NORVASC® (amlodipine besylate) Tablets Description

Print this page | Cancel

New user?

Why Register?

----------------------------------------------

Returning user?

----------------------------------------------

Forgot Password?

Registration FAQs

Patient Education Materials

Patient Assistance Programs

Clinical Trials

Pipeline

Pfizer Contacts

Pfizer Medical Information
(Search Medical Responses)

WyethHCP.com
(Access Wyeth for Professionals)

Explore Other Online Resources

ppn-vr-sso-links.htm

To report an adverse event or to speak to a member of Pfizer Medical Information, please call 1-800-438-1985

Prescribing Information

NORVASC^® (amlodipine besylate) Tablets
Description


	Return to the NORVASC Product Center

NORVASC^® 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•C₆H ₆O₃S, and its structural formula is:

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. NORVASC (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 magnesium stearate.

PRINTER-FRIENDLY

NORVASC Indication and Important Safety Information

Please scroll to see the Indication below.

Important Safety Information

NORVASC is indicated for the treatment of hypertension and angina.

In clinical trials, the most common side effects versus placebo were edema (8.3% vs 2.4%), headache (7.3% vs 7.8%), fatigue (4.5% vs 2.8%), and dizziness (3.2% vs 3.4%).

Generally CCBs should be used with caution in patients with heart failure. In studies with NORVASC, there has been no evidence of worsened heart failure.

Indication

Amlodipine

1, Hypertension: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents;

2. Coronary Artery Disease (CAD)
Chronic Stable Angina: Amlodipine is indicated for the treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal or antihypertensive agents;
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 CAD: In patients with recently documented 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.

Please see full prescribing information.

NORVASC ^® (amlodipine besylate)