NORVASC 5MG TABLET
Each 5-mg and 10-mg tablet contains amlodipine besilate equivalent to amlodipine 5 mg and 10 mg, respectively.
Norvasc also contains the following excipients: Calcium hydrogen phosphate anhydrous, microcrystalline cellulose, magnesium stearate, sodium starch glycollate.
Amlodipine besilate is the besilate salt of amlodipine, a long-acting calcium-channel blocker. It is 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulphonate. Its empirical formula is C20H25ClN2O5?C6H6O3S and has a molecular weight of 567.1.
Amlodipine besilate is a white crystalline powder and is slightly soluble in water and sparingly soluble in ethanol.
Indications / Uses :
Hypertension: 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, a-blockers, ?-adrenoceptor-blocking agent or an angiotensin-converting enzyme inhibitor.
Amlodipine besilate is also indicated to reduce the risk of fatal coronary heart disease and nonfatal myocardial infarction, and to reduce the risk of stroke.
Coronary Artery Disease: Reduce the risk of coronary revascularization and the need for hospitalization due to angina in patients with coronary artery disease.
Chronic Stable Angina: First-line treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal’s or variant angina) of coronary vasculature. Amlodipine besilate may be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of ?-blockers.
May be taken with or without food.
Hypersensitivity to dihydropyridines*, amlodipine or to any of the excipients of Norvasc.
*Amlodipine is a dihydropyridine calcium-channel blocker.
Special Precautions :
Use in Patients with Heart Failure: In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA class III and IV heart failure of non-ischemic etiology, amlodipine was associated with increased reports of pulmonary edema despite no significant differences in the incidence of worsening heart failure compared to placebo (see Pharmacology: Pharmacodynamics under Actions).
Use in Patients with Impaired Hepatic Function: As with all calcium antagonists, amlodipine t? is prolonged in patients with impaired liver function and dosage recommendations have not been established in these patients. Norvasc should therefore be administered with caution in these patients.
Effects on the Ability to Drive or Operate Machinery: Clinical experience with amlodipine indicates that it is unlikely to impair a patient’s ability to drive or use machinery.