دوپامین
Dopamine Hydrochloride (Dopamine)
دوپامین

نام ژنریک

Dopamine HCl

شکل دارویی

اشكال دارويي:


Injection: 40 mg/ml, 5ml

موارد مصرف

موارد و مقدار مصرف


الف) درمان كمكي در شوك براي افزايش برون ده قلبي، فشارخون‌ و جريان ادرار


بزرگسالان: مقدار mcg/kg/min5-2 تا mch/kg/min50-20 انفوزيون
وريدي مي شود. ميزان انفوزيون ممكن است به mcg/kg/min 4-1 ، در فواصل 30-10 دقيقه، تا حصول پاسخ مطلوب، افزايش يابد. در بيماران شديداً بدحال، انفوزيون ممكن است با مقدار mcg/kg/min5 شروع و به تدريج به ميزان mcg/kg/min10-5، تا كسب پاسخ مطلوب افزايش يابد. حداكثر دوز در اين حالت mcg/kg/min50-20 است.


ب) درمان كوتاه مدت نارسايي احتقاني شديد، مقاوم و مزمن قلب


بزرگسالان: ابتدا، mcg/kg/min5-2 انفوزيون وريدي مي شود. مقدار مصرف ممكن است تا به دست آمدن پاسخ مناسب كليوي، افزايش يابد. حد متوسط مقدار مصرف mcg/kg/min 3-1 است.


مكانيسم اثر


اثر تنگ كننده عروق: دوپامين به عنوان آخرين پيش ساز نوراپينفرين، گيرنده هاي دوپامينرژيك، بتا ـ آدرنرژيك و آلفا ـ آدرنرژيك سيستم اعصاب سمپاتيك را تحريك مي كند. اثرات عمده دوپامين به مقدار مصرف آن وابسته است. اين دارو اثر تحريك كننده مستقيم بر روي گيرنده هاي 1 (با تزريق وريدي mcg/kg/min10-2) دارد و داراي اثر ناچيزي بر روي گيرنده‌هاي 2 است يا اثري ندارد. با تزريق وريدي مقادير mcg/kg/min2-5/0، اين دارو بر روي گيرندههاي دوپامينرژيك اثر كرده و موجب گشاد شدن شاخههاي عروق داخل مغزي، كرونري، مزانتريك و كليوي مي شود. با تزريق وريدي مقادير بيش از mcg/kg/min10، اين دارو گيرنده هاي آلفا را تحريك مي كند.


مصرف مقادير كم تا متوسط اين دارو موجب تحريك قلب (اثرات اينوتروپيك مثبت) و گشاد شدن عروق كليوي و مزانتريك (پاسخ دوپامينرژيك) مي شود. مصرف مقادير زياد اين دارو مقاومت عروق محيطي و تنگ شدن عروق كليوي را افزايش مي دهد.

موارد منع مصرف

تداخل دارويي


مصرف همزمان با مهاركننده هاي MAO ممكن است اثرات دوپامين را تشديد و طولاني كند.


مصرف همزمان با داروهاي مسدودكننده بتا ـ ‌آدرنرژيك، اثرات قلبي دوپامين را خنثي مي كند.


مصرف همزمان با داروهاي مسدود كننده آلفا ـ ‌آدرنرژيك، تنگ شدن عروق محيطي ناشي از مصرف مقادير زياد دوپامين را خنثي مي سازد.


مصرف همزمان با داروهاي بيهوش كننده عمومي، ‌بخصوص هالوتان، ممكن است موجب آريتمي بطني و زيادي فشار خون شود.


مصرف همزمان با فنيتوئين به صورت تزريق وريدي ممكن است موجب كمي فشار خون و براديكاردي شود.


مصرف همزمان با داروهاي مدر اثرات ديورتيك هر دو دارو را افزايش مي‌دهد.


مصرف همزمان دوپامين با اكسيتوسين ممكن است موجب تنگي شديد عروق شود. تنظيم مقدار مصرف ممكن است ضروري شود.


دوپامين اثرات كاهنده فشار خون گوانتيدين، متيلدوپا و تريمتافان را از طريق اثرات شديد خود در تنگ كردن عروق، كاهش مي دهد.


مصرف همزمان با گليكوزيدهاي ديژيتال، لوودوپا و مقلدهاي سمپاتيك خطر آريتمي قلبي را افزايش مي دهد.


داروهاي اكسيتوسيك ممكن است باعث هايپرتانسيون پايدار شود از مصرف همزمان خودداري كنيد.


ضدافسردگيهاي سه حلقه اي ممكن است اثرات اين دارو را افزايش دهد. با احتياط استفاده كنيد.


فنيتوئين ممكن است باعث هايپوتنشن، ‌براديكاردي و يا تشنج شود. فشارخون و ضربان قلب را به دقت مانيتور نماييد.


آلكالوييدهاي ارگوت ممكن است باعث افزايش شديد در فشار خون شود. از مصرف همزمان خودداري كنيد.


فنلزين، ‌ترانيلسيپرومين ممكن است باعث سردرد شديد، هايپرتنشن، تب و بحران هايپرتنشن شود. از مصرف همزمان خودداري كنيد.

موارد قابل توجه

-

تداخل دارویی

اثر بر آزمايشهاي تشخيصي


دوپامين ممكن است موجب افزايش غلظت سرمي گلوكز شود، هرچند اين افزايش معمولاً بالاتر از حد طبيعي نيست.

مکانیزم اثر

اثر بر آزمايشهاي تشخيصي


دوپامين ممكن است موجب افزايش غلظت سرمي گلوكز شود، هرچند اين افزايش معمولاً بالاتر از حد طبيعي نيست.

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: فئوكروموسيتوما، فيبريلاسيون بطني يا تاكيآريتمي درمان نشده (خطر بروز اثرات شديد قلبي ـ عروقي وجود دارد).


موارد احتياط: تاكيكاردي آريتمي، بيماريهاي انسدادي عروقي، بيماران پس از MI، مصرف همزمان با MAOI و حساسيت نسبت به متا بيسولفيت.

سایر اطلاعات

طبقه بندي فارماكولوژيك: آدرنرژيك.


طبقه‌‌بندي درماني: محرك قلب، تنگ كننده عروق (آدرنرژيك).


طبقه‌بندي مصرف در بارداري: رده C


ملاحظات اختصاصي


علاوه بر ملاحظات مربوط به تمامي آدرنرژيكها، رعايت موارد زير نيز توصيه مي‌شود:


قبل از مصرف دوپامين، كمي حجم خون با مصرف يك حجيم كننده پلاسما جبران شود.


به منظور كنترل سرعت جريان محلول، دوپامين به وسيله دستگاه مخصوص انفوزيون وريدي (پمپ انفوزيون) شود.


براي جلوگيري از احتمال نشت دوپامين به بافتهاي اطراف رگ، اين دارو بايد در داخل يك وريد بزرگ تزريق شود. در صورت لزوم، ‌مي توان از وريدهاي دست يا مچ پا براي اين منظور استفاده كرد، ‌ولي محل تزريق را در صورت امكان بايد هر چه سريعتر به وريد بزرگتري انتقال داد. جريان آزاد دارو بايد مرتباً كنترل شود. دستيابي به يك وريد مركزي توصيه مي‌شود.


مقدار مصرف دارو براساس نياز بيمار و به دست آمدن پاسخ مطلوب باليني تنظيم شود. اگر مقدار مصرف مورد نياز براي به دست آوردن فشار خون سيستوليك مطلوب، بيش از آنچه براي پاسخ مناسب كليوي لازم است ‌باشد، مقدار مصرف بايد بلافاصله بعد از تثبيت وضعيت هموديناميك بدن، كاهش يابد.


با مصرف بيش از حد محلولهاي بدون پتاسيم، ‌امكان بروز کاهش شديد پتاسيم وجود دارد. سطح الكتروليتها پيگيري شود.


قطع ناگهاني انفوزيون دارو ممكن است موجب کاهش شديد فشار خون شود. بنابراين، مقدار مصرف به صورت تدريجي كاهش يابد.


در صورت نشت دارو، ‌بايد انفوزيون را قطع كرده و موضع را فوراً با
15-10 ميلي ليتر كلرورسديم تزريقي حاوي 10-5 ميلي گرم فنتولامين انفيلتره كرد. موضع با محلول فنتولامين و با استفاده از سرنگ حاوي سوزن نازك، به ميزان زياد انفيلتره مي شود.


ساير داروها را نبايد با محلول دوپامين مخلوط كرد. محلولهاي باقيمانده را بعد از 24 ساعت بايد دور ريخت.


فشار خون، برونده قلبي، ‌EKG و ميزان مصرف و دفع مايعات در طول انفوزيون بايد تحت كنترل قرار گيرد، بخصوص اگر مقدار مصرف بيش از mcg/kg/min50 باشد. بايد مراقب بروز سردي اندامها بود.


ممكن است در مصرف طولاني و دوز بالا بيمارن دچار گانگرن و انسداد عروقي شوند.


10. بعضي از فرمولاسيون ها حاوي سولفيت هستند و باعث واكنش شبه‌آلرژي در افراد حساس به سولفيد شوند.


روش تجويز: براي پيشگيري از خروج از رگ و ايجاد نكروز ترجيحاً از عروق بزرگ استفاده نماييد و به طور مرتب محل تزريق را از جهت عبور دارو مانيتور نماييد. براي تجويز از پمپ انفوزيون استفاده كنيد. زماني كه تصميم به قطع دارو مي‌گيريد دوز را آهسته كاهش دهيد زيرا در صورت قطع ناگهاني ممكن است هايپوتنشن بروز نمايد.


نكات قابل توصيه به بيمار


در صورت بروز هرگونه عوارض جانبي به پزشك اطلاع دهيد.


مصرف در سالمندان: كاهش مقدار مصرف در بيماران سالخورده لازم است، زيرا اين بيماران نسبت به اثرات دارو حساستر هستند.


مصرف در شيردهي: ترشح دارو در شير مشخص نيست با احتياط استفاده كنيد.


عوارض جانبي


قلبي ـ ‌عروقي: ضربان نابه جاي قلب، تاكيكاردي، آنژين صدري، طپش قلب، تنگي عروق، كمي فشارخون، اختلالات هدايتي قلب، پهن شدن كمپلكس QRS، براديكاردي، زيادي فشارخون، آريتمي بطني (با مصرف مقادير زياد). هايپرتنشن، انقباض عروق.


دستگاه گوارش: تهوع، استفراغ.


متابوليك: كاهش هورمون تحريك كننده تيروئيد، هورمون رشد و پرولاكتين خون، ‌افزايش قند خون تنفسي: حمله آسم، تنگي نفس.


ساير عوارض: سردرد، ازتمي، نشت دارو به بافتهاي اطراف مي تواند موجب نكروز موضعي و تخريب بافت شود.


توجه : در صورت بروز علائم حساسيت مفرط به دارو يا سولفيتها، آريتمي قلبي ‌يا تاكيفيلاكسي، بايد مصرف دارو قطع شود.


مسموميت و درمان


تظاهرات باليني: زيادي شديد و بيش از حد فشار خون.


درمان: تنها درمان لازم، كاهش مقدار مصرف و يا قطع مصرف دارو است. در صورت پايين نيامدن فشارخون بعد از قطع مصرف دارو، مصرف يك داروي مسدودكننده آلفا ـ آدرنرژيك كوتاه اثر ممكن است مفيد باشد.

Dopamine Hydrochloride (Dopamine)

Dopamine
(hydrochloride) Injection, USP

DRUG DESCRIPTION

Dopamine Hydrochloride Injection, USP is a clear, practically colorless, aqueous, additive solution for intravenous infusion after dilution. Each mL contains either 40 mg, 80 mg, or 160 mg dopamine (dopamine hydrochloride) HCl, USP (equivalent to 32.3 mg, 64.6 mg and 129.2 mg dopamine (dopamine hydrochloride) base respectively) in Water for Injection, USP, containing 9 mg sodium metabisulfite as an antioxidant. The pH range (2.5 to 5.0) may be adjusted with citric acid and/or sodium citrate. The solution is sterile and nonpyrogenic. Dopamine (dopamine hydrochloride) HCl, a naturally occurring catecholamine, is an inotropic vasopressor agent. Its chemical name is 3,4 dihydroxyphenethylamine hydrochloride and its chemical structure is:

Dopamine Hydrochloride structural formula illustration

Dopamine (dopamine hydrochloride) HCl is sensitive to alkalis, iron salts and oxidizing agents. DOPAMINE (dopamine hydrochloride) must be diluted in an appropriate, sterile parenteral solution (see DOSAGE AND ADMINISTRATION section) before intravenous administration.

What are the possible side effects of dopamine injection ()?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • chest pain;
  • fast, slow, or pounding heartbeats;
  • painful or difficult urination, blood in your urine;
  • weakness, confusion, swelling in your feet or ankles, urinating less than usual or not at all;
  • weak or shallow breathing;
  • feeling like you might pass out, even while lying down;
  • burning, pain,...

Read All Potential Side Effects and See Pictures of Dopamine »

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

DOPAMINE (dopamine hydrochloride) is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure.

Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of DOPAMINE (dopamine hydrochloride) .

Patients most likely to respond adequately to DOPAMINE (dopamine hydrochloride) 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 (dopamine hydrochloride) , the better the prognosis.

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 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 (dopamine hydrochloride) 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 (dopamine hydrochloride) has resulted in an increase in urine flow which in some cases reached normal levels. DOPAMINE (dopamine hydrochloride) may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of preexisting fluid accumulation. It should be noted that at doses above those optimal for the individual patient urine flow may decrease, necessitating reduction of dosage. Concurrent administration of DOPAMINE (dopamine hydrochloride) and diuretic agents may produce an additive or potentiating effect.

Low Cardiac Output: Increased cardiac output is related to the direct inotropic effect of DOPAMINE (dopamine hydrochloride) 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 (SVR). Static or decreased SVR associated with low or moderate increments 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. The increase in cardiac output produced by DOPAMINE (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 (dopamine hydrochloride) , which have little effect on SVR. At high therapeutic doses, the alpha adrenergic activity of DOPAMINE (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 (dopamine hydrochloride) as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.

DOSAGE AND ADMINISTRATION

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

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:

  1. Sodium Chloride Injection, USP
  2. Dextrose (5%) Injection, USP
  3. Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP
  4. 5% Dextrose in 0.45% Sodium Chloride Solution
  5. Dextrose (5%) in Lactated Ringer's Solution
  6. Sodium Lactate (1/6 Molar) Injection, USP
  7. Lactated Ringer's Injection, USP

DOPAMINE (dopamine hydrochloride) 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 (dopamine hydrochloride) Injection to Sodium Bicarbonate or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.

Mixing of dopamine (dopamine hydrochloride) with alteplase in the same container should be avoided as visible particulate matter has been observed.

It is recommended that dopamine (dopamine hydrochloride) not be added to amphotericin B solutions because amphotericin B is physically unstable in dopamine (dopamine hydrochloride) -containing solutions.

Rate of Administration: DOPAMINE (dopamine hydrochloride) , after dilution, is administered intravenously through a suitable intravenous catheter or needle. An i.v. drip chamber or other suitable metering device is essential for controlling the rate of flow in drops/minute. Each patient must be individually titrated to the desired hemodynamic and/or renal response with DOPAMINE (dopamine hydrochloride) . 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.

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 14-18 mm Hg.
  2. Begin administration of diluted solution at doses of 2-5 mcg/kg/minute DOPAMINE (dopamine hydrochloride) in patients who are likely to respond to modest increments of heart force and renal perfusion.

    In more seriously ill patients, begin administration of diluted solution at doses of 5 mcg/kg/minute DOPAMINE (dopamine hydrochloride) and increase gradually, using 5 to 10 mcg/kg/minute increments, up to 20 to 50 mcg/kg/minute as needed. If doses of DOPAMINE (dopamine hydrochloride) in excess of 50 mcg/kg/minute are required, it is suggested that urine output be checked frequently. Should the urine flow begin to decrease in the absence of hypotension, reduction of DOPAMINE (dopamine hydrochloride) dosage should be considered. Multiclinic trials have shown that more than 50% of the patients were satisfactorily maintained on doses of DOPAMINE (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 (dopamine hydrochloride) may be employed 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 myocardial contractility, and distribution of peripheral perfusion. Dosage of DOPAMINE (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 so as 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 (dopamine hydrochloride) HCl Injection, USP is available as follows:

Product No. Dopamine 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)

Store at controlled room temperature 15°-30°C (59°-86°F) (See USP).

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

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.
IV INFUSION ONLY.

AMERICAN REGENT LABORATORIES, INC. SHIRLEY, NY 11967. FDA Rev date: 10/5/2002

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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)
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 moderate to high doses were administered for prolonged periods or in patients with occlusive vascular disease receiving low doses of dopamine (dopamine hydrochloride) HCl.

A few cases of peripheral cyanosis have been reported.

Read the Dopamine (dopamine hydrochloride) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

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 (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 (dopamine hydrochloride) HCl to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. Results of studies in animals indicate that dopamine (dopamine hydrochloride) induced ventricular arrhythmias during anesthesia can be reversed by propranolol.

Because dopamine (dopamine hydrochloride) is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine (dopamine hydrochloride) . Patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine (dopamine hydrochloride) should receive initial doses of dopamine (dopamine hydrochloride) HCl not greater than one-tenth (1/10) of the usual dose.

Concurrent administration of low-dose dopamine (dopamine hydrochloride) 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 (dopamine hydrochloride) are antagonized by beta-adrenergic blocking agents, such as propranolol and metroprolol. The peripheral vasoconstriction caused by high doses of dopamine (dopamine hydrochloride) HCl is antagonized by alpha-adrenergic blocking agents. Dopamine (dopamine hydrochloride) -induced renal and mesenteric vasodilation is not antagonized by either alpha- or beta-adrenergic blocking agents.

Butyrophenones (such as haloperidol) and phenothiazines can suppress the dopamine (dopamine hydrochloride) rgic renal and mesenteric vasodilation induced with low-dose dopamine (dopamine hydrochloride) 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 (dopamine hydrochloride) HCl has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine (dopamine hydrochloride) HCl, alternatives to phenytoin should be considered if anticonvulsant therapy is needed.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Do NOT add DOPAMINE (dopamine hydrochloride) to any alkaline diluent solution, since the drug is inactivated in alkaline solution.

Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of DOPAMINE (dopamine hydrochloride) will require substantially reduced dosage. See DRUG INTERACTIONS, below.

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.

PRECAUTIONS

General

Careful monitoring required - Close monitoring of the following indices-urine flow, cardiac output and blood pressure - during DOPAMINE (dopamine hydrochloride) infusion is necessary as in the case of any adrenergic agent.

Avoid hypovolemia - Prior to treatment with DOPAMINE (dopamine hydrochloride) , 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.

Hypoxia, Hypercapnia, Acidosis - These conditions which may also reduce the effectiveness and/or increase the incidence of adverse effects of dopamine (dopamine hydrochloride) , must be identified and corrected prior to, or concurrently with administration of dopamine (dopamine hydrochloride) HCl.

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

Decreased Pulse Pressure - If a disproportionate rise in the diastolic pressure (i.e., a marked decrease in the pulse pressure) is observed in patients receiving DOPAMINE (dopamine hydrochloride) , the infusion rate should be decreased and the patient observed carefully for further evidence of predominant vasoconstrictor activity, unless such an effect is desired.

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 (dopamine hydrochloride) HCl should be discontinued and a more potent vasoconstrictor agent such as norepinephrine should be administered.

Extravasation - DOPAMINE (dopamine hydrochloride) 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 actecubital 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.

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 (dopamine hydrochloride) infusion should be weighed against the risk of possible necrosis. This condition may be reversed by either decreasing or discontinuing the rate of 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 Regitine® (brand of phentolamine), 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.

Weaning - When discontinuing the infusion, it may be necessary to gradually decrease the dose of dopamine (dopamine hydrochloride) HCl while expanding blood volume with IV fluids, since sudden cessation may result in marked hypotension.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate carcinogenic potential of dopamine hydrochloride.

Dopamine 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 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 hydrochloride, respectively.

Pregnancy: Pregnancy Category C

Teratogenic Effects: Teratogenicity studies in rats and rabbits at dopamine hydrochloride 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 hydrochloride 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 hydrochloride crosses the placental barrier. Dopamine hydrochloride 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 the interaction with some oxytocic drugs may cause severe hypertension.

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 (dopamine hydrochloride) is administered to a nursing mother.

Pediatric Use: Safety and effectiveness in children have not been established. Dopamine (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. Peripheral gangrene has been reported in neonates and children.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce rate of administration or temporarily discontinue DOPAMINE (dopamine hydrochloride) until patient's condition stabilizes. Since the duration of action of DOPAMINE (dopamine hydrochloride) 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.

CONTRAINDICATIONS

DOPAMINE (dopamine hydrochloride) should not be used in patients with pheochromocytoma.

DOPAMINE (dopamine hydrochloride) should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Dopamine (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 (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 (dopamine hydrochloride) 's onset of action occurs within five minutes of intravenous administration, and with dopamine (dopamine hydrochloride) '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 (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 (dopamine hydrochloride) are dose-related, although 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 (0.5-2 mcg/kg/min) dopamine (dopamine hydrochloride) causes vasodilation that is presumed to be due to a specific agonist action on dopamine (dopamine hydrochloride) receptors (distinct from alpha and beta adrenoceptors) in the renal, mesenteric, coronary, and intracerebral vascular beds. At these dopamine (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 (dopamine hydrochloride) is usually not associated with a decrease in osmolarity of the urine.

At intermediate rates of infusion (2-10 mcg/kg/min) dopamine (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 (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. At low and intermediate doses, total peripheral resistance (which would be raised by alpha activity) is usually unchanged.

At higher rates of infusion (10-20 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 dopamine (dopamine hydrochloride) rgic effects of dopamine (dopamine hydrochloride) , reversing renal dilation and natriuresis.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Dopamine
(hydrochloride) Injection, USP

DRUG DESCRIPTION

Dopamine Hydrochloride Injection, USP is a clear, practically colorless, aqueous, additive solution for intravenous infusion after dilution. Each mL contains either 40 mg, 80 mg, or 160 mg dopamine (dopamine hydrochloride) HCl, USP (equivalent to 32.3 mg, 64.6 mg and 129.2 mg dopamine (dopamine hydrochloride) base respectively) in Water for Injection, USP, containing 9 mg sodium metabisulfite as an antioxidant. The pH range (2.5 to 5.0) may be adjusted with citric acid and/or sodium citrate. The solution is sterile and nonpyrogenic. Dopamine (dopamine hydrochloride) HCl, a naturally occurring catecholamine, is an inotropic vasopressor agent. Its chemical name is 3,4 dihydroxyphenethylamine hydrochloride and its chemical structure is:

Dopamine Hydrochloride structural formula illustration

Dopamine (dopamine hydrochloride) HCl is sensitive to alkalis, iron salts and oxidizing agents. DOPAMINE (dopamine hydrochloride) must be diluted in an appropriate, sterile parenteral solution (see DOSAGE AND ADMINISTRATION section) before intravenous administration.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Dopamine
(hydrochloride) Injection, USP

DRUG DESCRIPTION

Dopamine Hydrochloride Injection, USP is a clear, practically colorless, aqueous, additive solution for intravenous infusion after dilution. Each mL contains either 40 mg, 80 mg, or 160 mg dopamine (dopamine hydrochloride) HCl, USP (equivalent to 32.3 mg, 64.6 mg and 129.2 mg dopamine (dopamine hydrochloride) base respectively) in Water for Injection, USP, containing 9 mg sodium metabisulfite as an antioxidant. The pH range (2.5 to 5.0) may be adjusted with citric acid and/or sodium citrate. The solution is sterile and nonpyrogenic. Dopamine (dopamine hydrochloride) HCl, a naturally occurring catecholamine, is an inotropic vasopressor agent. Its chemical name is 3,4 dihydroxyphenethylamine hydrochloride and its chemical structure is:

Dopamine Hydrochloride structural formula illustration

Dopamine (dopamine hydrochloride) HCl is sensitive to alkalis, iron salts and oxidizing agents. DOPAMINE (dopamine hydrochloride) must be diluted in an appropriate, sterile parenteral solution (see DOSAGE AND ADMINISTRATION section) before intravenous administration.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Dopamine
(hydrochloride) Injection, USP

DRUG DESCRIPTION

Dopamine Hydrochloride Injection, USP is a clear, practically colorless, aqueous, additive solution for intravenous infusion after dilution. Each mL contains either 40 mg, 80 mg, or 160 mg dopamine (dopamine hydrochloride) HCl, USP (equivalent to 32.3 mg, 64.6 mg and 129.2 mg dopamine (dopamine hydrochloride) base respectively) in Water for Injection, USP, containing 9 mg sodium metabisulfite as an antioxidant. The pH range (2.5 to 5.0) may be adjusted with citric acid and/or sodium citrate. The solution is sterile and nonpyrogenic. Dopamine (dopamine hydrochloride) HCl, a naturally occurring catecholamine, is an inotropic vasopressor agent. Its chemical name is 3,4 dihydroxyphenethylamine hydrochloride and its chemical structure is:

Dopamine Hydrochloride structural formula illustration

Dopamine (dopamine hydrochloride) HCl is sensitive to alkalis, iron salts and oxidizing agents. DOPAMINE (dopamine hydrochloride) must be diluted in an appropriate, sterile parenteral solution (see DOSAGE AND ADMINISTRATION section) before intravenous administration.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Dopamine Patient Information Including Side Effects

Brand Names:

Generic Name: dopamine (injection) (Pronunciation: DOE pa meen)

What is dopamine ?

Dopamine is a medication form of a substance that occurs naturally in the body. It works by improving the pumping strength of the heart and improves blood flow to the kidneys.

Dopamine is used to treat certain conditions that occur when you are in shock, which may be caused by heart attack, trauma, surgery, heart failure, kidney failure, and other serious medical conditions.

Dopamine may also be used for purposes not listed in this medication guide.

What are the possible side effects of dopamine injection ?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • chest pain;
  • fast, slow, or pounding heartbeats;
  • painful or difficult urination, blood in your urine;
  • weakness, confusion, swelling in your feet or ankles, urinating less than usual or not at all;
  • weak or shallow breathing;
  • feeling like you might pass out, even while lying down;
  • burning, pain, or swelling around the IV needle;
  • cold feeling, numbness, or blue-colored appearance in your hands or feet; or
  • darkening or skin changes in your hands or feet.

Less serious side effects may include:

  • headache;
  • feeling anxious;
  • nausea, vomiting; or
  • chills, goosebumps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Dopamine (dopamine hydrochloride) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about dopamine injection ?

If possible before you receive dopamine injection, tell your caregivers if you have pheochromocytoma (tumor of the adrenal gland).

Also tell your caregivers if you have hardened arteries, circulation problems, diabetes, frostbite, Buergers disease, asthma, sulfite allergy, or a history of blood clots.

Tell your doctor about all the prescription and over-the-counter medications you use, especially if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 21 days.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received this medication.

Side Effects Centers

Dopamine Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving dopamine injection ?

If possible before you receive dopamine injection, tell your caregivers if you have pheochromocytoma (tumor of the adrenal gland).

To make sure you can safely receive dopamine injection, tell your caregivers if you have any of these other conditions:

  • coronary artery disease (hardened arteries);
  • circulation problems such as Raynaud's syndrome;
  • a history of blood clots;
  • diabetes;
  • frostbite;
  • Buergers disease;
  • asthma;
  • sulfite allergy; or
  • if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 21 days.

FDA pregnancy category C. It is not known whether dopamine injection will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether dopamine injection passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

In an emergency situation, it may not be possible before you are treated with dopamine injection to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

How is dopamine injection given ?

Dopamine injection is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when dopamine injection is injected.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving dopamine injection.

To be sure this medication is helping your condition and not causing harmful effects, your blood cells and kidney function may need to be tested often. Do not miss any follow-up visits to your doctor for blood or urine tests.

Side Effects Centers

Dopamine Patient Information including If I Miss a Dose

What happens if I miss a dose ?

Since dopamine injection is given by a healthcare professional in a medical setting, you are not likely to miss a dose.

What happens if I overdose ?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving dopamine injection ?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect dopamine injection ?

Tell your doctor about all other medicines you use, especially:

  • droperidol (Inapsine);
  • epinephrine (EpiPen, Adrenaclick, Twinject, and others);
  • haloperidol (Haldol);
  • midodrine (ProAmatine);
  • phenytoin (dilantin);
  • vasopressin (Pitressin);
  • a diuretic (water pill);
  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others;
  • a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
  • cough or cold medicine that contains an antihistamine or decongestant;
  • ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), or methylergonovine (Methergine);
  • a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine);

There may be other drugs that can interact with dopamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about dopamine injection.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision date: 9/12/2011.

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Side Effects Centers

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