Trade Names:Norvasc- Tablets 2.5 mg- Tablets 5 mg- Tablets 10 mg
Inhibits movement of calcium ions across cell membrane in systemic and coronary vascular smooth muscle.
T max is 6 to 12 h. Bioavailability is 64% to 90%. Steady state is reached after 7 to 8 days of consecutive daily dosing.
About 93% is protein bound.
About 90% is converted to inactive metabolites in the liver.
10% of the parent compound and 60% of the metabolites are excreted in the urine. Elimination is biphasic. Half-life is about 30 to 50 h.
Pharmacokinetics not significantly influenced.Hepatic Function Impairment
Cl is decreased and AUC may increase about 40% to 60%.Elderly
Cl is decreased and AUC may increase about 40% to 60%.Moderate to severe heart failure
Cl is decreased and AUC may increase about 40% to 60%.
Treatment of hypertension; treatment of chronic stable angina; or vasospastic (Prinzmetal or variant) angina; reduction of the risk of hospitalization caused by angina; reduction of the risk of coronary revascularization procedure in patients with recently documented coronary artery disease (CAD).
PO Initial dose is 5 mg daily (max, 10 mg daily). 2.5 mg daily when adding amlodipine to other antihypertensive therapy.Children 6 to 17 years of age
PO 2.5 to 5 mg once daily.CADAdults
PO 5 to 10 mg once daily.Chronic stable or vasospastic anginaAdults
PO 5 to 10 mg once daily.Elderly
PO Start with 5 mg once daily.Hepatic ImpairmentHypertension
PO Initially 2.5 mg every day.Chronic stable or vasospastic angina
PO Start with 5 mg once daily.Elderly
PO Initially 2.5 mg every day.
Store at 59° to 86°F.
Concurrent use may increase the plasma concentrations of amlodipine.Protease inhibitors (eg, ritonavir)
Pharmacologic effects of amlodipine may be increased.Vasopressin receptor antagonists (conivaptan)
Plasma concentrations of amlodipine may be increased.
None well documented.
Flushing, palpitations (5%).
Headache (7%); fatigue (5%); dizziness (3%); somnolence (2%).
Nausea (3%); abdominal pain (2%).
Hepatic enzyme elevations, jaundice (postmaketing).
Edema (15%); gynecomastia (postmarketing).
Category C .
Safety and efficacy not established in children younger than 6 yr of age.
May require lower initial dose.
Use with caution in patients with severe hepatic impairment.
Use with caution in patients with severe aortic stenosis or CHF.
May occur when starting therapy or at the time of dosage increase.
Abrupt withdrawal may cause increased frequency and duration of chest pain. Gradually taper dose if amlodipine is to be discontinued.
Hypotension, peripheral vasodilation, reflex tachycardia.
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