Emcure Pharmaceuticals Ltd.
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Emcure Pharmaceuticals Ltd. Drugs
Nicardipine hydrochloride injection is intended for intravenous use. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Blood pressure should be monitored both during and after the infusion; too rapid or excessive reduction in either systolic or diastolic blood pressure during parenteral treatment should be avoided.
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: 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 30 mg q8h 1.2 mg/hr 40 mg q8h 2.2 mg/hr For Initiation of Therapy in a Drug Free Patient The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 mg/mL. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes and does not reach final steady state for about 50 hours. When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 ± 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for about 50 hours. Titration: For gradual reduction in blood pressure, 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 15 minutes up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved. For more rapid blood pressure reduction, 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 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, the infusion rate should be decreased to 30 mL/hr (3 mg/hr). Maintenance: The rate of infusion should be adjusted as needed to maintain desired response. Conditions Requiring Infusion Adjustment Hypotension or Tachycardia: If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. 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. Infusion Site Changes: Nicardipine hydrochloride injection should be continued as long as blood pressure control is needed. The infusion site should be changed every 12 hours if administered via peripheral vein. Impaired Cardiac, Hepatic, or Renal Function: Caution is advised when titrating Nicardipine hydrochloride injection in patients with congestive heart failure or impaired hepatic or renal function (see " PRECAUTIONS"). Transfer To Oral Antihypertensive Agents If treatment includes transfer to an oral antihypertensive agent other than nicardipine capsules, therapy should generally be initiated upon discontinuation of Nicardipine hydrochloride injection. If nicardipine capsules are to be used, the first dose of a TID regimen should be administered 1 hour prior to discontinuation of the infusion.
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