- Approval Id
- 5a6609bc93ea3eee
- Drug Name
- LOTUFLO-D CAPSULES 0.5 MG/0.4 MG
- Product Name
- LOTUFLO-D CAPSULES 0.5 MG/0.4 MG
- Approval Number
- SIN16678P
- Approval Date
- 2023-01-17
- Registrant
- LOTUS INTERNATIONAL PTE. LTD.
- Licence Holder
- LOTUS INTERNATIONAL PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
Where appropriate, dutasteride-tamsulosin may be used to substitute concomitant dutasteride and tamsulosin hydrochloride in existing dual therapy to simplify treatment.<br>
Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to dutasteride-tamsulosin may be considered.</p>
<p><em>Adults (including elderly)</em><br>
The recommended dose of dutasteride-tamsulosin is one capsule (0.5 mg/0.4 mg) taken orally approximately 30 minutes after the same meal each day. Capsules should be swallowed whole and not chewed or opened. Contact with the contents of the dutasteride capsule contained within the hard-shell capsule may result in irritation of the oropharyngeal mucosa.</p>
<p>Patients should be advised that dutasteride-tamsulosin should not be taken on an empty stomach as this may increase the potential for cardiovascular related adverse events such as orthostatic hypotension.</p>
<p><em>Renal impairment</em><br>
The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment (see section 4.4 and 5.2 – <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><br>
The effect of hepatic impairment on dutasteride-tamsulosin pharmacokinetics has not been studied (see section 4.4 and section 5.2 – <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-tamsulosin is contraindicated (see section 4.3).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
LOTUFLO-D treats and prevents progression of benign prostatic hyperplasia (BPH) through alleviating symptoms, reducing prostate size (volume), improving urinary flow rate and reducing the risk of acute urinary retention (AUR) and the need for BPH-related surgery.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Dutasteride-tamsulosin is contraindicated in:</p>
<ul class="dash">
<li>patients with known hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin hydrochloride or any component of the preparation (see section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>patients with a history of orthostatic hypotension.</li>
<li>patients with severe hepatic impairment (Child-Pugh scores >9).</li>
<li>patients with severe renal impairment (creatinine clearance less than 10mL/min).</li>
<li>combination with another α-1 adrenergic blocker.</li>
<li>For use in women and children (see Section 4.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Atc Code
- G04CA52
- Atc Item Name
- tamsulosin and dutasteride
- Pharma Manufacturer Name
- LOTUS INTERNATIONAL PTE. LTD.
