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Cardene IV

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Cardene I.V.

INDICATIONS

Hypertension

Cardene® I.V. (nicardipine hydrochloride) Premixed Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see DOSAGE AND ADMINISTRATION].

DOSAGE AND ADMINISTRATION

Recommended Dosing

Cardene I.V. (nicardipine hydrochloride) is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

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:

Oral Cardene Dose Equivalent I.V. Infusion Rate
20 mg q8h 0.5 mg/hr = 5 mL/hr
30 mg q8h 1.2 mg/hr = 12 mL/hr
40 mg q8h 2.2 mg/hr = 22 mL/hr

Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine

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 5 minutes (for rapid titration) to 15 minutes (for gradual titration) 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 utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr).

Drug Discontinuation and Transition to an Oral Antihypertensive Agent

Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.

If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of Cardene I.V. (nicardipine hydrochloride) Premixed Injection.

If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

Special Populations

Titrate Cardene I.V. (nicardipine hydrochloride) Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function [see WARNINGS AND PRECAUTIONS]

Monitoring

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

Monitor blood pressure and heart rate continually during infusion and avoid too rapid or excessive blood pressure drop during treatment. If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. Then, when blood pressure has stabilized, infusion of Cardene I.V. (nicardipine hydrochloride) Premixed Injection may be restarted at low doses such as 30-50 mL/hr (3.0 - 5.0 mg/hr) and adjusted to maintain desired blood pressure.

Instructions for Administration

Administer Cardene I.V. (nicardipine hydrochloride) by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site].

Cardene I.V. (nicardipine hydrochloride) Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

Inspect Cardene I.V. (nicardipine hydrochloride) Premixed Injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact. If leaks are found, discard solution as sterility may be impaired. Cardene I.V. (nicardipine hydrochloride) Premixed Injection is normally a clear, colorless to yellow solution.

Do not combine Cardene I.V. (nicardipine hydrochloride) Premixed Injection with any product in the same intravenous line or premixed container. Do not add supplementary medication to the bag. Protect from light until ready to use.

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

Preparation for administration
  1. Suspend container from eyelet support.
  2. Remove protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

HOW SUPPLIED

Dosage Forms And Strengths

Cardene I.V. (nicardipine hydrochloride) Premixed Injection is supplied as a single-use, ready-to-use, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 20 mg (0.1 mg/mL) nicardipine hydrochloride in either dextrose or sodium chloride.

Cardene I.V. (nicardipine hydrochloride) Premixed Injection is supplied as a single-use, ready-to-use, iso-osmotic solution for intravenous administration in a 200 mL GALAXY container with 20 mg (0.1 mg/mL) nicardipine hydrochloride in either dextrose or sodium chloride.

Pack Size Diluent NDC Number
10 bags, each containing 20 mg in 200 mL (0.1mg/mL) 4.8% Dextrose NDC 24477-312-02
10 bags, each containing 20 mg in 200 mL (0.1mg/mL) 0.86% Sodium Chloride NDC 24477-311-02

Storage and Handling

Store at controlled room temperature 20° to 25°C (68° to 77°F), refer to USP Controlled Room Temperature.

Protect from freezing. Avoid excessive heat. Protect from light, store in carton until ready to

Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015 USA. Marketed by: EKR Therapeutics, Inc Bedminster, NJ 07921 USA. Revised September 2010

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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