Schedule H

Intravenous (IV)

• 10% w/v infusion solution (100 mL, 500 mL)

• 15% w/v infusion solution (100 mL, 500 mL)

• 20% w/v infusion solution (100 mL, 350 mL, 500 mL)

• 25% w/v infusion solution (100 mL)

(Available in glass bottles or collapsible infusion bags/containers)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Raised Intracranial Pressure (Cerebral oedema due to trauma, stroke, tumours)

Parameter Dose Clinical Notes

Starting dose 0.25–1.0 g/kg IV over 20–30 minutes Use 20% solution; higher doses (1 g/kg) for acute herniation

Titration Based on clinical response and serum osmolality Target serum osmolality: ≤320 mOsm/kg

Usual maintenance dose 0.25–0.5 g/kg IV q6–8h Adjust frequency based on ICP monitoring

Maximum dose 2 g/kg/day Risk of rebound cerebral oedema increases if BBB is disrupted

Key Notes: Monitor serum osmolality, electrolytes, and urine output. Discontinue if osmolal gap >55 mOsm/kg or serum osmolality exceeds 320 mOsm/kg.

1. Prevention / Treatment of Acute Renal Failure (Oliguric phase — ATN risk)

Step Dose Clinical Notes

Test dose 200 mg/kg IV over 3–5 minutes Expected response: urine output >30–50 mL/hr within 2–3 hours

Starting dose 0.25 g/kg IV (if test dose successful) Administer over 15–30 minutes

Usual maintenance dose 0.25–0.5 g/kg IV q4–6h Maintain adequate hydration

Maximum dose 200 g/24 hours Stop if no diuretic response after test dose

1. Reduction of Intraocular Pressure (Acute angle-closure glaucoma – pre-operative)

Parameter Dose Clinical Notes

Starting dose 1.0–1.5 g/kg IV Lower dose in cardiac/elderly patients

Titration Not applicable Single dose typically sufficient pre-operatively

Usual dose 1.0–2.0 g/kg IV over 30–60 minutes Effect begins within 30–60 min, peaks at 1–2 hours

Maximum dose 2.0 g/kg per dose Monitor BP and serum osmolality

1. Promotion of Urinary Excretion of Toxins (Forced diuresis) — Specialist use only

Parameter Dose Clinical Notes

Starting dose 0.5–1 g/kg IV Administer with adequate volume expansion

Titration Based on urine output Target urine output ≥100 mL/hr

Usual maintenance dose Repeat doses as needed to maintain diuresis Only for toxins amenable to osmotic diuresis

Maximum dose 200 g/24 hours Ensure euvolemia; monitor osmolality closely

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

Not applicable. No commonly used off-label indications in Indian specialist practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications:

1. Raised ICP / Cerebral Oedema

Parameter Dose Comments

Starting dose 0.25–0.5 g/kg IV over 20–30 minutes Use 20% solution; reserve higher doses for imminent herniation

Titration Increase to 1 g/kg based on clinical response Monitor serum osmolality and sodium

Usual maintenance dose 0.25–0.5 g/kg IV q6–8h Continuous ICP monitoring preferred

Maximum dose 1 g/kg/dose; 2 g/kg/day Target serum osmolality ≤320 mOsm/kg

Minimum age: No absolute lower limit; neonates require extreme caution and NICU-level monitoring.

1. Acute Glaucoma (Pre-surgical) — Emergency only

Parameter Dose Comments

Starting dose 1.5 g/kg IV over 30–60 minutes Under ophthalmologic supervision

Maximum dose 2 g/kg per dose Single pre-operative dose only

Secondary Indications — Paediatrics (Off-label, if any)

• Forced diuresis: Not routinely used in Indian paediatric protocols

• Oliguric renal failure: Not recommended unless under specialist nephrology input

Safety Note: High risk of fluid/electrolyte shifts; continuous monitoring essential.

Use NOT RECOMMENDED below 6 months of age except in PICU/specialist care settings.

Mild impairment (eGFR 60–89) Use with caution; monitor osmolality

Moderate impairment (eGFR 30–59) Administer test dose first; monitor closely for accumulation

Severe impairment (eGFR <30) Avoid unless test dose confirms diuretic response

Anuria Contraindicated

Dialysis Mannitol is dialyzable; consult nephrology before use

Key threshold: Contraindicated if serum osmolality >320 mOsm/kg.

• Established anuria (unresponsive to test dose)

• Active intracranial bleeding (except during craniotomy)

• Severe dehydration

• Pulmonary oedema

• Decompensated congestive heart failure

• Severe renal impairment without test dose response

• Serum osmolality >320 mOsm/kg

• Known hypersensitivity to mannitol

• Pre-existing electrolyte imbalance (hyponatraemia, hypokalaemia)

• Borderline serum osmolality (risk of exceeding 320 mOsm/kg)

• Craniotomy patients with open dura (risk of rebound cerebral oedema)

• Cardiac disease (risk of acute fluid overload → heart failure)

• Traumatic brain injury with disrupted blood-brain barrier

• Prolonged use (risk of acute tubular necrosis)

• Concurrent nephrotoxic drug therapy

• Patients with poor IV access (risk of extravasation injury)

Aspect Recommendation

Risk category Not formally classified; avoid unless essential

Use in pregnancy Only if maternal benefit clearly outweighs fetal risk

Monitoring Maternal hydration, electrolytes, uterine perfusion

Preferred alternatives None when rapid osmotic effect is needed for life-threatening raised ICP

Osmotic shifts may affect placental perfusion — use minimum effective dose.

Aspect Recommendation

Compatibility Likely compatible; minimal expected transfer into breast milk

Milk levels Expected to be low (large molecule, poor oral absorption)

Recommendations May use if maternal benefit justifies; prefer short-term use

Infant monitoring Changes in feeding pattern, irritability, diarrhoea

Aspect Recommendation

Starting dose Use lower end of range (0.25 g/kg)

Titration Slower titration; longer intervals between doses

Special risks Increased risk of fluid overload, CHF exacerbation, electrolyte disturbances

Infusion rate Slower infusion preferred over rapid bolus in cardiac patients

Monitoring Close monitoring of renal function, fluid status, serum osmolality

Drug Interaction Management

Lithium Mannitol increases renal lithium excretion → reduced lithium efficacy Monitor lithium levels; may need lithium dose adjustment

Loop diuretics (Furosemide) Additive diuresis → severe electrolyte depletion, volume depletion Monitor potassium, sodium, volume status closely

Digoxin Mannitol-induced hypokalaemia → increased digoxin toxicity risk Monitor potassium; supplement if required

Drug Interaction Management

Aminoglycosides Combined nephrotoxicity and ototoxicity risk Monitor renal function and audiometry

Neuromuscular blockers Electrolyte shifts may alter neuromuscular blockade Monitor electrolytes; adjust NMB dosing as needed

Corticosteroids Additive sodium retention, hypokalaemia Monitor electrolytes

Other nephrotoxic drugs Additive renal injury Avoid combination where possible; monitor creatinine

• Thirst and dry mouth

• Headache

• Nausea and vomiting

• Polyuria

• Electrolyte disturbances (hyponatraemia, hypokalaemia)

• Transient volume expansion

• Blurred vision

• Rhinitis

Adverse Effect Clinical Notes

Acute renal failure Especially with serum osmolality >320 mOsm/kg or prolonged use

Pulmonary oedema Due to initial intravascular volume expansion

Rebound intracranial hypertension Particularly with BBB disruption; avoid abrupt discontinuation

Seizures Secondary to rapid fluid/electrolyte shifts

Heart failure exacerbation In patients with pre-existing cardiac compromise

Severe hyperkalaemia Initial shift of potassium out of cells

Extravasation injury Local phlebitis, tissue necrosis at infusion site

Hypersensitivity reactions Rare; anaphylaxis reported

Action: Discontinue immediately if signs of fluid overload, chest congestion, falling urine output, or rising ICP after initial response.

During therapy Serum osmolality every 6–12 hours; electrolytes daily or more frequently; urine output hourly; mental status and neurological signs in raised ICP

Thresholds for discontinuation Serum osmolality >320 mOsm/kg; osmolal gap >55 mOsm/kg; no diuretic response to test dose

Long-term use Monitor for signs of ATN; assess fluid balance daily

• Osmitrol

• Mannitop

• Mannto

• Avimol

• Intamann

• Lifemol

• Pharmannitol

• Mannitol IP (various generic manufacturers)

Note: Available as glass bottles or PVC infusion containers. Some formulations include in-line filters for crystallization.

• Government supply prices significantly lower under state health schemes and CGHS

• Not under current NPPA ceiling price (as of May 2024)

1. Always use in monitored settings (ICU/OT) — frequent electrolyte and osmolality checks are essential for safe use.

1. Test dose mandatory in oliguric states — if urine output does not increase within 2–3 hours, do not proceed with therapeutic doses.

1. Avoid overuse in TBI — rebound cerebral oedema risk is high when BBB is disrupted; limit therapy duration.

1. Crystallization risk — cold storage may precipitate mannitol crystals; warm the solution to dissolve before use. Do not use if solution remains cloudy.

1. Use inline filter — 5-micron filter recommended for concentrations ≥20% to prevent crystal infusion.

1. In acute glaucoma — mannitol acts rapidly (30–60 min onset); serves as effective bridge to definitive surgical therapy.

1. Hypertonic saline alternative — in some centres, 3% NaCl is used as alternative for raised ICP; mannitol remains standard where osmotherapy is needed quickly.

mannitol; osmotic diuretic; cerebral oedema; raised ICP; acute glaucoma; acute kidney injury; ICU drug; neurosurgery; electrolyte-monitoring; Schedule H

RxIndia v1.1 — 28 Apr 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• NFI 2021

• AIIMS Emergency and Critical Care Medicine Manual

• API Textbook of Medicine

• AIIMS Neurology and Trauma Guidelines

• ICMR Clinical Medicine Bulletins

• IAP Paediatric Drug Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive reference)