Schedule H

Intravenous (IV only in India)

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

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

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. 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

1. 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

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.

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

• 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)

• 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

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

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

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

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

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

• Headache

• Flushing

• Reflex tachycardia

• Nausea

• Peripheral oedema

• Dizziness

• Infusion site reactions (phlebitis, local irritation)

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

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

• 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.

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

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

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

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

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

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

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

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

RxIndia v1.0 — 10 Apr 2025

• 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)