Dopamine Hydrochloride in Dextrose

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Overview

What is Dopamine Hydrochloride in Dextrose?

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 (CHNO • HCl), a white crystalline powder freely soluble in water. It has the following structural formula:

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

Dextrose, USP is chemically designated D-glucose monohydrate (CHO • HO), a hexose sugar freely soluble in water. It has the following structural formula:

Water for Injection, USP is chemically designated HO.

The flexible plastic container is fabricated from a specially formulated CR3 plastic material. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

What does Dopamine Hydrochloride in Dextrose look like?

What are the available doses of Dopamine Hydrochloride in Dextrose?

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What should I talk to my health care provider before I take Dopamine Hydrochloride in Dextrose?

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How should I use Dopamine Hydrochloride in Dextrose?

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.

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.

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.

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:

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.

What interacts with Dopamine Hydrochloride in Dextrose?

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What are the warnings of Dopamine Hydrochloride in Dextrose?

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What are the precautions of Dopamine Hydrochloride in Dextrose?

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What are the side effects of Dopamine Hydrochloride in Dextrose?

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What should I look out for while using Dopamine Hydrochloride in Dextrose?

Dopamine hydrochloride should not be used in patients with pheochromocytoma.

Dopamine should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.

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 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.

What might happen if I take too much Dopamine Hydrochloride in Dextrose?

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 should I store and handle Dopamine Hydrochloride in Dextrose?

StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) 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-1153-1.0Revised: 03/2018Dopamine 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-1153-1.0Revised: 03/2018Dopamine 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-1153-1.0Revised: 03/2018Dopamine 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-1153-1.0Revised: 03/2018Dopamine 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-1153-1.0Revised: 03/2018Dopamine 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-1153-1.0Revised: 03/2018Dopamine 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-1153-1.0Revised: 03/2018

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Dopamine exhibits an inotropic action on the myocardium, resulting in increased cardiac output. It causes less increase in myocardial oxygen consumption than isoproterenol and the effect of dopamine usually is not associated with tachyarrhythmia. Reported clinical studies have revealed that the drug usually increases systolic and pulse pressure without any or only a minor elevating effect on diastolic pressure. Total peripheral resistance at low and intermediate doses is usually unchanged. Blood flow to peripheral vascular beds may decrease while mesenteric blood flow is increased. The drug also has been reported to produce dilation of the renal vasculature which is accompanied by increases in glomerular filtration rate, renal blood flow and sodium excretion. Increased urinary output produced by dopamine is usually not associated with decreased urine osmolality.

Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss due to perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes and sodium (Na) plays a major role in maintaining physiologic equilibrium.

The reported clearance rate of dopamine in critically ill infants and children has ranged from 46 to 168 mL/kg/min, with the higher values seen in the younger patients. The apparent volume of distribution in neonates is reported as 0.6 to 4 L/kg, leading to an elimination half-life of 5 to 11 minutes.

Non-Clinical Toxicology

Dopamine hydrochloride should not be used in patients with pheochromocytoma.

Dopamine should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.

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 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.

Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.

Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.

General:

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Laboratory Tests:

Weaning:

Drug Interactions:

Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine. Patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine should receive initial doses of dopamine hydrochloride no greater than one-tenth (1/10) of the usual dose.

Concurrent administration of low-dose dopamine HCl and diuretic agents may produce an additive or potentiating effect on urine flow.

Tricyclic antidepressants may potentiate the cardiovascular effects of adrenergic agents.

Cardiac effects of dopamine are antagonized by β-adrenergic blocking agents, such as propranolol and metoprolol. The peripheral vasoconstriction caused by high doses of dopamine HCl is antagonized by α-adrenergic blocking agents. Dopamine-induced renal and mesenteric vasodilation is not antagonized by either α- or β-adrenergic blocking agents.

Butyrophenones (such as haloperidol) and phenothiazines can suppress the dopaminergic renal and mesenteric vasodilation induced with low-dose dopamine infusion.

The concomitant use of vasopressors, vasoconstricting agents (such as ergonovine) and some oxytocic drugs may result in severe hypertension.

Administration of phenytoin to patients receiving dopamine HCl has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine HCl, alternatives to phenytoin should be considered if anticonvulsant therapy is needed.

Dopamine HCl at doses approaching maximal solubility showed no clear genotoxic potential in the Ames test. Although there was a reproducible dose-dependent increase in the number of revertant colonies with strains TA100 and TA98, both with and without metabolic activation, the small increase was considered inconclusive evidence of mutagenicity. In the L5178Y TK mouse lymphoma assay, dopamine HCl at the highest concentrations used of 750 μg/mL without metabolic activation, and 3000 μg/mL with activation, was toxic and associated with increases in mutant frequencies when compared to untreated and solvent controls; at the lower concentrations no increases over controls were noted.

No clear evidence of clastogenic potential was reported in the mouse or male rat bone marrow micronucleus test when the animals were treated intravenously with up to 224 mg/kg and 30 mg/kg of dopamine HCl, respectively.

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Cardiovascular System

Respiratory System

Gastrointestinal System

Metabolic/Nutritional System

Central Nervous System

Dermatological System

Other

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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