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Cardene

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Cardene SR

Indications
Dosage
How Supplied

INDICATIONS

CARDENE SR (nicardipine hydrochloride sustained release capsules) 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 (nicardipine hydrochloride sustained release capsules) 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 (nicardipine hydrochloride sustained release capsules) 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
  • Diuretics: CARDENE may be safely coadministered with thiazide diuretics.
  • Beta-Blockers: CARDENE may be safely coadministered with betablockers (see DRUG INTERACTIONS).

Special Patient Populations

Renal Insufficiency: Although there is no evidence that CARDENE SR (nicardipine hydrochloride sustained release capsules) impairs renal function, careful dose titration beginning with 30-mg CARDENE SR (nicardipine hydrochloride sustained release capsules) bid is advised (see PRECAUTIONS).

Hepatic Insufficiency: CARDENE SR (nicardipine hydrochloride sustained release capsules) has not been studied in patients with severe liver impairment (see PRECAUTIONS).

Congestive Heart Failure: Caution is advised when titrating CARDENE SR (nicardipine hydrochloride sustained release capsules) dosage in patients with congestive heart failure (see WARNINGS).

HOW SUPPLIED

CARDENE® SR (nicardipine hydrochloride sustained release capsules) 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR (nicardipine hydrochloride sustained release capsules) 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 (NDC 67286-0813-2) and bottles of 200 (NDC 67286-0813-1).

CARDENE® SR (nicardipine hydrochloride sustained release capsules) 45-mg capsules are available in opaque powder bluepowder 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 (NDC 67286-0813-4) and bottles of 200 (NDC 67286-0813-3).

CARDENE® SR (nicardipine hydrochloride sustained release capsules) 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR (nicardipine hydrochloride sustained release capsules) 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 (NDC 67286-0813-5).

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.

Marketed by: PDL BioPharma, Inc., Redwood City, CA 94063. Revised: January 2007.

Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Cardene SR - User Reviews

Cardene SR User Reviews

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