Dopamine in Dextrose 5%

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Dopamine in Dextrose 5% uses

Dopamine in Dextrose 5% consists of Dextrose, Dopamine Hydrochloride.

Dextrose:


INDICATIONS AND USAGE

70% Dopamine in Dextrose 5% (Dextrose) Injection USP is indicated as a caloric component in a parenteral nutrition regimen. 70% Dopamine in Dextrose 5% (Dextrose) Injection USP is used with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

CONTRAINDICATIONS

The infusion of 70% Dopamine in Dextrose 5% (Dextrose) Injection USP is contraindicated in patients having intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in patients who are anuric, and in patients in hepatic coma.

Solutions containing Dopamine in Dextrose 5% (Dextrose) may be contraindicated in patients with hypersensitivity to corn products.

WARNINGS

This injection is for compounding only, not for direct infusion.

Dilute before use to a concentration which will, when administered with an amino acid (nitrogen) source, result in an appropriate calorie to gram of nitrogen ratio and which has an osmolarity consistent with the route of administration.

Unless appropriately diluted, the infusion of hypertonic Dopamine in Dextrose 5% (Dextrose) injection into a peripheral vein may result in vein irritation, vein damage, and thrombosis. Strongly hypertonic nutrient solutions should only be administered through an indwelling intravenous catheter with the tip located in a large central vein such as the superior vena cava.

Use of 70% Dopamine in Dextrose 5% (Dextrose) Injection USP to prepare parenteral nutritional admixtures may be incompatible with other components, especially calcium and phosphate salts and lipid emulsions. Incompatibility of admixed components can produce precipitates which may cause particulate emboli. Use 70% Dopamine in Dextrose 5% (Dextrose) Injection USP only to prepare formulations that are known to be stable: refer to standard texts for further information.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration.

WARNING: 70% Dopamine in Dextrose 5% (Dextrose) Injection USP contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Prolonged infusion of isotonic or hypotonic Dopamine in Dextrose 5% (Dextrose) in water may increase the volume of extracellular fluid and cause water intoxication.

Solutions containing Dopamine in Dextrose 5% (Dextrose) without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration.

Excessive administration of potassium-free Dopamine in Dextrose 5% (Dextrose) solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required.

In very low birth weight infants, excessive or rapid administration of Dopamine in Dextrose 5% (Dextrose) injection may result in increased serum osmolality and possible intracerebral hemorrhage.

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PRECAUTIONS

General

This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

Solutions containing Dopamine in Dextrose 5% should be used with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

Essential electrolytes, minerals, and vitamins should be supplied as needed.

Hypokalemia may develop during parenteral administration of hypertonic Dopamine in Dextrose 5% (Dextrose) solutions. Sufficient amounts of potassium should be added to Dopamine in Dextrose 5% (Dextrose) solutions administered to fasting patients with good renal function, especially those on digitalis therapy.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. See WARNINGS .

Do not use plastic container in series connection.

If administration of 70% Dopamine in Dextrose 5% (Dextrose) Injection USP after admixture or dilution is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

This solution is intended for intravenous administration after admixture or dilution using sterile equipment. When using an automated compounding device replace all disposable components as recommended by manufacturer and at least every 24 hours.

Aseptic technique is essential with the use of sterile preparations for compounding nutritional admixtures. Discard container within 4 hours of entering closure.

Administration of hypertonic Dopamine in Dextrose 5% (Dextrose) and amino acid solutions via central venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to solution preparation, administration and patient monitoring.

It is essential that a carefully prepared protocol, based upon current medical practice, be followed, preferably by an experienced team. The package insert of the protein (nitrogen) source should be consulted for dosage and all precautionary information.

Use only if solution is clear and container and seals are intact.

70% Dopamine in Dextrose 5% (Dextrose) Injection USP contains no more than 25 µg/L of aluminum.

Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions.

Drug Interactions

Caution must be exercised in the administration of 70% Dopamine in Dextrose 5% Injection USP to patients receiving corticosteroids or corticotropin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Dispose of any unused product. See WARNINGS .

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Dopamine in Dextrose 5% (Dextrose) Injections USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Pregnancy Category C

There are no adequate and well controlled studies with Dopamine in Dextrose 5% Injections, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Dopamine in Dextrose 5% (Dextrose) Injections USP can cause fetal harm when administered to a pregnant woman. Dopamine in Dextrose 5% (Dextrose) Injections USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

Intrapartum maternal intravenous infusion of glucose-containing solutions may produce maternal hyperglycemia with subsequent fetal hyperglycemia and fetal metabolic acidosis. Fetal hyperglycemia can result in increased fetal insulin levels which may result in neonatal hypoglycemia following delivery. Consider the potential risks and benefits for each specific patient before administering Dopamine in Dextrose 5% (Dextrose) Injection, USP.

Nursing Mothers

It is not known if this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Dopamine in Dextrose 5% Injections USP are administered to a nursing woman.

Pediatric Use

The use of Dopamine in Dextrose 5% (Dextrose) in pediatric patients is based on clinical practice (see DOSAGE AND ADMINISTRATION ). Because of their hypertonicity, 70% Dopamine in Dextrose 5% (Dextrose) Injections must be diluted prior to administration.

Newborns – especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

Geriatric Use

An evaluation of literature revealed no clinical experience identifying differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

See WARNINGS .

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ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Incompatibility of admixed components can produce precipitates which may cause particulate emboli.

Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated Dopamine in Dextrose 5% (Dextrose) may cause hypovolemia, dehydration, mental confusion and/or loss of consciousness. Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION .)

Hypersensitivity reactions, including anaphylaxis and chills.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition and institute appropriate corrective treatment.

DOSAGE AND ADMINISTRATION

This solution is for intravenous use only after admixture or dilution.

70% Dopamine in Dextrose 5% Injection USP is designed for use with automated compounding devices for preparing intravenous nutritional admixtures or for the filling of empty sterile syringes. Dosages will be in accordance with the recommendation of the prescribing physician. 70% Dopamine in Dextrose 5% (Dextrose) Injection USP is not intended for direct infusion. Admixtures should be made by, or under the direction of, a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Pediatric Use

The dosage selection and constant infusion rate of intravenous Dopamine in Dextrose 5% (Dextrose) must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when Dopamine in Dextrose 5% (Dextrose) is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

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Directions for Use of Pharmacy Bulk Package Container

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration or admixture and final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration, whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

70% Dopamine in Dextrose 5% (Dextrose) Injection USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures.

Refer to standard texts and guidelines on the preparation of parenteral nutritional admixtures.

When compounding admixtures, use aseptic technique. Mix thoroughly.

Do not store any unused portion of 70% Dopamine in Dextrose 5% (Dextrose) Injection USP.

TO OPEN:

  • Inspect overwrap. Do not use if overwrap has been damaged.
  • Do not use unless solution is clear and closure is intact.
  • Tear overwrap starting from the tear notches. (Figure 1)

  • Inspect the container for minute leaks by squeezing inner bag firmly. If leaks are found, discard the bag as sterility may be impaired.
  • For compounding only. Do not use for direct infusion

    PREPARATION FOR ADMIXING

    Note: Important Admixing Information


  • The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar air flow hood (or an equivalent clean air compounding area).
  • The contents are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes.
  • Additives may be incompatible with the fluid withdrawn from this container. When compounding admixtures, use aseptic technique, mix thoroughly and do not store.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution container permits. (see PRECAUTIONS, General )
  • Do not use/penetrate blocked port.

  • Remove aluminum foil of set port at the bottom of container.
  • Attach suitable transfer device or compounding set (Figure 2). Refer to complete directions accompanying device.
  • Hang bag on suitable fixture (Figure 3).
  • Once container closure has been penetrated, withdrawal of content should be completed within 4 hours.
Bag Illustration Figure 1 Bag Hanger illustration Figure 2 Figure 3
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HOW SUPPLIED

70% Dopamine in Dextrose 5% (Dextrose) Injection USP is supplied in 2000 mL Pharmacy Bulk Package containers packaged 4 per case.

NDC REF SIZE

0264-7387-50 S8705 2000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Rx only

Initiated: February 2015

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862

www.bbraun.com

Y36-002-865 LD-355-2

Dopamine Hydrochloride:



Rx Only

DESCRIPTION

Dopamine in Dextrose 5% (Dopamine Hydrochloride), a sympathomimetic amine vasopressor, is the naturally occurring immediate precursor of norepinephrine. Dopamine in Dextrose 5% (Dopamine Hydrochloride) 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 in Dextrose 5% (Dopamine Hydrochloride) HCl is sensitive to alkalies, iron salts, and oxidizing agents. Chemically it is designated as 4-(2-aminoethyl) pyrocatechol hydrochloride, and the structural formula is:

Dopamine in Dextrose 5% (Dopamine Hydrochloride) Hydrochloride Injection is a clear, practically colorless, sterile, pyrogen-free, aqueous solution of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl for intravenous infusion after dilution. Each mL contains either 40 mg, 80 mg, or 160 mg of Dopamine in Dextrose 5% (Dopamine Hydrochloride) hydrochloride (equivalent to 32.3 mg, 64.6 mg and 129.2 mg of Dopamine in Dextrose 5% (Dopamine Hydrochloride) base respectively) in water for injection, q.s. Each mL of all preparations contains the following: sodium metabisulfite 9 mg added as an antioxidant; citric acid, anhydrous 10 mg and sodium citrate, dihydrate 5 mg added as a buffer. The pH range (2.5 to 5.0) may be adjusted with additional citric acid and/or sodium citrate.

Dopamine in Dextrose 5% (Dopamine Hydrochloride) must be diluted in an appropriate sterile parenteral solution (see DOSAGE AND ADMINISTRATION section).

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CLINICAL PHARMACOLOGY

Dopamine in Dextrose 5% (Dopamine Hydrochloride) is a natural catecholamine formed by the decarboxylation of 3,4-dihydroxyphenylalanine (DOPA). It is a precursor to norepinephrine in noradrenergic nerves and is also a neurotransmitter in certain areas of the central nervous system, especially in the nigrostriatal tract, and in a few peripheral sympathetic nerves.

Dopamine in Dextrose 5% (Dopamine Hydrochloride) produces positive chronotropic and inotropic effects on the myocardium, resulting in increased heart rate and cardiac contractility. This is accomplished directly by exerting an agonist action on beta-adrenoceptors and indirectly by causing release of norepinephrine from storage sites in sympathetic nerve endings.

Dopamine’s onset of action occurs within five minutes of intravenous administration, and with dopamine’s plasma half-life of about two minutes, the duration of action is less than ten minutes. If monoamine oxidase (MAO) inhibitors are present, however, the duration may increase to one hour. The drug is widely distributed in the body but does not cross the blood-brain barrier to a significant extent. Dopamine in Dextrose 5% (Dopamine Hydrochloride) is metabolized in the liver, kidney, and plasma by MAO and catechol-O-methyltransferase to the inactive compounds homovanillic acid (HVA) and 3,4-dihydroxyphenylacetic acid. About 25% of the dose is taken up into specialized neurosecretory vesicles (the adrenergic nerve terminals), where it is hydroxylated to form norepinephrine. It has been reported that about 80% of the drug is excreted in the urine within 24 hours, primarily as HVA and its sulfate and glucuronide conjugates and as 3,4-dihydroxyphenylacetic acid. A very small portion is excreted unchanged.

The predominant effects of Dopamine in Dextrose 5% (Dopamine Hydrochloride) are dose-related, although it should be noted that actual response of an individual patient will largely depend on the clinical status of the patient at the time the drug is administered. At low rates of infusion (0.5 to 2 mcg/kg/min) Dopamine in Dextrose 5% (Dopamine Hydrochloride) causes vasodilation that is presumed to be due to a specific agonist action on Dopamine in Dextrose 5% (Dopamine Hydrochloride) receptors (distinct from alpha and beta adrenoceptors) in the renal, mesenteric, coronary, and intracerebral vascular beds. At these Dopamine in Dextrose 5% (Dopamine Hydrochloride) receptors, haloperidol is an antagonist. The vasodilation in these vascular beds is accompanied by increased glomerular filtration rate, renal blood flow, sodium excretion, and urine flow. Hypotension sometimes occurs. An increase in urinary output produced by Dopamine in Dextrose 5% (Dopamine Hydrochloride) is usually not associated with a decrease in osmolarity of the urine.

At intermediate rates of infusion (2 to 10 mcg/kg/min) Dopamine in Dextrose 5% (Dopamine Hydrochloride) acts to stimulate the beta1- adrenoceptors, resulting in improved myocardial contractility, increased SA rate and enhanced impulse conduction in the heart. There is little, if any, stimulation of the beta2-adrenoceptors (peripheral vasodilation). Dopamine in Dextrose 5% (Dopamine Hydrochloride) causes less increase in myocardial oxygen consumption than isoproterenol, and its use is not usually associated with a tachyarrhythmia. Clinical studies indicate that it usually increases systolic and pulse pressure with either no effect or a slight increase in diastolic pressure. Blood flow to the peripheral vascular beds may decrease while mesenteric flow increases due to increased cardiac output. Total peripheral resistance (alpha effects) at low and intermediate doses is usually unchanged.

At higher rates of infusion (10 to 20 mcg/kg/min) there is some effect on alpha-adrenoceptors, with consequent vasoconstrictor effects and a rise in blood pressure. The vasoconstrictor effects are first seen in the skeletal muscle vascular beds, but with increasing doses they are also evident in the renal and mesenteric vessels. At very high rates of infusion (above 20 mcg/kg/min), stimulation of alpha-adrenoceptors predominates and vasoconstriction may compromise the circulation of the limbs and override the dopaminergic effects of Dopamine in Dextrose 5% (Dopamine Hydrochloride), reversing renal dilation and natriuresis.

INDICATIONS AND USAGE

Dopamine in Dextrose 5% HCl 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 dodpamine HCl are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished or completed prior to administration of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl.

Poor Perfusion of Vital Organs:

Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored. Nevertheless, the physician should also observe the patient for signs of reversal of confusion or reversal of comatose condition. Loss of pallor, increase in toe temperature, and/or adequacy of nail bed capillary filling may also be used as indices of adequate dosage. Clinical studies have shown that when dopamine HCl is administered before urine flow has diminished to levels approximating 0.3 mL/minute, prognosis is more favorable. Nevertheless, in a number of oliguric or anuric patients, administration of dopamine HCl has resulted in an increase in urine flow which in some cases reached normal levels. Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of pre-existing fluid accumulation. It should be noted that at doses above those optimal for the individual patient, urine flow may decrease, necessitating reduction of dosage.

Low Cardiac Output:

Increased cardiac output is related to dopamine's direct inotropic effect on the myocardium. Increased cardiac output at low or moderate doses appears to be related to a favorable prognosis. Increase in cardiac output has been associated with either static or decreased systemic vascular resistance. Static or decreased SVR associated with low or moderate movements in cardiac output is believed to be a reflection of differential effects on specific vascular beds with increased resistance in peripheral beds (e.g., femoral) and concomitant 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 in Dextrose 5% (Dopamine Hydrochloride) is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol.

Hypotension:

Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl, which have little effect on SVR. At high therapeutic doses, the alpha-adrenergic activity of Dopamine in Dextrose 5% (Dopamine Hydrochloride) becomes more prominent and thus may correct hypotension due to diminished SVR. As in the case of other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone profound deterioration. Therefore, it is suggested that the physician administer Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.

CONTRAINDICATIONS

Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl should not be used in patients with pheochromocytoma.

Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl should not be administered to patients with uncorrected tachyarrhythmias or ventricular fibrillation.

WARNINGS

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 in Dextrose 5% (Dopamine Hydrochloride) 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 in Dextrose 5% (Dopamine Hydrochloride) HCl will require substantially reduced dosage. See Drug Interactions below.

PRECAUTIONS

General:

1. Monitoring - Careful monitoring of the following indices is necessary during Dopamine in Dextrose 5% HCl infusion, as with any adrenergic agent: blood pressure, urine flow, and, when possible, cardiac output and pulmonary wedge pressure.

2. Hypovolemia - Prior to treatment with Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl, hypovolemia should be fully corrected, if possible, with either whole blood or plasma as indicated. Monitoring of central venous pressure of left ventricular filling pressure may be helpful in detecting and treating hypovolemia.

3. Hypoxia, Hypercapnia, Acidosis - These conditions which may also reduce the effectiveness and/or increase the incidence of adverse effects of Dopamine in Dextrose 5% (Dopamine Hydrochloride), must be identified and corrected prior to, or concurrently with administration of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl.

4. Decreased Pulse Pressure - If a disproportionate increase in diastolic pressure and a marked decrease in the pulse pressure are observed in patients receiving Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl, the rate of infusion should be decreased and the patient observed carefully for further evidence of predominant vasoconstrictor activity, unless such an effect is desired.

5. Ventricular Arrhythmias - If an increased number of ectopic beats are observed, the dose should be reduced if possible.

6. Hypotension - At lower infusion rates, if hypotension occurs, the infusion rate should be rapidly increased until adequate blood pressure is obtained. If hypotension persists, Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl should be discontinued and a more potent vasoconstrictor agent such as norepinephrine should be administered.

7. Extravasation - Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl should be infused into a large vein whenever possible to prevent the possibility of extravasation into tissue adjacent to the infusion site. Extravasation may cause necrosis and sloughing of surrounding tissue. Large veins of the antecubital fossa are preferred to veins in the dorsum of the hand or ankle. Less suitable infusion sites should be used only if the patient’s condition requires immediate attention. The physician should switch to more suitable sites as rapidly as possible. The infusion site should be continuously monitored for free flow.

8. Occlusive Vascular Disease - Patients with a history of occlusive vascular disease (for example, atheroscierosis, arterial embolism, and Raynaud’s disease, cold injury, diabetic endarteritis, and Buergers disease) should be closely monitored for any changes in color or temperature of the skin in the extremities. If a change in skin color or temperature occurs and is thought to be the result of compromised circulation to the extremities, the benefits of continued dopamine HCl infusion should be weighed against the risk of possible necrosis. This condition may be reversed by either decreasing the rate or discontinuing the infusion.

IMPORTANT - Antidote for Peripheral Ischemia - To prevent sloughing and necrosis in ischemic areas, the area should be infiltrated as soon as possible with 10 to 15 mL of saline solution containing 5 to 10 mg of phentolamine mesylate, an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, and the solution liberally infiltrated throughout the ischemic area. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

9. Weaning - When discontinuing the infusion, it may be necessary to gradually decrease the dose of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl while expanding blood volume with intravenous fluids, since sudden cessation may result in marked hypotension.

Drug Interactions:

1. Because Dopamine in Dextrose 5% (Dopamine Hydrochloride) is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of Dopamine in Dextrose 5% (Dopamine Hydrochloride). Patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl should receive initial doses of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl no greater than one-tenth (1/10) of the usual dose.

2. Concurrent administration of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl and diuretic agents may produce an additive or potentiating effect on urine flow.

3. Tricyclic antidepressants may potentiate the pressor response to adrenergic agents.

4. Cardiac effects of Dopamine in Dextrose 5% (Dopamine Hydrochloride) are antagonized by beta-adrenergic blocking agents , such as propranolol and metroprolol. The peripheral vasoconstriction caused by high doses of Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl is antagonized by alpha-adrenergic blocking agents . Dopamine-induced renal and mesenteric vasodilation is not antagonized by either alpha- or beta-adrenergic blocking agents.

5. Haloperidol appears to have strong central antidopaminergic properties. Haloperidol and haloperidol-like drugs suppress the dopaminergic renal and mesenteric vasodilation induced at low rates of Dopamine in Dextrose 5% (Dopamine Hydrochloride) infusion.

6. Cyclopropane or halogenated hydrocarbon anesthetics increase cardiac autonomic irritability and may sensitize the myocardium to the action of certain intravenously administered catecholamines, such as Dopamine in Dextrose 5% (Dopamine Hydrochloride). The interaction appears to be related both to pressor activity and to the beta-adrenergic stimulating properties of these catecholamines, and may produce ventricular arrhythmias. Therefore, EXTREME CAUTION should be exercised when administering Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. It has been reported that results of studies in animals indicated that dopamine-induced ventricular arrhythmias during anesthesia can be reversed by propranolol.

7. The concomitant use of vasopressors, vasoconstricting agents and some oxytocic drugs may result in severe persistent hypertension. See Labor and Delivery below.

8. Administration of phenytoin to patients receiving Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl, alternatives to phenytoin should be used if anticonvulsant therapy is needed.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term animal studies have not been performed to evaluate carcinogenic potential of Dopamine in Dextrose 5% hydrochloride.

Dopamine in Dextrose 5% (Dopamine Hydrochloride) hydrochloride at doses approaching maximal solubility shows 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 in Dextrose 5% (Dopamine Hydrochloride) hydrochloride at the highest concentrations used of 750 mcg/mL without metabolic activation, and 3000 mcg/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 in vivo 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 in Dextrose 5% (Dopamine Hydrochloride) hydrochloride, respectively.

Pregnancy:

Teratogenic Effects:

Teratogenicity studies in rats and rabbits at Dopamine in Dextrose 5% HCl dosages up to 6 mg/kg/day intravenously during organogenesis produced no detectable teratogenic or embryotoxic effects, although maternal toxicity consisting of mortalities, decrease body weight gain, and pharmacotoxic signs were observed in rats. In a published study, Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl administered at 10 mg/kg subcutaneously for 30 days, markedly prolonged metestrus and increased mean pituitary and ovary weights in female rats. Similar administration to pregnant rats throughout gestation or for 5 days starting on gestation day 10 or 15 resulted in decreased body weight gains, increased mortalities and slight increases in cataract formation among the offspring. There are no adequate and well-controlled studies in pregnant women, and it is not known if Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl crosses the placental barrier. Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery:

In obstetrics, if vasopressor drugs are used to correct hypotension or are added to a local anesthetic solution, some oxytocic drugs may cause severe persistent hypertension and may even cause rupture of a cerebral blood vessel to occur during the postpartum period.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dopamine in Dextrose 5% HCl is administered to a nursing mother.

Pediatric Use:

Safety and effectiveness in children have not been established. Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl has been used in a limited number of pediatric patients, but such use has been inadequate to fully define proper dosage and limitations for use.

Geriatric Use:

Clinical studies of Dopamine in Dextrose 5% (Dopamine Hydrochloride) injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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 (at very high doses), 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 in Dextrose 5% (Dopamine Hydrochloride) HCl.

OVERDOSAGE

In case of accidental overdosage, as evidenced by excessive elevation of blood pressure, reduce rate of administration or temporarily discontinue Dopamine in Dextrose 5% (Dopamine Hydrochloride) 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.

DOSAGE AND ADMINISTRATION

WARNING: This is a potent drug: It must be diluted before administration to the patient.

Dopamine in Dextrose 5% (Dopamine Hydrochloride) Hydrochloride Injection, USP is administered (only after dilution) by intravenous infusion.

Suggested Dilution: Transfer contents of one or more ampuls or vials by aseptic technique to either 250 mL or 500 mL of one of the following sterile intravenous solutions:

  • Sodium Chloride Injection, USP
  • Dextrose (5%) Injection, USP
  • Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP
  • 5% Dextrose in 0.45% Sodium Chloride Solution Injection, USP
  • Dextrose (5%) and Lactated Ringer’s Solution Injection
  • Sodium Lactate Injection, USP (1/6 Molar)
  • Lactated Ringer’s Injection, USP

Dopamine in Dextrose 5% (Dopamine Hydrochloride) Hydrochloride Injection, USP has been found to be stable for a minimum of 24 hours after dilution in the sterile intravenous solutions listed above. However, as with all intravenous admixtures, dilution should be made just prior to administration.

Do NOT add Dopamine in Dextrose 5% (Dopamine Hydrochloride) Hydrochloride to Sodium Bicarbonate Injection, USP or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.

Rate of Administration: Dopamine in Dextrose 5% (Dopamine Hydrochloride) Hydrochloride Injection, USP, after dilution, is administered intravenously by infusion through a suitable intravenous catheter or needle. When administering Dopamine in Dextrose 5% (Dopamine Hydrochloride) Hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control intravenous set. Each patient must be individually titrated to the desired hemodynamic or renal response to Dopamine in Dextrose 5% (Dopamine Hydrochloride).

Administration rates greater than 50 mcg/kg/minute have safely been used 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.

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 diluted solution at doses of 2 to 5 mcg/kg/minute of Dopamine in Dextrose 5% (Dopamine Hydrochloride) Hydrochloride in patients who are likely to respond to modest increments of heart force and renal perfusion.

In more seriously ill patients, begin infusion of diluted solution at doses of 5 mcg/kg/minute of Dopamine in Dextrose 5% (Dopamine Hydrochloride) Hydrochloride and increase gradually using 5 to 10 mcg/kg/minute increments up to 20 to 50 mcg/kg/minute as needed. If doses in excess of 50 mcg/kg/minute are required, it is advisable to check urine output frequently. Should urinary flow begin to decrease in the absence of hypotension, reduction of Dopamine in Dextrose 5% (Dopamine Hydrochloride) dosage should be considered. Multiclinic trials have shown that more than 50% of the patients have been satisfactorily maintained on doses of Dopamine in Dextrose 5% (Dopamine Hydrochloride) less than 20 mcg/kg/minute. In patients who do not respond to these doses with adequate arterial pressures or urine flow, additional increments of Dopamine in Dextrose 5% (Dopamine Hydrochloride) 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 the blood volume, augmentation of cardiac contractility, and distribution of peripheral perfusion. Dosage of Dopamine in Dextrose 5% (Dopamine Hydrochloride) should be adjusted according to the patient’s response, with particular attention to diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias as indices for decreasing or temporarily suspending the dosage.

4. As with all potent intravenously administered drugs, care should be taken to control the rate of administration to avoid inadvertent administration of a bolus of drug.

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

HOW SUPPLIED

Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl Injection, USP is available as follows:

Product No. Dopamine in Dextrose 5% (Dopamine Hydrochloride) HCl mg per volume fill How Packaged
NDC 0517-1805-25 200 mg/5 mL Vial

(40 mg/mL)

Packages of 25 vials

(color-coded WHITE)

NDC 0517-1905-25 400 mg/5 mL Vial

(80 mg/mL)

Packages of 25 vials

(color-coded GREEN)

NDC 0517-1305-25 800 mg/5 mL Vial

(160 mg/mL)

Packages of 25 vials

(color-coded YELLOW)


Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

NOTE - Do not use the injection if it is darker than slightly yellow or discolored in any other way.

WARNING: NOT FOR DIRECT INTRAVENOUS INJECTION, MUST BE DILUTED BEFORE USE.

INTRAVENOUS INFUSION ONLY.

The vial stopper is not made with natural rubber latex.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN1805

Rev. 12/14

MG #8090

Dopamine in Dextrose 5% pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Dopamine in Dextrose 5% available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Dopamine in Dextrose 5% destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Dopamine in Dextrose 5% Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Dopamine in Dextrose 5% pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."DEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."DOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "dextrose". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dopamine in Dextrose 5%?

Depending on the reaction of the Dopamine in Dextrose 5% after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dopamine in Dextrose 5% not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Dopamine in Dextrose 5% addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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sdrugs.com conducted a study on Dopamine in Dextrose 5%, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dopamine in Dextrose 5% consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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