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FDA Labeling Changes
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Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
Meloxicam tablets are 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)].
There is currently no drug history available for this drug.
Meloxicam, an oxicam derivative, is a member of the enolic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. It has the following structural formula.
C14H13N3O4S2 M.W. 351.4
Meloxicam is a pale yellow crystalline solid. It is slightly soluble in acetone; soluble in dimethylformamide; very slightly soluble in ethanol (96%) and in methanol. It is insoluble in water at an acid-neutral pH and very highly soluble at a basic pH. Meloxicam has pKa values of 1.09 and 4.18 at pH values of 0 to 3 and 2.5 to 6.5, respectively.
Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.
The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate dihydrate.