Cardene® I.V. is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.

For prolonged control of blood pressure, patients should be transferred to oral medication as soon as their clinical condition permits (see “Dosage and Administration”).

Cardene® I.V. (nicardipine hydrochloride) is intended for intravenous use. DOSAGE MUST BE INDIVID-UALIZED depending upon the severity of hypertension and the response of the patient during dosing. Blood pressure should be monitored both during and after the infusion; too rapid or excessive reduc-tion in either systolic or diastolic blood pressure during parenteral treatment should be avoided.

Preparation

WARNING: AMPULS MUST BE DILUTED BEFORE INFUSION

Dilution: Cardene® I.V. is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. Each ampul (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Cardene® I.V. has been found to be compatible and stable in glass or polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP

Dextrose (5%) with 40 mEq Potassium, USP

Sodium Chloride (0.45%) Injection, USP

Sodium Chloride (0.9%) Injection, USP

Cardene® I.V. is NOT compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer's Injection, USP.

THE DILUTED SOLUTION IS STABLE FOR 24 HOURS AT ROOM TEMPERATURE.

Inspection: As with all parenteral drugs, Cardene® I.V. should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Cardene® I.V. is normally light yellow in color.

Dosage

As a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

For Initiation of Therapy in a Drug Free Patient

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment.

Cardene® I.V. is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes and does not reach final steady state for about 50 hours. When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 ± 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for about 50 hours.

Titration: For gradual reduction in blood pressure, initiate therapy at 50 mL/hr (5.0 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 15 minutes up to a maximum of 150 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved.

For more rapid blood pressure reduction, initiate therapy at 50 mL/hr (5.0 mg/hr). If desired blood pres-sure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes up to a maximum of 150 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved. Following achievement of the blood pressure goal, the infusion rate should be decreased to 30 mL/hr (3 mg/hr).

Maintenance: The rate of infusion should be adjusted as needed to maintain desired response.

Conditions Requiring Infusion Adjustment

Hypotension or Tachycardia: If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. When blood pressure has stabilized, infusion of Cardene® I.V. may be restart-ed at low doses such as 30 - 50 mL/hr (3.0 - 5.0 mg/hr) and adjusted to maintain desired blood pressure.

Infusion Site Changes: Cardene® I.V. should be continued as long as blood pressure control is needed. The infusion site should be changed every 12 hours if administered via peripheral vein.

Impaired Cardiac, Hepatic, or Renal Function: Caution is advised when titrating Cardene® I.V. in patients with congestive heart failure or impaired hepatic or renal function (see "PRECAUTIONS").

Transfer To Oral Anytihypertensive Agents

If treatment includes transfer to an oral antihypertensive agent other than Cardene® capsules, therapy should generally be initiated upon discontinuation of Cardene® I.V.

If Cardene® capsules are to be used, the first dose of a TID regimen should be administered 1 hour prior to discontinuation of the infusion.

Cardene® I.V. (nicardipine hydrochloride) is available in packages of 10 ampuls of 10 mL as follows: 25 mg (2.5 mg/mL), NDC 67286-0812-3.

Store at controlled room temperature 20º to 25ºC (68º to 77ºF), refer to USP Controlled Room Temperature.

Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided.

Protect from light. Store ampuls in carton until used.

Cardene® I.V. is a registered trademark of Hoffman-La Roche Inc.
Manufactured under license from Roche Palo Alto LLC by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Marketed by: PDL BioPharma, Inc. Fremont, CA 94555 For questions of a medical nature call 1-866-437-7742 Revised January 2006
FDA Rev date: 6/22/2007

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