NORVASC TABLET 10 MG [SIN05278P]

Product Info

NORVASC TABLET 10 MG

[SIN05278P]

4.1 Therapeutic indications

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.

4.2 Posology and method of 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 (see section 5.1. Pharmacodynamic properties - Use in Patients with Coronary Artery Disease – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 4.4. 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.

4.3 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.