Schedule H

Intravenous (IV)

• Injection: 1 mg per vial (lyophilized powder for reconstitution)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Variceal Bleeding in Cirrhosis

Parameter Recommendation

Starting dose 2 mg IV bolus

Titration Reduce to 1 mg IV every 4–6 hours once bleeding controlled (usually within 24–48 hours)

Usual maintenance dose 1 mg IV every 4–6 hours

Maximum dose 12 mg/day

Clinical Notes:

• Duration: 2–5 days; reassess after 48 hours based on clinical and endoscopic findings

• Always use in conjunction with endoscopic therapy (band ligation or sclerotherapy)

• Initiate antibiotic prophylaxis (ceftriaxone or norfloxacin) concurrently per Indian guidelines

• Start prior to endoscopy when variceal bleeding suspected

1. Hepatorenal Syndrome Type 1 (HRS-AKI)

Parameter Recommendation

Starting dose 1 mg IV every 4–6 hours

Titration Increase to 2 mg IV every 4–6 hours if serum creatinine does not decrease by ≥25% after 3 days

Usual maintenance dose 1–2 mg IV every 4–6 hours

Maximum dose 12 mg/day

Clinical Notes:

• Duration: 7–14 days; continue until serum creatinine returns to <1.5 mg/dL or improvement plateaus

• Must co-administer with IV albumin (20–40 g/day) for optimal response

• Response criteria: ≥25% reduction in serum creatinine by day 3

• Discontinue if no response after 14 days or if ischemic complications develop

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

Not applicable.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

No approved paediatric indications in India. Use is limited to specialist settings only.

Secondary Indications – Paediatric Doses (Off-label, if any)

Acute Variceal Bleeding — OFF-LABEL

Parameter Recommendation

Starting dose 10–20 mcg/kg IV bolus

Titration Not applicable

Usual maintenance dose 10–20 mcg/kg IV every 4–6 hours

Maximum dose 1 mg per dose

Duration: Up to 5 days

Evidence Basis: Limited case series and paediatric hepatology specialist practice; used when endoscopy is delayed or unavailable

Age Restriction Statement: Not recommended for use below 2 years of age except under paediatric hepatology or paediatric critical care specialist supervision.

Mandatory Monitoring:

• Blood pressure every 2–4 hours

• Heart rate and ECG monitoring

• Fluid balance and urine output

• Peripheral perfusion assessment

• Serum electrolytes daily

Mild to moderate impairment No dose adjustment required

Severe impairment / ESRD No specific adjustment; use with caution due to risk of volume overload and electrolyte disturbance

Haemodialysis Not significantly dialyzed; no supplemental dosing required

Additional Notes: Monitor fluid balance and serum electrolytes closely in patients with renal impairment.

• Known hypersensitivity to terlipressin or any formulation component

• Pregnancy

• Ischaemic heart disease or unstable angina

• Acute coronary syndrome

• Symptomatic peripheral vascular disease

• Uncontrolled hypertension

• Septic shock of non-variceal aetiology

• History of cerebrovascular disease or stroke

• Stable coronary artery disease (closely monitor for ischemia)

• Cardiac arrhythmias or conduction abnormalities

• Compensated heart failure

• History of arterial thrombosis

• Elderly patients (increased ischemic risk)

• Concurrent use with other vasoconstrictors (additive ischemic risk)

• Electrolyte imbalances (particularly hyponatraemia)

• Patients at risk of fluid overload

• Asthma or chronic obstructive pulmonary disease (bronchospasm risk)

Aspect Recommendation

Risk category Contraindicated; teratogenic in animal studies; insufficient human data

Preferred alternatives Endoscopic therapy with octreotide for acute variceal bleeding

When may be used Only in life-threatening situations where no alternatives exist; requires hepatology and obstetric critical care input

Monitoring Uterine activity; fetal growth and wellbeing; uteroplacental perfusion

Aspect Recommendation

Compatibility Not recommended during breastfeeding

Expected levels in milk Unknown; no human data available

Preferred alternatives Octreotide if vasoactive therapy needed

Recommendation Consider temporary cessation of breastfeeding during treatment and for 24 hours after last dose

Aspect Recommendation

Starting dose 1 mg IV every 4–6 hours (lower end of range)

Titration Slower titration; increase only if clearly needed and well-tolerated

Specific risks Increased risk of ischaemic complications (myocardial infarction, mesenteric ischaemia, digital gangrene); electrolyte disturbance; fluid overload

Monitoring Close cardiovascular monitoring; ECG at baseline and during therapy; frequent assessment of peripheral perfusion

Interacting Drug Mechanism/Effect Recommendation

Norepinephrine, epinephrine, dopamine Additive vasoconstriction → severe tissue ischaemia Avoid combination if possible; if essential, use lowest effective doses with close monitoring

Non-selective beta-blockers (propranolol) Enhanced vasoconstrictor effect; severe bradycardia risk Monitor heart rate and signs of ischaemia closely

Ergot alkaloids Additive peripheral vasoconstriction → gangrene risk Avoid concurrent use

Digitalis glycosides May aggravate bradyarrhythmias, especially in hypovolaemic states Monitor ECG; correct electrolyte abnormalities

Interacting Drug Effect Management

Vasodilators (nitroglycerin, nitroprusside) May attenuate vasoconstrictor efficacy of terlipressin Adjust doses based on clinical response

NSAIDs May counteract renal protective effect in HRS; increased ischaemic risk Avoid if possible in HRS; monitor renal function

Loop diuretics Increased risk of hyponatraemia and renal hypoperfusion Monitor serum sodium and renal function closely

IV Albumin Beneficial synergistic interaction in HRS; improves renal response Recommended co-administration in HRS

Antihypertensives Altered blood pressure response Monitor BP closely; adjust doses as needed

• Abdominal cramps and pain

• Nausea and vomiting

• Diarrhoea

• Headache

• Transient hypertension

• Peripheral pallor

• Bradycardia

• Facial pallor

Adverse Effect Clinical Significance

Mesenteric ischaemia Presents as severe abdominal pain; requires urgent discontinuation and surgical consultation

Myocardial ischaemia/infarction Monitor ECG; discontinue if chest pain or ECG changes

Digital ischaemia/gangrene Monitor extremities; discontinue if progressive pallor or cyanosis

Severe hyponatraemia Especially with concurrent diuretic use; can cause seizures

Pulmonary oedema Particularly in patients with fluid overload or cardiac dysfunction

Cardiac arrhythmias Bradycardia, torsades de pointes (rare); continuous ECG monitoring recommended

Skin necrosis If extravasation occurs at injection site

After initiation/dose change BP and HR every 4–6 hours; serum creatinine and electrolytes every 24–48 hours

Ongoing during therapy Daily assessment of peripheral perfusion (digits, extremities); daily fluid balance; signs of ischaemia (abdominal pain, chest pain, limb changes)

In HRS Daily urine output, weight, and renal function; serum creatinine trend to assess response

• Glypressin (Ferring)

• Terlyz (Zydus Cadila)

• Teriglow (La Renon Healthcare)

• HRS-Terli (Intas Pharmaceuticals)

• Hepa-Terp (Alniche Life Sciences)

• Terlipin (Sun Pharma)

Notes:

• Not listed in NLEM 2022

• Variable pricing between private retail and institutional procurement

• Higher-volume institutional purchasing may reduce per-unit cost

1. Albumin co-administration mandatory in HRS: Always administer IV albumin (20–40 g/day) alongside terlipressin in hepatorenal syndrome; combination significantly improves renal response rates

1. Adjunct to endoscopy, not replacement: In variceal bleeding, terlipressin is pharmacological bridge therapy; do not delay endoscopy—definitive haemostasis requires band ligation or sclerotherapy

1. Early ischaemia detection: Monitor for subtle signs of ischaemia (perioral tingling, abdominal discomfort, digital pallor) before overt complications develop; discontinue promptly if suspected

1. BP rise ≠ efficacy: Transient blood pressure elevation is expected pharmacological effect; do not use BP change alone to assess therapeutic response in variceal bleeding or HRS

1. Response assessment in HRS: Evaluate creatinine reduction by day 3; if no ≥25% improvement, escalate to 2 mg every 4–6 hours; if no response by day 7, consider alternative therapies

1. Terlipressin vs octreotide: Terlipressin preferred in variceal bleeding per Indian guidelines due to superior efficacy; octreotide is alternative when terlipressin contraindicated or unavailable

terlipressin; vasopressin analogue; variceal bleeding; hepatorenal syndrome; cirrhosis; portal hypertension; ICU drug; gastroenterology; specialist only; ischaemia risk

RxIndia v1.1 — 03 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia / National Formulary of India

• API Textbook of Medicine

• AIIMS Hepatology Department Protocols

• Indian National Association for Study of Liver (INASL) Guidelines

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• CONFIRM Trial (terlipressin in HRS — for efficacy data)