Cardene SR (Page 4 of 4)

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

Special Patient Populations

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

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

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

HOW SUPPLIED

NDC:68151-0089-0 in a PACKAGE of 1 CAPSULE, EXTENDED RELEASES

Nicardipine HCL 30 mg SR caps

Label ImageLabel Image
CARDENE SR
nicardipine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-0089(NDC:24477-515)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICARDIPINE HYDROCHLORIDE (NICARDIPINE) NICARDIPINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CORN
LACTOSE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code CARDENE;SR;30;mg;EKR;Therapeutics;Inc
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-0089-0 1 CAPSULE, EXTENDED RELEASE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020005 02/21/1992
Labeler — Carilion Materials Management (079239644)
Registrant — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-0089)

Revised: 08/2016 Carilion Materials Management

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