- Approval Id
- 03c01d4de15ec1c0
- Drug Name
- BONDRONAT TABLET 50MG
- Product Name
- BONDRONAT TABLET 50MG
- Approval Number
- SIN13425P
- Approval Date
- 2008-03-10
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>3.2 Dosage and Method of Administration</strong><br>
The recommended dose is one 50 mg film-coated tablet daily.</p>
<p>Bondronat should be taken after an overnight fast and before the first food or drink of the day. Medications and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets. Fasting should be continued for at least 60 minutes after taking the tablet. Plain water may be taken at any time during the course of Bondronat treatment.</p>
<ul class="dash">
<li>The tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is standing or sitting in an upright position.</li>
<li>Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.</li>
<li>Plain water is the only drink that should be taken with Bondronat. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.</li>
<li>Patients should not lie down for 60 minutes after taking Bondronat.</li>
</ul>
<p><em>Patients with hepatic impairment</em><br>
No dosage adjustment is expected to be necessary (see 4.2.5 Pharmacokinetics in Special Populations – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Patients with renal impairment</em><br>
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary. For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended. For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly (<em>see section</em> 4.2.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Elderly</em><br>
No dose adjustment is necessary.</p>
<p><em>Children</em><br>
Safety and efficacy have not been established in patients less than 18 years old.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>3.1 Therapeutic Indications</strong><br>
Bondronat is indicated for the prevention of skeletal events associated with metastatic bone disease due to breast cancer.</p>
- Contraindications
- <p><strong>3.3 Contraindications</strong><br>
Bondronat film-coated tablets is contraindicated in patients with:</p>
<ul>
<li>hypocalcemia</li>
<li>known hypersensitivity to ibandronic acid or to any of its excipients</li>
<li>abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia</li>
<li>inability to stand or sit upright for at least 60 minutes</li>
</ul>
- Atc Code
- M05BA06
- Atc Item Name
- ibandronic acid
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
