Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

norvasc_product

Indications¹

First-line treatment of hypertension; patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of amlodipine. First-line treatment of myocardial ischaemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature.

Clinical Evidence

Reduced the incidence of major cardiovascular events than the atenolol-based regimen²

23% relative risk reduction in the cumulative incidence of fatal and nonfatal stroke

16% relative risk reduction in the cumulative incidence of total cardiovascular events and procedures

Safety Profile¹

Very common & common adverse events¹

Flushing, fatigue, edema, dizziness, headache, palpitation, abdominal pain, nausea, somnolence

Drug Interactions¹

None

Dosages¹

For both hypertension and angina the usual initial dose is 5mg amlodipine once daily which may be increased to a maximum dose of 10mg depending on the individual patient’s response.

Use in Children

The recommended antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5 mg to 5 mg once daily.

Packing

Tab 5 mg x 30’s. 10 mg x 30’s.

Strengths

5 mg, 10 mg.

Important Safety Information

Contraindications¹

Amlodipine is contraindicated in patients with a known sensitivity to dihydropyridines, amlodipine, or any of the inert ingredients.

Precautions & Warnings

Use in Patients with Heart Failure¹

In a long-term, placebo controlled study (PRAISE-2) of Amlodipine in patients with NYHA III and IV heart failure of nonischemic etiology, amlodipine was associated with increased reports of pulmonary edema despite no significant difference in the incidence of worsening heart failure as compared to placebo.

Use in Patients with Impaired Hepatic Function¹

As with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established in these patients. The drug should therefore be administered with caution in these patients.

Common adverse events¹

Flushing, fatigue, edema, dizziness, headache, palpitation, abdominal pain, nausea, somnolence

Pregnancy & lactation¹

Pregnancy category: C

Safety of Amlodipine in lactation has not been established

Please refer to the full prescribing information for more safety information.

References

1. Norvasc PI (Jan 2006)
2. Dahlöf B, et al. Lancet 2005;366:895-906.

Please review the full product information or package insert before prescribing.

NOR11007P