- Approval Id
- 6042fdfaab3a6df8
- Drug Name
- ACTONEL ONCE-A-WEEK TABLET 35 MG
- Product Name
- ACTONEL ONCE-A-WEEK TABLET 35 MG
- Approval Number
- SIN12284P
- Approval Date
- 2003-04-30
- 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 plain water.</p>
<p>Actonel must be taken 30 minutes before the first food or drink other than water.</p>
<p>To facilitate delivery to the stomach, Actonel should be taken in an upright position and the patient should avoid lying down for 30 minutes.</p>
<p>Patients should not chew or suck on the tablet because of the potential for oropharyngeal irritation.</p>
<p>Osteoporosis: The recommended dose is 35mg once a week, taken on the same day each week. Patients should be instructed that if they miss a dose of ACTONEL 35mg Once-A-Week, they should take 1 tablet on the morning after they remember and return to taking 1 tablet once a week, as originally scheduled on their chosen day. Patient should not take 2 tablets on the same day.</p>
<p><em>Use in the elderly:</em> No dose adjustment is necessary.</p>
<p><em>Renal impairment:</em> 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><em>Children:</em> Safety and efficacy of Actonel has not been established in patients under 18 years of age.</p>
<p><em>Men:</em> No dose adjustment is necessary.</p>
<p><u>Compatibility with other Drugs</u><br>
Calcium, antacids, aluminium and some oral medications will interfere with the absorption of Actonel and therefore should be taken at a different time of the day.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<ul>
<li>Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures.</li>
<li>Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis.</li>
<li>To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses > 7.5mg/day prednisone or equivalent.</li>
<li>Treatment to increase bone mass in men with osteoporosis.</li>
</ul>
<p>The optimal duration of use of bisphosphates 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>
<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>
<li>Pregnancy & lactation</li>
<li>Severe renal impairment (creatinine clearance <30ml/min)</li>
</ul>
- Atc Code
- M05BA07
- Atc Item Name
- risedronic acid
- Pharma Manufacturer Name
- ZUELLIG PHARMA PTE. LTD.
