- Approval Id
- ddf7d21b9d6d6d45
- Drug Name
- AVEXA ADUTAS SOFT CAPSULE 0.5MG
- Product Name
- AVEXA ADUTAS SOFT CAPSULE 0.5MG
- Approval Number
- SIN17296P
- Approval Date
- 2025-07-29
- Registrant
- APEX PHARMA MARKETING PTE. LTD.
- Licence Holder
- APEX PHARMA MARKETING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE, LIQUID FILLED
- Dosage
- <p><strong>4.2. Posology and method of administration</strong><br>
<strong>Adult males (including elderly):</strong><br>
Capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.</p>
<p>Adutas may be taken with or without food.</p>
<p>The recommended dose of Adutas is one capsule (0.5 mg) taken orally once a day.</p>
<p>Although an improvement may be observed at an early stage, treatment for at least 6 months may be necessary in order to assess objectively whether a satisfactory response to the treatment can be achieved.</p>
<p>For the treatment of BPH, dutasteride can be administered alone or in combination with the alpha-blocker tamsulosin (0.4 mg).</p>
<p><strong>Renal Impairment:</strong><br>
The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment (see <strong>“5.2 Pharmacokinetic properties”</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Hepatic impairment:</strong><br>
The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment (see <strong>“4.4 Special warnings and precautions for use” and “5.2 Pharmacokinetic properties”</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). In patients with severe hepatic impairment, the use of dutasteride is contraindicated (see <strong>“4.3 Contraindications”</strong>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong><br>
<strong>Monotherapy</strong><br>
Adutas is indicated for the treatment and control of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery.</p>
<p><strong>Combination With Alpha-Blocker</strong><br>
Adutas in combination with the alpha-blocker tamsulosin is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong><br>
Adutas is contraindicated in:</p>
<ul class="dash">
<li>women and children and adolescents (see <strong>“4.6 Fertility, pregnancy and lactation”</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or any of the other excipients.</li>
<li>patients with severe hepatic impairment.</li>
</ul>
