- Approval Id
- 8e2de710112fea71
- Drug Name
- Tenox tablets 5 mg
- Product Name
- Tenox tablets 5 mg
- Approval Number
- SIN14548P
- Approval Date
- 2014-05-19
- Registrant
- SINGAPORE PHARMACEUTICAL PRIVATE LIMITED
- Licence Holder
- SINGAPORE PHARMACEUTICAL PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>For both hypertension and angina, the usual initial dose is 5 mg amlodipine once daily, which may be increased to a maximum dose of 10 mg depending on the individual patient’s response.</p>
<p>For patients with coronary artery disease, the recommended dosage range is 5 mg to 10 mg once daily. In clinical studies, the majority of patients required 10 mg once daily (see section 5.1. Pharmacodynamic properties - Use in Patients with Coronary Artery Disease – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta-blockers, and ACE inhibitors.</p>
<p><em>Use in the Elderly</em></p>
<p>Normal dosage regimens are recommended. Amlodipine, used at similar doses in the elderly or younger patients, is equally well-tolerated.</p>
<p><em>Use in Children</em></p>
<p>Safety and effectiveness of amlodipine in children have not been established.</p>
<p><em>Use in Patients with Impaired Hepatic Function</em></p>
<p>See section 4.4. Special warnings and precautions for use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><em>Use in Patients with Renal Failure</em></p>
<p>Amlodipine may be used at normal doses in patients with renal failure. Changes in amlodipine plasma concentrations are not correlated with the degree of renal impairment. Amlodipine is not dialyzable.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><u>Hypertension</u></p>
<p>Amlodipine is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, alpha blockers, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme (ACE) inhibitor.</p>
<p><u>Coronary Artery Disease</u></p>
<p><u><em>Chronic Stable Angina</em></u><br>
Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal drugs.</p>
<p><u><em>Vasospastic Angina (Prinzmetal’s or Variant Angina)</em></u><br>
Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy, or in combination with other antianginal drugs.</p>
<p><em><u>Angiographically Documented Coronary Artery Disease</u></em><br>
In patients with recently documented coronary artery disease (CAD) by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Amlodipine is contraindicated in patients with a known hypersensitivity to dihydropyridines* or any of the inert ingredients.</p>
<p>* Amlodipine is a dihydropyridine calcium channel blocker.</p>
- Atc Code
- C08CA01
- Atc Item Name
- amlodipine
- Pharma Manufacturer Name
- SINGAPORE PHARMACEUTICAL PRIVATE LIMITED
