- Approval Id
- 2eae658f0e53e016
- Drug Name
- ARIPSA SOFT CAPSULES 0.5MG
- Product Name
- ARIPSA SOFT CAPSULES 0.5MG
- Approval Number
- SIN16476P
- Approval Date
- 2022-04-13
- Registrant
- NOVEM HEALTHCARE PTE LTD
- Licence Holder
- NOVEM HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE, LIQUID FILLED
- Dosage
- <p><strong>4.2. Posology and Method of Administration</strong></p>
<p><em>Adult males (including elderly):</em></p>
<p><em>ARIPSA</em> can be administered alone or in combination with the alpha-blocker tamsulosin (0.4 mg).</p>
<p>The recommended dose of <em>ARIPSA</em> 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.</p>
<p><em>ARIPSA</em> may be taken with or without food.</p>
<p>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>Renal impairment</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 (see 5.2 Pharmacokinetic Properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Hepatic impairment</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 (see 4.4 Special Warnings and Special Precautions for Use and 5.2 Pharmacokinetic Properties – <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 section 4.3 Contraindications).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1. Therapeutic Indications</strong></p>
<p><em>ARIPSA</em> is indicated for the 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, <em>ARIPSA</em> 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></p>
<p><em>ARIPSA</em> is contraindicated for use in women, children and adolescents (see 4.6 Pregnancy and Lactation – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>ARIPSA</em> is contraindicated in patients with hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, or any of the excipients.</p>
<p><em>ARIPSA</em> is contraindicated in patients with severe hepatic impairment.</p>
- Atc Code
- G04CB02
- Atc Item Name
- dutasteride
- Pharma Manufacturer Name
- NOVEM HEALTHCARE PTE LTD
