Composition:

Each tablet contains 7.5 or 15mg Meloxicam.

Mechanism of action:

• Meloxicam has analgesic, anti-inflammatory, and antipyretic properties.
• The mechanism of action like that of other NSAIDs, involves inhibition of cyclooxygenase (COX-1 and COX-2).
• meloxicam is an inhibitor of prostaglandin synthesis (mediators of inflammation).

Pharmacokinetics:

• Meloxicam is well absorbed from the gastrointestinal tract; mean maximum plasma concentration is achieved within 5-6 hours. Extent of absorption for Meloxicam following oral administration is not altered by concomitant food intake.
• Distribution : Meloxicam is 99.4% bound to human plasma proteins (primarily albumin).
• Meloxicam is extensively metabolized in the liver.
• Meloxicam excretion occurs to equal extents in the urine and feces.

Indications:

• Relief of the signs and symptoms of osteoarthritis.
• Relief of the signs and symptoms of rheumatoid arthritis.
• Relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis.

Dosage:

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. The product may be taken without regard to timing of meals.
• Osteoarthritis and Rheumatoid Arthritis: the recommended starting and maintenance oral dose is 7.5mg once daily. Some patients may receive additional benefit by increasing the dose to 15mg once daily.
• Juvenile Rheumatoid Arthritis: the recommended oral dose of Meloxicam  is 7.5mg once daily in children who weigh ≥60 kg. There was no additional benefit demonstrated by increasing thedose above 7.5mg in clinical trials.
• It should not be used in children who weigh <60 kg.
• Renal Impairment: The use of Meloxicam in subjects with severe renal impairment is not recommended. In patients on hemodialysis, the maximum dosage is 7.5mg per day.

Overdose:

Symptoms: drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care.

Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare.

- Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes.

Side effects: Cardiovascular Thrombotic Events, GI Bleeding, Ulceration, Perforation, Hepatotoxicity, Hypertension, Heart Failure and Edema, Renal Toxicity and Hyperkalemia, Anaphylactic Reactions, Serious Skin Reactions, and Hematologic Toxicity.

Contraindications:

• Known hypersensitivity meloxicam or any components of the product.
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
• In the setting of coronary artery bypass graft (CABG) surgery.

Drug interactions:

• Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking MOBIC with drugs that interfere with hemostasis. Concomitant use of Meloxicam and analgesic doses of aspirin is not generally recommended.
• ACE Inhibitors, Angiotensin Receptor Blockers (ARBs) or Beta-Blockers: Concomitant use with Meloxicam may diminish the antihypertensive effect of these drugs.
• ACE Inhibitors and ARBs: Concomitant use with Meloxicam in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. When these drugs are administered concomitantly, patients should be adequately hydrated.
• Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
• NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance.
• Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
• Concomitant use of the product and cyclosporine may increase cyclosporine's nephrotoxicity.
• Concomitant use of meloxicam with other NSAIDs or salicylates, increases the risk of GI toxicity.

Precautions:

• Patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
• The concurrent use of aspirin and an NSAID, such as meloxicam, increases the risk of serious gastrointestinal (GI) events.
• following CABG surgery found an increased incidence of myocardial infarction and stroke. When using the product for treatment of pain.
• NSAIDs, including meloxicam, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. Use the lowest effective dosage for the shortest possible duration.
• Patients with advanced liver disease and/or coagulopathy, patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age are at increased risk for GI bleeding.
• Elevations of ALT or AST may occur in up to 15% of patients treated with NSAIDs including meloxicam.
• It can lead to new onset or worsening of preexisting hypertension.
• Avoid the use of Meloxicam in patients with severe heart failure.
• Fluid retention and edema have been observed in some patients treated with NSAIDs.
• Long-term administration has resulted in acute renal failure, and other renal injury and Increases in serum potassium concentration.
• Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam.
• The product is contraindicated in patients with this form of aspirin-sensitive asthma because cross-reactivity between aspirin and other NSAIDs.
• NSAIDs, including meloxicam, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN).
• Anemia has occurred in NSAID-treated patients, NSAIDs may increase the risk of bleeding events.
• The pharmacological activity of the product in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

Use in pregnancy or lactation:
- There are no adequate and well-controlled studies of MOBIC in pregnant women. Avoid use of NSAIDs, including Meloxicam, in pregnant women starting at 30 weeks of gestation (third trimester).

- 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.