CARDENE IV

CARDENE IV- nicardipine hydrochloride injection, solution
Baxter Healthcare Corporation

1 INDICATIONS AND USAGE

1.1 Hypertension

CARDENE I.V. (nicardipine hydrochloride) 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 (2.1)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

CARDENE I.V. 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 in 200 mL(0.1 mg/mL)

Equivalent I.V. Infusion Rate

40 mg in 200 mL (0.2 mg/mL)

20 mg q8h

0.5 mg/hr = 5 mL/hr

0.5 mg/hr = 2.5 mL/hr

30 mg q8h

1.2 mg/hr = 12 mL/hr

1.2 mg/hr = 6 mL/hr

40 mg q8h

2.2 mg/hr = 22 mL/hr

2.2 mg/hr = 11mL/hr

Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine
CARDENE I.V. 20 mg in 200 mL (0.1 mg/mL): 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 (for rapid titration) to 15 minutes (for gradual titration) 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 utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr).

CARDENE I.V. 40 mg in 200 mL (0.2 mg/mL): Initiate therapy at 25 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 12.5 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 75 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved.

Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 15 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. 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. slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.2 , 5.3 and 5.4) ]

2.2 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. may be restarted at low doses such as 30-50 mL/hr (3 — 5 mg/hr) for 20 mg in 200 mL or 15-25 mL/hr (3 — 5 mg/hr) for 40 mg in 200 mL and adjusted to maintain desired blood pressure.

2.3 Instructions for Administration

Administer CARDENE I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Warnings and Precautions (5.5)].

CARDENE I.V. is available as a single-dose, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

Inspect CARDENE I.V. 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. is normally a clear, colorless to yellow solution.

Do not combine CARDENE I.V. 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 a bottom of container.
3.
Attach administration set. Refer to complete directions accompanying set.

3 DOSAGE FORMS AND STRENGTHS

Injection: 200 mL nicardipine (0.1 mg/mL) in either dextrose (4.8%) or sodium chloride (0.86%) as a clear, colorless solution, ready-to-use, iso-osmotic solution in a single-dose GALAXY container

Injection: 200 mL nicardipine (0.2 mg/mL) in sodium chloride (0.83%) as a clear, colorless solution, ready-to-use, iso-osmotic solution in a single-dose GALAXY container

4 CONTRAINDICATIONS

4.1 Advanced Aortic Stenosis

CARDENE I.V. is contraindicated in patients with advanced aortic stenosis because part of the effect of CARDENE I.V. is secondary to reduced afterload. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

5 WARNINGS AND PRECAUTIONS

5.1 Exacerbation of Angina

Increases in frequency, duration, or severity of angina have been seen in chronic therapy with oral nicardipine. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with CARDENE I.V. The mechanism of this effect has not been established.

5.2 Exacerbation of Heart Failure

Titrate slowly when using CARDENE I.V., particularly in combination with a beta-blocker, in patients with heart failure or significant left ventricular dysfunction because of possible negative inotropic effects.

5.3 Increased effect with Impaired Hepatic Function

Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor responses in patients with impaired liver function or reduced hepatic blood flow.

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