Schedule H

Oral, Intranasal, Parenteral (IV/SC)

• Tablets: 0.1 mg, 0.2 mg

• Intranasal solution: 10 mcg per spray (0.1 mg/mL)

• Injection: 4 mcg/mL (1 mL ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Central Diabetes Insipidus (CDI)

A. Oral Route

Parameter Details

Starting dose 0.1 mg twice daily

Titration Increase by 0.05–0.1 mg increments every 2–3 days based on urine output and osmolality

Usual maintenance dose 0.1–0.4 mg twice to thrice daily

Maximum dose 1.2 mg/day

B. Intranasal Route

Parameter Details

Starting dose 10 mcg (one spray) once or twice daily

Titration Increase by 5–10 mcg based on clinical response

Usual maintenance dose 10–20 mcg once or twice daily

Maximum dose 40 mcg/day

C. Parenteral Route (IV/SC) — Inpatient/Specialist Use Only

Parameter Details

Starting dose 1–2 mcg once or twice daily

Titration Adjust based on urine output and serum sodium

Usual maintenance dose 1–4 mcg/day in 1–2 divided doses

Maximum dose 4 mcg/day (rarely exceeded)

Clinical Notes:

• Adjust dose to achieve urine output of 1.5–2 L/day

• Monitor serum sodium closely during dose titration

• Oral route preferred for chronic management; intranasal for patients unable to take oral

1. Primary Nocturnal Enuresis (Children ≥6 years and Adolescents)

Parameter Details

Starting dose 0.2 mg orally at bedtime

Titration May increase to 0.4 mg at bedtime after 1–2 weeks if inadequate response

Usual maintenance dose 0.2–0.4 mg at bedtime

Maximum dose 0.4 mg at bedtime

Clinical Notes:

• Restrict fluid intake from 1 hour before to 8 hours after dose

• Trial discontinuation after 3 months to assess need for continued therapy

• Institute structured withdrawal periods to evaluate response

1. Haemophilia A and von Willebrand Disease Type 1 (Mild Bleeding or Procedural Prophylaxis)

Specialist Use Only — Haematologist Supervision Mandatory

A. Intravenous Route

Parameter Details

Starting dose 0.3 mcg/kg diluted in 50–100 mL normal saline, infused over 15–30 minutes

Repeat dosing May repeat after 12–24 hours if needed (maximum 2–3 doses)

Maximum dose 0.3 mcg/kg per dose

B. Intranasal Route (High-Concentration Preparation)

Parameter Details

Body weight >50 kg 300 mcg (150 mcg per nostril)

Body weight <50 kg 150 mcg (single nostril)

Clinical Notes:

• Test dose recommended to confirm response before reliance for procedures

• Tachyphylaxis occurs with repeated dosing within 24–48 hours

• Monitor Factor VIII and von Willebrand factor levels

• Not effective in Type 2B or Type 3 von Willebrand disease

Secondary Indications – Adults Only (Off-label)

Indication Dose Duration Notes

Uraemic Bleeding 0.3 mcg/kg IV over 15–30 minutes Single dose before invasive procedure OFF-LABEL; Specialist only (Nephrologist); Evidence: Small trials and specialist practice in haemodialysis settings

Nocturia due to Nocturnal Polyuria 0.1 mg orally at bedtime; may increase to 0.2 mg Long-term with careful monitoring OFF-LABEL; Specialist only (Urologist/Geriatrician); High hyponatraemia risk in elderly; Evidence: Limited RCTs

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Central Diabetes Insipidus

<1 year Oral 0.025 mg twice daily 0.05–0.1 mg/day in divided doses 0.2 mg/day

1–6 years Oral 0.05 mg twice daily 0.1–0.2 mg/day in divided doses 0.4 mg/day

6 years Oral 0.1 mg twice daily 0.1–0.4 mg twice daily 0.8 mg/day

≥2 years Intranasal 5–10 mcg once daily 5–20 mcg once or twice daily 20 mcg/day

All ages (hospital) IV/SC 0.1–0.4 mcg/dose 0.25 mcg/kg every 12–24 hours 1 mcg/dose

Safety Monitoring:

• Baseline: Serum sodium, urine osmolality, serum osmolality

• During titration: Serum sodium every 2–3 days

• Monitor fluid intake strictly

• Daily weight monitoring during initiation

1. Primary Nocturnal Enuresis (≥6 years)

Parameter Details

Starting dose 0.2 mg orally at bedtime

Titration Increase to 0.4 mg after 1–2 weeks if inadequate response

Usual maintenance dose 0.2–0.4 mg at bedtime

Maximum dose 0.4 mg at bedtime

Safety Monitoring:

• Baseline serum sodium before initiation

• Repeat serum sodium 1 week after starting and after dose changes

• Strict fluid restriction from 1 hour before to 8 hours after dose

Secondary Indications – Paediatrics (Off-label)

Not applicable — No established off-label paediatric indications with sufficient evidence for routine use.

Age Restriction: NOT RECOMMENDED below 1 year of age except under paediatric endocrinologist supervision in tertiary care settings due to high risk of hyponatraemia.

Key Point: Impaired renal function reduces water excretion, significantly increasing hyponatraemia risk.

• Hyponatraemia (current or history of)

• Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

• Moderate to severe renal impairment (eGFR <50 mL/min)

• Primary or psychogenic polydipsia

• Known cardiac insufficiency or conditions requiring diuretic treatment

• Hypersensitivity to desmopressin or any excipient

• Habitual or compulsive water drinking

• von Willebrand Disease Type 2B (risk of thrombocytopenia)

• Elderly patients (≥65 years) — significantly increased hyponatraemia risk

• Conditions predisposing to fluid/electrolyte imbalance (heart failure, renal impairment)

• Concurrent conditions causing polydipsia (uncontrolled diabetes mellitus, psychiatric disorders)

• Cystic fibrosis — altered electrolyte handling

• Patients unable to restrict fluid intake reliably

• Monitor serum sodium closely during acute illness (fever, gastroenteritis)

• Intranasal absorption may be unreliable during rhinitis or nasal congestion

• Children with nocturnal enuresis — ensure strict fluid restriction protocol

Aspect Details

Overall safety Limited human data; animal studies do not indicate teratogenicity

Preferred alternatives No direct alternative for CDI; desmopressin may be continued if clinically required

When it may be used Central diabetes insipidus (pregnancy may worsen CDI); mild bleeding disorders — specialist supervision mandatory

Advantages No vasoconstrictive effect on uterine vessels (unlike vasopressin)

Monitoring required Maternal serum sodium, fluid balance, blood pressure; fetal growth monitoring

Aspect Details

Compatibility Compatible with breastfeeding at therapeutic doses

Expected levels in milk Very low (minimal oral bioavailability limits infant exposure)

Preferred alternatives None required; desmopressin can be continued

Infant monitoring Weight gain, feeding adequacy, urine output

Aspect Recommendation

Starting dose Lowest possible dose (e.g., 0.05 mg oral at bedtime for CDI)

Titration Very gradual; increase at intervals of 1 week or longer

Additional risks Hyponatraemia, water intoxication, confusion, falls, cardiac decompensation

Specific caution Avoid use for nocturia in elderly (≥65 years) due to unacceptably high hyponatraemia risk

Monitoring Serum sodium at baseline, 1 week, and frequently during dose changes

Key Point: Elderly patients have reduced thirst sensation and impaired renal concentrating ability, making them highly susceptible to desmopressin-induced hyponatraemia.

Interacting Drug Effect Recommendation

NSAIDs (ibuprofen, diclofenac, naproxen) Reduced renal prostaglandin-mediated water excretion; increased hyponatraemia risk Avoid concurrent use; if essential, monitor sodium closely

SSRIs (fluoxetine, sertraline, escitalopram) Additive SIADH effect; significantly increased hyponatraemia risk Avoid combination if possible; close sodium monitoring essential

Tricyclic antidepressants (amitriptyline, imipramine) Additive antidiuretic effect Monitor sodium closely

Carbamazepine, Oxcarbazepine Potentiates ADH action; additive hyponatraemia risk Avoid if possible; frequent sodium monitoring if used together

Chlorpropamide Enhances desmopressin action Avoid combination

Interacting Drug Effect Recommendation

Thiazide diuretics Additive hyponatraemia risk Monitor sodium closely

Loop diuretics Electrolyte disturbances Monitor sodium and potassium

Lithium Antagonises ADH effect; may reduce desmopressin efficacy Monitor response; may need dose adjustment

Lamotrigine Potential SIADH potentiation Monitor sodium

Antipsychotics (haloperidol, risperidone) May cause SIADH Monitor water balance and sodium

Loperamide Enhanced antidiuretic effect Use with caution

• Headache

• Nausea

• Abdominal cramps

• Facial flushing

• Nasal congestion (intranasal route)

• Nasal irritation or epistaxis (intranasal route)

• Transient hypotension (IV administration)

• Dizziness

Adverse Effect Action Required

Hyponatraemia (serum Na+ <130 mEq/L) Common and potentially severe; may cause seizures, altered consciousness, coma; discontinue immediately; hospitalisation may be required

Water intoxication Signs: nausea, vomiting, headache, confusion, weight gain; discontinue and assess

Seizures (secondary to hyponatraemia) Emergency management; discontinue desmopressin permanently

Anaphylaxis Rare; immediate discontinuation and emergency treatment

Thrombosis Rare; reported with IV use in predisposed individuals

Phase Parameters Frequency

Baseline Serum sodium, serum osmolality, urine osmolality, serum creatinine, blood pressure, body weight Before initiation

After initiation / dose change Serum sodium At 3–7 days

Nocturnal enuresis Serum sodium 1 week after starting and after each dose change

Stable long-term therapy Serum sodium Every 1–3 months

CDI patients Urine volume, urine osmolality, serum sodium Periodically (monthly initially)

Bleeding disorder use Factor VIII levels, von Willebrand factor levels Before and after administration

All patients Signs/symptoms of water intoxication (headache, nausea, confusion) At each visit

Single-ingredient formulations:

• Minirin (Ferring) — Tablets 0.1 mg, 0.2 mg; Nasal spray

• Desmopressin Injection (Abbott, Samarth)

• Desmostat (Various)

Note: High-concentration intranasal preparation for bleeding disorders (150 mcg/spray) may have limited availability in India.

Note: Desmopressin is NOT included in NLEM 2022; not under NPPA price control.

1. Fluid restriction is mandatory: Always counsel patients on strict fluid restriction (limit intake from 1 hour before to 8 hours after dose) to prevent hyponatraemia — this is the most critical patient education point.

1. Intranasal absorption variability: During rhinitis, nasal congestion, or use of nasal corticosteroids, intranasal absorption may be unpredictable. Consider switching to oral route during upper respiratory infections.

1. Tachyphylaxis in bleeding disorders: Response to desmopressin diminishes with repeated dosing within 24–48 hours due to depletion of endothelial von Willebrand factor stores. Space doses at least 24 hours apart and limit to 2–3 doses.

1. Avoid in elderly nocturia: Despite off-label use for nocturia, desmopressin carries unacceptably high hyponatraemia risk in patients ≥65 years and should generally be avoided.

1. Test dose for bleeding disorders: Always perform a test dose and measure Factor VIII/vWF response before relying on desmopressin for surgical prophylaxis.

1. Do not prescribe without sodium monitoring: Avoid prescribing in settings where reliable serum sodium monitoring is unavailable (e.g., poor follow-up capacity).

desmopressin; central diabetes insipidus; vasopressin analogue; nocturnal enuresis; von Willebrand disease; haemophilia A; antidiuretic; hyponatraemia-risk; paediatric; specialist-drug

RxIndia v1.0 — 25 Jan 2025

• CDSCO Approved Product Database

• Indian Pharmacopoeia (latest edition)

• API Textbook of Medicine (2022)

• AIIMS Paediatrics Prescribing Manual

• IAP Drug Formulary

• Ferring Pharmaceuticals India Product Insert (Minirin)

• ICMR Guidelines for Management of Bleeding Disorders

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Indian specialist protocols for CDI and von Willebrand disease management