éclat Pharmaceuticals, Llc

éclat Pharmaceuticals, Llc Drugs

• Nifedipine
  

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  Nifedipine

  

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  2.1 General Dosage and Administration Instructions

  VAZCULEP (phenylephrine hydrochloride) Injection, 10 mg/mL must be diluted before administration as an intravenous bolus or continuous intravenous infusion to achieve the desired concentration:

  Bolus: Dilute with normal saline or 5% dextrose in water. Continuous infusion: Dilute with normal saline or 5% dextrose in water.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy, or if it contains particulate matter. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

  During VAZCULEP administration:

  Correct intravascular volume depletion. Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine.

  2.2 Dosing for Treatment of Hypotension during Anesthesia

  The following are the recommended dosages for the treatment of hypotension during anesthesia.

  The recommended initial dose is 40 to 100 mcg administered by intravenous bolus. May administer additional boluses every 1-2 minutes as needed; not to exceed a total dosage of 200 mcg. If blood pressure is below the target goal, start a continuous intravenous infusion with an infusion rate of 10 to 35 mcg/minute; not to exceed 200 mcg/minute. Adjust dosage according to the blood pressure goal.

  2.3 Prepare a 100 mcg/mL Solution for Bolus Intravenous Administration

  For bolus intravenous administration, prepare a solution containing a final concentration of 100 mcg/mL of VAZCULEP:

  Withdraw 10 mg (1 mL of 10 mg/mL) of VAZCULEP and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.

  2.4 Prepare a Solution for Continuous Intravenous Administration

  For continuous intravenous infusion, prepare a solution containing a final concentration of 20 mcg/mL of VAZCULEP in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP:

  Withdraw 10 mg (1 mL of 10 mg/mL) of VAZCULEP and dilute with 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.

  2.5 Directions for Dispensing from Pharmacy Bulk Vial

  The Pharmacy Bulk Vial is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. Each closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. The Pharmacy Bulk Vial is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated.

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