Versant-XR Special Precautions

Hypotension: Felodipine, like other calcium antagonists, may occasionally precipitate significant hypotension and, rarely, syncope. It may lead to reflex tachycardia which, in susceptible individuals, may precipitate angina pectoris.
Heart Failure: Although acute hemodynamic studies in a small number of patients with NYHA Class II or III heart failure treated with felodipine have not demonstrated negative inotropic effects, the safety of felodipine in patients with heart failure has not been established. Thus, exercise caution when using felodipine in patients with heart failure or compromised ventricular function, particularly in combination with a beta-blocker.
Peripheral Edema: The most common adverse effect associated with felodipine in clinical studies is peripheral edema (generally mild and not associated with generalized fluid retention) (see Pharmacology: Pharmacodynamics under Actions). The incidence of peripheral edema was both dose and age dependent. This adverse effect generally occurs within 2 to 3 weeks after initiation of felodipine treatment.
Use in Children: The safety and efficacy of felodipine in children have not been established.
Use in the Elderly: Clinical studies on felodipine did not include sufficient numbers of subjects 65 years and older to determine whether they respond differently from younger subjects. General caution must be observed in dosing for an elderly since felodipine plasma levels appear to be higher in older patients.