MOBITIL is a new potent nonsteroidal anti-inflammatory drug, belonging to the enolic acid group. It acts through the preferential inhibition of cyclo-oxygenase-2 (COX-2), with potentially high anti-inflammatory and analgesic actions. Meloxicam-beta-cyclodextrin is a novel formulation of meloxicam, which is the product of supermolecular encapsulation of meloxicam with the cyclic oligosaccharide beta-cyclodextrin. As a result, the absorption rate of meloxicam is increased with a more rapid onset of action and reduced gastropathic effects.

4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide

MOBITIL is a new potent nonsteroidal anti-inflammatory drug, belonging to the enolic acid group. It acts through the preferential inhibition of cyclo-oxygenase-2 (COX-2), with potentially high anti-inflammatory and analgesic actions. Meloxicam-beta-cyclodextrin is a novel formulation of meloxicam, which is the product of supermolecular encapsulation of meloxicam with the cyclic oligosaccharide beta-cyclodextrin. As a result, the absorption rate of meloxicam is increased with a more rapid onset of action and reduced gastropathic effects.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are potent anti-inflammatory agents that act through the inhibition of the cyclo- oxygenase (COX) enzyme and the subsequent inhibition of prostaglandin synthesis at the site of inflammation. Recently two isoforms of the COX enzyme have been identified;
1- COX-1, which is constitutively (naturally) expressed in many cells and tissues including the gastric mucosa, where the inhibition of COX-1 is responsible for the toxicity associated with the clinically active NSAIDs.
2- COX-2, which is induced by the proinflammatory cytokines at the site of inflammation, where the anti-inflammatory properties of NSAIDs are caused by the inhibition of inducible COX-2.
MOBITIL preferentially inhibits COX-2 enzyme.

Anti-inflammatory.
Analgesic.
Anti-pyretic.
Inhibitor of both bradykinin-induced and PAF-induced bronchospasm without exacerbation of acetylcholine-induced bronchospasm (i.e. relatively safe in asthmatic patients).

Absorption : Almost complete after oral or rectal administration. The absorption rate of meloxicam from the inclusion complex of meloxicam-beta-cyclodextrin is very rapid and accordingly, meloxicam is almost immediately bioavailable after oral or rectal administration. Pharmacokinetic characteristics, other than absorption, remain unchanged.
Distribution :
Plasma protein binding : 99.1 - 99.7 %.
Steady state plasma concentration : Achieved within 3-5 days.
Metabolism : Meloxicam is extensively metabolized in the liver, with only traces of the drug appearing unchanged in the urine and feces. The main metabolites are formed by hydroxylation and further oxidation of the methyl group of the thiazolyl moiety.
Excretion :
Meloxicam is excreted through both renal and hepatic pathways. The excretion of a single dose is complete in 6 days.
Elimination half life (t ½) : 17-20 hours.
Total plasma clearance (CL) : 0.42 - 0.48 liter / hour.
The pharmacokinetic parameters of meloxicam are linear over the dose range of 7.5 -30 mg.
Neither moderate hepatic insufficiency nor moderate renal dysfunction has any relevant effects on the pharmacokinetics of meloxicam.

Inflammatory and degenerative articular and extra-articular rheumatic diseases of muscles, joints, joint capsules, bursae, tendons, tendon sheaths and vertebral column such as chronic rheumatoid arthritis, osteoarthritis, arthrosis, spondylarthrosis, ankylosing spondylitis, soft tissue rheumatism, bursitis, tenditis, lumbago, sciatica and other types of neuritis and neuralgia.
Post-traumatic and post-operative pain, inflammation and swelling.
Painful syndromes of the vertebral column.
Painful and/or inflammatory conditions in gynecology such as primary dysmenorrhea or adnexitis.

Hypersensitivity to the oxicam group of NSAIDs.
Use with caution in patients known to be hypersensitive to other NSAIDs    or aspirin as there is a probability for cross sensitivity.
Active peptic ulcer.
Severe hepatic insufficiency.
Severe, non-dialyzed renal insufficiency.
Pregnancy and breast-feeding.

No interactions were reported following the concomitant administration of food, cimetidine, antacids, aspirin, digoxin, warfarin, methotrexate, or furosemide.
Cholestyramine binds meloxicam in the gastrointestinal tract leading to a decreased absorption of meloxicam.

The following adverse reactions were infrequently reported (not more than 1%) in the clinical trials:
CNS : Headache, drowsiness, tinnitus.
GIT : Dyspepsia, nausea, flatulence, diarrhea or constipation.
Cardiovascular : Peripheral edema.
Dermatological : Pruritus, skin rash.

Orally : Depending on the severity of the condition, the recommended oral dose is 7.5mg to 15mg taken after meals once daily.
Rectally : One suppository containing 15mg once daily.
The maximum recommended daily dose is 15mg either orally, rectally or combined.
Dosage adjustments are not required in the elderly or in case of mild to moderate liver or renal insufficiency.
In patients with severe renal failure, the daily dosage should not exceed 7.5mg.

Tablets : Box containing 10 tablets of 7.5mg or 15mg meloxicam.
Suppositories : Box containing 6 suppositories of 15mg meloxicam.