- Approval Id
- 88079b24cf3856a5
- Drug Name
- PROSCAR TABLET 5 mg
- Product Name
- PROSCAR TABLET 5 mg
- Approval Number
- SIN07513P
- Approval Date
- 1993-10-04
- Registrant
- ORGANON SINGAPORE PTE. LTD.
- Licence Holder
- ORGANON SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p>The recommended dosage is one 5 mg tablet daily with or without food.</p>
<p><u>DOSAGE IN RENAL INSUFFICIENCY</u></p>
<p>No adjustment in dosage is required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL/min) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.</p>
<p><u>DOSAGE IN THE ELDERLY</u></p>
<p>No adjustment in dosage is required although pharmacokinetic studies indicated the elimination of finasteride is somewhat decreased in patients more than 70 years of age.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<ul>
<li><p>PROSCAR is indicated for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events as it:</p>
<ul class="dash">
<li>May reduce the risk of acute urinary retention</li>
<li>May reduce the risk of surgery including transurethral resection of the prostate (TURP) and prostatectomy.</li>
</ul>
</li>
<li><p>PROSCAR causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH.</p></li>
</ul>
<p>Patients with an enlarged prostate are the appropriate candidates for therapy with PROSCAR.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>PROSCAR is not indicated for use in women or children.</p>
<p>PROSCAR is contraindicated in the following:</p>
<ul>
<li><p>Hypersensitivity to any component of this product.</p></li>
<li><p>Pregnancy – Use in women when they are or may potentially be pregnant (see PRECAUTIONS: PREGNANCY and EXPOSURE TO FINASTERIDE – RISK TO MALE FETUS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p></li>
</ul>
- Atc Code
- G04CB01
- Atc Item Name
- finasteride
- Pharma Manufacturer Name
- ORGANON SINGAPORE PTE. LTD.
