Nicardipine Hydrochloride

NICARDIPINE HYDROCHLORIDE- nicardipine hydrochloride injection, solution
Civica, Inc.

1. INDICATIONS AND USAGE

1.1 Hypertension

niCARdipine Hydrochloride Injection, USP 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

niCARdipine Hydrochloride Injection, USP is intended for intravenous use. Vial must be diluted 0.1 mg/mL before use [see Dosage and Administration (2.3)]. 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:

Table 1: Oral Equivalent Dosage

Oral Nicardipine Dose

Equivalent Intravenous Infusion Rate (0.1 mg/mL)

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 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).

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 nicardipine hydrochloride injection.

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

Specific Populations

Titrate nicardipine hydrochloride injection 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, restart infusion of nicardipine hydrochloride injection at low doses such as 30 to 50 mL/hr (3 to 5 mg/hr) and adjust to maintain desired blood pressure.

2.3 Instructions for Administration

Administer 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 Warnings and Precautions (5.5)].
Preparation for Administration
Vials must be diluted before infusion.

Inspection
As with all parenteral drugs, nicardipine hydrochloride injection should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine hydrochloride injection is normally clear, yellow in color.

Dilution
Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. Each vial (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.

Nicardipine hydrochloride injection 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

Nicardipine hydrochloride injection 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.

3. DOSAGE FORMS AND STRENGTHS

Injection: 25 mg of nicardipine hydrochloride in 10 mL (2.5 mg/mL) as a clear, yellow solution in a vial for dilution.

4. CONTRAINDICATIONS

4.1 Advanced Aortic Stenosis

Nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection 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 oral therapy with oral nicardipine. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with nicardipine hydrochloride. The mechanism of this effect has not been established.

5.2 Exacerbation of Heart Failure

Titrate slowly when using nicardipine hydrochloride injection, 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.

5.4 Prolonged effect with Impaired Renal Function

When nicardipine hydrochloride injection was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) was observed. These results are consistent with those seen after oral administration of nicardipine. Titrate gradually in patients with renal impairment.

5.5 Local Irritation

To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the occurrence of vascular impairment, administer drug through large peripheral veins or central veins rather than arteries or small peripheral veins, such as those on the dorsum of the hand or wrist. To minimize the risk of peripheral venous irritation, change the site of the drug infusion every 12 hours.

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