FELODUR ER

What it is

FELODUR ER is a modified release tablet containing felodipine in strengths of 2.5 mg, 5 mg, or 10 mg. Felodipine is a calcium antagonist which lowers arterial blood pressure by decreasing peripheral vascular resistance. Felodipine 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.

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, with the usual maintenance dose being 5 mg to 10 mg daily. Doses higher than 20 mg daily of FELODUR ER are not recommended. FELODUR ER tablets should be swallowed whole and taken with water and must not be divided, crushed or chewed.

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 and/or severity of angina, particularly in patients who have severe obstructive coronary artery disease, and the possibility of precipitation of myocardial ischaemia exists, 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/peridontitis, but the enlargement can be avoided or reversed by careful dental hygiene.

Contraindications

FELODUR ER is contraindicated in pregnancy, including the early stages, 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 a contraindication. FELODUR ER is contraindicated in uncompensated heart failure, acute myocardial infarction, unstable angina pectoris, haemodynamically significant cardiac valvular obstruction, and dynamic cardiac outflow obstruction.

PBS listing

FELODUR ER 5 mg tablets are listed on the PBS with an ex-manufacturer price of A$3.75, with both unrestricted and restricted items available. FELODUR ER 10 mg tablets are listed on the PBS with an ex-manufacturer price of A$6.79, with both restricted and unrestricted items available.

Regulatory history

FELODUR ER was first listed on the ARTG on 10 November 1997, with registrations for 2.5 mg, 5 mg, and 10 mg extended release tablet formulations.