Dopamine 



Dopamine is a prescription medicine used to treat the symptoms of low blood pressure, low cardiac output and improves blood flow to the kidneys. Dopamine may be used alone or with other medications.

Dopamine belongs to a class of drugs called Inotropic Agents.

What are the possible side effects of Dopamine?

Dopamine may cause serious side effects including:

  • lightheadedness,
  • chest pain,
  • fast, slow or pounding heartbeats,
  • shortness of breath,
  • cold feeling,
  • numbness,
  • blue-colored appearance in your hands or feet, and
  • darkening or skin changes in your hands or feet

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Dopamine include:

  • headache,
  • anxiety,
  • nausea,
  • vomiting,
  • chills and
  • goose bumps

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Dopamine. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Dopamine, a sympathomimetic amine vasopressor, is the naturally occurring immediate precursor of norepinephrine. Dopamine hydrochloride is a white to off-white crystalline powder, which may have a slight odor of hydrochloric acid. It is freely soluble in water and soluble in alcohol. Dopamine HCl is sensitive to alkalies, iron salts, and oxidizing agents. Chemically it is designated as 4-(2-aminoethyl) pyrocatechol hydrochloride, and the structural formula is:

Dopamine Hydrochloride - Structural Formula Illustration

Dopamine Hydrochloride Injection is a clear, practically colorless, sterile, pyrogen-free, aqueous solution of dopamine HCl for intravenous infusion after dilution. Each mL contains either 40 mg, 80 mg, or 160 mg of dopamine hydrochloride (equivalent to 32.3 mg, 64.6 mg and 129.2 mg of dopamine base respectively) in water for injection, q.s. Each mL of all preparations contains the following: sodium metabisulfite 9 mg added as an antioxidant; citric acid, anhydrous 10 mg and sodium citrate, dihydrate 5 mg added as a buffer. The pH range (2.5 to 5.0) may be adjusted with additional citric acid and/or sodium citrate.

Dopamine must be diluted in an appropriate sterile parenteral solution (see DOSAGE AND ADMINISTRATION section).

DOSAGE AND ADMINISTRATION

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

Dopamine 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

Dopamine 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 Dopamine Hydrochloride to Sodium Bicarbonate Injection, USP or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.

Rate of Administration: Dopamine Hydrochloride Injection, USP, after dilution, is administered intravenously by infusion through a suitable intravenous catheter or needle. When administering Dopamine 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 dopamine.

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 Dopamine 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 Dopamine 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 dopamine dosage should be considered. Multiclinic trials have shown that more than 50% of the patients have been satisfactorily maintained on doses of dopamine 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 dopamine 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 dopamine 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.