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Fenoldopam Uses, Dosage, Side Effects & Price | DrugsAtlas

Authoritative Clinical Reference

DRUG NAME: Fenoldopam

Therapeutic Class: Antihypertensive

Subclass: Peripheral dopamine-1 (DA1) receptor agonist

Speciality: Critical Care Medicine

Schedule (India): Schedule H

Route(s): Intravenous (IV)

Formulations Available in India:

• Fenoldopam injection: 10 mg/mL in 1 mL ampoule (concentrate for dilution)
• Fenoldopam injection: 10 mg/mL in 2 mL ampoule

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hypertensive Emergency (including patients with renal impairment or perioperative hypertension)

Parameter	Recommendation
Starting dose	0.1 mcg/kg/min IV continuous infusion
Titration	Increase by 0.05–0.1 mcg/kg/min every 15–20 minutes based on BP response
Usual maintenance dose	0.1–0.3 mcg/kg/min
Maximum dose	1.6 mcg/kg/min

Clinical Notes:
→ Onset of action: within 5 minutes; duration of effect: 30–60 minutes after discontinuation
→ Requires continuous invasive or non-invasive arterial BP monitoring
→ Preserves or enhances renal blood flow — preferred agent in patients with acute kidney injury or renal compromise
→ Must be diluted before infusion; do not administer as bolus
→ Prepare infusion fresh; stable for 24 hours at room temperature once diluted

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

1. Controlled Hypotension During Surgery (OFF-LABEL)
• Dose: 0.05–0.5 mcg/kg/min IV infusion
• Duration: Intraoperative period only; discontinue at end of surgery
• Specialist only: Anaesthesiologist supervision required
• Evidence basis: Institutional protocols in neurosurgery and major vascular procedures

2. Renal Protection in High-Risk Cardiac Surgery (OFF-LABEL)
• Dose: 0.03–0.1 mcg/kg/min IV infusion
• Duration: Initiated perioperatively; continued for up to 24 hours postoperatively
• Specialist only: Cardiac anaesthesia/ICU settings
• Evidence basis: Mixed results in RCTs; some centres use as part of renal protection protocols

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Hypertensive Crisis (Age >1 month) — ICU/Specialist Setting Only

Parameter	Recommendation
Starting dose	0.2 mcg/kg/min IV continuous infusion
Titration	Increase by 0.05–0.1 mcg/kg/min every 15–30 minutes
Usual maintenance dose	0.2–0.5 mcg/kg/min
Maximum dose	0.8 mcg/kg/min

Clinical Notes:
→ Continuous arterial BP monitoring mandatory
→ Monitor urine output hourly
→ Minimum age: >1 month (safety in neonates not established)
→ Use only in paediatric ICU with specialist supervision
→ Monitor for hypotension and reflex tachycardia

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

• Not routinely established in paediatric practice
• Any off-label use requires paediatric critical care or cardiology specialist input
• NOT RECOMMENDED in neonates (<1 month) except under specialist supervision in tertiary centres

RENAL ADJUSTMENT

• No dose adjustment required in renal impairment
• Drug possesses renal vasodilatory properties via DA1 receptor activation — increases renal blood flow
• Often preferred over other IV antihypertensives in patients with elevated creatinine or oliguria
• Safe to use in patients on haemodialysis

HEPATIC ADJUSTMENT

Severity (Child-Pugh)	Recommendation
Class A (Mild)	No dose adjustment required
Class B (Moderate)	Use with caution; initiate at lower end of dosing range; slower titration
Class C (Severe)	Use only in ICU setting with close haemodynamic monitoring

CONTRAINDICATIONS

• Known hypersensitivity to fenoldopam or any excipient
• Acute angle-closure glaucoma or conditions predisposing to elevated intraocular pressure
• Sulphite allergy (some formulations contain sodium metabisulphite)
• Severe uncorrected hypovolaemia or shock states

CAUTIONS

• Volume depletion — correct hypovolaemia before initiating therapy to prevent profound hypotension
• Coronary artery disease — reflex tachycardia may precipitate myocardial ischaemia
• Elevated intraocular pressure — may exacerbate glaucoma
• Concurrent use of potassium-depleting agents — risk of hypokalaemia
• Tachyarrhythmias — may worsen with reflex sympathetic activation
• Aortic stenosis or hypertrophic cardiomyopathy — hypotension may be poorly tolerated

PREGNANCY

Parameter	Guidance
Overall safety	Limited human data; animal studies inconclusive
When permissible	Only in severe refractory hypertensive emergency when standard agents inadequate; ICU/specialist setting
Preferred alternatives	Labetalol IV, hydralazine IV, nifedipine oral (per Indian obstetric guidelines)
Monitoring	Continuous maternal BP; fetal heart rate monitoring; assess uteroplacental perfusion

LACTATION

Parameter	Guidance
Breastfeeding compatibility	Unknown; use not routinely recommended during active breastfeeding
Milk levels	Not established; expected low due to short half-life
Preferred alternatives	Labetalol IV or hydralazine IV
Infant monitoring	If used, observe for hypotension, poor feeding, lethargy

ELDERLY

• Starting dose: 0.05–0.1 mcg/kg/min (use lower end of range)
• Titration: Slower increments (0.05 mcg/kg/min every 20–30 minutes)
• Increased risk of:

Excessive hypotension
Reflex tachycardia precipitating ischaemia
Falls upon mobilisation post-infusion
• ECG monitoring recommended in patients with known cardiovascular disease
• Ensure adequate volume status before initiation

MAJOR DRUG INTERACTIONS

Interacting Drug	Effect	Management
Non-selective beta-blockers (propranolol)	May unmask alpha-mediated vasoconstriction; paradoxical hypertension possible in some cases; also blunts compensatory tachycardia	Avoid concurrent use or use cardioselective beta-blocker with caution
MAO inhibitors	Potentiation of hypotensive effect; unpredictable response	AVOID — discontinue MAOIs at least 14 days before
IV nitroglycerin/nitroprusside	Additive profound hypotension	Avoid concurrent use; if essential, reduce doses of both agents

MODERATE DRUG INTERACTIONS

Interacting Drug	Effect	Management
Loop diuretics (furosemide)	Additive hypotension; additive hypokalaemia	Monitor BP closely; check serum potassium every 6–12 hours
Thiazide diuretics	Potentiates hypokalaemia	Monitor electrolytes
ACE inhibitors/ARBs	Additive hypotension, especially in volume-depleted patients	Monitor BP; ensure euvolaemia
Alpha-blockers (prazosin, tamsulosin)	Additive antihypertensive effect	Monitor for symptomatic hypotension
Inhalational anaesthetics (sevoflurane, isoflurane)	Enhanced hypotensive response	Dose adjustment during anaesthesia; anaesthetist coordination
NSAIDs	May attenuate renal vasodilatory benefit	Avoid in patients where renal protection is a treatment goal

COMMON ADVERSE EFFECTS

• Headache
• Flushing
• Nausea
• Dizziness
• Reflex tachycardia
• Injection site reactions
• Hypokalaemia (with prolonged infusion)

SERIOUS ADVERSE EFFECTS

• Severe symptomatic hypotension — may require fluid resuscitation and dose reduction
• Myocardial ischaemia or angina — secondary to reflex tachycardia; may require discontinuation
• Acute angle-closure glaucoma — discontinue immediately; ophthalmology referral
• Significant hypokalaemia — can precipitate arrhythmias; requires IV potassium supplementation
• Anaphylaxis or severe hypersensitivity (rare; associated with sulphite content) — discontinue; supportive care

MONITORING REQUIREMENTS

Baseline:
• Blood pressure (arterial line preferred in ICU)
• Heart rate and ECG (especially if cardiac disease)
• Serum electrolytes including potassium
• Renal function (serum creatinine, urine output)
• Assess volume status

During Infusion:
• Continuous BP monitoring (arterial line or every 5 minutes non-invasively during titration)
• Heart rate every 15–30 minutes
• Hourly urine output
• Serum potassium every 6–12 hours for prolonged infusions (>24 hours)

Post-Infusion:
• Monitor for rebound hypertension for 2–4 hours after discontinuation
• Reassess electrolytes before discharge from ICU

BRANDS AVAILABLE IN INDIA

• Corlopam (Abbott/Pfizer)
• Fenopres (Samarth Life Sciences)
• Dopafen (La Renon Healthcare)

PRICE RANGE (INR)

• ₹450–₹900 per ampoule (10 mg/mL concentration)
• NLEM status: Not included
• Availability: Primarily in tertiary care hospitals and ICU settings; not routinely stocked in peripheral centres
• Government supply: Limited availability

CLINICAL PEARLS

• Preferred IV antihypertensive in hypertensive emergencies with renal impairment — improves renal perfusion via DA1-mediated vasodilation
• Very short half-life (~5 minutes) allows precise titration; effect wears off rapidly upon discontinuation
• Reflex tachycardia is expected — avoid in patients with active coronary ischaemia or recent myocardial infarction
• Always check for sulphite allergy before administration; patients with asthma may have higher sulphite sensitivity
• Does not cause cyanide or thiocyanate toxicity — safer than sodium nitroprusside for prolonged infusions
• Not suitable for outpatient or ward-level use; requires ICU-level monitoring infrastructure

Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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