- Approval Id
- 84f229d0b0b6eedc
- Drug Name
- FINAINTAS 5 FILM COATED TABLET 5 MG
- Product Name
- FINAINTAS 5 FILM COATED TABLET 5 MG
- Approval Number
- SIN16529P
- Approval Date
- 2022-06-29
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- 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>
<p>FINAINTAS tablets are 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>
<p>FINAINTAS tablets causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH.</p>
<p>Patients with an enlarged prostate are the appropriate candidates for therapy with FINAINTAS tablets.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>Finasteride is not indicated for use in women or children.<br>
Finasteride is contraindicated in the following:</p>
<ul>
<li>Hypersensitivity to any component of this product.</li>
<li>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>).</li>
</ul>
- Atc Code
- G04CB01
- Atc Item Name
- finasteride
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
