dopamine hydrochloride injection, USP VIAL Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Preparation and Administration Instructions

Correct Hypovolemia, Acidosis, and Hypoxia

Address hypovolemia, acidosis, and hypoxia before initiating Dopamine HCl Injection. If patient does not respond to therapy, suspect occult hypovolemia. Acidosis may reduce the effectiveness of dopamine [see Warnings and Precautions (5.1)].

Preparation

For the 40‑mg/mL preparation, transfer by aseptic technique the contents containing either 5 mL (200 mg) or 10 mL (400 mg) of Dopamine HCl Injection to either a 250‑mL or a 500‑mL bottle of one of the sterile intravenous solutions listed below:

0.9% Sodium Chloride Injection, USP
5% Dextrose Injection, USP
5% Dextrose and 0.9% Sodium Chloride Injection, USP
5% Dextrose and 0.45% Sodium Chloride Injection, USP
5% Dextrose and Lactated Ringer’s Injection
Sodium Lactate Injection, USP 1/6 Molar
Lactated Ringer’s Injection, USP

The resultant dilutions are summarized in the following chart:

Volume of IV solution

Volume of Dopamine Hydrochloride Injection

5 mL

10 mL

250 mL

800 mcg/mL

1600 mcg/mL

500 mL

400 mcg/mL

800 mcg/mL

1000 mL

200 mcg/mL

400 mcg/mL

Dopamine HCl Injection has been found to be stable for 24 hours after dilution in the foregoing intravenous solutions.

Administration

Dopamine HCl Injection is administered (only after dilution) by intravenous infusion.

Administer Dopamine HCl Injection into a large vein [see Warnings and Precautions (5.1)] with the use of an infusion pump preferably in an intensive care setting.

Inspect Dopamine HCl Injection for particulate matter and discoloration prior to administration whenever solution and container permit (the solution is clear, practically colorless). Do not administer if the solution is darker or discolored.

Use higher concentration solutions (e.g., 3200 mcg/mL or 1600 mcg/mL strengths) in patients requiring fluid restriction.

Discontinuation

When discontinuing Dopamine HCl Injection, gradually reduce the infusion rate while expanding blood volume with intravenous fluids [see Warnings and Precautions (5.3)].

2.2 Recommended Dosage

The recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion [see Dosage and Administration (2.3)]. Titrate the infusion rate in increments of 5 to 10 mcg/kg/minute based on hemodynamic response and tolerability, but do not exceed 50 mcg/kg/minute.

Infusion rates may be calculated using the following formula:

Infusion Rate (mL/hour) = [Dose (mcg/kg/minute) x Weight (kg) x 60 (minutes/hour)]

Concentration (mcg/mL)

Example calculations for infusion rates are as follows:

Example 1: for a 60 kg person at the recommended initial dose of 2 mcg/kg/minute using a 800 mcg/mL concentration, the infusion rate would be as follows:

Infusion Rate (mL/hour) = [2 (mcg/kg/minute) x 60 (kg) x 60 (minutes/hour)] = 9 (mL/hour)

 
800 (mcg/mL)

Example 2: for a 70 kg person at a dose of 5 mcg/kg/minute using a 1600 mcg/mL concentration, the infusion rate would be as follows:

Infusion Rate (mL/hour) = [5 (mcg/kg/minute) x 70 (kg) x 60 (minutes/hour)] = 13.13 (mL/hour)

 
1600 (mcg/mL)

2.3 Drug Incompatibilities

Dopamine HCl Injection is incompatible with the following products; therefore, avoid simultaneous administration (through the same infusion set):

Sodium bicarbonate or other alkalinizing substances, because dopamine is inactivated in alkaline solution
Blood, because of the risk of pseudoagglutination of red cells
Iron salts

Do not add additional medications in the diluted infusion solution.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Preparation and Administration Instructions

Correct Hypovolemia, Acidosis, and Hypoxia

Address hypovolemia, acidosis, and hypoxia before initiating Dopamine HCl Injection. If patient does not respond to therapy, suspect occult hypovolemia. Acidosis may reduce the effectiveness of dopamine [see Warnings and Precautions (5.1)].

Preparation

For the 40‑mg/mL preparation, transfer by aseptic technique the contents containing either 5 mL (200 mg) or 10 mL (400 mg) of Dopamine HCl Injection to either a 250‑mL or a 500‑mL bottle of one of the sterile intravenous solutions listed below:

0.9% Sodium Chloride Injection, USP
5% Dextrose Injection, USP
5% Dextrose and 0.9% Sodium Chloride Injection, USP
5% Dextrose and 0.45% Sodium Chloride Injection, USP
5% Dextrose and Lactated Ringer’s Injection
Sodium Lactate Injection, USP 1/6 Molar
Lactated Ringer’s Injection, USP

The resultant dilutions are summarized in the following chart:

Volume of IV solution

Volume of Dopamine Hydrochloride Injection

5 mL

10 mL

250 mL

800 mcg/mL

1600 mcg/mL

500 mL

400 mcg/mL

800 mcg/mL

1000 mL

200 mcg/mL

400 mcg/mL

Dopamine HCl Injection has been found to be stable for 24 hours after dilution in the foregoing intravenous solutions.

Administration

Dopamine HCl Injection is administered (only after dilution) by intravenous infusion.

Administer Dopamine HCl Injection into a large vein [see Warnings and Precautions (5.1)] with the use of an infusion pump preferably in an intensive care setting.

Inspect Dopamine HCl Injection for particulate matter and discoloration prior to administration whenever solution and container permit (the solution is clear, practically colorless). Do not administer if the solution is darker or discolored.

Use higher concentration solutions (e.g., 3200 mcg/mL or 1600 mcg/mL strengths) in patients requiring fluid restriction.

Discontinuation

When discontinuing Dopamine HCl Injection, gradually reduce the infusion rate while expanding blood volume with intravenous fluids [see Warnings and Precautions (5.3)].

2.2 Recommended Dosage

The recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion [see Dosage and Administration (2.3)]. Titrate the infusion rate in increments of 5 to 10 mcg/kg/minute based on hemodynamic response and tolerability, but do not exceed 50 mcg/kg/minute.

Infusion rates may be calculated using the following formula:

Infusion Rate (mL/hour) = [Dose (mcg/kg/minute) x Weight (kg) x 60 (minutes/hour)]

Concentration (mcg/mL)

Example calculations for infusion rates are as follows:

Example 1: for a 60 kg person at the recommended initial dose of 2 mcg/kg/minute using a 800 mcg/mL concentration, the infusion rate would be as follows:

Infusion Rate (mL/hour) = [2 (mcg/kg/minute) x 60 (kg) x 60 (minutes/hour)] = 9 (mL/hour)

 
800 (mcg/mL)

Example 2: for a 70 kg person at a dose of 5 mcg/kg/minute using a 1600 mcg/mL concentration, the infusion rate would be as follows:

Infusion Rate (mL/hour) = [5 (mcg/kg/minute) x 70 (kg) x 60 (minutes/hour)] = 13.13 (mL/hour)

 
1600 (mcg/mL)

2.3 Drug Incompatibilities

Dopamine HCl Injection is incompatible with the following products; therefore, avoid simultaneous administration (through the same infusion set):

Sodium bicarbonate or other alkalinizing substances, because dopamine is inactivated in alkaline solution
Blood, because of the risk of pseudoagglutination of red cells
Iron salts

Do not add additional medications in the diluted infusion solution.

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