amlodipine

Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-
4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its
empirical formula is C20H25CIN2O5•C6H6O3S,

Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly
soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as white
tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active
ingredient, amlodipine besylate, each tablet contains the following inactive ingredients:
microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and

Hypertension

Amlodipine besylate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. 2. Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. They may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina) Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. They may be used as monotherapy or in combination with other antianginal drugs. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction

CONTRAINDICATIONS

Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

WARNINGS

Increased Angina and/or Myocardial Infarction: Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.

PRECAUTIONS General

Since the vasodilation induced by amlodipine besylate tablets is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering amlodipine besylate tablets, particularly in patients with severe aortic stenosis. Use in Patients with Congestive Heart Failure: In general, calcium channel blockers should be used with caution in patients with heart failure. Amlodipine besylate tablets (5-10 mg per day) have been studied in a placebo-controlled trial of 1153 patients with NYHA Class III or IV heart failure (see CLINICAL PHARMACOLOGY) on stable doses of ACE inhibitor, digoxin, and diuretics. Follow-up was at least 6 months, with a mean of about 14 months. There was no overall adverse effect on survival or cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure). Amlodipine besylate tablets have been compared to placebo in four 8-12 week studies of patients with NYHA class II/III heart failure, involving a total of 697 patients. In these studies, there was no evidence of worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms, or LVEF.

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