Schedule H

Intravenous (IV infusion only)

• Dopamine hydrochloride injection: 40 mg/mL in 5 mL ampoules (200 mg/5 mL)

• Dopamine hydrochloride injection: 200 mg/5 mL vials

• Dopamine hydrochloride injection: 400 mg/5 mL vials

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Hypotension (Septic Shock, Cardiogenic Shock)

Parameter Recommendation

Starting dose 2–5 mcg/kg/min IV infusion

Titration Increase by 5–10 mcg/kg/min every 10–30 minutes based on BP, urine output, lactate

Usual maintenance dose 5–15 mcg/kg/min

Maximum dose 50 mcg/kg/min (rarely required; high arrhythmia risk)

Dose-Effect Relationship:

Dose Range Predominant Receptor Clinical Effect

1–5 mcg/kg/min Dopaminergic (D1) Renal/splanchnic vasodilation (clinical benefit unproven)

5–10 mcg/kg/min β1-adrenergic Positive inotropy and chronotropy

10 mcg/kg/min α1-adrenergic Peripheral vasoconstriction

Clinical Notes:

• Central venous access mandatory for infusions exceeding 6 hours

• Correct hypovolemia before initiation

• Norepinephrine is now preferred first-line for septic shock per ICMR/AIIMS protocols

1. Decompensated Congestive Heart Failure (Short-Term Adjunct)

Parameter Recommendation

Starting dose 2–3 mcg/kg/min IV infusion

Titration Increase by 2–5 mcg/kg/min every 15–30 minutes as tolerated

Usual maintenance dose 5–10 mcg/kg/min

Maximum dose 20 mcg/kg/min

Clinical Notes:

• Use under cardiologist/intensivist supervision only

• Monitor for tachyarrhythmias and myocardial ischemia

• Short-term use only; not for chronic heart failure management

Secondary Indications – Adults (Off-label, if any)

Indication Evidence/Recommendation

"Renal-dose" dopamine for renal protection in critically ill NOT RECOMMENDED — Multiple meta-analyses show no benefit in preventing acute kidney injury or improving outcomes

Bradycardia unresponsive to atropine Limited use; specialist only; prefer alternative chronotropes

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Shock (Septic, Cardiogenic) in Neonates and Children

Parameter Recommendation

Starting dose 2–5 mcg/kg/min IV infusion

Titration Increase by 2–5 mcg/kg/min every 15 minutes based on response

Usual maintenance dose 5–15 mcg/kg/min

Maximum dose 20 mcg/kg/min (higher only under PICU supervision)

Age-Specific Considerations:

Age Group Special Considerations

Neonates Use only in NICU setting; immature hepatic metabolism; start at lower end

Infants (1–12 months) Higher weight-adjusted clearance; may require relatively higher doses

Children (1–12 years) Standard weight-based dosing applies

Adolescents Approach adult dosing; monitor for arrhythmias

Minimum Age: Can be used from the neonatal period; PICU/NICU supervision mandatory

Mandatory Monitoring:

• Continuous ECG and invasive BP monitoring

• Urine output (target ≥1 mL/kg/hr in children)

• Capillary refill time

• Serum lactate levels

Secondary Indications – Paediatric Doses (Off-label, if any)

Indication Recommendation

"Renal-dose" dopamine NOT RECOMMENDED in paediatric practice; no evidence of renal protective benefit

Mild to moderate impairment No dose adjustment required

• Pheochromocytoma (risk of hypertensive crisis)

• Uncorrected tachyarrhythmias (ventricular tachycardia, ventricular fibrillation, rapid atrial fibrillation)

• Known hypersensitivity to dopamine hydrochloride or sulfite preservatives

• Mechanical cardiac outflow obstruction (severe aortic stenosis, hypertrophic obstructive cardiomyopathy)

• Extravasation risk: High potential for tissue necrosis; use central venous access when possible

• Uncorrected hypovolemia: Must restore intravascular volume before or during dopamine therapy

• Coronary artery disease: Risk of precipitating or worsening myocardial ischemia at higher doses

• Pre-existing arrhythmias: May exacerbate atrial fibrillation or ventricular ectopy

• Peripheral vascular disease: High doses may worsen limb ischemia

• Abrupt discontinuation: Taper gradually to prevent rebound hypotension

Aspect Recommendation

Risk category Use with caution — limited human data; animal studies show fetal effects at high doses

When may be used Maternal shock, cardiac arrest, or life-threatening hypotension where benefit outweighs risk

Preferred alternatives Norepinephrine is preferred for septic shock in pregnancy per Indian obstetric critical care guidance

Monitoring Continuous fetal heart rate monitoring; uteroplacental perfusion assessment; maternal hemodynamics

Aspect Recommendation

Compatibility Likely compatible for short-term critical care use

Drug levels in milk No human data; expected to be low due to poor oral bioavailability

Concerns May suppress prolactin secretion and reduce milk production

Infant monitoring Not applicable during acute maternal critical illness

Recommendation Use if essential for maternal hemodynamic support; not a contraindication to future breastfeeding

Aspect Recommendation

Starting dose 1–3 mcg/kg/min (lower than standard adult dose)

Titration Slower increments; allow longer intervals between dose changes

Specific risks Increased sensitivity to chronotropic and vasoconstrictive effects; higher arrhythmia risk

Monitoring Close attention to myocardial ischemia, renal perfusion, and volume status

Caution Reduced physiological reserve; concurrent cardiovascular disease common

Interacting Drug Mechanism/Effect Recommendation

MAO inhibitors (phenelzine, tranylcypromine, selegiline) Inhibition of dopamine metabolism → severe hypertensive crisis AVOID — reduce dopamine dose to 1/10th if essential

Phenytoin (IV) Profound hypotension, bradycardia reported AVOID concurrent use; monitor closely if unavoidable

Ergot alkaloids (ergotamine, methylergometrine) Additive peripheral vasoconstriction → gangrene risk AVOID concurrent use

Halogenated anaesthetics (halothane, sevoflurane) Sensitise myocardium to catecholamines → arrhythmias Use with extreme caution intraoperatively

Interacting Drug Effect Management

Beta-blockers Antagonise β1 inotropic effects; may cause unopposed α-vasoconstriction Monitor heart rate and BP; may need dose adjustment

Tricyclic antidepressants Potentiate catecholamine effects Use lower dopamine doses; monitor for hypertension

Diuretics Altered volume status affects dopamine response Optimise fluid balance; monitor hemodynamics

Vasodilators/Nitrates May blunt pressor response Adjust doses based on clinical response

Oxytocin Additive vasoconstrictor effect Monitor BP closely in obstetric settings

• Tachycardia

• Palpitations

• Nausea and vomiting

• Headache

• Anxiety or restlessness

• Anginal discomfort

• Dyspnoea

• Widened QRS complex on ECG

Adverse Effect Clinical Significance

Ventricular arrhythmias May require immediate dose reduction or discontinuation

Myocardial ischaemia/infarction Risk increases at higher doses; monitor ECG continuously

Severe hypertension Especially with MAO inhibitor interaction or overdose

Extravasation necrosis Requires immediate phentolamine infiltration (5–10 mg in 10–15 mL NS locally)

Peripheral gangrene Due to intense vasoconstriction at high doses; monitor extremities

Cardiac conduction abnormalities Aberrant conduction, ectopic beats

After initiation/dose change Continuous invasive BP monitoring (preferred); continuous ECG; urine output hourly; lactate every 4–6 hours

Ongoing during infusion Peripheral perfusion (capillary refill, extremity temperature); signs of extravasation at infusion site

Before discontinuation Gradual taper; monitor for rebound hypotension

• Dopamax (Samarth Life Sciences)

• Dopamin (Neon Laboratories)

• Dopaject (Zydus Cadila)

• Intawin (Intas Pharmaceuticals)

• Dopanorm (VHB Life Sciences)

• Dopath (Vascon Pharma)

Formulation Approximate Retail Price

200 mg/5 mL ampoule ₹20–40

400 mg/5 mL vial ₹40–70

Notes:

• Lower cost in government hospital supply

• Listed under emergency/essential drug category

• Not NPPA price-controlled under NLEM as of current list

1. Volume first: Always correct hypovolemia before initiating dopamine; pressors without adequate preload are ineffective and harmful

1. Central access preferred: Peripheral IV use acceptable only for short-term emergency; shift to central line within 6 hours to prevent extravasation injury

1. Norepinephrine superiority: Dopamine is no longer first-line for septic shock — norepinephrine is preferred per AIIMS/ICMR protocols due to lower arrhythmia risk

1. Abandon "renal-dose" concept: Low-dose dopamine for renal protection is obsolete; no evidence of benefit in any patient population

1. Extravasation management: Keep phentolamine available; infiltrate 5–10 mg diluted in 10–15 mL normal saline around extravasation site within 12 hours

1. Weaning: Taper gradually (by 2–5 mcg/kg/min every 15–30 minutes) once hemodynamics stabilise; abrupt discontinuation can cause hypotension

dopamine; vasopressor; inotrope; septic shock; cardiogenic shock; ICU drug; critical care; catecholamine; PICU; neonatal shock; sympathomimetic

RxIndia v0.7 — 29 Apr 2025

• CDSCO approved product information

• Indian Pharmacopoeia / National Formulary of India

• AIIMS Critical Care Protocols

• API Textbook of Medicine

• ICMR COVID-19 Clinical Management Guidelines (vasopressor recommendations)

• Indian Academy of Pediatrics — PICU protocols

• Surviving Sepsis Campaign Guidelines (international reference for off-label notation)

• Meta-analyses: Friedrich JO et al. (dopamine vs norepinephrine); Bellomo R et al. (low-dose dopamine in renal protection)