Nicardipine (Cardene ®)

Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

Dosage and Administration
Acute hypertension: Initial: 5 mg/hour increased by 2.5 mg/hour every 15 minutes to a maximum of 15 mg/hour; consider reduction to 3 mg/hour after response is achieved. Monitor and titrate to lowest dose necessary to maintain stable blood pressure.

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 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 mg/hr), until desired blood pressure reduction is achieved.

For more rapid blood pressure reduction, initiate therapy at 50 mL/hr (5 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 5 minutes up to a maximum of 150 mL/hr (15 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 restarted at low doses such as 30 - 50 mL/hr (3 - 5 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 package insert for "Precautions").

TRANSFER TO ORAL ANTIHYPERTENSIVE 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.

How Supplied
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.

U S Patent Nos.: 3,985,758; 4,880,823; and 5,164,405
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
Rev: January 2006

Source: [package insert]