PLENDIL ER

What it is

PLENDIL ER is a calcium antagonist which lowers arterial blood pressure by decreasing peripheral vascular resistance. It exhibits a high degree of selectivity for smooth muscle in the arterioles and in therapeutic doses has no direct effect on cardiac contractility or conduction. PLENDIL ER is available in three strengths: 2.5 mg, 5 mg, and 10 mg felodipine modified release tablets.

Approved indications

— Hypertension.

Dosing overview

Treatment should be started with 5 mg once daily. In elderly patients a starting dose of 2.5 mg once daily should be considered. If necessary, the dose can be increased in 2.5 or 5 mg/day increments. The usual maintenance dose is 5 mg to 10 mg daily. Doses higher than 20 mg daily of PLENDIL ER are not recommended. PLENDIL ER tablets should be swallowed whole and taken with water and must not be divided, crushed or chewed. The dose of felodipine should be reduced in patients with severely impaired hepatic function. Impaired renal function does not influence felodipine peak plasma concentrations or area under the curve, and a dosage reduction is not necessary for patients with renal impairment.

Key safety warnings

Because felodipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of felodipine is suggested, with close observation especially recommended for patients already taking medications that are known to lower blood pressure. Felodipine, like other vasodilators, can cause hypotension, which, in susceptible individuals, may result in myocardial ischaemia. Rarely, too great a reduction in blood pressure with an initial reflexogenic increase in heart rate may lead to increased frequency, duration or severity of angina, particularly in patients with severe obstructive coronary artery disease, with the possibility of precipitation of myocardial ischaemia existing, which may occur in the initial stages of felodipine treatment or following a dosage increase. Mild to moderate peripheral oedema resulting from precapillary vasodilation may occur in about 20% of patients treated with felodipine, and this oedema appears to be dose related. Mild gingival enlargement has been reported in patients with pronounced gingivitis or peridontitis, and the enlargement can be avoided or reversed by careful dental hygiene. Clinical data on the use of felodipine in children are unavailable and its use in this age group is not recommended.

Contraindications

Pregnancy, including the early stages, is a contraindication, and women who are likely to become pregnant should not be treated with felodipine. Known hypersensitivity to felodipine or any other component of the product is contraindicated. PLENDIL ER is also contraindicated in uncompensated heart failure, acute myocardial infarction, unstable angina pectoris, haemodynamically significant cardiac valvular obstruction, and dynamic cardiac outflow obstruction.

Regulatory history

PLENDIL ER felodipine was first listed on the Australian Register of Therapeutic Goods on 6 July 1995 for three strengths: 2.5 mg, 5 mg, and 10 mg extended release tablets.