Regulatory Information
MEDOCHEMIE SINGAPORE PTE. LTD.
MEDOCHEMIE SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET
**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_).
ORAL
Medical Information
**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.
M01AC06
meloxicam
Manufacturer Information
MEDOCHEMIE SINGAPORE PTE. LTD.
MEDOCHEMIE LTD
Active Ingredients
Documents
Package Inserts
Melox 7.5mg tabs 100s PI.pdf
Approved: December 9, 2021