Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**DOSAGE AND ADMINISTRATION:** 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. 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. No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta-blockers, and ACE inhibitors. _**Use in the Elderly**_ Normal dosage regimens are recommended. Amlodipine, used at similar doses in the elderly or younger patients, is equally well-tolerated. _**Use in Children**_ Safety and effectiveness of amlodipine in children have not been established. _**Use in Patients with Impaired Hepatic Function**_ See “Special warnings and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _**Use in Patients with Renal Failure**_ 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.
ORAL
Medical Information
**INDICATIONS & USES:** **Hypertension** 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. **Coronary Artery Disease** _**Chronic Stable Angina**_ Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal drugs. _**Vasospastic Angina (Prinzmetal’s or Variant Angina)**_ 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. _**Angiographically Documented Coronary Artery Disease**_ 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.
**CONTRAINDICATIONS:** Amlodipine is contraindicated in patients with a known hypersensitivity to dihydropyridines\* or any of the inert ingredients. \\* Amlodipine is a dihydropyridine calcium channel blocker.
C08CA01
amlodipine
Manufacturer Information
HALDANE PHARMACEUTICALS PTE. LTD.
Ind-Swift Limited.
Active Ingredients
Documents
Package Inserts
Amlodane Tablet PI.pdf
Approved: February 11, 2022