Felodipine warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Warnings and Precautions
PRECAUTIONS
General
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. (See ADVERSE REACTIONS.)
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, safety in patients with heart failure has not been established. Caution, therefore, should be exercised when using PLENDIL in patients with heart failure or compromised ventricular function, particularly in combination with a beta blocker.
Patients with Impaired Liver Function – Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of PLENDIL; therefore, a starting dose of 2.5 mg once a day is recommended. These patients should have their blood pressure monitored closely during dosage adjustment of PLENDIL. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION.)
===Peripheral Edema – Peripheral edema, generally mild and not associated with generalized fluid retention, was the most common adverse event in the clinical trials. The incidence of peripheral edema was both dose and age dependent. Frequency of peripheral edema ranged from about 10% in patients under 50 years of age taking 5 mg daily to about 30% in those over 60 years of age taking 20 mg daily. This adverse effect generally occurs within 2−3 weeks of the initiation of treatment.[1]
References
- ↑ "PLENDIL (FELODIPINE) TABLET, EXTENDED RELEASE [ASTRAZENECA LP]". Retrieved 28 February 2014.