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AMLODIPINE

NORVASC

10mg, Tablet

Indication*

Hypertension: Amlodipine besilate in 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 (other than amlodipine) may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, alpha blocker, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine besilate is also indicated to reduce the risk of fatal coronary heart diease (CHD) and non-fatal myocardial infarction (MI), and to reduce the risk of stroke. Coronary Artery Disease: Amlodipine besilate is indicated to reduce the risk of coronary revascularization and the need for hospitalization due to angina in patients with coronary artery disease (CAD). Chronic Stable Angina: Amlodipine besilate in indicated for the first-line treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Amlodipine besilate may be used alone, as monotherapy, or in combination with other anti-anginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta-blockers.

Directions for Use*

For hypertension, dosage range of amlodipine is 2.5 to 10mg once daily, depending on the patient's blood pressure level. For angina, the usual initial dose is 5 mg amlodipine once daily, which may be increased to a maximum dose of 10mg depending on the individual patient's response. For patients with coronary artery disease, the recommended dosage range is 5mg to 10mg once daily. In clinical studies, the majority of patients required 10mg. Pharmacodynamics: Use in Patients with Coronary Artery Disease under Actions. No dose adjustment of amlodipine besilate is required upon concomitant administration of thiazide diuretics, beta-blockers and ACE inhibitors. Use in Children: The recommended antihypertensive oral dose in pediatric patients aged 6 to 17 years is 2.5 to 5mg once daily. Doses in excess of 5mg daily have not been studied in pediatric patients. The effect of amlodipine on blood pressure in patients younger than 6 years of age is not known. Use in Patients with Impaired Hepatic Function: 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.

Administration*

May be taken with or without food.

*written indications, directions, and administration are updated as of May 11, 2025 and may not be accurate with the actual product purchased. Please read the details in the packaging.

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