Plendil (Felodipine) - Indications and Dosage

INDICATIONS AND USAGE

PLENDIL is indicated for the treatment of hypertension.

PLENDIL may be used alone or concomitantly with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

The recommended starting dose is 5 mg once a day. Depending on the patient's response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5−10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS). Modification of the recommended dosage is usually not required in patients with renal impairment.

PLENDIL should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). PLENDIL should be swallowed whole and not crushed or chewed.

Geriatric Use – Patients over 65 years of age are likely to develop higher plasma concentrations of felodipine (see CLINICAL PHARMACOLOGY). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment.

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, patients should have their blood pressure monitored closely during dosage adjustment of PLENDIL (see CLINICAL PHARMACOLOGY).

HOW SUPPLIED

No. 3584 — Tablets PLENDIL, 2.5 mg, are sage green, round convex tablets, with code 450 on one side and PLENDIL on the other. They are supplied as follows:

NDC 0186-0450-28 unit dose packages of 100

NDC 0186-0450-58 unit of use bottles of 100

No. 3585 — Tablets PLENDIL, 5 mg, are light red-brown, round convex tablets, with code 451 on one side and PLENDIL on the other. They are supplied as follows:

NDC 0186-0451-28 unit dose packages of 100

NDC 0186-0451-58 unit of use bottles of 100

No. 3586 — Tablets PLENDIL, 10 mg, are red-brown, round convex tablets, with code 452 on one side and PLENDIL on the other. They are supplied as follows:

NDC 0186-0452-28 unit dose packages of 100

NDC 0186-0452-58 unit of use bottles of 100

Storage:

Store below 30°C (86°F). Keep container tightly closed. Protect from light.

PLENDIL is a trademark of the AstraZeneca group of companies

©AstraZeneca 2000, 2003

Rev 11/03

Manufactured for: AstraZeneca LP

Wilmington, DE 19850

By: Merck & Co., Inc., Whitehouse Station, NJ, 08889 USA

9179716

630002-16