Nicardipine Schedule (India)

Schedule H

Nicardipine Routes

Intravenous (IV only in India)

Nicardipine Formulations

Injection: 10 mg/10 mL ampoule (Nicardipine hydrochloride)

Note: Oral formulations (capsules/tablets) are NOT AVAILABLE in India.

Nicardipine Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Hypertensive Emergency (IV)

Indicated for rapid BP control in neurological emergencies, perioperative settings, and acute severe hypertension requiring ICU management.

Parameter Recommendation

Starting dose 5 mg/hour IV infusion

Titration Increase by 2.5 mg/hour every 5–15 minutes based on BP response

Usual maintenance dose 5–15 mg/hour

Maximum dose 15 mg/hour

Clinical Notes:

Onset of action: 5–15 minutes

Use infusion pump for precise rate control

Central venous access recommended for infusions exceeding 24 hours

Avoid bolus administration

Reduce infusion rate once target BP achieved

Perioperative Hypertension (IV)

For intraoperative or immediate postoperative BP control, particularly in cardiac and neurosurgical procedures.

Parameter Recommendation

Starting dose 5 mg/hour IV infusion

Titration Increase by 2.5 mg/hour every 5–15 minutes based on haemodynamic response

Usual maintenance dose 5–15 mg/hour

Maximum dose 15 mg/hour

Clinical Notes:

Coordinate with anaesthesia team

Continuous arterial BP monitoring preferred

Reduce or discontinue once oral antihypertensives can be initiated

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Subarachnoid Haemorrhage-Induced Vasospasm (OFF-LABEL) IV infusion: 5–15 mg/hour Until vasospasm resolves (typically 14–21 days post-bleed) Specialist only; used in neurosurgery/neuro-ICU; based on tertiary hospital protocols (AIIMS, NIMHANS); supportive evidence from international observational studies

Nicardipine Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not approved for paediatric use in India. No established paediatric indications in Indian regulatory approvals.

Secondary Indications — Paediatrics (Off-label)

Hypertensive Crisis — OFF-LABEL (PICU/NICU setting only)

Parameter Recommendation

Age ≥1 year

Starting dose 0.5–1 mcg/kg/min IV infusion

Titration Increase every 15–30 minutes as needed

Maximum dose 3 mcg/kg/min

Monitoring Required:

Continuous intra-arterial BP monitoring mandatory

ECG monitoring for reflex tachycardia

Watch for sudden drops in cerebral perfusion pressure

Age Restriction: Not recommended below 1 year of age except under paediatric intensivist or paediatric cardiologist supervision.

Note: Most Indian paediatric critical care protocols prefer labetalol or esmolol as first-line agents for paediatric hypertensive emergencies.

Nicardipine Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation

Mild to severe impairment Standard dosing; no adjustment needed

Haemodialysis Not dialyzable due to high lipophilicity and protein binding (~95%); no supplemental dosing required

Peritoneal dialysis No supplemental dosing required

Nicardipine Hepatic adjustment

Severity	Recommendation
Mild impairment Start at lower infusion rate (2.5–5 mg/hour)	; slower titration
Moderate impairment	Use with caution; start at 2.5 mg/hour; titrate slowly with close monitoring
Severe impairment	Avoid use — significantly impaired hepatic metabolism leads to unpredictable drug accumulation and increased risk of prolonged hypotension

Nicardipine Contraindications

Severe aortic stenosis

Severe hepatic impairment (Child-Pugh C)

Cardiogenic shock

Acute decompensated heart failure with reduced ejection fraction

Hypersensitivity to nicardipine or other dihydropyridine calcium channel blockers

Unstable angina or acute myocardial infarction (risk of reflex tachycardia)

Nicardipine Cautions

Ischaemic heart disease — reflex tachycardia may precipitate or worsen angina

Cardiac conduction disorders — monitor ECG

Hypovolaemia/dehydration — risk of profound hypotension; correct volume status before initiation

Raised intracranial pressure — rapid BP drops may compromise cerebral perfusion

Peripheral venous access — risk of phlebitis and extravasation injury; use central line for infusions >24 hours

Portal hypertension — may worsen hepatic congestion

Concurrent use with other antihypertensives — additive hypotensive effects

Nicardipine Pregnancy

Aspect Details

Safety Status Not preferred; limited safety data in pregnancy

Known Risks Potential for maternal hypotension affecting uteroplacental perfusion; fetal bradycardia

Preferred Alternatives Labetalol IV, hydralazine IV (for acute severe hypertension in pregnancy in Indian obstetric practice)

When to Use Only in ICU settings when preferred agents are contraindicated or ineffective; specialist input mandatory

Monitoring Continuous maternal BP, fetal heart rate monitoring, uterine perfusion assessment

Nicardipine Lactation

Aspect Details

Compatibility Not routinely recommended; insufficient human data

Drug Levels in Milk Likely low due to high protein binding (~95%)

Preferred Alternatives Nifedipine (oral dihydropyridine with better lactation safety data) if CCB needed

Infant Monitoring If used, monitor infant for hypotonia, lethargy, poor feeding

Nicardipine Elderly

Aspect Recommendation

Starting dose 2.5–5 mg/hour IV infusion

Titration Slower titration intervals (every 15–30 minutes)

Special Risks Exaggerated hypotensive response, reflex tachycardia, orthostatic events, increased risk of falls post-ICU, reduced hepatic metabolism

Additional Notes Lower maintenance doses often sufficient; close haemodynamic monitoring essential

Nicardipine Major drug interactions

Interacting Drug Effect/Risk Management

Beta-blockers (especially IV) Profound hypotension, bradycardia, cardiac depression Monitor cardiac function closely; avoid concurrent IV beta-blocker boluses

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, clarithromycin) Increased nicardipine plasma levels; enhanced hypotension Reduce nicardipine dose; close monitoring

Fentanyl (IV) Additive hypotension in perioperative settings Anticipate enhanced hypotensive effect; dose adjustment may be needed

Cyclosporine Increased cyclosporine levels due to CYP3A4 inhibition by nicardipine Monitor cyclosporine trough levels; adjust dose if needed

Nicardipine Moderate drug interactions

Interacting Drug Effect/Risk Management

Other antihypertensives (ACE inhibitors, ARBs, diuretics) Additive BP lowering Anticipate enhanced effect; adjust doses accordingly

Simvastatin / Atorvastatin Increased statin levels via CYP3A4 inhibition; myopathy risk Use lowest effective statin dose; monitor for muscle symptoms

Cimetidine Increased nicardipine bioavailability Monitor for excessive hypotension

Antipsychotics (quetiapine, risperidone) Enhanced hypotensive effects Monitor BP and mental status

Rifampicin Reduced nicardipine efficacy via CYP3A4 induction May require higher nicardipine doses; monitor BP response

Nicardipine Common Adverse effects

Headache

Flushing

Reflex tachycardia

Nausea

Peripheral oedema

Dizziness

Infusion site reactions (phlebitis, local irritation)

Nicardipine Serious Adverse effects

Adverse Effect Action Required

Severe hypotension requiring vasopressors Reduce or stop infusion; supportive care; IV fluids

Worsening myocardial ischaemia/angina Discontinue; consider alternative agent

Extravasation injury/tissue necrosis Stop infusion immediately; local management; may require surgical consultation

Significant hepatotoxicity (elevated transaminases) Discontinue infusion

Hypersensitivity reactions (urticaria, angioedema, bronchospasm) Immediate discontinuation; supportive treatment

Nicardipine Monitoring requirements

Timing	Parameters
Baseline	BP, heart rate, ECG, serum creatinine, liver function tests (ALT, AST)

During infusion Continuous BP monitoring (preferably intra-arterial in ICU); continuous ECG; heart rate; infusion site inspection

Extended infusion (>24 hours) Daily LFTs; assess for peripheral oedema; check infusion site for phlebitis

After discontinuation Monitor for rebound hypertension; transition to oral antihypertensives

Administration Notes:

Use controlled infusion pump

Central venous access preferred for infusions exceeding 24 hours

Protect from light during infusion

Nicardipine Brands in India

Nicardia RT (J.B. Chemicals & Pharmaceuticals) — 10 mg/10 mL injection

Cardinip (Samarth Pharma) — 10 mg/10 mL ampoule

Nicardil (Neon Laboratories) — 10 mg/10 mL injection

Note: Oral nicardipine formulations are NOT AVAILABLE in India.

Nicardipine Price range (INR)

Formulation	Approximate Price (per tablet)
Injection 10 mg/10 mL ampoule	₹300–600 per ampoule

Note: Not included in NLEM; not under DPCO price control. Typically available through hospital/ICU formularies; may require indent in some institutions.

Nicardipine Clinical pearls

Titratable IV CCB: Nicardipine offers precise, minute-to-minute BP control — preferred in neurological emergencies (stroke, SAH) where avoiding rapid BP swings is critical.

Reflex tachycardia: More pronounced than with labetalol — avoid in patients with active myocardial ischaemia or significant coronary artery disease.

No bolus dosing: Always administer via controlled infusion; bolus can cause precipitous hypotension.

Central line preferred: For infusions exceeding 24 hours, use central venous access to prevent phlebitis and extravasation injury.

Transition planning: Unlike oral nifedipine, nicardipine IV is not for chronic management — plan transition to oral antihypertensives once patient is stable.

Renal safety: One of the few IV antihypertensives requiring no renal adjustment — useful in patients with AKI or CKD presenting with hypertensive emergency.

Nicardipine Tags

Nicardipine; hypertensive emergency; IV CCB; calcium channel blocker; perioperative hypertension; stroke; subarachnoid haemorrhage; ICU-only; renal-safe; critical care

Nicardipine Version

RxIndia v1.0 — 10 Apr 2025

Nicardipine Reference

CDSCO approved prescribing information

Indian Pharmacopoeia (IP)

Harrison's Principles of Internal Medicine

Goodman & Gilman's The Pharmacological Basis of Therapeutics

AIIMS Hospital Drug Formulary

ICMR Stroke Management Guidelines

Indian Society of Critical Care Medicine (ISCCM) protocols

Tertiary hospital ICU protocols (AIIMS, TMH, NIMHANS)

RxIndia

The Drug Registry

Nicardipine