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Dynacirc CR (Isradipine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Hypertension

DynaCirc CR® (isradipine) is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.

DOSAGE AND ADMINISTRATION

The dosage of DynaCirc CR® (isradipine) Controlled Release Tablets should be individualized. The recommended initial dose of DynaCirc CR® (isradipine) is 5 mg once-daily as monotherapy or in combination with a thiazide diuretic. An antihypertensive response usually occurs within 2 hours, with the peak antihypertensive response occurring 8‑10 hours post-dose; blood pressure reduction is maintained for at least 24 hours following drug administration. If necessary, the dose may be adjusted in increments of 5 mg at 2‑4 week intervals up to a maximum dose of 20 mg/day. Adverse experiences are increased in frequency above 10 mg/day.

DynaCirc CR® (isradipine) Controlled Release Tablets should be swallowed whole and should not be bitten or divided.

The bioavailability (increased AUC) of immediate-release DynaCirc® (isradipine) is increased in elderly patients (above 65 years of age), patients with hepatic functional impairment, and patients with mild renal impairment. Ordinarily, a starting dose of DynaCirc CR® (isradipine) 5 mg once-daily should be used in these patients.

HOW SUPPLIED

DynaCirc CR® (isradipine) Controlled Release Tablets

5 mg:

A light pink, round, standard, biconvex and film coated tablet. Printing is in red with "DynaCirc CR" in a semicircle with "5" centered below the semicircle.

Bottles of 100 controlled release tablets (NDC 65726-235-25)

Bottles of 30 controlled release tablets (NDC 65726-235-10)

10 mg:

A beige, round, standard biconvex and film coated tablet. Printing is in red with “DynaCirc CR” in a semicircle with “10” centered below the semicircle.

Bottles of 100 controlled release tablets (NDC 65726-236-25)

Bottles of 30 controlled release tablets (NDC 65726-236-10)

Store and Dispense:

Below 86ºF (30ºC) in a tight container, protected from moisture and humidity.

Rx Only

Revised: August, 2005

Distributed by:

Reliant Pharmaceuticals, Inc.

Liberty Corner, NJ 07938

Address Medical Inquiries to:

Reliant Medical Inquiries

c/o PPD

2655 Meridian Parkway

Durham, NC 27713-2203

or Call: 877-311-7515

©2005 Reliant Pharmaceuticals, Inc.

2352F-01

22350401

2001295PRINTED IN USA

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