- Approval Id
- e0f14bf991a1db0f
- Drug Name
- ACTONEL® ONCE -A-MONTH FILM COATED TABLET 150MG
- Product Name
- ACTONEL® ONCE -A-MONTH FILM COATED TABLET 150MG
- Approval Number
- SIN13948P
- Approval Date
- 2011-04-18
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p>Actonel must only be taken with <strong>plain water</strong>.<br>
Plain water is the only drink that should be taken with Actonel tablets. Please note that some mineral waters or water from regional areas may have a higher concentration of calcium and therefore should not be used.<br>
Actonel must be taken 30 minutes before the first food or drink other than water. To facilitate delivery to the stomach, Actonel should be taken in an upright position and the patient should avoid lying down for 30 minutes. Patients should not chew or suck on the tablet because of the potential for oropharyngeal irritation.</p>
<p><strong>Osteoporosis:</strong></p>
<p>Actonel 150 mg tablets should be taken orally once a month. The tablet should be taken on the same date each month.<br>
Patients who miss a dose of Actonel 150 mg Once-a-Month should be instructed to take one Actonel 150 mg tablet the morning after the day it is remembered, unless the time to the next month's scheduled doses are within 7 days.<br>
If the next month's scheduled doses of Actonel 150 mg are within 7 days, patients should wait until their next month's scheduled doses and then continue taking Actonel 150 mg as originally scheduled.</p>
<p><strong>Use in the Elderly:</strong></p>
<p>No dose adjustment is necessary.</p>
<p><strong>Renal Impairment:</strong></p>
<p>No dose adjustment is necessary in patients with mild to moderate renal insufficiency (creatinine clearance 30 to 60 mL/minute). Actonel is not recommended in patients with severe renal impairment (creatinine clearance < 30 mL/minute) due to limited clinical data.</p>
<p><strong>Paediatrics:</strong></p>
<p>Safety and efficacy of Actonel has not been established in patients under 18 years of age.</p>
<p><strong>Compatibility with other Drugs:</strong></p>
<p>Calcium, antacids, aluminum and some oral medications will interfere with the absorption of risedronate and therefore should be taken at different time of the day.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<p>Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures, and the treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures.</p>
<p>The optimal duration of use of bisphosphonate for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p><u>Risedronate</u></p>
<ul>
<li>Known hypersensitivity to the drug or any of the ingredients.</li>
<li>Hypocalcaemia (see Precautions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Inability to stand or sit upright for at least 30 minutes.</li>
</ul>
- Atc Code
- M05BA07
- Atc Item Name
- risedronic acid
- Pharma Manufacturer Name
- ZUELLIG PHARMA PTE. LTD.
- Company Detail Path
- /organization/zuellig-pharma-pte-ltd
