- Approval Id
- 7feec67c4374bc57
- Drug Name
- DUTABIT 0.5 SOFT CAPSULES 0.5MG
- Product Name
- DUTABIT 0.5 SOFT CAPSULES 0.5MG
- Approval Number
- SIN16448P
- Approval Date
- 2022-03-22
- Registrant
- APOTHECA MARKETING PTE LTD
- Licence Holder
- APOTHECA MARKETING PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE, LIQUID FILLED
- Dosage
- <p><strong>Posology and method of administration</strong></p>
<p>Posology</p>
<p>Dutasteride can be administered alone or in combination with the alpha-blocker tamsulosin (0.4 mg)</p>
<p><em><strong>Adults (including elderly):</strong></em></p>
<p>The recommended dose of Dutasteride is one capsule (0.5 mg) taken orally once a day. The capsules should be swallowed whole and not chewed or opened as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. The capsules may be taken with or without food. Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the elderly.</p>
<p><em><strong>Renal impairment</strong></em></p>
<p>The effect of renal impairment on Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment</p>
<p><em><strong>Hepatic impairment</strong></em></p>
<p>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. In patients with severe hepatic impairment, the use of dutasteride is contraindicated.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Therapeutic indications</strong></p>
<p>Treatment and control of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce prostate size, reduce the risk of acute urinary retention, and reduce the need for BPH-related surgery.</p>
<p>In addition, Dutasteride 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>Contraindications</strong></p>
<p>Dutasteride is contraindicated in:</p>
<ul class="dash">
<li><p>Women, children and adolescents.</p></li>
<li><p>Patients with hypersensitivity to dutasteride, to other 5-alpha reductase inhibitors or any of the other excipients.</p></li>
<li><p>Patients with severe hepatic impairment.</p></li>
</ul>
- Atc Code
- G04CB02
- Atc Item Name
- dutasteride
- Pharma Manufacturer Name
- APOTHECA MARKETING PTE LTD
- Company Detail Path
- /organization/apotheca-marketing-pte-ltd
