- Approval Id
- 74c8656c88f1a7cd
- Drug Name
- ACTOS TABLET 30 mg
- Product Name
- ACTOS TABLET 30 mg
- Approval Number
- SIN12442P
- Approval Date
- 2003-10-10
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
<em><strong>actos</strong></em>® should be taken orally once daily with or without food.<br>
<strong>Dosage in Adults</strong><br>
<em><strong>actos</strong></em>® may be initiated at 15 mg or 30mg once daily. The dose may be increased to up to a maximum dose of 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.<br>
In combination with metformin, the current metformin dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycaemia, the dose of metformin should be decreased.</p>
<p>In combination with sulphonylurea, the current sulphonylurea dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycaemia, the dose of sulphonylurea should be decreased.</p>
<p>The dose of <em><strong>actos</strong></em>® should not exceed 45 mg once daily in monotherapy or in combination with metformin or sulphonylurea.</p>
<p><strong>Elderly</strong><br>
No dosage adjustment is necessary for elderly patients.</p>
<p><strong>Patients with renal impairment</strong><br>
No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance > 4ml/min). No information is available from dialysed patients therefore pioglitazone should not be used in such patients.</p>
<p><strong>Patients with hepatic impairment</strong><br>
Pioglitazone should not be used in patients with hepatic impairment.</p>
<p><strong>Children and adolescents</strong><br>
There are no data available on the use of pioglitazone in patients under 18 years of age, and therefore its use is not recommended in this age group.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong><br>
<em><strong>actos</strong></em>® is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.</p>
<p><em><strong>actos</strong></em>® is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or sulphonylurea :</p>
<ul>
<li>In combination with metformin particularly in overweight patients</li>
<li>In combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated</li>
</ul>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
<em><strong>actos</strong></em>® is contraindicated in patients with the following conditions:</p>
<ul class="dash">
<li>known hypersensitivity to pioglitazone or to any of the excipients of the tablet</li>
<li>cardiac failure or history of cardiac failure (NYHA stages I to IV)</li>
<li>hepatic impairment</li>
<li>active or history of bladder cancer</li>
<li>uninvestigated macroscopic haematuria</li>
</ul>
<p><em><strong>actos</strong></em>® is also contraindicated for use in combination with insulin.</p>
- Atc Code
- A10BG03
- Atc Item Name
- pioglitazone
- Pharma Manufacturer Name
- CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
