- Approval Id
- cfd2afc065e7f05d
- Drug Name
- ANAST 1 FILM COATED TABLET 1 MG
- Product Name
- ANAST 1 FILM COATED TABLET 1 MG
- Approval Number
- SIN15633P
- Approval Date
- 2019-02-20
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<table class="borderless-100">
<tbody>
<tr>
<td>Adults including elderly<br><br></td>
<td>: One 1 mg tablet to be taken orally once a day<br><br></td>
</tr>
<tr>
<td>Children<br><br></td>
<td>:Anastrozole Tablets is not recommended for use in children<br><br></td>
</tr>
<tr>
<td>Renal impairment<br><br></td>
<td>: No dose change is recommended in patients with mild or moderate renal impairment<br><br></td>
</tr>
<tr>
<td>Hepatic impairment<br><br></td>
<td>: No dose change is recommended in patients with mild hepatic disease.</td>
</tr>
</tbody>
</table>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
Anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer.</p>
<p>Treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Anastrozole is contraindicated in:</p>
<ul class="dash">
<li>Premenopausal women.</li>
<li>Pregnant or lactating women.</li>
<li>Patients with severe renal impairment (creatinine clearance less than 20ml/min)</li>
<li>Patients with moderate or severe hepatic disease.</li>
<li>Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced on the carton.</li>
</ul>
<p>Oestrogen-containing therapies should not be co-administered with Anastrozole as they would negate its pharmacological action.<br>
Concurrent tamoxifen therapy.</p>
- Atc Code
- L02BG03
- Atc Item Name
- anastrozole
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
- Company Detail Path
- /organization/accord-healthcare-private-limited
