Norvasc may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

Hypertension:

• For the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Coronary Artery Disease:

• Chronic Stable Angina: 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): For the treatment of confirmed or suspected vasospastic angina. NORVASC may be used as monotherapy or in combination with other antianginal agents.

• 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 for angina and to reduce the risk of a coronary revascularization procedure.

Doses in excess of 5 mg daily have not been studied in pediatric patients.

Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of NORVASC, particularly in patients with severe obstructive coronary artery disease.

Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment.

No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.

Monitor for hypotension when sildenafil is co-administered with amlodipine.

Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate.

The limited available data based on post-marketing reports with NORVASC use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal studies: decreased litter size and intrauterine deaths.

Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%.

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• Dosage greater than 5 mg per day for pediatric patients. GoToSource

• Dosage greater than 10 mg per day for adult patients. GoToSource

• Pulmonary hypertension. GoToSource

• Cluster headaches and migraines. GoToSource

• Congestive heart failure. GoToSource 

• Raynaud’s syndrome. GoToSource

Use of calcium-channel blockers for 10 or more years is associated with higher risk of ductal breast cancer. GoToSource

Hypotension (low blood pressure). GoToSource

Liver injury, jaundice and elevated hepatic enzymes. GoToSource

Lymphomatoid drug reactions including diffuse erythema (skin redness) with desquamation to macules, papules and annular plaques (skin lesions). GoToSource 

Toxic epidermal necrolysis (potentially life-threatening skin disorder). GoToSource

Gingival hyperplasia (enlarged gums) and palpitations (irregular or rapid heartbeat). GoToSource 

Extrapyramidal (movement) disorders. GoToSource

Dysgeusia (loss of taste sensation), peripheral edema (accumulation of fluid causing swelling), gynecomastia (enlargement of male breast tissue), impotence, depression, insomnia, tachycardia (rapid heart rate), hepatitis (inflammation of the liver), hyperglycemia (high blood sugar), tremor and stevens-johnson syndrome (severe skin reaction).  GoToSource

Lawsuits filed for stevens-johnson syndrome.