I. Stable Angina

Nicardipine HCl is indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine HCl may be used alone or in combination with beta-blockers.

II. Hypertension

Nicardipine HCl is indicated for the treatment of hypertension. Nicardipine HCl may be used alone or in combination with other anti hypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect. (See DOSAGE AND ADMINISTRATION.)

Angina

The dose should be individually titrated for each patient beginning with 20 mg to 40 mg three times daily. Doses in the range of 20-40 mg three times a day have been shown to be effective. At least three days should be allowed before increasing the CARDENE dose to ensure achievement of steady state plasma drug concentrations.

Concomitant Use with Other Antihypertensive Agents

Sublingual NTG may be taken as required to abort acute anginal attacks during CARDENE therapy.

Prophylactic Nitrate Therapy - CARDENE may be safely coadministered with short- and long-acting nitrates.

Beta-blockers - CARDENE may be safely coadministered with beta-blockers. (See DRUG INTERACTIONS.)

Hypertension

The dose of CARDENE should be individually adjusted according to the blood pressure response beginning with 20 mg three times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg three times daily. The maximum blood pressure lowering effect occurs approximately 1-2 hours after dosing. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1-2 hours after dosing, particularly during initiation of therapy. (See PRECAUTIONS, Blood Pressure, INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY, Effects in Hypertension.) At least three days should be allowed before increasing the nicardipine HCl dose to ensure achievement of steady state plasma drug concentrations.

Concomitant use with other Antihypertensive Agents

Diuretics - CARDENE may be safely coadministered with thiazide diuretics.

Beta-blockers - CARDENE may be safely coadministered with beta-blockers (See DRUG INTERACTIONS.)

Special Patient Populations

Renal Insufficiency - Although there is no evidence that nicardipine HCl impairs renal function, careful dose titration beginning with 20 mg TID is advised. (See PRECAUTIONS.)

Hepatic Insufficiency - CARDENE should be administered cautiously in,patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule. (See PRECAUTIONS.)

Congestive Heart Failure - Caution is advised when titrating CARDENE dosage in patients with congestive heart failure. (See WARNINGS).

CARDENE® 20 mg capsules are available in opaque white-white hard gelatin capsules with a brilliant blue band and printed CARDENE 20 mg on the cap and ROCHE on the capsule body. These are supplied in bottles of 100 (NDC 0004-0183-01).

CARDENE® 30 mg capsules are available in opaque light blue-powder blue hard gelatin capsules with a brilliant blue band and printed CARDENE 30 mg on the cap and ROCHE on the capsule body. These are supplied in bottles of 100 (NDC 0004-0184-01) and bottles of 500 (NDC 0004-0184-14).

Store bottles at 15° to 30°C (59° to 86° F) and dispense in light-resistant containers.

*Maalox is a registered trademark of Novartis.

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Roche Laboratories Inc.
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Nutley, New Jersey 07110-1199

Revised: September 1999
Printed in USA
Copyright © 1999 by Hoffmann-La Roche Inc. All rights reserved.

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