- Approval Id
- ae4a6531359461d1
- Drug Name
- AMVAL FILM COATED TABLETS 5MG/160MG
- Product Name
- AMVAL FILM COATED TABLETS 5MG/160MG
- Approval Number
- SIN17358P
- Approval Date
- 2025-10-10
- Registrant
- SEA PHARMA CONSULTANCY PTE LTD
- Licence Holder
- SEA PHARMA CONSULTANCY PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE REGIMEN AND ADMINISTRATION</strong><br>
<strong>General target population</strong><br>
The recommended dose of Amval is one tablet per day.</p>
<p>A patient whose blood pressure is not adequately controlled on monotherapy may be switched to combination therapy with Amval. When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered. Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination.</p>
<p>Amval may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Amval as initial therapy for hypertension should be based on an assessment of potential benefits and risks.</p>
<p>For initial therapy, the usual starting dose is Amval 5/80 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure. Amval is not recommended as initial therapy in patients with intravascular volume depletion (see Warnings and Precautions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The maximum dose is 10/320 mg. Amval can be used with or without food. It is recommended to take Amval with some water.</p>
<p>For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Amval containing the same component doses.</p>
<p><strong>Special populations</strong><br>
<strong>Renal impairment</strong><br>
No dosage adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment.</p>
<p><strong>Hepatic impairment</strong><br>
Due to amlodipine and valsartan,caution should be exercised when administering Amval to patients with hepatic impairment or biliary obstructive disorders. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of Amval contains 5 mg of amlodipine. (See Warnings and Precautions and Clinical Pharmacology – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.</p>
<p><strong>Geriatric patients (aged 65 years or above)</strong><br>
In elderly patients, no dose adjustment of the starting dose is required. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of Amval contains 5 mg of amlodipine. However, caution is required when increasing the dosage. (See section CLINICAL PHARMACOLOGY – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Pediatric patients (below 18 years)</strong><br>
Amval is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATION</strong><br>
Treatment of essential hypertension</p>
<p>Amval is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<ul>
<li>Known hypersensitivity to amlodipine, valsartan, to dihydropyridine derivatives, or to any of the excipients.</li>
<li>Severe hepatic impairment, biliary cirrhosis or cholestasis.</li>
<li>Severe renal impairment (GFR <30 ml/min/1.73 m2) and patients undergoing dialysis.</li>
<li>Pregnancy (see section PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>The concomitant use of amlodipine/valsartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2) (see section INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
