Schedule H

Subcutaneous (SC), Intramuscular (IM), Intravenous (IV)

Short-acting injection 50 mcg/mL Ampoule/Vial

Short-acting injection 100 mcg/mL Ampoule/Vial

Long-acting release (LAR) depot injection 10 mg Vial for IM use

Long-acting release (LAR) depot injection 20 mg Vial for IM use

Long-acting release (LAR) depot injection 30 mg Vial for IM use

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acromegaly (When Surgery/Radiotherapy Unsuitable or as Adjunct)

A. Short-acting SC Formulation

Parameter Details

Starting dose 50 mcg SC twice to three times daily

Titration Increase by 50–100 mcg per dose every 2 weeks based on GH/IGF-1 levels and tolerability

Usual maintenance dose 100–200 mcg SC three times daily

Maximum dose 500 mcg SC three times daily

Clinical notes:

• Administer between meals or at bedtime to reduce GI side effects

• Monitor GH and IGF-1 levels for dose titration

• Confirm response to SC formulation before switching to LAR

B. Long-acting IM Formulation (After SC Response Confirmed)

Parameter Details

Starting dose 20 mg IM every 4 weeks

Titration After 3 months, adjust by 10 mg increments based on serum IGF-1 and GH levels

Usual maintenance dose 20–30 mg IM every 4 weeks

Maximum dose 40 mg IM every 4 weeks

Clinical notes:

• Administer deep gluteal IM injection; rotate injection sites

• Overlap SC therapy for first 2 weeks after initial LAR dose

1. Carcinoid Syndrome / VIPoma-related Diarrhoea

A. Short-acting SC Formulation

Parameter Details

Starting dose 100–150 mcg SC twice to three times daily

Titration Increase based on symptom control; may increase up to 500 mcg three times daily

Usual maintenance dose 150–300 mcg SC three times daily

Maximum dose 500 mcg SC three times daily

B. Long-acting IM Formulation (For Stable Patients)

Parameter Details

Starting dose 20 mg IM every 4 weeks

Titration Adjust based on symptom control

Usual maintenance dose 20–30 mg IM every 4 weeks

Maximum dose 30 mg IM every 4 weeks

Clinical notes:

• Rescue SC doses (100–200 mcg) may be required during breakthrough symptoms even while on LAR

• Continue calcium and vitamin D supplementation if steatorrhoea occurs

1. Acute Variceal Bleeding (Oesophageal/Gastric Varices in Cirrhosis)

Parameter Details

Starting dose 50 mcg IV bolus over 1–2 minutes

Titration Not applicable

Usual maintenance dose 25–50 mcg/hour IV continuous infusion

Maximum dose 50 mcg/hour IV continuous infusion

Duration Continue for 2–5 days

Clinical notes:

• Initiate promptly alongside endoscopic intervention

• Use as adjunct therapy; not a substitute for endoscopic haemostasis

• Monitor for bradycardia during IV administration

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Chylothorax (postoperative/traumatic) 50–100 mcg SC three times daily Until resolution; typically 7–14 days OFF-LABEL; Specialist only; Evidence: Indian thoracic surgery practice, case series

Chemotherapy-induced diarrhoea (refractory) 100–150 mcg SC 2–3 times daily; IV if severe Variable; based on diarrhoea resolution OFF-LABEL; Specialist only; Evidence: Indian oncology hospital protocols

Dumping syndrome (post-gastrectomy) 50–100 mcg SC 30 minutes before meals Long-term as needed OFF-LABEL; Specialist only; Evidence: International RCTs, Indian gastroenterology practice

Pancreatic fistula 100 mcg SC three times daily Until fistula closure OFF-LABEL; Specialist only; Evidence: Indian surgical practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Congenital Hyperinsulinism

Parameter Details

Starting dose 5 mcg/kg/day SC divided in 2–3 doses

Titration Increase by 5 mcg/kg/day every 2–3 days based on blood glucose response

Usual maintenance dose 15–30 mcg/kg/day SC divided in 3–4 doses

Maximum dose 50 mcg/kg/day (under strict endocrinology supervision)

Safety Monitoring:

• Intensive blood glucose monitoring (at least 6-hourly initially)

• Watch for necrotising enterocolitis (NEC) in neonates — abdominal distension, feeding intolerance

• Hepatobiliary ultrasound if prolonged use anticipated

• Growth monitoring

1. Gastrointestinal Neuroendocrine Tumours

Parameter Details

Starting dose 1–2 mcg/kg/day SC divided in 2–3 doses

Titration Increase based on symptom control and tumour markers

Usual maintenance dose 5–10 mcg/kg/day SC divided in 2–3 doses

Maximum dose 10 mcg/kg/day

Clinical notes:

• LAR formulation may be considered in children >12 years with established SC tolerance

• Specialist (paediatric oncologist/endocrinologist) supervision mandatory

Secondary Indications — Paediatric (Off-label)

Indication Dose Duration Notes

Chylothorax (neonates/infants) 1–4 mcg/kg/dose SC every 6–8 hours (max 10 mcg/kg/day) Until resolution of chyle leak OFF-LABEL; Specialist only; Evidence: Paediatric surgical case series, Indian NICU practice

Postoperative intestinal lymphatic leak 1–2 mcg/kg/dose SC three times daily Variable OFF-LABEL; Specialist only

Age Restrictions:

• Not recommended below 1 month of age except under specialist supervision in tertiary care NICU/PICU settings

• Monitor closely for NEC risk in neonates

Severe impairment (eGFR <30) Use with caution; monitor for accumulation and adverse effects

Haemodialysis Not significantly dialysed; no supplemental dose needed

• Known hypersensitivity to octreotide or any excipients

• Symptomatic cholelithiasis with biliary obstruction (for elective/long-term use)

• Diabetes mellitus (may cause hypoglycaemia or hyperglycaemia; frequent glucose monitoring required)

• Pre-existing cardiac disease (risk of bradycardia, conduction abnormalities)

• History of gallstones (chronic use increases cholelithiasis risk)

• Thyroid dysfunction (may suppress TSH secretion)

• Vitamin B12 deficiency (chronic use may impair absorption)

• Pancreatic disorders (rare association with acute pancreatitis)

• Neonates (risk of necrotising enterocolitis)

Parameter Details

Risk category Limited human data; animal studies show potential fetal harm

Use recommendation Avoid unless clearly indicated; use only if benefit outweighs risk

Preferred alternatives Not defined in Indian obstetric practice; specialist decision required

When may be used Tumour-related indications where no alternatives exist — endocrinologist/oncologist supervision mandatory

Monitoring Fetal growth parameters, maternal glucose levels, placental perfusion

Parameter Details

Compatibility Unknown; likely excreted in breast milk in low amounts

Drug levels in milk Low (based on limited data)

Preferred alternatives Not defined; specialist discretion

Use recommendation Use only if benefit outweighs risk; consider temporary cessation of breastfeeding

Infant monitoring Feeding behaviour, signs of hypoglycaemia, weight gain, GI disturbances

Parameter Recommendation

Recommended starting dose 50 mcg SC once or twice daily (lower end of range)

Titration Slower than standard — increase at 2-week intervals

Extra risks Increased sensitivity to bradycardia; higher risk of gallstone formation; GI intolerance more pronounced; reduced renal reserve — monitor closely

Additional notes Baseline ECG recommended; more frequent glucose monitoring if diabetic

Interacting Drug Mechanism/Effect Recommendation

Insulin and oral antidiabetics Octreotide suppresses glucagon and GH; may cause hypoglycaemia or hyperglycaemia Frequent glucose monitoring; dose adjustment of antidiabetic agents often required

Beta-blockers (propranolol, atenolol) Additive bradycardia Avoid combination if possible; if unavoidable, monitor heart rate and ECG closely

Calcium channel blockers (verapamil, diltiazem) Additive bradycardia and conduction delay Use with caution; baseline and periodic ECG monitoring

Cyclosporine Reduced cyclosporine absorption and levels Monitor cyclosporine trough levels; dose adjustment may be needed

QT-prolonging drugs (amiodarone, fluoroquinolones, antipsychotics) Additive QT prolongation risk Use with caution; baseline and periodic ECG monitoring

Interacting Drug Mechanism/Effect Recommendation

Levothyroxine Octreotide may reduce TSH secretion Monitor thyroid function tests with long-term use

Diuretics May worsen electrolyte imbalances Monitor serum electrolytes periodically

Antihypertensives Additive hypotension via bradycardia Monitor blood pressure

Bromocriptine/Cabergoline Combined use in acromegaly — additive effect Monitor for enhanced efficacy and adverse effects

Oral contraceptives May reduce absorption Consider alternative contraception during therapy

• Diarrhoea (initial; usually transient)

• Abdominal pain and cramping

• Nausea and vomiting

• Flatulence

• Steatorrhoea

• Injection site pain and erythema (SC administration)

• Headache and dizziness

• Bradycardia (usually asymptomatic)

• Gallstone formation (with prolonged use)

• Hyperglycaemia or hypoglycaemia

Adverse Effect Clinical Action

Severe bradycardia / heart block Discontinue; ECG monitoring; cardiology consultation

Acute pancreatitis Discontinue immediately; supportive management

Severe hypoglycaemia Glucose administration; adjust antidiabetic therapy

Cholecystitis / biliary obstruction Discontinue; surgical consultation

Necrotising enterocolitis (neonates) Immediate discontinuation; surgical and NICU care

Anaphylaxis (rare) Emergency management; contraindicate future use

Severe steatorrhoea with malnutrition Dose reduction; pancreatic enzyme supplementation

Phase Parameters

Baseline Blood glucose (fasting and postprandial); liver function tests; thyroid function tests; gallbladder ultrasound (if long-term use planned); ECG (if cardiac risk factors); vitamin B12 levels

After initiation/dose change Blood glucose monitoring (daily initially, especially in diabetics); heart rate and blood pressure; GI symptoms assessment

Long-term Thyroid function tests every 6 months; gallbladder ultrasound every 6–12 months (for LAR therapy); periodic vitamin B12 levels; GH and IGF-1 levels (acromegaly); tumour markers (neuroendocrine tumours)

Brand Name Manufacturer Formulation

Sandostatin Novartis Short-acting injection

Sandostatin LAR Novartis Long-acting depot

Octride Sun Pharma Short-acting injection

Octreotide Cipla Short-acting and LAR

Octreo Intas Short-acting injection

SomaLAR Dr. Reddy's Long-acting depot

• NPPA status: Not under NLEM price control

• Government supply: Limited availability through tertiary care centres and oncology programmes

1. Confirm SC response first: Always establish efficacy and tolerability with short-acting SC formulation before transitioning to LAR depot; overlap SC therapy for 2 weeks after first LAR injection.

1. Gallbladder monitoring essential: Chronic octreotide use promotes biliary sludge and gallstones — perform baseline and periodic (6–12 monthly) gallbladder ultrasound, especially with LAR formulations.

1. Glucose dysregulation is bidirectional: Octreotide can cause both hypoglycaemia (by suppressing glucagon) and hyperglycaemia (by suppressing insulin) — adjust antidiabetic therapy accordingly with frequent monitoring.

1. Breakthrough symptoms on LAR: Patients on long-acting formulations may require rescue short-acting SC doses during symptom flares, especially in carcinoid syndrome.

1. Variceal bleeding adjunct: In acute variceal haemorrhage, initiate octreotide infusion promptly but always alongside endoscopic intervention — not as standalone therapy.

1. Thyroid monitoring with chronic use: TSH suppression may occur with prolonged therapy — monitor thyroid function tests every 6 months and supplement levothyroxine if indicated.

Octreotide; somatostatin analogue; acromegaly; carcinoid syndrome; VIPoma; variceal bleeding; neuroendocrine tumour; growth hormone suppression; congenital hyperinsulinism; high-cost

RxIndia v1.0 — 05 Apr 2025

• CDSCO (Product Information)

• Indian Pharmacopoeia

• NLEM 2022

• API Textbook of Medicine

• AIIMS Endocrinology and Gastroenterology Protocols

• AIIMS and tertiary hospital protocols for hepatic emergencies and neuroendocrine tumours

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• IAP Guidelines (paediatric hyperinsulinism)

• WHO Model EML (supportive paediatric data)