- Approval Id
- f9c72538dbdeedeb
- Drug Name
- MOBIC TABLET 7.5 MG
- Product Name
- MOBIC TABLET 7.5 MG
- Approval Number
- SIN09554P
- Approval Date
- 1997-11-28
- Registrant
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Licence Holder
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Posology</strong></p>
<p>As the potential for adverse reactions increases with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.</p>
<p>The total daily dose of MOBIC® should be administered as a single dose.</p>
<p><strong><u>Painful osteoarthritis, rheumatoid arthritis and ankylosing spondylitis</u></strong></p>
<p>For adults the maximum recommended daily dose regardless of formulation is 15 mg.</p>
<p>Painful osteoarthritis<br>
7.5 mg/day. If necessary, the dose may be increased to 15 mg/day.</p>
<p>Rheumatoid arthritis<br>
15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day.</p>
<p>Ankylosing spondylitis<br>
15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day</p>
<p><strong>Special populations</strong><br>
In patients with increased risks of adverse reactions, e.g. a history of gastro-intestinal disease or risk factors for cardiovascular disease, the treatment should be started at a dose of 7.5 mg/day (see Special warnings and precautions for use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients with a creatinine clearance of greater than 25 ml/min). In non-dialysed patients with severe renal impairment MOBIC® is contraindicated (see Contraindications). In patients with end-stage renal failure on haemodialysis the maximum daily dose should not exceed 7.5 mg/day.</p>
<p>As a dosage for use in adolescents has not yet been established, usage should be restricted to adults.</p>
<p><strong>Method of administration</strong><br>
MOBIC® tablets are swallowed with water or other fluid in conjunction with food.</p>
<p>There is insufficient information on the effect of mixing crushed tablets or contents of a capsule with food or fluids.</p>
<p>Tablet break mark does not allow subdividing the 7.5 mg tablet into fractions of a full dose. Tablets 7.5 mg can only be subdivided for ease of swallowing.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><strong>MOBIC®</strong> is a non-steroidal anti-inflammatory drug indicated for symptomatic treatment of</p>
<ul class="dash">
<li>painful osteoarthritis (arthrosis, degenerative joint disease).</li>
<li>rheumatoid arthritis.</li>
<li>ankylosing spondylitis.</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Known hypersensitivity to meloxicam or any excipient of the product.</li>
<li>Use in patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), because of a potential for cross sensitivity.</li>
<li>Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery</li>
<li>Active or recent gastro-intestinal ulceration / perforation</li>
<li>Active inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)</li>
<li>Severe hepatic insufficiency</li>
<li>Non-dialysed severe renal insufficiency</li>
<li>Overt gastro-intestinal bleeding, recent cerebrovascular bleeding or established systemic bleeding disorders</li>
<li>Severe uncontrolled heart failure</li>
<li>Pregnancy or breastfeeding.</li>
<li>rare hereditary conditions that may be incompatible with an excipient of the product (see Special warnings and precautions for use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
</ul>
- Atc Code
- M01AC06
- Atc Item Name
- meloxicam
- Pharma Manufacturer Name
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
