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Mobic

Clinical Pharmacology
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CLINICAL PHARMACOLOGY

Mechanism of Action

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits antiinflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition.

Pharmacokinetics

Absorption

The absolute bioavailability of meloxicam capsules was 89% following a single oral dose of 30 mg compared with 30 mg IV bolus injection. Following single intravenous doses, dose-proportional pharmacokinetics were shown in the range of 5 mg to 60 mg. After multiple oral doses the pharmacokinetics of meloxicam capsules were dose-proportional over the range of 7.5 mg to 15 mg. Mean Cmax was achieved within four to five hours after a 7.5 mg meloxicam tablet was taken under fasted conditions, indicating a prolonged drug absorption. With multiple dosing, steady state concentrations were reached by Day 5. A second meloxicam concentration peak occurs around 12 to 14 hours post-dose suggesting biliary recycling.

Meloxicam oral suspension doses of 7.5 mg/5 mL and 15 mg/10 mL have been found to be bioequivalent to meloxicam 7.5 mg and 15 mg capsules, respectively. Meloxicam capsules have been shown to be bioequivalent to Mobic® (meloxicam) tablets.

Table 1: Single Dose and Steady State Pharmacokinetic Parameters for Oral 7.5 mg and 15 mg Meloxicam (Mean and % CV)1

Pharmacokinetic
Parameters
(%CV)
Steady State Single Dose
Healthy
male adults
(Fed)2
Elderly
males
(Fed)2
Elderly
females
(Fed)2
Renal
failure
(Fasted)
Hepatic
insufficiency
(Fasted)
7.5 mg³ tablets 15 mg capsules 15mg capsules 15mg capsules 15 mg capsules
N 18 5 8 12 12
Cmax[μg/mL] 1.05 (20) 2.3 (59) 3.2(24) 0.59(36) 0.84 (29)
tmax[h] 4.9 (8) 5 (12) 6(27) 4(65) 10 (87)
t½[h] 20.1 (29) 21 (34) 24(34) 18(46) 16 (29)
CL/f[mL/min] 8.8 (29) 9.9 (76) 5.1(22) 19(43) 11 (44)
Vz/f4[L] 14.7 (32) 15 (42) 10(30) 26(44) 14 (29)
1The parameter values in the Table are from various studies
2not under high fat conditions
3MOBIC tablets
4 Vz/f =Dose/(AUC•Kel)

Food and Antacid Effects
Brand Name: Mobic
Generic Name: Meloxicam

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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