Dopamine 40mg/ml Inj, 10ml

Manufacturer HIKMA PHARMACEUTICALS USA Active Ingredient Dopamine(DOE pa meen) Pronunciation DOE pa meen
It is used to treat heart failure (weak heart).It is used to treat low blood pressure. It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Vasopressor; Inotropic Agent
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Pharmacologic Class
Adrenergic Agonist; Dopaminergic Agonist
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Pregnancy Category
Category C
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FDA Approved
Jun 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Dopamine is a medicine given through an IV to help your heart pump stronger, raise your blood pressure, and sometimes help your kidneys make more urine. It's used in serious conditions like shock or heart failure.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered via infusion into a vein over a specified period of time.

For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • This medication is given in a hospital setting under close medical supervision.
  • Report any discomfort, pain, or swelling at the IV site immediately.
  • Report any new or worsening symptoms like chest pain, shortness of breath, or dizziness.

Dosing & Administration

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Adult Dosing

Standard Dose: Titrated to desired hemodynamic response, typically starting at 2-5 mcg/kg/min and increasing by 1-4 mcg/kg/min increments every 10-30 minutes.
Dose Range: 2 - 20 mg

Condition-Specific Dosing:

renalDose: 1-5 mcg/kg/min (dopaminergic effects, increased renal perfusion, urine output)
inotropicDose: 5-10 mcg/kg/min (beta-1 adrenergic effects, increased cardiac contractility and heart rate)
vasopressorDose: 10-20 mcg/kg/min (alpha-1 adrenergic effects, vasoconstriction, increased systemic vascular resistance and blood pressure)
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Pediatric Dosing

Neonatal: Initial: 1-5 mcg/kg/min IV infusion; titrate to desired effect, max 20 mcg/kg/min.
Infant: Initial: 1-5 mcg/kg/min IV infusion; titrate to desired effect, max 20 mcg/kg/min.
Child: Initial: 1-5 mcg/kg/min IV infusion; titrate to desired effect, max 20 mcg/kg/min.
Adolescent: Initial: 1-5 mcg/kg/min IV infusion; titrate to desired effect, max 20 mcg/kg/min.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor response.
Moderate: No specific adjustment, monitor response.
Severe: No specific adjustment, monitor response.
Dialysis: Not applicable, dopamine is rapidly metabolized and not significantly removed by dialysis. Dosing is based on hemodynamic response.

Hepatic Impairment:

Mild: No specific adjustment, monitor response.
Moderate: No specific adjustment, monitor response.
Severe: No specific adjustment, monitor response.

Pharmacology

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Mechanism of Action

Dopamine is a naturally occurring catecholamine with dose-dependent effects. At low doses (1-5 mcg/kg/min), it primarily stimulates dopaminergic D1 receptors in the renal, mesenteric, coronary, and cerebral vascular beds, causing vasodilation and increased renal blood flow and urine output. At moderate doses (5-10 mcg/kg/min), it stimulates beta-1 adrenergic receptors, leading to increased myocardial contractility, heart rate, and cardiac output. At high doses (>10 mcg/kg/min), it stimulates alpha-1 adrenergic receptors, causing peripheral vasoconstriction, increased systemic vascular resistance, and elevated blood pressure.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV administration)
Tmax: Not applicable (continuous infusion)
FoodEffect: Not applicable

Distribution:

Vd: 0.89 L/kg
ProteinBinding: Not available
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2 minutes (range 1-5 minutes)
Clearance: Not available
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <25%
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Pharmacodynamics

OnsetOfAction: Within 5 minutes
PeakEffect: Within 5-10 minutes
DurationOfAction: Less than 10 minutes (due to rapid metabolism)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Shortness of breath
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Cool or pale arm or leg
Changes in skin color, such as turning black or purple
Difficulty urinating or changes in urine output

Infusion Site Reactions

If you experience any of the following symptoms at the injection site, notify your nurse immediately:

Redness
Burning
Pain
Swelling
Blisters
Skin sores
Leaking of fluid

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Upset stomach or vomiting
Headache
Anxiety
* Goosebumps

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache
  • Chest pain or tightness
  • Irregular heartbeat or palpitations
  • Difficulty breathing
  • Coldness, numbness, or pain in fingers or toes
  • Swelling or pain at the IV site
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have been diagnosed with pheochromocytoma, a type of adrenal gland tumor.
If you have a history of irregular or rapid heartbeat.
If you have low levels of potassium or magnesium in your blood.
* If you have low blood volume or a condition that causes acidic blood (acidosis).

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

Additionally, it is crucial to check your blood pressure as instructed by your doctor.

Stopping this medication too quickly can lead to low blood pressure, which may cause severe dizziness or fainting. If you experience either of these symptoms, contact your doctor immediately.

If you have a sulfite allergy, consult your doctor before taking this medication, as some products may contain sulfites.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive hypertension (very high blood pressure)
  • Tachycardia (very fast heart rate)
  • Arrhythmias (irregular heartbeats)
  • Peripheral vasoconstriction (cold, pale extremities)
  • Nausea, vomiting

What to Do:

Treatment involves reducing the dose or discontinuing the infusion. For severe hypertension, an alpha-adrenergic blocking agent (e.g., phentolamine) may be administered. For arrhythmias, antiarrhythmics may be considered. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Contraindicated Interactions

  • Patients with pheochromocytoma (risk of severe hypertension)
  • Patients with uncorrected tachyarrhythmias or ventricular fibrillation
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Major Interactions

  • MAO inhibitors (e.g., phenelzine, selegiline, tranylcypromine): Potentiates pressor effects, leading to severe hypertension and arrhythmias. Concomitant use is contraindicated or requires extreme caution and reduced dopamine dose.
  • Beta-blockers (e.g., propranolol, metoprolol): May antagonize cardiac effects of dopamine.
  • Alpha-blockers (e.g., phentolamine): May antagonize peripheral vasoconstrictive effects of dopamine.
  • Tricyclic antidepressants (e.g., amitriptyline, imipramine): May potentiate pressor effects of dopamine.
  • Ergot alkaloids (e.g., ergotamine): Increased vasoconstriction and risk of ischemia.
  • General anesthetics (e.g., halothane, cyclopropane): May sensitize myocardium to dopamine, increasing risk of arrhythmias.
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Moderate Interactions

  • Diuretics (e.g., furosemide): May enhance renal effects of dopamine, but also risk of hypovolemia.
  • Phenytoin: Risk of hypotension and bradycardia when administered with dopamine.
  • Oxytocic drugs: May potentiate pressor effects.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide titration for desired hemodynamic effect.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for tachycardia/arrhythmias.

Timing: Prior to initiation

Urine Output

Rationale: To establish baseline renal function and monitor response to renal-dose dopamine.

Timing: Prior to initiation

ECG

Rationale: To assess for pre-existing arrhythmias and monitor for new onset.

Timing: Prior to initiation

Peripheral Perfusion (skin color, temperature, capillary refill)

Rationale: To assess baseline tissue perfusion, especially important with higher doses.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Continuously (arterial line preferred) or every 5-15 minutes during titration, then hourly once stable.

Target: Individualized based on clinical goal (e.g., MAP >65 mmHg)

Action Threshold: MAP below target, or excessive hypertension

Heart Rate (HR)

Frequency: Continuously (ECG monitor) or every 5-15 minutes during titration, then hourly once stable.

Target: Individualized, avoid excessive tachycardia (>120 bpm or significant increase from baseline)

Action Threshold: Significant tachycardia, new arrhythmias

Urine Output

Frequency: Hourly

Target: >0.5 mL/kg/hr

Action Threshold: <0.5 mL/kg/hr for 2 consecutive hours

ECG

Frequency: Continuous monitoring

Target: Normal sinus rhythm, absence of significant arrhythmias

Action Threshold: New onset of arrhythmias (e.g., ventricular tachycardia, frequent PVCs)

Peripheral Perfusion

Frequency: Every 1-4 hours, or more frequently if concerns arise

Target: Warm, dry skin, good capillary refill

Action Threshold: Cool, mottled extremities, prolonged capillary refill

IV Site

Frequency: Hourly or more frequently

Target: No signs of extravasation (redness, swelling, pain)

Action Threshold: Any signs of extravasation (stop infusion immediately, infiltrate with phentolamine)

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Symptom Monitoring

  • Chest pain (angina)
  • Palpitations
  • Shortness of breath
  • Headache
  • Nausea/vomiting
  • Anxiety/restlessness
  • Cold, mottled extremities (signs of peripheral ischemia)

Special Patient Groups

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Pregnancy

Category C. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Dopamine may reduce uterine blood flow.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data, but human data limited.
Second Trimester: Potential for fetal harm based on animal data, but human data limited.
Third Trimester: Potential for fetal harm based on animal data, but human data limited. May reduce uterine blood flow.
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Lactation

L3 (Moderately Safe). It is not known whether dopamine is excreted in human milk. Due to its short half-life and poor oral bioavailability, systemic exposure to the infant is likely minimal. Caution should be exercised, and the benefits of breastfeeding versus the potential risks to the infant should be weighed.

Infant Risk: Low due to short half-life and poor oral absorption, but potential for adverse effects on infant cardiovascular system if significant exposure occurs. Monitor infant for signs of adrenergic effects (e.g., irritability, feeding difficulties, changes in heart rate).
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Pediatric Use

Dopamine is used in pediatric patients, including neonates, for similar indications as adults (shock, heart failure). Dosing is weight-based (mcg/kg/min) and titrated to effect. Close monitoring of vital signs, urine output, and perfusion is crucial. Neonates may be more sensitive to its effects.

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Geriatric Use

Elderly patients may be more sensitive to the effects of dopamine, particularly the pressor and chronotropic effects, and may be more prone to adverse reactions such as arrhythmias and excessive hypertension. Start with lower doses and titrate carefully, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Dopamine's effects are highly dose-dependent: 'renal dose' (low), 'inotropic dose' (moderate), 'vasopressor dose' (high). Understand the desired effect to guide titration.
  • Always administer via continuous IV infusion, preferably through a central line. If a peripheral line is used, ensure it is a large vein and monitor closely for extravasation.
  • Extravasation is a serious complication; have phentolamine readily available for infiltration if it occurs.
  • Correct hypovolemia prior to initiating dopamine, as it is not a substitute for fluid resuscitation.
  • Monitor for arrhythmias, especially at higher doses, and in patients with pre-existing cardiac conditions.
  • Dopamine is often used as a second-line vasopressor after norepinephrine in septic shock, but its role in other forms of shock varies.
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Alternative Therapies

  • Norepinephrine (Levophed) - primarily alpha-1 agonist, potent vasoconstrictor, less beta-1 effect than dopamine at high doses.
  • Epinephrine (Adrenalin) - potent alpha and beta agonist, used for severe hypotension and cardiac arrest.
  • Phenylephrine (Neo-Synephrine) - pure alpha-1 agonist, vasoconstrictor, no inotropic effect.
  • Dobutamine (Dobutrex) - primarily beta-1 agonist, inotropic agent, less effect on blood pressure.
  • Vasopressin (Pitressin) - non-adrenergic vasopressor, used in refractory shock.
  • Milrinone (Primacor) - phosphodiesterase inhibitor, inotropic and vasodilator, used in heart failure.
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Cost & Coverage

Average Cost: Varies widely, typically low cost for generic per 10ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your prescription medications with others, and never take medication that has been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best method for disposal. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is essential to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare providers deliver appropriate care.