MELOX TABLET 7.5 mg

Therapeutic Indications

Meloxicam is indicated for the short term symptomatic therapy of acute exacerbations of osteoarthritis, long term symptomatic therapy of rheumatoid arthritis (chronic polyarthritis), and the symptomatic therapy of ankylosing spondylitis.

Contra-indications

Meloxicam is contraindicated in the following situations:

• Hypersensitivity to meloxicam, or to any other components of the tablet (see 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The possibility of cross sensitivity of meloxicam with other non-steroidal anti-inflammatory drugs (NSAIDS) or aspirin exists. Therefore, in patients who have developed asthma, nasal polyps, angioneurotic oedema, urticaria, or any other hypersensitivity reaction following administration of any NSAIDS or aspirin, meloxicam is also contraindicated.
• Active peptic ulcer, or a history of recurrent peptic ulcer disease.
• Severe hepatic impairment.
• Severe renal impairment without dialysis.
• Cerebrovascular bleeding, gastrointestinal bleeding, or any other bleeding disorder.

Dosage and Method of Administration

Melox tablets are for oral administration only. The total daily dose should be taken as a single dose, with water or another liquid, during a meal.

The maximum daily dose is 15 mg. Do not exceed this dose.

Adults:

Acute exacerbations of osteoarthritis: The recommended dose is 7.5 mg (one Melox 7.5 mg tablet, half a Melox 15 mg tablet). If necessary, and depending upon the severity of symptoms, dosage may be increased to 15 mg daily (two Melox 7.5 mg tablets, one Melox 15 mg tablet).

Rheumatoid arthritis: The recommended dose is 15 mg (two Melox 7.5 mg tablets, one Melox 15 mg tablet) a day. Patients at increased risk for adverse reactions should initiate therapy at 7.5 mg (one Melox 7.5 mg tablet, half a Melox 15 mg tablet) a day.

Ankylosing spondylitis: The recommended dose is 15 mg (two Melox 7.5 mg tablets, one Melox 15 mg tablet) a day. Patients at increased risk for adverse reactions should initiate therapy at 7.5 mg (one Melox 7.5 mg tablet, half a Melox 15 mg tablet) a day.

Elderly:

In elderly patients being treated for rheumatoid arthritis, the recommended dose for long term treatment is 7.5 mg (one Melox 7.5 mg tablet, half a Melox 15 mg tablet) a day.

Children:

The safety and efficacy of meloxicam have not been established in children under the age of fifteen years.

Hepatic impairment: Meloxicam is contraindicated in severe hepatic impairment (see Contraindications). Caution should be exercised in patients with lesser degrees of hepatic impairment, and they should be closely monitored. Diuresis and renal function should be carefully monitored during meloxicam therapy (see also Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment: Meloxicam is contraindicated in none dialysed severe renal failure. Patients with severe renal failure undergoing dialysis should not exceed a dose of 7.5 mg (one Melox 7.5 mg tablet, half a Melox 15 mg tablet) a day. Diuresis and renal function should be carefully monitored during meloxicam therapy (see also Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).