- Approval Id
- bb2fca67436cdb69
- Drug Name
- ATACAND PLUS TABLET
- Product Name
- ATACAND PLUS TABLET
- Approval Number
- SIN11383P
- Approval Date
- 2000-08-26
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
<strong>Dosage in Hypertension</strong><br>
The recommended dose of Atacand Plus is 1 tablet once daily.</p>
<p>The dose of candesartan cilexetil should be titrated before switching to Atacand Plus.</p>
<p>Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment.<br>
When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered. Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy.</p>
<p><em><u><strong>Administration</strong></u></em><br>
Atacand Plus should be taken once daily with or without food.</p>
<p><u><em><strong>Use in the elderly</strong></em></u><br>
No dosage adjustment is necessary in elderly patients.</p>
<p><u><em><strong>Use in patients with intravascular volume depletion</strong></em></u><br>
Dose titration of candesartan cilexetil is recommended in patients at risk for hypotension, such as patients with possible volume depletion (an initial dose of candesartan cilexetil of 4 mg may be considered in these patients).</p>
<p><u><em><strong>Use in impaired renal function</strong></em></u><br>
In patients with mild to moderate renal impairment (ie, creatinine clearance between 30–80 ml/min/1.73 m<sup>2</sup> BSA), a dose titration is recommended.</p>
<p>Atacand Plus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m<sup>2</sup> BSA).</p>
<p><u><em><strong>Use in impaired hepatic function</strong></em></u><br>
Patients with hepatic impairment: Dose titration is recommended in patients with mild to moderate chronic liver disease.</p>
<p>Atacand Plus should not be used in patients with severe hepatic impairment and/or cholestasis.</p>
<p><strong><em><u>Use in children</u></em></strong><br>
The safety and efficacy of Atacand Plus have not been established in children.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
Hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
Hypersensitivity to the active substances or to any of the excipients or to sulfonamide derived drugs (hydrochlorothiazide is a sulfonamide derived drug) or to any of the excipients.</p>
<p>Pregnancy and lactation (see section Fertility, pregnancy and lactation – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Severe renal impairment (creatinine clearance < 30 ml/min/1.73 m<sup>2</sup> BSA).</p>
<p>Severe hepatic impairment and/or cholestasis.</p>
<p>Refractory hypokalaemia and hypercalcaemia.</p>
<p>Gout.</p>
<p>The concomitant use of Atacand Plus with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m<sup>2</sup>) (see section Interaction with other medicinal products and other form of interaction – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- C09DA06
- Atc Item Name
- candesartan and diuretics
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
- Company Detail Path
- /organization/astrazeneca-singapore-pte-ltd
