Dopamine Hci In 5% Dextrose
FDA Drug Information • Also known as: Dopamine Hci In 5% Dextrose
- Brand Names
- Dopamine Hci In 5% Dextrose
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Dopamine Hydrochloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dopamine hydrochloride in 5% dextrose injection. It is administered by intravenous infusion. Each 100 mL contains dopamine hydrochloride 80 mg (0.8 mg/mL), 160 mg (1.6 mg/mL) or 320 mg (3.2 mg/mL) and dextrose, hydrous 5 g in water for injection, with sodium metabisulfite added 50 mg as a stabilizer; osmolar concentration, respectively 261, 269, or 286 mOsmol/liter (calc.), pH 3.8 (2.5 to 4.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dopamine administered intravenously is a myocardial inotropic agent, which also may increase mesenteric and renal blood flow plus urinary output. Dopamine Hydrochloride is chemically designated 3, 4-dihydroxyphenethylamine hydrochloride (C8H11NO2
What Is Dopamine Hci In 5% Dextrose Used For?
INDICATIONS & USAGE Dopamine Hydrochloride in 5% Dextrose Injection, USP is indicated for the correction of hemodynamic imbalances present in shock due to myocardial infarction, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in refractory congestive failure. When indicated, restoration of circulatory volume should be instituted or completed with a suitable plasma expander or whole blood, prior to administration of dopamine hydrochloride. Patients most likely to respond to dopamine are those whose physiological parameters (such as urine flow, myocardial function and blood pressure) have not undergone extreme deterioration. Reports indicate that the shorter the time between onset of signs and symptoms and initiation of therapy with volume restoration and dopamine, the better the prognosis. Poor Perfusion of Vital Organs: Although urine flow is apparently one of the better diagnostic signs for monitoring vital organ perfusion, the physician also should observe the patient for signs of reversal of mental confusion or coma. Loss of pallor, increase in toe temperature or adequacy of nail bed capillary filling also may be observed as indices of adequate dosage. Reported studies indicate that when dopamine is administered before urine flow has decreased to approximately 0.3 mL/minute prognosis is more favorable. However, it has been observed that in some oliguric or anuric patients, administration of the drug has produced an increase in urine flow which may reach normal levels. The drug also may increase urine flow in patients whose output is within normal limits and thus may help in reducing the degree of pre-existing fluid accumulation. Conversely, at higher than optimal doses for a given patient, urinary flow may decrease, requiring a reduction of dosage. Concomitant administration of dopamine and diuretic agents may produce an additive or potentiating effect. Low Cardiac Output: Dopamine's direct inotropic effect on the myocardium which increases cardiac output at low or moderate doses is related to a favorable prognosis. Increased output has been associated with unchanged or decreased systemic vascular resistance (SVR). The association of static or decreased SVR with low or moderate increases in cardiac output is regarded as a reflection of differential effects on specific vascular beds, with increased resistance in peripheral beds (e.g., femoral), and concurrent decreases in mesenteric and renal vascular beds. Redistribution of blood flow parallels these changes so that an increase in cardiac output is accompanied by an increase in mesenteric and renal blood flow. In many instances the renal fraction of the total cardiac output has been found to increase. Increase in cardiac output produced by dopamine is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol. Hypotension: Low to moderate doses of dopamine, which have little effect on SVR, can...
Dosage and Administration
DOSAGE & ADMINISTRATION Do NOT administer if solution is darker than slightly yellow or discolored in any other way. Do NOT administer unless solution is clear and container is undamaged. Discard unused portion. Dextrose solutions without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur. Do NOT add sodium bicarbonate or other alkalinizing substance, since dopamine is inactivated in alkaline solution. Dopamine Hydrochloride in 5% Dextrose Injection should be infused into a large vein whenever possible to prevent the infiltration of perivascular tissue adjacent to the infusion site. Extravasation may cause necrosis and sloughing of the surrounding tissue. Large veins of the antecubital fossa are preferred to veins of the dorsum of the hand or ankle. Less suitable infusion sites should be used only when larger veins are unavailable and the patient's condition requires immediate attention. The physician should switch to a more suitable site as soon as possible and the infusion site in use should be continuously monitored for free flow. The less concentrated 800 mcg/mL solution may be preferred when fluid expansion is not a problem. The more concentrated 1600 mcg/mL or 3200 mcg/mL solutions, may be preferred in patients with fluid retention or when a slower rate of infusion is desired. Rate of Administration: Administration into an umbilical artery catheter is not recommended. Dopamine in 5% Dextrose Injection should not be infused through ordinary intravenous apparatus, regulated only by gravity and mechanical clamps. Only an infusion pump, preferably a volumetric pump, should be used. Each patient must be individually titrated to the desired hemodynamic or renal response to dopamine. In titrating to the desired increase in systolic blood pressure, the optimum dosage rate for renal response may be exceeded, thus necessitating a reduction in rate after the hemodynamic condition is stabilized. If a disproportionate rise in diastolic pressure (i.e., a marked decrease in pulse pressure) is observed in patients receiving dopamine, the infusion rate should be decreased and the patient observed carefully for further evidence of predominant vasoconstrictor activity, unless such an effect is desired. Administration rates greater than 50 mcg/kg/min have safely been used in adults 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. When discontinuing the infusion, it may be necessary to gradually decrease the dose of dopamine HCl while expanding the blood volume with intravenous fluids to prevent the development of marked hypotension. 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...
Side Effects (Adverse Reactions)
ADVERSE REACTIONS 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.
Warnings and Precautions
WARNINGS Do NOT add any alkalinizing substance, since dopamine is inactivated in alkaline solution. Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to administration of dopamine should receive substantially reduced dosage of the latter. See PRECAUTIONS , Drug Interactions, below. Additive medications should not be delivered via this solution. Dopamine Hydrochloride in 5% Dextrose Injection, USP 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.
Contraindications
CONTRAINDICATIONS Dopamine hydrochloride should not be used in patients with pheochromocytoma. Dopamine should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.
Overdosage
OVERDOSAGE In the case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce rate of infusion, or temporarily discontinue administration of the drug 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, consider using an alpha-adrenergic blocking agent (e.g., phentolamine).
How Supplied
HOW SUPPLIED DOPAMINE HCI IN 5% DEXTROSE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1458-1 DOPAMINE HCI IN 5% DEXTROSE INJECTION, USP 800mg/500mL (1,600mcg/mL) 500mL BAG HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Dopamine Hydrochloride in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare flexible containers as follows: Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts. Do not use the injection if it is darker than slightly yellow or discolored in any other way. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1153-1.0 Revised: 03/2018 HOW SUPPLIED LOGO
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.