Schedule H

Oral

• Tablets: 1 mg

• Tablets: 2 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Chronic Idiopathic Constipation in Adults (when laxatives have failed to provide adequate relief)

Parameter Recommendation

Starting dose 2 mg orally once daily

Titration Not typically required

Usual maintenance dose 2 mg once daily

Maximum dose 2 mg/day

Clinical notes:

• Administer at any time of day, with or without food

• Evaluate clinical response after 4 weeks of treatment

• Discontinue if no meaningful improvement in bowel function within 4 weeks

• Exclude organic causes of constipation (colonic obstruction, mechanical causes) before initiation

• Ensure adequate fluid and dietary fibre intake during treatment

• Not intended as a general-purpose laxative — reserved for refractory chronic idiopathic constipation

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Opioid-induced constipation (non-cancer patients) 2 mg once daily As long as patient remains on opioid therapy Specialist only — OFF-LABEL. Evidence: Select international RCTs support efficacy; not approved for this indication in India

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not approved for use in patients below 18 years in India.

Age Group Recommendation

<18 years Safety and efficacy not established; not recommended

Secondary Indications — Paediatrics (Off-label)

Indication Age Dose Duration Notes

Severe refractory functional constipation 12–17 years 1 mg once daily Short-term; reassess after 4 weeks Specialist only — OFF-LABEL. Evidence: Limited international paediatric trial data; not approved in India

Not recommended in children <12 years — insufficient safety and efficacy data.

• Known hypersensitivity to prucalopride or any excipient

• Intestinal perforation

• Intestinal obstruction (mechanical or functional)

• Obstructive ileus

• Severe inflammatory conditions of the gastrointestinal tract (Crohn's disease, ulcerative colitis, toxic megacolon/megarectum in active phase)

• Severe hepatic impairment (Child-Pugh C)

• Elderly patients (≥65 years) or frail patients — start with reduced dose (1 mg)

• Severe renal impairment (eGFR <30 mL/min)

• History of cardiac arrhythmia or significant cardiovascular disease

• Patients with risk factors for QT prolongation

• History of depression or psychiatric illness — monitor for worsening mood or suicidal ideation

• Pre-existing electrolyte imbalances (correct hypokalaemia, hypomagnesaemia before initiation)

• Dehydration — ensure adequate hydration before and during treatment

• Concurrent use of drugs that may cause electrolyte disturbances

Parameter Details

Overall safety Limited human data; animal studies did not show direct harmful effects at therapeutic exposures

Risk category Not formally classified in India; use with caution

Preferred alternatives Lactulose, ispaghula husk (first-line options in pregnancy)

When may be used Only if alternative laxatives are ineffective and benefit clearly outweighs potential risk; specialist consultation advised

Monitoring Maternal hydration status, gastrointestinal symptoms

Parameter Details

Compatibility Use with caution — limited data available

Drug levels in milk Unknown in humans; expected to be low based on molecular characteristics and pharmacokinetic profile

Preferred alternatives Lactulose, ispaghula husk

Infant monitoring Observe for diarrhoea, feeding difficulties, irritability

Parameter Recommendation

Starting dose 1 mg once daily (for patients ≥65 years, especially if frail)

Titration May increase to 2 mg once daily if 1 mg well tolerated and additional efficacy required

Risks Increased susceptibility to dehydration, electrolyte imbalance; reduced renal reserve; monitor hydration status

Additional considerations Baseline renal function assessment essential; cardiac monitoring if history of arrhythmia

Interacting Drug Effect & Mechanism Management

P-glycoprotein inhibitors (ketoconazole, itraconazole, verapamil, erythromycin, clarithromycin, ciclosporin) May increase prucalopride plasma concentrations via P-gp inhibition Use with caution; monitor for increased adverse effects; no dose adjustment typically required but be vigilant

QT-prolonging drugs (amiodarone, sotalol, haloperidol, ondansetron at high doses, certain fluoroquinolones) Potential additive risk of QT prolongation and cardiac arrhythmias Avoid combination if possible; if unavoidable, obtain baseline ECG, monitor electrolytes, and maintain close surveillance

Interacting Drug Effect Management

Digoxin May increase digoxin plasma levels due to P-gp interaction Monitor digoxin levels; watch for signs of digoxin toxicity

Diuretics (thiazides, loop diuretics) Increased risk of electrolyte imbalance (hypokalaemia) and dehydration Monitor serum electrolytes; ensure adequate hydration

Anticholinergic drugs May theoretically reduce prokinetic efficacy Monitor clinical response; avoid unnecessary combination

CNS depressants Additive sedation if CNS effects (fatigue, dizziness) occur Monitor for excessive sedation

• Headache (most common, especially in first few days)

• Nausea

• Abdominal pain or cramping

• Diarrhoea

• Flatulence

• Dizziness

• Fatigue

Note: Most adverse effects occur early in treatment (day 1–2) and typically resolve with continued use.

Adverse Effect Notes

Suicidal ideation / Worsening depression Rare; reported in post-marketing surveillance; discontinue immediately and refer for psychiatric evaluation

Cardiac arrhythmias Rare; palpitations and ventricular arrhythmias reported; caution in at-risk patients

Severe diarrhoea with dehydration May lead to electrolyte imbalance and hypovolaemia; may require hospitalisation for rehydration

Ischaemic colitis Very rare; discontinue if suspected (abdominal pain with bloody diarrhoea)

After initiation (Week 1–2) Monitor for diarrhoea severity, abdominal symptoms, CNS effects (mood changes, dizziness), hydration status

At 4 weeks Assess clinical efficacy — discontinue if no improvement in bowel function

Long-term Periodic reassessment of continued need; monitor for mood changes; renal function annually in elderly

• Resolor

• Resnor

• Prucal

• Pruvict

• Constilax

Note: Availability may vary by region; confirm with local distributors

• NLEM status: Not listed under NLEM 2022

• Government supply: Not routinely stocked in public facilities

1. Patient selection is critical: Reserve prucalopride for true chronic idiopathic constipation unresponsive to adequate trial of laxatives (osmotic, stimulant) — not a first-line agent

1. Assess at 4 weeks: If no meaningful improvement in spontaneous bowel movements by 4 weeks, discontinue therapy; prolonged ineffective use is not justified

1. Dose reduction in special populations: Use 1 mg dose in elderly (≥65 years), frail patients, moderate hepatic impairment, and renal impairment (eGFR <50 mL/min)

1. Early adverse effects are transient: Headache and nausea commonly occur on day 1–2 and typically resolve spontaneously; counsel patients to persist unless severe

1. Psychiatric vigilance: Monitor for new or worsening depression or suicidal thoughts, particularly in patients with psychiatric history

1. Distinguish from IBS-C: Chronic idiopathic constipation differs from IBS with constipation; ensure correct diagnosis before prescribing

prucalopride; chronic constipation; prokinetic; 5-HT4 agonist; gastroprokinetic; renal-adjustment; elderly-caution; psychiatric-monitoring; not-in-NLEM

RxIndia v1.0 — 06 Apr 2025

• CDSCO Drug Approval Database

• Indian Pharmacopoeia

• National Formulary of India 2021

• AIIMS Pharmacology and Formulary

• API Textbook of Medicine

• Goodman & Gilman's Pharmacological Basis of Therapeutics

• International RCTs (for opioid-induced constipation — off-label information only)