- Approval Id
- 215365c9fae14934
- Drug Name
- COZAAR®XQ® TABLET 5MG/100MG
- Product Name
- COZAAR®XQ® TABLET 5MG/100MG
- Approval Number
- SIN14193P
- Approval Date
- 2012-07-16
- Registrant
- ORGANON SINGAPORE PTE. LTD.
- Licence Holder
- ORGANON SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p>The recommended dose of COZAAR XQ is one tablet per day.</p>
<p>COZAAR XQ may be administered with or without food. It is recommended to take COZAAR XQ with water. Taking COZAAR XQ on a regular schedule (i.e. every morning) is recommended.</p>
<p>Dosage adjustment with each active ingredient (amlodipine or losartan) is recommended prior to starting COZAAR XQ. A patient whose blood pressure is not adequately controlled with losartan alone or amlodipine alone may be switched to combination therapy with COZAAR XQ.</p>
<p>COZAAR XQ 5 mg/50 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or losartan 50 mg alone.</p>
<p>COZAAR XQ 5 mg/100 mg may be administered in patients whose blood pressure is not adequately controlled with losartan 100 mg or COZAAR XQ 5 mg/50 mg.</p>
<p>A patient co-administered with losartan and amlodipine may be switched to COZAAR XQ (fixed dose combination containing same dose of each ingredient) for compliance improvement.</p>
<p><u><em>Use in patients with renal impairment</em></u><br>
No dosage adjustment is necessary in patients with mild renal impairment (i.e. creatinine clearance 20–50 mL/min). For patients with moderate to severe renal impairment (i.e. creatinine clearance <20 mL/min) or patients on dialysis, administration of COZAAR XQ is not recommended.</p>
<p><em><u>Use in patients with intravascular volume depletion</u></em><br>
COZAAR XQ is not recommended for patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics).</p>
<p><em><u>Use in patients with hepatic impairment</u></em><br>
In cases where a lower dose of losartan (i.e. 25 mg once daily) is required for patients with a history of hepatic impairment, administration of COZAAR XQ is not recommended.</p>
<p><u><em>Use in the elderly</em></u><br>
A starting dose of 25 mg of losartan once daily is recommended in elderly patients for those over 75 years, thus, administration of COZAAR XQ (combination) for initial dose is not recommended in elderly patients for those over 75 years.</p>
<p><u><em>Use in adolescents and children</em></u><br>
Since safety and efficacy of COZAAR XQ in children ≤18 years of age has not been established, administration of COZAAR XQ is not recommended.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<p>Essential hypertensive patients not adequately controlled with amlodipine or losartan monotherapy.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<ol>
<li>Patient with known history of sensitivity to active ingredients or dihydropyridines or patients who are hypersensitive to any component of this product.</li>
<li>Pregnancy or possible to be pregnant, nursing mothers (see PREGNANCY and NURSING MOTHERS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Severe hepatic impairment.</li>
<li>Severe aortic valvular stenosis.</li>
<li>Patient in shock.</li>
<li>The concomitant use of COZAAR XQ with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73m<sup>2</sup>) (see DRUG INTERACTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ol>
- Atc Code
- C09DB06
- Atc Item Name
- losartan and amlodipine
- Pharma Manufacturer Name
- ORGANON SINGAPORE PTE. LTD.
