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Nicardipine (Nicardipine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE:

Nicardipine hydrochloride 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:


Nicardipine hydrochloride injection 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.
 
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.
 
Preparation
 
WARNING: VIALS MUST BE DILUTED BEFORE IV INFUSION
 
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.
 
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 light yellow in color.
 
Dosage
 
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 Nicardipine 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 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 Transfer to Oral Antihypertensive Agents
 
Discontinuation of infusion is followed by a 50% offset 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.

HOW SUPPLIED:


Nicardipine hydrochloride injection 25 mg/10 mL (2.5 mg/mL) is available in single dose vial (1 x 10 mL) and supplied as follows:
In a carton of one single dose vial (NDC 0781-9324-70) or ten such individual cartons placed into one outer carton (NDC 0781-9324-95).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided.
Protect from light.  Store vial in carton until ready to use.


Manufactured By:
Emcure Pharmaceuticals Ltd.
Hinjwadi, Pune 411 057, INDIA.
for:
Sandoz Inc.
Princeton, NJ 08540

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