in patients under the age of 2. GoToSource

• Gout. GoToSource

• Lupus. GoToSource

• Alzheimer’s disease. GoToSource 

• Adjunctive therapy for pollinosis. GoToSource

• Primary dysmenorrhea. GoToSource

• Preemptive treatment for postoperative pain relief after abdominal hysterectomy. GoToSource

• Use with tamsulosin hydrochloride for benign prostatic hyperplasia symptoms. GoToSource 

• Decrease risk of squamous cell carcinoma and malignant melanoma. GoToSource 

• Adjunctive therapy for prostate cancer. GoToSource 

Acute myocardial infarction, angina, stroke and transient ischaemic attack. GoToSource

Small bowel mucosal injuries (bleeding, ulcers and erosions). GoToSource

Rhabdomyolysis (breakdown of muscle tissue). GoToSource

Stevens-johnson syndrome and toxic epidermal necrolysis (severe skin disorder). GoToSource 

Worsening of hypertension and preexisting cardiac failure, hyperkalemia (high potassium levels), acute kidney injury and papillary necrosis (kidney disorder). GoToSource 

Hyponatremia (low sodium level). GoToSource 

Acute generalized exanthematous pustulosis (skin eruption). GoToSource 

Acute colitis. GoToSource 

Reversible delay in ovulation. GoToSource

Lawsuits filed for heart attacks, strokes, heart failure, kidney failure, bleeding ulcers, life-threatening skin reactions, liver failure and asthma attacks.