п»їProduct info: Pain medicine
Mobic (Meloxicam) is used for treating rheumatoid arthritis, osteoarthritis, and juvenile arthritis. It may also be used for other conditions as determined by your doctor.
Mobic is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.
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п»їMobic - Clinical Pharmacology
Mechanism of Action
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, 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 MobicВ® (meloxicam) tablets.
Table 1 Single Dose and Steady State Pharmacokinetic Parameters for Oral 7.5 mg and 15 mg Meloxicam (Mean and % CV)1 Steady State Single Dose
Pharmacokinetic
Parameters
(% CV) 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 15 mg
capsules 15 mg
capsules 15 mg
capsules
N 18 5 8 12 12
Cmax [Вµg/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)
t1/2 [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
Administration of meloxicam capsules following a high fat breakfast (75 g of fat) resulted in mean peak drug levels (i.e., Cmax) being increased by approximately 22% while the extent of absorption (AUC) was unchanged. The time to maximum concentration (Tmax) was achieved between 5 and 6 hours. In comparison, neither the AUC nor the Cmax values for meloxicam suspension were affected following a similar high fat meal, while mean Tmax values were increased to approximately 7 hours. No pharmacokinetic interaction was detected with concomitant administration of antacids. Based on these results, Mobic tablets/oral suspension can be administered without regard to timing of meals or concomitant administration of antacids.
Distribution
The mean volume of distribution (Vss) of meloxicam is approximately 10 L. Meloxicam is в€ј 99.4% bound to human plasma proteins (primarily albumin) within the therapeutic dose range. The fraction of protein binding is independent of drug concentration, over the clinically relevant concentration range, but decreases to в€ј 99% in patients with renal disease. Meloxicam penetration into human red blood cells, after oral dosing, is less than 10%. Following a radiolabeled dose, over 90% of the radioactivity detected in the plasma was present as unchanged meloxicam.
Meloxicam concentrations in synovial fluid, after a single oral dose, range from 40% to 50% of those in plasma. The free fraction in synovial fluid is 2.5 times higher than in plasma, due to the lower albumin content in synovial fluid as compared to plasma. The significance of this penetration is unknown.
Metabolism
Meloxicam is almost completely metabolized to four pharmacologically inactive metabolites. The major metabolite, 5′-carboxy meloxicam (60% of dose), from P-450 mediated metabolism was formed by oxidation of an intermediate metabolite 5′-hydroxymethyl meloxicam which is also excreted to a lesser extent (9% of dose). In vitro studies indicate that cytochrome P-450 2C9 plays an important role in this metabolic pathway with a minor contribution of the CYP 3A4 isozyme. Patients’ peroxidase activity is probably responsible for the other two metabolites which account for 16% and 4% of the administered dose, respectively.
Excretion
Meloxicam excretion is predominantly in the form of metabolites, and occurs to equal extents in the urine and feces. Only traces of the unchanged parent compound are excreted in the urine (0.2%) and feces (1.6%). The extent of the urinary excretion was confirmed for unlabeled multiple 7.5 mg doses: 0.5%, 6% and 13% of the dose were found in urine in the form of meloxicam, and the 5′-hydroxymethyl and 5′-carboxy metabolites, respectively. There is significant biliary and/or enteral secretion of the drug. This was demonstrated when oral administration of cholestyramine following a single IV dose of meloxicam decreased the AUC of meloxicam by 50%.
The mean elimination half-life (t1/2) ranges from 15 hours to 20 hours. The elimination half-life is constant across dose levels indicating linear metabolism within the therapeutic dose range. Plasma clearance ranges from 7 to 9 mL/min.
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Compare Mobic with other medications for the treatment of:
Tendonitis, Osteoarthritis, Fibromyalgia, Inflammatory Conditions, Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis
User reviews
29 review(s) for Mobic
Support Group Questions & Answers
Can Mobic cause stomach pain?
Have you tried pantoprazole or meloxicam? Which works for you?
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