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Cardene SR (Nicardipine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

CARDENE SR is indicated for the treatment of hypertension. CARDENE SR may be used alone or in combination with other antihypertensive drugs.

DOSAGE AND ADMINISTRATION

The dose of CARDENE SR should be individually adjusted according to the blood pressure response beginning with 30 mg two times daily. The effective doses in clinical trials have ranged from 30 mg to 60 mg two times daily. The maximum blood pressure lowering effect at steady-state is sustained from 2 hours until 6 hours after dosing.

When initiating therapy or upon increasing dose, blood pressure should be measured 2 to 4 hours after the first dose or dose increase, as well as at the end of a dosing interval.

The total daily dose of immediate release nicardipine (CARDENE) may not be a useful guide to judging the effective dose of CARDENE SR. Patients currently receiving immediate release nicardipine may be titrated with CARDENE SR starting at their current total daily dose of immediate release nicardipine and then reexamined to assess the adequacy of blood pressure control.

Concomitant Use With Other Antihypertensive Agents

  1. Diuretics: CARDENE may be safely coadministered with thiazide diuretics.
  2. Beta-Blockers: CARDENE may be safely coadministered with beta-blockers (see Drug Interactions).

Special Patient Populations

Renal Insufficiency

Although there is no evidence that CARDENE SR impairs renal function, careful dose titration beginning with 30-mg CARDENE SR bid is advised (see PRECAUTIONS).

Hepatic Insufficiency

CARDENE SR has not been studied in patients with severe liver impairment (see PRECAUTIONS).

Congestive Heart Failure

Caution is advised when titrating CARDENE SR dosage in patients with congestive heart failure (see WARNINGS).

HOW SUPPLIED

CARDENE® SR 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.

CARDENE® SR 45-mg capsules are available in opaque powder blue-powder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 and bottles of 200.

CARDENE® SR 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60.

Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container.

For questions of a medical nature or to report an adverse event, call 1-866-437-7742.

U.S. Patent No.s 4,940,556 and 5,198,226
Cardene® is a registered trademark of PDL BioPharma, Inc.

Marketed by:

PDL Biopharma, Inc.
Redwood City, CA 94063

Revised: September 2007
151102

Printed in USA

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