Nicardipine

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

Recommended Dosing Nicardipine hydrochloride injection is intended for intravenous use. Vial must be diluted to 0.1 mg per mL before use [see Dosage and Administration ] . 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 : [See table below.] Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine Nicardipine Hydrochloride Injection 25 mg in 10 mL (2.5 mg per 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).

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. Special 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 )] .

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 nicardipine hydrochloride injection may be restarted at low doses such as 30-50 mL/hr (3 - 5 mg/hr) and adjusted to maintain desired blood pressure.

Instructions for Administration Administer nicardipine hydrochloride injection 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 ] . Nicardipine hydrochloride injection is available as a single-dose solution for intravenous administration.

Vials must be diluted before infusion. Inspect nicardipine hydrochloride injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine hydrochloride injection is normally yellow in color. Do not combine nicardipine hydrochloride injection with any product in the same intravenous line or premixed container.

Protect from light until ready to use. Preparation for administration Dilution Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF

MG PER 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 per 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.