Cardene I.v.

Cardene I.v. Manufacturers

• Ekr Therapeutics, Inc.
  

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  Cardene I.v. | Ekr Therapeutics, Inc.

  

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  2.1 Recommended Dosing

  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.

  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 I.V. Infusion Rate 20 mg q8h 0.5 mg/hr = 2.5 mL/hr 30 mg q8h 1.2 mg/hr = 6 mL/hr 40 mg q8h 2.2 mg/hr = 11 mL/hr

  Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine

  Initiate therapy at 25 mL/hr (5.0 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 12.5 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 75 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 15 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 Cardene I.V. Premixed Injection.

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

  Special Populations

  Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.3, 5.4 and 5.5)]

  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, infusion of Cardene I.V. Premixed Injection may be restarted at low doses such as 15-25 mL/hr (3.0 - 5.0 mg/hr) and adjusted to maintain desired blood pressure.

  2.3 Instructions for Administration

  Administer Cardene I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.6)].

  Cardene I.V. Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

  Inspect Cardene I.V. Premixed Injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact. If leaks are found, discard solution as sterility may be impaired. Cardene I.V. Premixed Injection is normally a clear, colorless to yellow solution.

  Do not combine Cardene I.V. Premixed Injection with any product in the same intravenous line or premixed container. Do not add supplementary medication to the bag. Protect from light until ready to use.

  Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

  Preparation for administration

  Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

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• Ekr Therapeutics, Inc.
  

  ×

  Cardene I.v. | Ekr Therapeutics, Inc.

  

  ---

  2.1 Recommended Dosing

  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.

  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 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 (5.0 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 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 Cardene I.V. Premixed Injection.

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

  Special Populations

  Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.3, 5.4 and 5.5)].

  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, infusion of Cardene I.V. Premixed Injection may be restarted at low doses such as 30-50 mL/hr (3.0 - 5.0 mg/hr) and adjusted to maintain desired blood pressure.

  2.3 Instructions for Administration

  Administer Cardene I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.6)].

  Cardene I.V. Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

  Inspect Cardene I.V. Premixed Injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact. If leaks are found, discard solution as sterility may be impaired. Cardene I.V. Premixed Injection is normally a clear, colorless to yellow solution.

  Do not combine Cardene I.V. Premixed Injection with any product in the same intravenous line or premixed container. Do not add supplementary medication to the bag. Protect from light until ready to use.

  Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

  Preparation for administration

  Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

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• Ekr Therapeutics
  

  ×

  Cardene I.v. | Ekr Therapeutics

  

  ---

  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.

  Preparation

  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

  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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