Dopamine Hydrochloride
FDA Drug Information • Also known as: Dopamine, Dopamine Hydrochloride, Dopamine Hydrochloride And Dextrose, Dopamine Phenolic
- Brand Names
- Dopamine, Dopamine Hydrochloride, Dopamine Hydrochloride And Dextrose, Dopamine Phenolic
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 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 its molecular formula is C 8 H 11 NO 2
What Is Dopamine Hydrochloride Used For?
1 INDICATIONS AND USAGE Dopamine HCl Injection is indicated to improve hemodynamic status in patients in distributive shock or shock due to reduced cardiac output. Dopamine HCl Injection is a catecholamine indicated to improve hemodynamic status in patients in shock. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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. ( 2.1 , 2.3 ) 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: 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 )]. chart 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: 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...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS 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 postapproval 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 The most common adverse reaction is localized vasoconstriction due to extravasation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with dopamine. Table 1: Clinically Significant Drug Interactions with Dopamine Halogenated Anesthetics Clinical Impact: Concomitant use may increase cardiac autonomic irritability and can sensitize the myocardium to the action of dopamine which may lead to ventricular arrhythmias and hypertension. Intervention: Monitor cardiac rhythm. Examples: desflurane, enflurane, isoflurane, and sevoflurane. MAO Inhibitors Clinical Impact: Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine which may result in severe hypertension and cardiac arrhythmia. Intervention: Reduce the recommended starting dosage to no greater than one-tenth (1/10) of the recommended dose in patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of Dopamine HCl Injection. Examples: isocarboxazid, phenelzine, tranylcypromine, rasagiline, selegiline, linezolid. Tricyclic Antidepressants Clinical Impact: Concomitant use may potentiate the cardiovascular effects of dopamine (e.g., hypertension). Intervention: Monitor blood pressure. Examples: amitriptyline, desipramine, doxepin, imipramine, nortriptyline. Vasopressors Clinical Impact: Concomitant use may result in severe hypertension. Intervention: Monitor blood pressure. Examples: norepinephrine, epinephrine, oxytocin. Halogenated anesthetics : Can sensitize the myocardium to the effects of dopamine and can produce ventricular arrhythmias and hypertension. ( 7 ) MAO inhibitors : Risk of severe hypertension. Reduce recommended Dopamine HCl Injection dosage. ( 7 ) Tricyclic antidepressants : Risk of hypertension. Monitor blood pressure. ( 7 ) Vasopressors : Risk of severe hypertension. Monitor blood pressure. ( 7 )
Contraindications
4 CONTRAINDICATIONS Dopamine is contraindicated in patients with pheochromocytoma. Dopamine is contraindicated in patients with pheochromocytoma. ( 4 )
Overdosage
10 OVERDOSAGE Manifestations of overdosage include excessive blood pressure elevation. In the case of accidental overdosage, reduce rate of Dopamine HCl Injection administration or temporarily discontinue the dopamine HCl until the overdosage related adverse reactions resolves. Since dopamine’s duration of action is quite 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).
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Dopamine Hydrochloride Injection, USP is a clear, colorless to slightly yellow aqueous solution supplied as follows: Strength Packaged NDC No. 200 mg/5 mL (40 mg/mL) Carton of 25 vials 0143-9252-25 400 mg/5 mL (80 mg/mL) Carton of 25 vials 0143-9253-25 400 mg/10 mL (40 mg/mL) Carton of 25 vials 0143-9254-25 800 mg/10 mL (80 mg/mL) Carton of 25 vials 0143-9255-25 Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.