pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic Agonists; Dopamine Agonists.

AdrenergicDopamine

Indications

Sourced from openFDA
  • Dopamine Hydrochloride, USP is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Patients most likely to respond adequately to Dopamine Hydrochloride, USP are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration.ICD-10: I21.9

Contraindications

Sourced from openFDA
  • Dopamine HCl should not be used in patients with pheochromocytoma. Dopamine HCl should not be administered to patients with uncorrected tachyarrhythmias or ventricular fibrillation.contraindicated

Dosage & administration

Sourced from openFDA

WARNING: This is a potent drug; it must be diluted before administration to the patient. Dopamine hydrochloride injection is administered (only after dilution) by intravenous infusion. Suggested Dilution – 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 hydrochloride to either a 250 mL or 500 mL bottle of one of the sterile I.V. solutions listed below. For the 80 mg/mL preparation, transfer by aseptic technique the contents containing 10 mL, 800 mg of dopamine hydrochloride to a 250 mL, 500 mL or 1000 mL bottle of one of the following sterile I.V. solutions: 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: Concentration of dopamine hydrochloride 40 mg/mL 80 mg/mL Volume of dopamine Hydrochloride Injection, USP 5 mL 10 mL 10 mL 250 mL Bottle of I.V. Solution 800 mcg/mL 1600 mcg/mL 3200 mcg/mL 500 mL Bottle of I.V. Solution 400 mcg/mL 800 mcg/mL 1600 mcg/mL 1000 mL Bottle of I.V. Solution 200 mcg/mL 400 mcg/mL 800 mcg/mL Dopamine hydrochloride injection has been found to be stable for a minimum of 24 hours after dilution in the foregoing I.V. solutions. However, as with all I.V. admixtures, dilution should be made just prior to administration.

Warnings & precautions

Sourced from openFDA

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 nonasthmatic people. Do NOT add dopamine HCl to any alkaline diluent solution since the drug is inactivated in alkaline solution. Patients who have been receiving MAO inhibitors prior to the administration of dopamine HCl will require substantially reduced dosage. See Drug Interactions below.

Adverse reactions

Sourced from openFDA

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Cardiovascular System: -ventricular arrhythmia -atrial fibrillation -ectopic beats -tachycardia -anginal pain -palpitation -cardiac conduction abnormalities -widened QRS complex -bradycardia -hypotension -hypertension -vasoconstriction Respiratory System: -dyspnea Gastrointestinal System: -nausea -vomiting Metabolic/Nutritional System: -azotemia Central Nervous System: -headache -anxiety Dermatological System: -piloerection Other: Gangrene of the extremities has occurred when high doses were administered for prolonged periods or in patients with occlusive vascular disease receiving low doses of dopamine HCl. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1‐877‐233‐2001 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: Pregnancy Category C Animal studies have revealed no evidence of teratogenic effects due to dopamine. However, in one study, administration of dopamine HCl to pregnant rats resulted in a decreased survival rate of the newborn and a potential for cataract formation in the survivors. There are no adequate and well-controlled studies in pregnant women and it is not known if dopamine crosses the placental barrier. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if, in the judgment of the physician, the potential benefit justifies the potential risk to the fetus.

Overdosage

Sourced from openFDA

In the case of accidental overdosage, as evidenced by excessive elevation of blood pressure, reduce rate of administration or temporarily discontinue dopamine HCl until patient’s condition stabilizes. Since dopamine’s duration of action is quite short, no additional remedial measures are usually necessary. If these measures fail to stabilize the patient’s condition, use of the short-acting alpha-adrenergic blocking agent phentolamine should be considered.

Approval history

Sourced from openFDA
  • May 19, 1981NDANDA018132Hospira
  • Sep 30, 1983NDANDA018826Hospira
  • Mar 27, 1987NDANDA019615Baxter Hlthcare
  • Apr 11, 2018ANDAANDA207707Hikma Intl Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,757 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective61016%
  2. 2Hypotension38610%
  3. 3Off Label Use2797.4%
  4. 4Cardiac Arrest2045.4%
  5. 5Renal Failure2005.3%
  6. 6Acute Kidney Injury1995.3%
  7. 7Condition Aggravated1694.5%
  8. 8Pneumonia1494.0%
  9. 9Sepsis1494.0%
  10. 10Death1433.8%
  11. 11Pyrexia1413.8%
  12. 12Dyspnoea1353.6%
  13. 13Renal Impairment1353.6%
  14. 14Respiratory Failure1353.6%
  15. 15Toxicity To Various Agents1323.5%

Literature

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Recent PubMed references pinned to Dopamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 900 ClinicalTrials.gov registrations naming Dopamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dopamine work?
Mechanism-of-action classes: Adrenergic Agonists; Dopamine Agonists.
What is Dopamine used for?
According to FDA labeling, Dopamine carries indications including: Dopamine Hydrochloride, USP is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Patients most likely to respond adequately to Dopamine Hydrochloride, USP are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dopamine?
Dopamine is classified as Adrenergic and dopaminergic agents, Catecholamine, Adrenergic Agonists, Dopamine Agonists, Positive Chronotropy, Positive Inotropy, Renal Arterial Vasodilation, Systemic Arterial Vasoconstriction.
What are the contraindications for Dopamine?
Dopamine labeling lists contraindications including: Dopamine HCl should not be used in patients with pheochromocytoma. Dopamine HCl should not be administered to patients with uncorrected tachyarrhythmias or ventricular fibrillation.. Always consult the full prescribing information and a clinician.
Note. Data for dopamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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