Ezdopa Dosage

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Dosage of Ezdopa in details

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WARNING: This is a potent drug: It must be diluted before administration to the patient.

Ezdopa Hydrochloride Injection, USP is administered (only after dilution) by intravenous infusion.

Suggested Dilution: Transfer contents of one or more ampuls or vials by aseptic technique to either 250 mL or 500 mL of one of the following sterile intravenous solutions:

  1. Sodium Chloride Injection, USP
  2. Dextrose (5%) Injection, USP
  3. Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP
  4. 5% Dextrose in 0.45% Sodium Chloride Solution Injection, USP
  5. Dextrose (5%) and Lactated Ringer'™s Solution Injection
  6. Sodium Lactate Injection, USP (1/6 Molar)
  7. Lactated Ringer'™s Injection, USP

Ezdopa Hydrochloride Injection, USP has been found to be stable for a minimum of 24 hours after dilution in the sterile intravenous solutions listed above. However, as with all intravenous admixtures, dilution should be made just prior to administration.

Do NOT add Ezdopa Hydrochloride to Sodium Bicarbonate Injection, USP or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.

Rate of Administration: Ezdopa Hydrochloride Injection, USP, after dilution, is administered intravenously by infusion through a suitable intravenous catheter or needle. When administering Ezdopa Hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control intravenous set. Each patient must be individually titrated to the desired hemodynamic or renal response to Ezdopa.

Administration rates greater than 50 mcg/kg/minute have safely been used in advanced circulatory decompensation states. If unnecessary fluid expansion is of concern, adjustment of drug concentration may be preferred over increasing the flow rate of a less concentrated dilution.

Suggested Regimen

  1. When appropriate, increase blood volume with whole blood or plasma until central venous pressure is 10 to 15 cm H2O or pulmonary wedge pressure is 14 to 18 mm Hg.
  2. Begin infusion of diluted solution at doses of 2 to 5 mcg/kg/minute of Ezdopa Hydrochloride in patients who are likely to respond to modest increments of heart force and renal perfusion.

    In more seriously ill patients, begin infusion of diluted solution at doses of 5 mcg/kg/minute of Ezdopa Hydrochloride and increase gradually using 5 to 10 mcg/kg/minute increments up to 20 to 50 mcg/kg/minute as needed. If doses in excess of 50 mcg/kg/minute are required, it is advisable to check urine output frequently. Should urinary flow begin to decrease in the absence of hypotension, reduction of Ezdopa dosage should be considered. Multiclinic trials have shown that more than 50% of the patients have been satisfactorily maintained on doses of Ezdopa less than 20 mcg/kg/minute. In patients who do not respond to these doses with adequate arterial pressures or urine flow, additional increments of Ezdopa may be given in an effort to produce an appropriate arterial pressure and central perfusion.

  3. Treatment of all patients requires constant evaluation of therapy in terms of the blood volume, augmentation of cardiac contractility, and distribution of peripheral perfusion. Dosage of Ezdopa should be adjusted according to the patient's response, with particular attention to diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias as indices for decreasing or temporarily suspending the dosage.
  4. As with all potent intravenously administered drugs, care should be taken to control the rate of administration to avoid inadvertent administration of a bolus of drug.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How supplied

Ezdopa Injection, USP is available as follows:

Product No. Ezdopa mg per volume fill How Packaged
NDC 0517-1805-25 200 mg/5 mL Vial (40 mg/mL) Packages of 25 vials (color-coded WHITE)
NDC 0517-1905-25 400 mg/5 mL Vial (80 mg/mL) Packages of 25 vials (color-coded GREEN)
NDC 0517-1305-25 800 mg/5 mL Vial (160 mg/mL) Packages of 25 vials (color-coded YELLOW)

Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

NOTE - Do not use the injection if it is darker than slightly yellow or discolored in any other way.

WARNING: NOT FOR DIRECT INTRAVENOUS INJECTION, MUST BE DILUTED BEFORE USE.

INTRAVENOUS INFUSION ONLY.

The vial stopper is not made with natural rubber latex.

American Regent, Inc., Shirley, NY 11967. Revised: Dec 2014

What other drugs will affect Ezdopa?

Tell your doctor about all other medicines you use, especially:

There may be other drugs that can interact with Ezdopa. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Ezdopa interactions

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Cyclopropane and halogenated hydrocarbon anaesthetics may sensitise myocardium to Ezdopa and precipitate ventricular arrhythmias. MAO inhibitors prolong and increase Ezdopa effects. Ergots potentiate vasoconstriction action of Ezdopa. Alpha-blockers unmask Ezdopa’s beta action.

Lab Interference

Suppresses pituitary secretion of thyroid-stimulating hormone, growth hormone and prolactin.

References

  1. FDA/SPL Indexing Data. "VTD58H1Z2X: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  2. MeSH. "Sympathomimetics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "dopamine: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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