These Highlights Do Not Include All The Information Needed To Use Dopamine Hydrochloride In Dextrose Injection Safely And Effectively. See Full Prescribing Information For Dopamine Hydrochloride In Dextrose Injection.

Correct Hypovolemia, Acidosis, and Hypoxia

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

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Discard unused portion.

Manifestations of overdosage include excessive blood pressure elevation.

In the case of accidental overdosage, reduce rate of Dopamine HCl in Dextrose Injection infusion, or temporarily discontinue the Dopamine HCl in Dextrose Injection infusion until the overdosage related adverse reactions resolves. Since dopamine's duration of action is short, no additional remedial measures are usually necessary. If these measures fail to resolve the overdosage related adverse reactions, consider using an alpha-adrenergic blocking agent (e.g., phentolamine).

Dopamine Hydrochloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, premixed solution of dopamine hydrochloride in 5% dextrose injection for intravenous infusion.

Each 100 mL contains 160 mg (1,600 mcg/mL) or 320 mg (3,200 mcg/mL) of dopamine HCl; 5 grams of hydrous dextrose, in Water for Injection, and 50 mg of sodium metabisulfite (a stabilizer); pH = 2.5 to 4.5, and the following osmolar concentrations: 269, or 286 mOsmol/liter, respectively. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.

Dopamine HCl is chemically designated 3, 4-dihydroxyphenethylamine hydrochloride (C₈H₁₁NO₂ ∙ HCl), a white crystalline powder freely soluble in water. Dopamine HCl has a molecular weight of 189.64 and it has the following structural formula:

Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring endogenous catecholamine.

Dextrose, USP is chemically designated D-glucose monohydrate (C₆H₁₂O₆ ∙ H₂O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17 and it has the following structural formula:

Water for Injection, USP is chemically designated H₂O.

Dopamine HCl infusions have been used in pediatric patients from birth through adolescence. Most reports in pediatric patients describe dosing that is similar (on a mcg/kg/minute basis) to that used in adults [see Dosage and Administration (2.2)]. Except for vasoconstrictive effects caused by inadvertent infusion of dopamine into the umbilical artery, adverse reactions unique to pediatric patients have not been identified, nor have adverse reactions identified in adults been found to be more common in pediatric patients.

Clinical studies of dopamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Dopamine is contraindicated in patients with pheochromocytoma.

Administration of dopamine to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and hypouresis, tissue hypoxia, lactic acidosis, and poor systemic blood flow despite "normal" blood pressure. Address hypovolemia prior to initiating Dopamine HCl in Dextrose Injection [see Dosage and Administration (2.2)].

Gangrene of the extremities has occurred in patients with occlusive vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients.

Extravasation of Dopamine HCl in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein [see Dosage and Administration (2.1)], check the infusion site frequently for free flow, and monitor for signs of extravasation.

The following adverse reactions are described elsewhere in the labeling:

• •
  Tissue Ischemia [see Warnings and Precautions (5.1)]
• •
  Cardiac Arrhythmias [see Warnings and Precautions (5.2)]
• •
  Hypotension [see Warnings and Precautions (5.3)]
• •
  Severe Hypersensitivity Reactions [see Warnings and Precautions (5.4)]

The following adverse reactions have been identified during post-approval use of dopamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac Disorders: anginal pain, palpitation

Gastrointestinal Disorders: nausea, vomiting

Metabolism and Nutrition Disorders: azotemia

Nervous System Disorders: headache, anxiety

Respiratory Disorders: dyspnea

Skin and Subcutaneous Tissue Disorders: piloerection

Vascular Disorders: hypertension

See Table 1 for clinically significant drug interactions with dopamine.

Dopamine's onset of action occurs within five minutes of intravenous administration and the duration of action is less than about ten minutes. Dopamine effects are dosage-dependent.

• •
  At <5 mcg/kg/minute, dopamine HCl activates dopamine D1 and D2 receptors in the renal, mesenteric, and coronary vasculature causing vasodilation.
• •
  At 5 to 10 mcg/kg/minute, dopamine HCl activates beta-1 receptors enhancing heart rate and contractility.
• •
  At >10 mcg/kg/minute, dopamine HCl activates alpha-1 receptors causing vasoconstriction and increased blood pressure

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 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to but not more than 50 mcg/kg/minute.

Infusion rates may be calculated using the following formula:

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 1,600 mcg/mL concentration, the infusion rate would be as follows:

Example 2: for a 70 kg person at a dose of 5 mcg/kg/minute using a 3,200 mcg/mL concentration, the infusion rate would be as follows:

Dopamine Hydrochloride in Dextrose Injection is indicated to improve hemodynamic status in patients in distributive shock, or shock due to reduced cardiac output.

Dopamine may cause arrhythmias. Monitor patients with arrhythmias and treat appropriately.

Dopamine is a natural catecholamine formed by the decarboxylation of 3,4-dihydroxyphenylalanine (DOPA). It is a precursor to norepinephrine in noradrenergic nerves and is also a neurotransmitter in certain areas of the central nervous system, especially in the nigrostriatal tract, and in a few peripheral sympathetic nerves.

Dopamine elicits its pharmacological action by activating dopamine D1 and D2 receptors, beta-1 receptors and alpha-1 receptors. The activation of different receptors leading to its effects are dependent on dopamine dose.

Dopamine HCl in Dextrose 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 premixed infusion solution.

• •
  Tissue ischemia: Severe peripheral and visceral vasoconstriction can occur. Address hypovolemia prior to use, monitor extremities, and infuse into large vein. (5.1)
• •
  Cardiac arrhythmias: Monitor closely. (5.2)
• •
  Hypotension after abrupt discontinuation: Gradually reduce infusion rate while expanding blood volume with intravenous fluids. (5.3)
• •
  Severe hypersensitivity reactions due to sodium metabisulfite excipient: May cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals. (5.4)

• •
  Correct hypovolemia, acidosis, and hypoxia prior to use. (2.1)
• •
  Administer in a large vein with an infusion pump preferably in an intensive care setting. (2.1)
• •
  Recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion. Titrate in 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to not more than 50 mcg/kg/minute. (2.2)
• •
  See the Full Prescribing Information for important preparation instructions and drug incompatibilities. (2.3)

The following strengths of Dopamine Hydrochloride in 5% Dextrose Injection, USP, are supplied in single-dose flexible plastic containers (the solutions are clear to slightly yellow in appearance):

• •
  1,600 mcg/mL (250 or 500 mL)
• •
  3,200 mcg/mL (250 mL)

Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection.

Dopamine Hydrochloride in 5% Dextrose Injection, USP, is supplied in 250 and 500 mL single-dose flexible plastic containers (the solutions are clear to slightly yellow in appearance) as follows. Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection.

Sudden cessation of the infusion rate may result in marked hypotension. Gradually reduce the infusion rate while expanding blood volume with intravenous fluids.

250 mL

NDC 0409-0042-01



DOPAMINE HCl

in 5% Dextrose Injection, USP

400 mg/250 mL

(1,600 mcg/mL)



Each 100 mL contains dopamine hydrochloride 160 mg;

dextrose, hydrous 5 g in water for injection; sodium

metabisulfite added 50 mg. May contain hydrochloric

acid and/or sodium hydroxide for pH adjustment.

269 mOsmol/liter (calc.) pH 2.5 to 4.5

Single-dose container. Discard unused portion. For

intravenous use only. Recommended Dosage: See

Prescribing Information. Warning: contains sulfites.



Drug additives should not be made to this solution.



Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged.

Not made with natural rubber latex.



Rx only

5

OTHER

MADE IN GERMANY

Hospira

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

12726-02

250 mL

NDC 0409-1858-01

DOPAMINE HCl

in 5% Dextrose Injection, USP



800 mg/250 mL

(3,200 mcg/mL)

Each 100 mL contains dopamine hydrochloride 320 mg;

dextrose, hydrous 5 g in water for injection; sodium

metabisulfite added 50 mg. May contain hydrochloric

acid and/or sodium hydroxide for pH adjustment.

286 mOsmol/liter (calc.) pH 2.5 to 4.5

Single-dose container. Discard unused portion. For

intravenous use only. Recommended Dosage: See

Prescribing Information. Warning: contains sulfites



Drug additives should not be made to this solution.



Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged.

Not made with natural rubber latex.



Rx only

5

OTHER

MADE IN GERMANY

Hospira

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

12727-02

250 mL

NDC 0409-7809-11

DOPAMINE HCl

in 5% Dextrose Injection, USP

400 mg/250 mL

(1,600 mcg/mL)

EACH 100 mL CONTAINS

DOPAMINE HYDROCHLORIDE

160 mg; DEXTROSE, HYDROUS 5 g IN

WATER FOR INJECTION; SODIUM

METABISULFITE ADDED 50 mg. MAY

CONTAIN HYDROCHLORIC ACID

AND/OR SODIUM HYDROXIDE FOR

pH ADJUSTMENT.

269 mOsmol/LITER (CALC.) pH 3.8

(2.5 to 4.5). SINGLE-DOSE

CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS

USE. USUAL DOSAGE: SEE INSERT.

WARNING: CONTAINS SULFITES.

DRUG ADDITIVES SHOULD NOT

BE MADE TO THIS SOLUTION.

STERILE NONPYROGENIC.

USE ONLY IF SOLUTION IS CLEAR

AND CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

7

OTHER

Hospira

IM-4355

DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA

250 mL

NDC 0409-7810-11

DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/250 mL

(3,200 mcg/mL)

EACH 100 mL CONTAINS DOPAMINE

HYDROCHLORIDE 320 mg; DEXTROSE,

HYDROUS 5 g IN WATER FOR

INJECTION; SODIUM METABISULFITE

ADDED 50 mg. MAY CONTAIN

HYDROCHLORIC ACID AND/OR

SODIUM HYDROXIDE FOR pH

ADJUSTMENT. 286 mOsmol/LITER

(CALC.) pH 3.8 (2.5 to 4.5). SINGLE-

DOSE CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS USE.

USUAL DOSAGE: SEE INSERT.

WARNING: CONTAINS SULFITES.

DRUG ADDITIVES SHOULD NOT

BE MADE TO THIS SOLUTION.

STERILE NONPYROGENIC.

USE ONLY IF SOLUTION IS CLEAR

AND CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

7

OTHER

IM-4357

Hospira

DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA

TO OPEN — TEAR AT NOTCH

Each 100 mL contains dopamine hydrochloride 160 mg; dextrose,

hydrous 5 g in water for injection; sodium metabisulfite added 50 mg.

May contain hydrochloric acid and/or sodium hydroxide for pH

adjustment.

269 mOsmol/liter (calc.)

ph 3.8 (2.5 to 4.5).

Single-dose container. Discard unused portion. For intravenous use.

Usual dosage: see insert. WARNING: CONTAINS SULFITES.

Drug additives should not be made to this solution. The overwrap is a

moisture and oxygen barrier. Do not remove unit from overwrap until

ready for use. Visually inspect overwrap for tears or holes. Discard

unit if overwrap is damaged or if solution is darker than slightly yellow

or discolored in any other way. Use unit promptly when overwrap is

opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing. See insert. After removing the

overwrap, check for minute leaks by squeezing container firmly. If

leaks are found, discard solution as sterility may be impaired.

Rx only

250 mL

NDC 0409-7809-11

DOPAMINE HCl

in 5% Dextrose Injection, USP

400 mg/250 mL

(1,600 mcg/mL)

Single-dose container

F WR-1540

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

TO OPEN — TEAR AT NOTCH

Each 100 mL contains dopamine hydrochloride 320 mg; dextrose,

hydrous 5 g in water for injection; sodium metabisulfite added 50 mg.

May contain hydrochloric acid and/or sodium hydroxide for pH

adjustment.

286 mOsmol/liter (calc.)

ph 3.8 (2.5 to 4.5).

Single-dose container. Discard unused portion. For intravenous use.

Usual dosage: see insert. WARNING: CONTAINS SULFITES.

Drug additives should not be made to this solution. The overwrap is a

moisture and oxygen barrier. Do not remove unit from overwrap until

ready for use. Visually inspect overwrap for tears or holes. Discard

unit if overwrap is damaged or if solution is darker than slightly yellow

or discolored in any other way. Use unit promptly when overwrap is

opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing. See insert. After removing the

overwrap, check for minute leaks by squeezing container firmly. If

leaks are found, discard solution as sterility may be impaired.

Rx only

250 mL

NDC 0409-7810-11

DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/250 mL

(3,200 mcg/mL)

Single-dose container

F WR-1544

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

TO OPEN — TEAR AT NOTCH

Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in

water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric

acid and/or sodium hydroxide for pH adjustment.

269 mOsmol/liter (calc.)

pH 2.5 to 4.5

Single-dose container. Discard unused portion. For intravenous use only.

Recommended Dosage: See Prescribing Information

WARNING: CONTAINS SULFITES.



Drug additives should not be made to this solution.

The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap

until ready for use. Visually inspect overwrap for tears or holes. Discard unit if

overwrap is damaged or if solution is darker than slightly yellow or discolored in

any other way. Use unit promptly when overwrap is opened. Store at 20°C to 25°C

(68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

After removing the overwrap, check for minute leaks by squeezing container firmly.

If leaks are found, discard solution as sterility may be impaired.



Not made with natural rubber latex.

Rx only

7

OTHER

250 mL

NDC 0409-0042-01

DOPAMINE HCl

in 5% Dextrose Injection, USP

400 mg/250 mL

(1,600 mcg/mL)

Single-dose container

13444-01

Hospira

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

TO OPEN — TEAR AT NOTCH



Each 100 mL contains dopamine hydrochloride 320mg; dextrose, hydrous 5 g in

water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric

acid and/or sodium hydroxide for pH adjustment.

286 mOsmol/liter (calc.)

pH 2.5 to 4.5

Single-dose container. Discard unused portion. For intravenous use only.

Recommended Dosage: See Prescribing Information.

WARNING: CONTAINS SULFITES.



Drug additives should not be made to this solution.

The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap

until ready for use. Visually inspect overwrap for tears or holes. Discard unit if

overwrap is damaged or if solution is darker than slightly yellow or discolored in

any other way. Use unit promptly when overwrap is opened. Store at 20°C to 25°C

(68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

After removing the overwrap, check for minute leaks by squeezing container

firmly. If leaks are found, discard solution as sterility may be impaired.



Not made with natural rubber latex.

Rx only

7

OTHER

250 mL

NDC 0409-1858-01



DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/250 mL

(3,200 mcg/mL)

Single-dose container

13445-01

Hospira

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

500 mL

NDC 0409-7809-31

DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/500 mL

(1,600 mcg/mL)

EACH 100 mL CONTAINS DOPAMINE

HYDROCHLORIDE 160 mg; DEXTROSE,

HYDROUS 5 g IN WATER FOR INJECTION;

SODIUM METABISULFITE ADDED 50 mg.

MAY CONTAIN HYDROCHLORIC ACID

AND/OR SODIUM HYDROXIDE FOR pH

ADJUSTMENT.

269 mOsmol/LITER (CALC.) pH 3.8 (2.5 to

4.5). SINGLE-DOSE CONTAINER. DISCARD

UNUSED PORTION. FOR INTRAVENOUS

USE. USUAL DOSAGE: SEE INSERT.

WARNING: CONTAINS SULFITES.

DRUG ADDITIVES SHOULD NOT

BE MADE TO THIS SOLUTION.

STERILE NONPYROGENIC.

USE ONLY IF SOLUTION IS CLEAR AND

CONTAINER IS UNDAMAGED. MUST NOT

BE USED IN SERIES CONNECTIONS.

Rx ONLY

7

OTHER

Hospira

IM-4356

DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA

TO OPEN — TEAR AT NOTCH

Each 100 mL contains dopamine hydrochloride 160 mg; dextrose,

hydrous 5 g in water for injection; sodium metabisulfite added 50 mg.

May contain hydrochloric acid and/or sodium hydroxide for pH

adjustment.

269 mOsmol/liter (calc.)

ph 3.8 (2.5 to 4.5).

Single-dose container. Discard unused portion. For intravenous use.

Usual dosage: see insert. WARNING: CONTAINS SULFITES.

Drug additives should not be made to this solution. The overwrap is a

moisture and oxygen barrier. Do not remove unit from overwrap until

ready for use. Visually inspect overwrap for tears or holes. Discard

unit if overwrap is damaged or if solution is darker than slightly yellow

or discolored in any other way. Use unit promptly when overwrap is

opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing. See insert. After removing the

overwrap, check for minute leaks by squeezing container firmly. If

leaks are found, discard solution as sterility may be impaired.

Rx only

500 mL

NDC 0409-7809-31

DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/500 mL

(1,600 mcg/mL)

Single-dose container

F WR-1543

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

Dopamine HCl in Dextrose Injection, contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Correct Hypovolemia, Acidosis, and Hypoxia

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

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Discard unused portion.

Manifestations of overdosage include excessive blood pressure elevation.

In the case of accidental overdosage, reduce rate of Dopamine HCl in Dextrose Injection infusion, or temporarily discontinue the Dopamine HCl in Dextrose Injection infusion until the overdosage related adverse reactions resolves. Since dopamine's duration of action is short, no additional remedial measures are usually necessary. If these measures fail to resolve the overdosage related adverse reactions, consider using an alpha-adrenergic blocking agent (e.g., phentolamine).

Dopamine Hydrochloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, premixed solution of dopamine hydrochloride in 5% dextrose injection for intravenous infusion.

Each 100 mL contains 160 mg (1,600 mcg/mL) or 320 mg (3,200 mcg/mL) of dopamine HCl; 5 grams of hydrous dextrose, in Water for Injection, and 50 mg of sodium metabisulfite (a stabilizer); pH = 2.5 to 4.5, and the following osmolar concentrations: 269, or 286 mOsmol/liter, respectively. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.

Dopamine HCl is chemically designated 3, 4-dihydroxyphenethylamine hydrochloride (C₈H₁₁NO₂ ∙ HCl), a white crystalline powder freely soluble in water. Dopamine HCl has a molecular weight of 189.64 and it has the following structural formula:

Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring endogenous catecholamine.

Dextrose, USP is chemically designated D-glucose monohydrate (C₆H₁₂O₆ ∙ H₂O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17 and it has the following structural formula:

Water for Injection, USP is chemically designated H₂O.

Dopamine HCl infusions have been used in pediatric patients from birth through adolescence. Most reports in pediatric patients describe dosing that is similar (on a mcg/kg/minute basis) to that used in adults [see Dosage and Administration (2.2)]. Except for vasoconstrictive effects caused by inadvertent infusion of dopamine into the umbilical artery, adverse reactions unique to pediatric patients have not been identified, nor have adverse reactions identified in adults been found to be more common in pediatric patients.

Clinical studies of dopamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Dopamine is contraindicated in patients with pheochromocytoma.

Administration of dopamine to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and hypouresis, tissue hypoxia, lactic acidosis, and poor systemic blood flow despite "normal" blood pressure. Address hypovolemia prior to initiating Dopamine HCl in Dextrose Injection [see Dosage and Administration (2.2)].

Gangrene of the extremities has occurred in patients with occlusive vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients.

Extravasation of Dopamine HCl in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein [see Dosage and Administration (2.1)], check the infusion site frequently for free flow, and monitor for signs of extravasation.

The following adverse reactions are described elsewhere in the labeling:

• •
  Tissue Ischemia [see Warnings and Precautions (5.1)]
• •
  Cardiac Arrhythmias [see Warnings and Precautions (5.2)]
• •
  Hypotension [see Warnings and Precautions (5.3)]
• •
  Severe Hypersensitivity Reactions [see Warnings and Precautions (5.4)]

The following adverse reactions have been identified during post-approval use of dopamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac Disorders: anginal pain, palpitation

Gastrointestinal Disorders: nausea, vomiting

Metabolism and Nutrition Disorders: azotemia

Nervous System Disorders: headache, anxiety

Respiratory Disorders: dyspnea

Skin and Subcutaneous Tissue Disorders: piloerection

Vascular Disorders: hypertension

See Table 1 for clinically significant drug interactions with dopamine.

Dopamine's onset of action occurs within five minutes of intravenous administration and the duration of action is less than about ten minutes. Dopamine effects are dosage-dependent.

• •
  At <5 mcg/kg/minute, dopamine HCl activates dopamine D1 and D2 receptors in the renal, mesenteric, and coronary vasculature causing vasodilation.
• •
  At 5 to 10 mcg/kg/minute, dopamine HCl activates beta-1 receptors enhancing heart rate and contractility.
• •
  At >10 mcg/kg/minute, dopamine HCl activates alpha-1 receptors causing vasoconstriction and increased blood pressure

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 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to but not more than 50 mcg/kg/minute.

Infusion rates may be calculated using the following formula:

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 1,600 mcg/mL concentration, the infusion rate would be as follows:

Example 2: for a 70 kg person at a dose of 5 mcg/kg/minute using a 3,200 mcg/mL concentration, the infusion rate would be as follows:

Dopamine Hydrochloride in Dextrose Injection is indicated to improve hemodynamic status in patients in distributive shock, or shock due to reduced cardiac output.

Dopamine may cause arrhythmias. Monitor patients with arrhythmias and treat appropriately.

Dopamine is a natural catecholamine formed by the decarboxylation of 3,4-dihydroxyphenylalanine (DOPA). It is a precursor to norepinephrine in noradrenergic nerves and is also a neurotransmitter in certain areas of the central nervous system, especially in the nigrostriatal tract, and in a few peripheral sympathetic nerves.

Dopamine elicits its pharmacological action by activating dopamine D1 and D2 receptors, beta-1 receptors and alpha-1 receptors. The activation of different receptors leading to its effects are dependent on dopamine dose.

Dopamine HCl in Dextrose 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 premixed infusion solution.

• •
  Tissue ischemia: Severe peripheral and visceral vasoconstriction can occur. Address hypovolemia prior to use, monitor extremities, and infuse into large vein. (5.1)
• •
  Cardiac arrhythmias: Monitor closely. (5.2)
• •
  Hypotension after abrupt discontinuation: Gradually reduce infusion rate while expanding blood volume with intravenous fluids. (5.3)
• •
  Severe hypersensitivity reactions due to sodium metabisulfite excipient: May cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals. (5.4)

• •
  Correct hypovolemia, acidosis, and hypoxia prior to use. (2.1)
• •
  Administer in a large vein with an infusion pump preferably in an intensive care setting. (2.1)
• •
  Recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion. Titrate in 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to not more than 50 mcg/kg/minute. (2.2)
• •
  See the Full Prescribing Information for important preparation instructions and drug incompatibilities. (2.3)

The following strengths of Dopamine Hydrochloride in 5% Dextrose Injection, USP, are supplied in single-dose flexible plastic containers (the solutions are clear to slightly yellow in appearance):

• •
  1,600 mcg/mL (250 or 500 mL)
• •
  3,200 mcg/mL (250 mL)

Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection.

Dopamine Hydrochloride in 5% Dextrose Injection, USP, is supplied in 250 and 500 mL single-dose flexible plastic containers (the solutions are clear to slightly yellow in appearance) as follows. Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection.

Sudden cessation of the infusion rate may result in marked hypotension. Gradually reduce the infusion rate while expanding blood volume with intravenous fluids.

250 mL

NDC 0409-0042-01



DOPAMINE HCl

in 5% Dextrose Injection, USP

400 mg/250 mL

(1,600 mcg/mL)



Each 100 mL contains dopamine hydrochloride 160 mg;

dextrose, hydrous 5 g in water for injection; sodium

metabisulfite added 50 mg. May contain hydrochloric

acid and/or sodium hydroxide for pH adjustment.

269 mOsmol/liter (calc.) pH 2.5 to 4.5

Single-dose container. Discard unused portion. For

intravenous use only. Recommended Dosage: See

Prescribing Information. Warning: contains sulfites.



Drug additives should not be made to this solution.



Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged.

Not made with natural rubber latex.



Rx only

5

OTHER

MADE IN GERMANY

Hospira

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

12726-02

250 mL

NDC 0409-1858-01

DOPAMINE HCl

in 5% Dextrose Injection, USP



800 mg/250 mL

(3,200 mcg/mL)

Each 100 mL contains dopamine hydrochloride 320 mg;

dextrose, hydrous 5 g in water for injection; sodium

metabisulfite added 50 mg. May contain hydrochloric

acid and/or sodium hydroxide for pH adjustment.

286 mOsmol/liter (calc.) pH 2.5 to 4.5

Single-dose container. Discard unused portion. For

intravenous use only. Recommended Dosage: See

Prescribing Information. Warning: contains sulfites



Drug additives should not be made to this solution.



Sterile, nonpyrogenic.

Use only if solution is clear and container is undamaged.

Not made with natural rubber latex.



Rx only

5

OTHER

MADE IN GERMANY

Hospira

Distributed by Hospira, Inc.,

Lake Forest, IL 60045 USA

12727-02

250 mL

NDC 0409-7809-11

DOPAMINE HCl

in 5% Dextrose Injection, USP

400 mg/250 mL

(1,600 mcg/mL)

EACH 100 mL CONTAINS

DOPAMINE HYDROCHLORIDE

160 mg; DEXTROSE, HYDROUS 5 g IN

WATER FOR INJECTION; SODIUM

METABISULFITE ADDED 50 mg. MAY

CONTAIN HYDROCHLORIC ACID

AND/OR SODIUM HYDROXIDE FOR

pH ADJUSTMENT.

269 mOsmol/LITER (CALC.) pH 3.8

(2.5 to 4.5). SINGLE-DOSE

CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS

USE. USUAL DOSAGE: SEE INSERT.

WARNING: CONTAINS SULFITES.

DRUG ADDITIVES SHOULD NOT

BE MADE TO THIS SOLUTION.

STERILE NONPYROGENIC.

USE ONLY IF SOLUTION IS CLEAR

AND CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

7

OTHER

Hospira

IM-4355

DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA

250 mL

NDC 0409-7810-11

DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/250 mL

(3,200 mcg/mL)

EACH 100 mL CONTAINS DOPAMINE

HYDROCHLORIDE 320 mg; DEXTROSE,

HYDROUS 5 g IN WATER FOR

INJECTION; SODIUM METABISULFITE

ADDED 50 mg. MAY CONTAIN

HYDROCHLORIC ACID AND/OR

SODIUM HYDROXIDE FOR pH

ADJUSTMENT. 286 mOsmol/LITER

(CALC.) pH 3.8 (2.5 to 4.5). SINGLE-

DOSE CONTAINER. DISCARD UNUSED

PORTION. FOR INTRAVENOUS USE.

USUAL DOSAGE: SEE INSERT.

WARNING: CONTAINS SULFITES.

DRUG ADDITIVES SHOULD NOT

BE MADE TO THIS SOLUTION.

STERILE NONPYROGENIC.

USE ONLY IF SOLUTION IS CLEAR

AND CONTAINER IS UNDAMAGED.

MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

7

OTHER

IM-4357

Hospira

DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA

TO OPEN — TEAR AT NOTCH

Each 100 mL contains dopamine hydrochloride 160 mg; dextrose,

hydrous 5 g in water for injection; sodium metabisulfite added 50 mg.

May contain hydrochloric acid and/or sodium hydroxide for pH

adjustment.

269 mOsmol/liter (calc.)

ph 3.8 (2.5 to 4.5).

Single-dose container. Discard unused portion. For intravenous use.

Usual dosage: see insert. WARNING: CONTAINS SULFITES.

Drug additives should not be made to this solution. The overwrap is a

moisture and oxygen barrier. Do not remove unit from overwrap until

ready for use. Visually inspect overwrap for tears or holes. Discard

unit if overwrap is damaged or if solution is darker than slightly yellow

or discolored in any other way. Use unit promptly when overwrap is

opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing. See insert. After removing the

overwrap, check for minute leaks by squeezing container firmly. If

leaks are found, discard solution as sterility may be impaired.

Rx only

250 mL

NDC 0409-7809-11

DOPAMINE HCl

in 5% Dextrose Injection, USP

400 mg/250 mL

(1,600 mcg/mL)

Single-dose container

F WR-1540

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

TO OPEN — TEAR AT NOTCH

Each 100 mL contains dopamine hydrochloride 320 mg; dextrose,

hydrous 5 g in water for injection; sodium metabisulfite added 50 mg.

May contain hydrochloric acid and/or sodium hydroxide for pH

adjustment.

286 mOsmol/liter (calc.)

ph 3.8 (2.5 to 4.5).

Single-dose container. Discard unused portion. For intravenous use.

Usual dosage: see insert. WARNING: CONTAINS SULFITES.

Drug additives should not be made to this solution. The overwrap is a

moisture and oxygen barrier. Do not remove unit from overwrap until

ready for use. Visually inspect overwrap for tears or holes. Discard

unit if overwrap is damaged or if solution is darker than slightly yellow

or discolored in any other way. Use unit promptly when overwrap is

opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing. See insert. After removing the

overwrap, check for minute leaks by squeezing container firmly. If

leaks are found, discard solution as sterility may be impaired.

Rx only

250 mL

NDC 0409-7810-11

DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/250 mL

(3,200 mcg/mL)

Single-dose container

F WR-1544

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

TO OPEN — TEAR AT NOTCH

Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in

water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric

acid and/or sodium hydroxide for pH adjustment.

269 mOsmol/liter (calc.)

pH 2.5 to 4.5

Single-dose container. Discard unused portion. For intravenous use only.

Recommended Dosage: See Prescribing Information

WARNING: CONTAINS SULFITES.



Drug additives should not be made to this solution.

The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap

until ready for use. Visually inspect overwrap for tears or holes. Discard unit if

overwrap is damaged or if solution is darker than slightly yellow or discolored in

any other way. Use unit promptly when overwrap is opened. Store at 20°C to 25°C

(68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

After removing the overwrap, check for minute leaks by squeezing container firmly.

If leaks are found, discard solution as sterility may be impaired.



Not made with natural rubber latex.

Rx only

7

OTHER

250 mL

NDC 0409-0042-01

DOPAMINE HCl

in 5% Dextrose Injection, USP

400 mg/250 mL

(1,600 mcg/mL)

Single-dose container

13444-01

Hospira

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

TO OPEN — TEAR AT NOTCH



Each 100 mL contains dopamine hydrochloride 320mg; dextrose, hydrous 5 g in

water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric

acid and/or sodium hydroxide for pH adjustment.

286 mOsmol/liter (calc.)

pH 2.5 to 4.5

Single-dose container. Discard unused portion. For intravenous use only.

Recommended Dosage: See Prescribing Information.

WARNING: CONTAINS SULFITES.



Drug additives should not be made to this solution.

The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap

until ready for use. Visually inspect overwrap for tears or holes. Discard unit if

overwrap is damaged or if solution is darker than slightly yellow or discolored in

any other way. Use unit promptly when overwrap is opened. Store at 20°C to 25°C

(68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

After removing the overwrap, check for minute leaks by squeezing container

firmly. If leaks are found, discard solution as sterility may be impaired.



Not made with natural rubber latex.

Rx only

7

OTHER

250 mL

NDC 0409-1858-01



DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/250 mL

(3,200 mcg/mL)

Single-dose container

13445-01

Hospira

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

500 mL

NDC 0409-7809-31

DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/500 mL

(1,600 mcg/mL)

EACH 100 mL CONTAINS DOPAMINE

HYDROCHLORIDE 160 mg; DEXTROSE,

HYDROUS 5 g IN WATER FOR INJECTION;

SODIUM METABISULFITE ADDED 50 mg.

MAY CONTAIN HYDROCHLORIC ACID

AND/OR SODIUM HYDROXIDE FOR pH

ADJUSTMENT.

269 mOsmol/LITER (CALC.) pH 3.8 (2.5 to

4.5). SINGLE-DOSE CONTAINER. DISCARD

UNUSED PORTION. FOR INTRAVENOUS

USE. USUAL DOSAGE: SEE INSERT.

WARNING: CONTAINS SULFITES.

DRUG ADDITIVES SHOULD NOT

BE MADE TO THIS SOLUTION.

STERILE NONPYROGENIC.

USE ONLY IF SOLUTION IS CLEAR AND

CONTAINER IS UNDAMAGED. MUST NOT

BE USED IN SERIES CONNECTIONS.

Rx ONLY

7

OTHER

Hospira

IM-4356

DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA

TO OPEN — TEAR AT NOTCH

Each 100 mL contains dopamine hydrochloride 160 mg; dextrose,

hydrous 5 g in water for injection; sodium metabisulfite added 50 mg.

May contain hydrochloric acid and/or sodium hydroxide for pH

adjustment.

269 mOsmol/liter (calc.)

ph 3.8 (2.5 to 4.5).

Single-dose container. Discard unused portion. For intravenous use.

Usual dosage: see insert. WARNING: CONTAINS SULFITES.

Drug additives should not be made to this solution. The overwrap is a

moisture and oxygen barrier. Do not remove unit from overwrap until

ready for use. Visually inspect overwrap for tears or holes. Discard

unit if overwrap is damaged or if solution is darker than slightly yellow

or discolored in any other way. Use unit promptly when overwrap is

opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.] Protect from freezing. See insert. After removing the

overwrap, check for minute leaks by squeezing container firmly. If

leaks are found, discard solution as sterility may be impaired.

Rx only

500 mL

NDC 0409-7809-31

DOPAMINE HCl

in 5% Dextrose Injection, USP

800 mg/500 mL

(1,600 mcg/mL)

Single-dose container

F WR-1543

Distributed by

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

Dopamine HCl in Dextrose Injection, contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.