Meloxicam

Meloxicam oral suspension is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA). Rheumatoid Arthritis (RA). Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older

Meloxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of meloxicam oral suspension, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Meloxicam is a potent inhibitor of prostaglandin synthesis in vitro. Meloxicam concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because meloxicam is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. OA and RA: Starting dose: 7.5 mg once daily Dose may be increased to 15 mg once daily JRA: 0.125 mg/kg once daily up to a maximum of 7.5 mg. JRA dosing using the oral suspension should be individualized based on the weight of the child. Meloxicam oral suspension is not interchangeable with approved formulations of oral meloxicam even if the total milligram strength is the same

Meloxicam oral suspension is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients In the setting of coronary artery bypass graft (CABG) surgery Known hypersensitivity to meloxicam or any components of the drug product. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. In the setting of CABG surgery

Boxed warning: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Meloxicam oral suspension is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events GI Bleeding, Ulceration, and Perforation Hepatotoxicity Hypertension Heart Failure and Edema Renal Toxicity and Hyperkalemia Anaphylactic Reactions Serious Skin Reactions Hematologic Toxicity Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms. Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience

See Table 3 for clinically significant drug interactions with meloxicam. See also Warnings and Precautions and Clinical Pharmacology. Table 3 Clinically Significant Drug Interactions with Meloxicam Drugs that Interfere with Hemostasis Clinical Impact: Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of meloxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).