MELOREX Tablet Ref.[50648] Active ingredients: Meloxicam

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2022  Publisher: REX Medical Ltd, Unit 18/273 Neilson Street, Onehunga, Auckland 1061, PO Box 18-119, Glen Innes 1743, AUCKLAND Ph (09) 574 6060 Fax (09) 574 6070

4.1. Therapeutic indications

Symptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease).

Symptomatic treatment of rheumatoid arthritis.

In patients for whom longer-term use may be required, treatment efficacy should be reviewed within the first month of treatment and Melorex tablets withdrawn if there is a lack of therapeutic benefit. Patients on long-term treatment should be reviewed regularly, such as every three months with regards to efficacy, risk factors and the ongoing need for treatment.

The decision to prescribe a selective COX-2 inhibitor should only be made after assessment of the individual patient’s overall risk for developing severe adverse events e.g. history of cardiovascular, renal, or gastrointestinal disease, and after use of alternative therapies such as non-pharmacological interventions and simple analgesic therapy where these have been found to lack analgesic efficacy or to have unacceptable adverse effects.

4.2. Posology and method of administration

Melorex tablets may be administered in a dose of 7.5mg daily. As the potential for adverse reactions increases with dose and duration of exposure, all patients taking

Melorex tablets should commence therapy at the lowest recommended dose, and be titrated to the lowest dose compatible with effective control of symptoms for the shortest possible period.

Osteoarthritis: 7.5 mg per 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.

In dialysis patients with severe renal failure

The dose should not exceed 7.5mg per day.

In patients with mild to moderate renal impairment (creatinine clearance of greater than 25mL/min)

The dose should not exceed 7.5mg per day.

Adolescents

The maximum recommended dose for adolescents is 0.25mg/kg.

In general usage should be restricted to adolescents and adults, see contraindications.

Tablets should be swallowed with water and other fluid in conjunction with food.

4.9. Overdose

In case of overdose the standard measures of gastric evacuation and general supportive measures should be used, as there is no known antidote. It has been shown in a clinical trial that cholestyramine accelerates the elimination of meloxicam.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

6.3. Shelf life

Shelf life is 36 months (3 years) from manufacture.

6.4. Special precautions for storage

Store below 25°C in a safe place out of the reach of children.

6.5. Nature and contents of container

Al/PVC/PVdC blister packs:

7.5mg = 30 tablets

15mg = 30 tablets

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