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Arrox tabletArrox

 

COMPOSITION

Each tablet contains Meloxicam 7.5mg

 

PHARMACODYNAMICS

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. As with other NSAIDs, its precise mechanism of action remains unknown. However, there is at least one common mode of action shared by all NSAIDs (including meloxicam) : inhibition of the biosynthesis of prostaglandins, known inflammation mediators.

 

PHARMACOKINETICS

Absorption: Meloxicam is well absorbed from the gastrointestinal tract, which is reflected by a high absolute bioavailability of 89% following oral administration (capsule). Tablets, oral suspension and capsules were shown to he bioequivalent. Following single dose administration of meloxicam, mean maximum plasma concentrations are achieved within 5-6 hours with capsules and tablets. With multiple dosing, steady state conditions were reached within 3 to 5 days. Once daily dosing leads to drug plasma concentrations with a relatively small peak-trough fluctuation in the range of 0.4 - 1.0 g/mL for 7.5 mg doses and 0.8 - 2.0 g/mL for 15 mg doses, respectively (Cmin and Cmax at steady state, respectively). Maximum plasma concentrations of meloxicam at steady state, are achieved within five to six hours. 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.

 

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 CYP 2C9 plays an important role in this metabolic pathway, with a minor contribution from the CYP 3A4 isoenzyme. 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.

 

Special populations: Hepatic/renal insufficiency: Neither hepatic, mild nor moderate renal insufficiency have 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 (see section Recommended Dose).

 

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

 

INDICATIONS

Symptomatic treatment of:

painful osteoarthritis (arthrosis, degenerative joint disease)

rheumatoid arthritis

ankylosing spondylitis

 

RECOMMENDED DOSE

Exacerbations of osteoarthrosis : 7.5 mg/day (one 7.5 mg tablet). If necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two 7.5 mg tablets).

 

Rheumatoid arthritis, ankylosing spondylitis : 15 mg/day (two 7.5 mg tablets). (See also 'special populations'). According to the therapeutic response, the dose may be reduced to 7.5 mg/day (one 7.5 mg tablet). DO NOT EXCEED THE DOSE OF 15 MG/DAY. The total daily amount should be taken as a single dose, with water or another liquid, during a meal.

 

Special populations

Elderly patients and patients with increased risks for adverse reaction: The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day. Patients with increased risks for adverse reactions should start treatment with 7.5 mg per day.

 

Renal impairment: In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg per day. No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with a creatinine clearance of greater than 25 ml/min).

 

Hepatic impairment: No dose reduction is required in patients with mild to moderate hepatic impairment

 

Children: Arrox should not be used in children aged under 15. This medicinal product exists in other dosages, which may be more appropriate.

 

CONTRAINDICATIONS

This medicinal product is contra-indicated in the following situations:

pregnancy and lactation (See section 'Pregnancy and lactation')

hypersensitivity to meloxicam or to one of the excipients or hypersensitivity to substances with a similar action, e.g. NSAIDs, aspirin. Arrox 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 gastro-intestinal 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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