- Approval Id
- 8fc2c3c6b35b2420
- Drug Name
- DUOCOXIB FILM COATED TABLET 120 MG
- Product Name
- DUOCOXIB FILM COATED TABLET 120 MG
- Approval Number
- SIN17203P
- Approval Date
- 2025-03-11
- Registrant
- DUOPHARMA (SINGAPORE) PTE LTD
- Licence Holder
- DUOPHARMA (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><u><strong>POSOLOGY AND METHOD OF ADMINISTRATION:</strong></u><br>
Duocoxib is administered orally and may be taken with or without food. The onset of drug effect may be faster when Duocoxib is administered without food. This should be considered when rapid symptomatic relief is needed. Duocoxib should be administered for the shortest duration possible and the lowest effective daily dose should be used.</p>
<img src="/TGIF/Duocoxib-Table1.png" alt="Duocoxib Dosage Table 1" /><br><br>
<p>Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore,<br>
The dose for OA should not exceed 60 mg daily.<br>
The dose for RA should not exceed 90 mg daily.<br>
The dose for ankylosing spondylitis should not exceed 90 mg daily.<br>
The dose for acute gout should not exceed 120 mg daily.<br>
The dose for acute pain and primary dysmenorrhea should not exceed 120 mg daily.<br>
The dose for post-procedure dental surgery pain should not exceed 90 mg daily.</p>
<p>As the cardiovascular risks of selective COX-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically (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>Renal insufficiency: No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see PHARMACOKINETIC PROPERTIES – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The use of etoricoxib in patients with creatinine clearance <30 ml/min is contraindicated (see CONTRAINDICATIONS and 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>Hepatic insufficiency: In patients with mild hepatic insufficiency (Child-Pugh score 5–6) a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic insufficiency (Child-Pugh score 7–9) the recommended dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered. Clinical experience is limited, particularly in patients with moderate hepatic insufficiency and caution is advised. There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score >9); therefore, its use is contra-indicated in these patients (see CONTRAINDICATIONS, SPECIAL WARNINGS AND PRECAUTIONS FOR USE and PHARMACOKINETIC PROPERTIES – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Paediatric use: Etoricoxib is contra-indicated in children and adolescents under 16 years of age (see CONTRAINDICATIONS).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><u><strong>THERAPEUTIC INDICATIONS:</strong></u><br>
Duocoxib is indicated for:</p>
<ul>
<li>Symptomatic relief of osteoarthritis (OA),</li>
<li>Rheumatoid arthritis (RA),</li>
<li>Symptomatic relief of ankylosing spondylitis (AS),</li>
<li>Pain and signs of inflammation associated with acute gouty arthritis,</li>
<li>Treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures.</li>
</ul>
<p>The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks, taking into consideration other available therapeutic options (see CONTRAINDICATIONS and 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>
- Contraindications
- <p><u><strong>CONTRAINDICATIONS:</strong></u><br>
Duocoxib is contraindicated in:</p>
<ul>
<li>patients with known hypersensitivity to etoricoxib or to any of the excipients of this medicinal product</li>
<li>patients with congestive heart failure (NYHA II–IV)</li>
<li>patients with established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty)</li>
<li>patients with hypertension whose blood pressure has not been adequately controlled</li>
<li>patients with active peptic ulceration or gastrointestinal (Gl) bleeding</li>
<li>patients with severe hepatic dysfunction (Child-Pugh score >9)</li>
<li>patients with estimated creatinine clearance <30 ml/min</li>
<li>patients who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)</li>
<li>pregnancy and lactation (see PREGNANCY AND LACTATION and PRECLINICAL SAFETY DATA – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>children and adolescents under 16 years of age</li>
<li>patients with inflammatory bowel disease</li>
</ul>
- Atc Code
- M01AH05
- Pharma Manufacturer Name
- DUOPHARMA (SINGAPORE) PTE. LTD.
- Company Detail Path
- /organization/duopharma-singapore-pte-ltd
