- Approval Id
- 77b0c1d9271cc87c
- Drug Name
- LOSARTAN HEXAL 50MG FILM-COATED TABLETS
- Product Name
- LOSARTAN HEXAL 50MG FILM-COATED TABLETS
- Approval Number
- SIN13852P
- Approval Date
- 2010-08-25
- Registrant
- SANDOZ SINGAPORE PTE. LTD.
- Licence Holder
- SANDOZ SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
<strong>Posology</strong><br>
Losartan may be administered with other antihypertensive agents.</p>
<p><u>Hypertension</u><br>
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3–6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily.</p>
<p>For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>No initial dosage adjustment is necessary for elderly patients up to 75 years of age, or for patients with mild renal impairment. For patients above 75 years of age, patients with moderate to severe renal impairment and patients on dialysis, a lower starting dose of 25 mg is recommended. A lower dose should be considered for patients with a history of hepatic impairment (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p><u>Renal Protection in Type 2 Diabetic Patients with Proteinuria</u><br>
The usual starting dose is 50 mg once daily.<br>
The dose may be increased to 100 mg once daily based on blood pressure response.<br>
Losartan may be administered with other antihypertensive agents (e.g., diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycaemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).</p>
<p><u>Reduction in the Risk of Stroke in Hypertensive Patients with Left Ventricular Hypertrophy</u><br>
The usual starting dose is 50 mg of Losartan once daily. A low dose of hydrochlorothiazide should be added and/or the dose of Losartan should be increased to 100 mg once daily based on blood pressure response.</p>
<p><strong>Method of administration</strong><br>
Losartan should be swallowed with a glass of water.<br>
Losartan may be administered with or without food.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<ul>
<li>Losartan is indicated for the treatment of hypertension.</li>
<li>Losartan is indicated for the reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Losartan is indicated to delay the progression of renal disease as measured by a reduction in the incidence of doubling of serum creatinine and end stage renal disease (need for dialysis or renal transplantation), and to reduce proteinuria (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
Losartan is contraindicated in patients who are hypersensitive to any component of this product.<br>
The concomitant use of losartan 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 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- C09CA01
- Atc Item Name
- losartan
- Pharma Manufacturer Name
- SANDOZ SINGAPORE PTE. LTD.
