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Norvasc (Amlodipine Besylate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

1. Hypertension

NORVASC 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

NORVASC is indicated for the symptomatic treatment of chronic stable angina. NORVASC may be used alone or in combination with other antianginal agents.

Vasospastic Angina (Prinzmetal's or Variant Angina)

NORVASC is indicated for the treatment of confirmed or suspected vasospastic angina. NORVASC 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%, NORVASC is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.

DOSAGE AND ADMINISTRATION

Adults

The usual initial antihypertensive oral dose of NORVASC is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding NORVASC to other antihypertensive therapy.

Dosage should be adjusted according to each patient's need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

The recommended dose for chronic stable or vasospastic angina is 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect. See ADVERSE REACTIONS section for information related to dosage and side effects.

The recommended dose range for patients with coronary artery disease is 5–10 mg once daily. In clinical studies the majority of patients required 10 mg (see CLINICAL PHARMACOLOGY, Clinical Studies).

Children

The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients. See CLINICAL PHARMACOLOGY.

Co-administration with Other Antihypertensive and/or Antianginal Drugs

NORVASC has been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitroglycerin.

HOW SUPPLIED

NORVASC–2.5 mg Tablets (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, diamond, flat-faced, beveled edged engraved with "NORVASC" on one side and "2.5" on the other side and supplied as follows:

  NDC 0069-1520-68          Bottle of 90

NORVASC–5 mg Tablets (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both "NORVASC" and "5" on one side and plain on the other side and supplied as follows:

  NDC 0069-1530-68          Bottle of 90
  NDC 0069-1530-41          Unit Dose package of 100
  NDC 0069-1530-72          Bottle of 300

NORVASC–10 mg Tablets (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white, round, flat-faced, beveled edged engraved with both "NORVASC" and "10" on one side and plain on the other side and supplied as follows:

  NDC 0069-1540-68          Bottle of 90
  NDC 0069-1540-41          Unit Dose package of 100

Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).

Rx only

LAB-0014-6.0

August 2006

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