Schedule H

Oral, Intravenous (continuous IV infusion only)

• Tablet: 30 mg

• Intravenous infusion solution: 10 mg/mL (50 mL vial) — lipid-based formulation

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Prevention and Treatment of Vasospasm Following Aneurysmal Subarachnoid Haemorrhage (aSAH)

▸ ORAL THERAPY — Post-aSAH Vasospasm Prophylaxis

Parameter Recommendation

Starting dose 60 mg orally every 4 hours

Titration Not applicable (fixed-dose regimen)

Usual maintenance dose 60 mg orally every 4 hours

Maximum dose 360 mg/day (60 mg × 6 doses)

Duration 21 days from onset of SAH

Key Clinical Notes:

• Initiate within 96 hours (4 days) of aSAH onset

• Maintain adequate intravascular volume and blood pressure

• Monitor for hypotension; hold dose if SBP < 90 mmHg

• Do not crush tablets — reduces bioavailability

▸ INTRAVENOUS THERAPY — Neurosurgical ICU Only

Parameter Recommendation

Starting dose 1 mg/hour via continuous IV infusion

Titration Increase to 2 mg/hour after 2 hours if tolerated without hypotension

Usual maintenance dose 1–2 mg/hour continuous infusion

Maximum dose 2 mg/hour

Duration Up to 5 days, then switch to oral

Key Clinical Notes:

• Use ONLY lipid emulsion formulation

• IV bolus administration is CONTRAINDICATED — causes precipitous hypotension

• Administer via dedicated IV line with infusion pump

• Continuous BP and neurological monitoring mandatory

Secondary Indications — Adults Only (Off-label)

Indication Delayed Cerebral Ischaemia Post-aSAH Without Angiographic Vasospasm

Dose 60 mg orally every 4 hours

Duration 21 days

Status OFF-LABEL; Specialist only

Evidence Supported in international neurology practice; AIIMS neurosurgical protocols commonly initiate empirically after aneurysmal clipping/coiling

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

• NOT routinely recommended for paediatric use

• Safety and efficacy data in children are very limited

Secondary Indications — Paediatric Doses (Off-label)

Parameter Cerebral Vasospasm Post-SAH (Experimental/Rare Use)

Starting dose 0.5 mg/kg/day divided every 4 hours orally

Titration May increase to 1 mg/kg/day based on clinical response and tolerance

Maximum dose 1 mg/kg/day

Duration Up to 21 days

Status OFF-LABEL; Specialist only; ICU/Neurology supervision mandatory

Evidence Extrapolated from adult experience; not standardised in Indian paediatric guidelines

Safety Monitoring:

• Continuous BP monitoring

• Neurological assessment for signs of cerebral hypoperfusion

• LFTs at baseline and periodically

⚠️ Not recommended below 12 years except under specialist ICU/neurology supervision

Mild to severe impairment No dose adjustment required

Haemodialysis No supplemental dose required

Note: Monitor blood pressure closely in chronic kidney disease — enhanced hypotensive effect possible

• Hypersensitivity to nimodipine or other dihydropyridines

• Concurrent use with strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) — significantly reduces efficacy

• IV bolus administration — profound hypotension risk

• Uncorrected hypotension (SBP < 90 mmHg)

• Unstable angina or acute myocardial infarction within 4 weeks

• Pre-existing hypotension — especially in elderly or those on concurrent antihypertensives

• Hepatic impairment — reduced drug clearance

• Cerebral oedema or raised intracranial pressure — BP reduction may compromise cerebral perfusion pressure

• Concurrent use of grapefruit juice — increases serum drug concentration

• Hypovolaemia — correct before initiating therapy

• Concomitant use of nephrotoxic drugs

Parameter Information

Risk category Not well established; limited human data

When to use Only if potential benefit clearly justifies fetal risk; requires specialist neurology/obstetric consultation

Preferred alternatives Not a first-line antihypertensive in pregnancy; labetalol, methyldopa preferred for hypertensive disorders of pregnancy

Monitoring Maternal BP, fetal well-being (heart rate, growth)

Parameter Information

Excretion in milk Limited human data; likely low concentrations

Compatibility Probably compatible if clinically essential

Preferred alternatives Consider alternatives if available; use only when clearly indicated

Infant monitoring Sedation, feeding difficulties, adequacy of weight gain

Parameter Recommendation

Starting dose 60 mg orally every 4 hours (same as adults)

Titration Use with increased caution

Specific risks Increased susceptibility to hypotension; higher fall risk; potential for reduced renal reserve

Monitoring Frequent BP checks; monitor renal function despite no formal dose adjustment required

Interacting Drug/Class Mechanism Clinical Effect Recommendation

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, erythromycin, clarithromycin) Inhibit nimodipine metabolism Increased plasma levels; severe hypotension risk Avoid combination or monitor very closely

Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital) Accelerate nimodipine metabolism Markedly reduced efficacy Contraindicated

IV magnesium sulfate Additive vasodilation and neuromuscular effects Severe hypotension; neuromuscular blockade Avoid concurrent use

Interacting Drug/Class Effect Recommendation

Other antihypertensives (ACE inhibitors, ARBs, diuretics) Additive hypotension Monitor BP closely; adjust doses as needed

Beta-blockers Additive hypotensive and negative chronotropic effects Monitor BP and heart rate

Antiepileptics (valproate) Potential additive CNS depression Monitor for excessive sedation

Digoxin Moderate increase in digoxin levels Monitor digoxin levels if used together

Fluoxetine Moderate CYP3A4 inhibition Monitor for hypotension

Alcohol Additive CNS and BP-lowering effects Advise patient to avoid

• Hypotension

• Flushing

• Headache

• Nausea

• Dizziness

• Peripheral oedema

• Tachycardia (reflex)

Adverse Effect Action Required

Severe hypotension (SBP < 80 mmHg) Hold or discontinue drug; supportive care

Bradycardia (less common than with non-dihydropyridines) Monitor; dose adjustment may be needed

Hepatic dysfunction (rare) Discontinue; obtain LFTs

Thrombocytopenia (rare) Monitor platelet count; consider discontinuation

Allergic reactions/anaphylactoid response (rare) Discontinue immediately; supportive care

Phase Parameters

Baseline Blood pressure, heart rate, liver function tests, electrolytes, platelet count

During initiation/titration BP every 4–6 hours; neurological status; signs of reduced cerebral perfusion

Long-term (if prolonged use) LFTs periodically; BP trends

• Nimotop (Bayer)

• Nimodura

• Nimostar

• Nimocard

• Nimdip

• Nimoz

Note: Available as oral tablets (30 mg) and IV lipid-based infusion solution — IV formulation is NOT for bolus use

Note: Not under NPPA price control (not listed in NLEM); prices vary widely across neurosurgical private setups

1. Timing is critical — Initiate nimodipine within 96 hours of SAH onset for optimal prevention of delayed cerebral ischaemia

1. IV bolus is dangerous — NEVER administer IV nimodipine as bolus; use only diluted continuous infusion via pump to avoid fatal hypotension

1. Do not crush tablets — High first-pass metabolism means crushing significantly reduces bioavailability; administer tablets whole

1. Avoid CYP3A4 inducers — Rifampicin, carbamazepine, and phenytoin substantially reduce nimodipine levels rendering therapy ineffective

1. BP management is key — Hypotension compromises cerebral perfusion; maintain adequate volume status and hold dose if SBP < 90 mmHg

1. Transition strategy — After 5 days of IV therapy and clinical stabilisation, switch to oral route to complete the 21-day treatment course

Nimodipine; subarachnoid haemorrhage; cerebral vasospasm; calcium channel blocker; dihydropyridine; neurosurgery; ICU drug; CYP3A4 substrate; vasospasm prophylaxis; delayed cerebral ischaemia

RxIndia v1.0 — 10 Apr 2025

• CDSCO-approved product labelling (India)

• Indian Pharmacopoeia

• AIIMS Clinical Protocols — Neurosurgery & Neurology

• API Textbook of Medicine

• Harrison's Principles of Internal Medicine

• ICMR/AIIMS Stroke and SAH Management Guidelines

• NLEM India — Not listed

• International RCTs/meta-analyses (for off-label delayed cerebral ischaemia prophylaxis)