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Meloxim

 

Composition

Meloxim 1.5 mg: Each tablet contains meloxicam 7.5 mg

Meloxim 15 mg: Each tablet contains meloxicam 15 mg

 

Description

Meloxim 7.5 mg: Yellow coloured round shape tablet with score line on one side

Meloxim 15 mg: Yellow coloured oblong tablet with score line on one side

 

Pharmacodynamic

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti-inflammatory, analgesic and antipyretic properties. The anti-inflammatory activity of meloxicam has been proven in classical models of inflammation. It inhibits the biosynthesis of prostaglandins, known inflammation mediators.

 

Pharmacokinetic

Absorption

Meloxicam is well absorbed from the gastrointestinal tract with bioavailability of 89% following oral administration. Mean maximum plasma concentration is achieved within 5-6 hours following single dose administration. With multiple dosing, steady state conditions were reached within 3 to 5 days. Continuous treatment for periods of more than one year results in similar drug concentrations to those seen once steady state is first achieved. Extent of absorption for meloxicam following oral administration is not altered by concomitant food intake.

 

Distribution

Meloxicam is very strongly bound to plasma proteins, essentially albumin (99%). Meloxicam penetrates into synovial fluid to give concentrations approximately half of those in plasma. Volume of distribution is low, on average 11 L. Interindividual variation is about 30-40%.

 

Biotransformation

Meloxicam undergoes extensive hepatic biotransformation. Four different metabolites of meloxicam were identified in urine, which are all pharmacodynamically inactive. The major metabolite, 5'-carboxymeloxicam (60% of dose), is formed by oxidation of an intermediate metabolite 5'- hydroxymethylmeloxicam, which is also excreted to a lesser extent (9% of dose). In vitro studies suggest that GYP 2G9 plays an important role in this metabolic pathway, with a minor contribution from the GYP 3A4 isoenryme. The patient's peroxidase activity is probably responsible for the other two metabolites, which account for 16% and 4% of the administered dose respectively.

 

Elimination

Meloxicam is excreted predominantly in the form of metabolites and occurs to equal extents in urine and faeces. Less than 5% of the daily dose is excreted unchanged in faeces, while only traces of the parent compound are excreted in urine. The mean elimination half-life is about 20 hours. Total plasma clearance amounts on average 8 mL/min.

 

Linearity/non-linearity

Meloxicam demonstrates linear pharmacokinetics in the therapeutic dose range of 7.5 mg 15 mg following per oral or intramuscular administration.

 

Special populations

Hepatic/renal Insufficiency: Neither hepatic, mild nor moderate renal insufficiency has a substantial effect on meloxicam pharmacokinetics. In terminal renal failure, the increase in the volume of distribution may result in higher free meloxicam concentrations, and a daily dose of 7.5 mg must not be exceeded.

Elderly: Mean plasma clearance at steady state in elderly subjects was slightly lower than that reported for younger subjects.

Indication

Symptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis.

 

Recommended dosage

Osteoarthritis: 7.5mg/day. If necessary, the dose may be increased to 15 mg/day.

Rheumatoid Arthritis: 15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day.

Ankylosing Spondylitis: 15 mg/day

In patients with increased risks of adverse reactions, start treatment at the dose of 7.5mg/day.

In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg/day.

Maximum Recommended Daily Dose: 15 mg

The total daily dosage should not exceed 15 mg

The tablets should be swallowed with water or other fluid in conjunction with food.

After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.

 

Contraindication

This product is contraindicated in the following situations:

Pregnancy and lactation

Hypersensitivity to meloxicam or to any of the excipients or hypersensitivity to substances with similar action, e.g. NSAIDS, aspirin. Meloxim should not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other NSAIDS.

Active gastro-intestinal ulcer or history of recurrent gastrointestinal ulcer

Severely impaired liver function

Non-dialysed severe renal failure

Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders

Severe uncontrolled heart failure

 

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