Osteoarthritis (OA) MOBIC: US FDA label indications

Indications and usage (label excerpt)

MOBIC is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older (1.3) 1.1 Osteoarthritis (OA) 1.2 Rheumatoid Arthritis (RA) 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course 1 INDICATIONS AND USAGE 1.1 Osteoarthritis (OA) MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1) ]. 1.2 Rheumatoid Arthritis (RA) MOBIC is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1) ]. 1.3 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 2 years of age and older [see Clinical Studies (14.2) ]. INDICATIONS FOR USE Trepadone is intended for the clinical dietary management of the metabolic processes of pain disorders and inflammatory conditions, particularly those associated with joint pain. CLINICAL EXPERIENCE Administration of Trepadone has demonstrated significant reduction in symptoms of pain and inflammation in patients with acute and chronic pain when used for the dietary management of the metabolic processes associated with pain disorders and inflammatory conditions. Administration of Trepadone results in the induction and maintenance of pain relief in patients with pain d…

Warnings (label excerpt)

Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk. (5.1) Serious gastrointestinal (GI) adverse events which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at higher risk for GI events, especially the elderly. (5.2) Elevated liver enzymes, and rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen. (5.3) New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment. (5.4) Fluid retention and edema. Should be used with caution in patients with fluid retention or heart failure. (5.5) Renal papillary necrosis and other renal injury with long-term use. Use with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II an…

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Trials whose interventions mention this drug

Canadian trials first. A match on the drug name does not mean the trial studied this specific product.