Dopamine Hci In 5% Dextrose


Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1458
Dopamine Hci In 5% Dextrose is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Dopamine Hci In 5% Dextrose is 51662-1458. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Dopamine Hci In 5% Dextrose drug includes Dopamine Hydrochloride - 1.6 mg/mL . The currest status of Dopamine Hci In 5% Dextrose drug is Active.

Drug Information:

Drug NDC: 51662-1458
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Dopamine Hci In 5% Dextrose
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Dopamine Hci In 5% Dextrose
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Hf Acquisition Co Llc, Dba Healthfirst
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:DOPAMINE HYDROCHLORIDE - 1.6 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 12 Dec, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 25 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: NDA018826
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:HF Acquisition Co LLC, DBA HealthFirst
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1743879
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UNII:7L3E358N9L
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Catecholamine [EPC]
Catecholamines [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
51662-1458-1500 mL in 1 BAG (51662-1458-1)12 Dec, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Dopamine hci in 5% dextrose dopamine hci in 5% dextrose water hydrochloric acid sodium hydroxide dextrose monohydrate sodium metabisulfite bisulfite ion dopamine hydrochloride dopamine

Indications and Usage:

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 phy
sician 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 be used to manage hypotension due to inadequate cardiac output. at high therapeutic doses, dopamine's α-adrenergic action becomes more prominent and thus may correct hypotension due to diminished svr. as in other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone extreme deterioration. therefore, it is suggested the physician administer dopamine as soon as a definite trend toward decreased systolic and diastolic pressure becomes apparent.

Warnings:

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.

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 pressure is 14 to 18 mm hg. 2. begin infusion of dopamine hydrochloride solution at doses of 2 to 5 mcg/kg/min in adult or pediatric patients who are likely to respond to modest increments of heart force and renal perfusion. in more seriously ill patients, begin infusion of dopamine hydrochloride at doses of 5 mcg/kg/min and increase gradually, using 5 to 10 mcg/kg/min increments, up to a rate of 20 to 50 mcg/kg/min as needed. if doses in excess of 50 mcg/kg/min are required, check urine output frequently. should urinary flow begin to decrease in the absence of hypotension, reduction of dopamine dosage should be considered. more than 50% of adult patients have been satisfactorily maintained on doses less than 20 mcg/kg/min. 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 blood volume, augmentation of cardiac contractility, urine flow, cardiac output, blood pressure, and distribution of peripheral perfusion. dosage of dopamine should be adjusted according to the patient's response. diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias are reasons to consider decreasing or temporarily suspending the dosage. 4. as with all potent intravenously administered drugs, care should be taken to control the rate of infusion so as to avoid inadvertent administration of a bolus of the drug. 800 mcg/ml dosing chart for dopamine (ml/hr) infusion rate 1600 mcg/ml dosing chart for dopamine (ml/hr) infusion rate 3200 mcg/ml dosing chart for dopamine (ml/hr) infusion rate parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. dosage 1 dosage 2 dosage 3

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.

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.

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).

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 • 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 (c6h12o6 • h2o), a hexose sugar freely soluble in water. it has the following structural formula: water for injection, usp is chemically designated h2o. 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. structure 1 structure 2

Clinical Pharmacology:

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 calo
ries. 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.

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

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