Meloxicam Suspension
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
Meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
Meloxicam 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)].
History
There is currently no drug history available for this drug.
Other Information
Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow meloxicam tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Each bottle of Meloxicam oral suspension contains 7.5 mg meloxicam per 5 mL. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula:
Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2.
Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, and as an oral suspension containing 7.5 mg meloxicam per 5 mL.
The inactive ingredients in meloxicam tablets include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate dihydrate.
The inactive ingredients in meloxicam oral suspension include colloidal silicon dioxide, hydroxyethylcellulose, sorbitol, glycerol, xylitol, monobasic sodium phosphate (dihydrate), saccharin sodium, sodium benzoate, citric acid (monohydrate), raspberry flavor, and purified water.
Sources
Meloxicam Suspension Manufacturers
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Roxane Laboratories, Inc.
![Meloxicam Suspension [Roxane Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Meloxicam Suspension | Roxane Laboratories, Inc.
2.1 General InstructionsCarefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.4)].
After observing the response to initial therapy with meloxicam, adjust the dose to suit an individual patient's needs.
In adults, the maximum recommended daily oral dose of meloxicam is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Warnings and Precautions (5.6), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].
Meloxicam oral suspension 7.5 mg/5 mL or 15 mg/10 mL may be substituted for meloxicam tablets 7.5 mg or 15 mg, respectively.
Shake the oral suspension gently before using.
Meloxicam may be taken without regard to timing of meals.
2.2 OsteoarthritisFor the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.3 Rheumatoid ArthritisFor the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.4 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular CourseTo improve dosing accuracy in smaller weight children, the use of the meloxicam oral suspension is recommended. meloxicam oral suspension is available in the strength of 7.5 mg/5 mL. For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of meloxicam is 0.125 mg/kg once daily up to a maximum of 7.5 mg. There was no additional benefit demonstrated by increasing the dose above 0.125 mg/kg once daily in these clinical trials.
Juvenile Rheumatoid Arthritis dosing using the oral suspension should be individualized based on the weight of the child:
0.125 mg/kg
Weight
Dose
(1.5 mg/mL)Delivered dose
12 kg (26 lb)
1.0 mL
1.5 mg
24 kg (54 lb)
2.0 mL
3.0 mg
36 kg (80 lb)
3.0 mL
4.5 mg
48 kg (106 lb)
4.0 mL
6.0 mg
≥60 kg (132 lb)
5.0 mL
7.5 mg
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