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Ekr Therapeutics Drugs
The dose of CARDENE SR should be individually adjusted according to the blood pressure response beginning with 30 mg two times daily. The effective doses in clinical trials have ranged from 30 mg to 60 mg two times daily. The maximum blood pressure lowering effect at steady-state is sustained from 2 hours until 6 hours after dosing.
When initiating therapy or upon increasing dose, blood pressure should be measured 2 to 4 hours after the first dose or dose increase, as well as at the end of a dosing interval.
The total daily dose of immediate release nicardipine (CARDENE) may not be a useful guide to judging the effective dose of CARDENE SR. Patients currently receiving immediate release nicardipine may be titrated with CARDENE SR starting at their current total daily dose of immediate release nicardipine and then reexamined to assess the adequacy of blood pressure control.
Concomitant Use With Other Antihypertensive Agents:Diuretics: CARDENE may be safely coadministered with thiazide diuretics. Beta-Blockers: CARDENE may be safely coadministered with beta-blockers (see Drug Interactions).
Special Patient Populations
Renal Insufficiency: Although there is no evidence that CARDENE SR impairs renal function, careful dose titration beginning with 30-mg CARDENE SR bid is advised (see PRECAUTIONS).
Hepatic Insufficiency: CARDENE SR has not been studied in patients with severe liver impairment (see PRECAUTIONS).
Congestive Heart Failure: Caution is advised when titrating CARDENE SR dosage in patients with congestive heart failure (see WARNINGS).
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.
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.
WARNING: AMPULS MUST BE DILUTED BEFORE INFUSION
Dilution: Cardene ® I.V. is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. Each ampul (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.
Cardene ® I.V. 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
Cardene ® I.V. 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, Cardene ® I.V. should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Cardene ® I.V. 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 Cardene® Dose Equivalent l.V. Infusion Rate 20 mg q8h 0.5 mg/hr = 5mL/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 (5.0 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 (15.0 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 Cardene ® I.V.
If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.
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