Schedule H

Oral

• Tablets: 1.5 mg (sustained-release), 2.5 mg (immediate-release)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Essential Hypertension

Parameter Sustained-Release (SR) Immediate-Release (IR)

Starting dose 1.5 mg once daily in the morning 2.5 mg once daily in the morning

Titration Usually not required; assess BP response after 4–6 weeks Usually not required; assess BP response after 4–6 weeks

Usual maintenance dose 1.5 mg once daily 2.5 mg once daily

Maximum dose 1.5 mg once daily (SR formulation) 2.5 mg once daily

Clinical Notes:

• Preferred thiazide-like agent in elderly hypertensives due to favourable metabolic profile

• SR formulation provides smoother 24-hour BP control

• May be used as monotherapy or in combination with ACE inhibitors/ARBs/CCBs

• Administer in the morning to avoid nocturia

Secondary Indications – Adults Only (Off-label)

Indication Dose Duration Notes

Mild-to-Moderate Heart Failure (adjunct therapy) 2.5 mg once daily (IR) Chronic use as needed OFF-LABEL; Specialist only; adjunct to loop diuretics for refractory fluid overload; Evidence: Indian cardiology specialist practice

Recurrent Nephrolithiasis (calcium oxalate stones with hypercalciuria) 1.25–2.5 mg once daily Long-term under specialist supervision OFF-LABEL; Specialist only; reduces urinary calcium excretion; Evidence: RCTs and Indian nephrology practice

PAEDIATRIC DOSING (Specialist Only)

Important: NOT RECOMMENDED in patients below 18 years of age. Insufficient safety and efficacy data available in Indian paediatric population. Not routinely used in paediatric practice.

Primary Indications

Not applicable — no approved paediatric indications in India.

Secondary Indications – Paediatrics (Off-label)

Indication Dose Maximum Notes

Hypertension (refractory) 0.05–0.3 mg/kg/day once daily 2.5 mg/day OFF-LABEL; Specialist only (Paediatric Cardiologist/Nephrologist); Limited evidence in Indian paediatric practice

Hypercalciuria with recurrent nephrolithiasis 0.05–0.2 mg/kg/day once daily 2.5 mg/day OFF-LABEL; Specialist only (Paediatric Nephrologist); Evidence: International paediatric nephrology protocols

Safety Monitoring:

• Serum electrolytes (Na⁺, K⁺, Mg²⁺) at baseline and every 2–4 weeks initially

• Renal function (serum creatinine, eGFR)

• Blood pressure monitoring at each visit

• Growth parameters

Age Restriction: Not recommended below 18 years except under specialist supervision in tertiary care settings.

• Hypersensitivity to indapamide or sulfonamide derivatives

• Severe renal impairment (eGFR <30 mL/min/1.73m²)

• Hepatic encephalopathy or severe hepatic impairment

• Severe hypokalaemia (<3.0 mEq/L)

• Severe hyponatraemia

• Anuria

• Recent stroke (within 4 weeks)

• Pre-existing electrolyte disturbances (hypokalaemia, hyponatraemia, hypomagnesaemia) — correct before initiation

• Diabetes mellitus — may impair glucose tolerance; monitor blood glucose

• Gout or hyperuricaemia — may precipitate acute gout attacks

• Hypercalcaemia

• History of sulfonamide allergy (rare cross-sensitivity possible)

• Patients at risk of cardiac arrhythmias (especially with concurrent low K⁺/Mg²⁺)

• Systemic lupus erythematosus — may exacerbate disease

• Avoid abrupt withdrawal in patients with heart failure

• Elderly patients — increased susceptibility to electrolyte disturbances

Aspect Details

Overall safety Not recommended; limited human data; animal studies suggest risk

Preferred alternatives Labetalol, methyldopa, nifedipine (for hypertension in pregnancy)

When it may be used Only if no safer alternative available and maternal benefit clearly outweighs fetal risk; specialist supervision mandatory

Monitoring required Maternal electrolytes, blood pressure, fetal growth (serial USG), amniotic fluid volume

Aspect Details

Compatibility Likely compatible; excreted in very low amounts in breast milk

Expected levels in milk Low

Preferred alternatives If diuretic essential, may continue indapamide with monitoring

Infant monitoring Hydration status, feeding adequacy, weight gain, urine output

Aspect Recommendation

Starting dose 1.5 mg SR once daily or 1.25 mg IR once daily

Titration Slower than younger adults; reassess after 4–6 weeks

Additional risks Orthostatic hypotension, falls, electrolyte disturbances (especially hyponatraemia), dehydration

Advantages More favourable metabolic profile compared to hydrochlorothiazide (less impact on glucose and lipids)

Monitoring Electrolytes and renal function every 2–4 weeks initially, then every 3 months

Interacting Drug Effect Recommendation

Lithium Reduced renal clearance; increased lithium toxicity risk Avoid combination; if unavoidable, monitor lithium levels closely

QT-prolonging agents (amiodarone, sotalol, haloperidol, certain fluoroquinolones) Risk of torsades de pointes, especially with concurrent hypokalaemia/hypomagnesaemia Avoid combination; if essential, monitor ECG and electrolytes

Cisplatin Additive nephrotoxicity and ototoxicity Avoid combination

Cyclosporine Enhanced nephrotoxicity Avoid; if essential, monitor renal function closely

Interacting Drug Effect Recommendation

NSAIDs (ibuprofen, diclofenac, naproxen) Reduced antihypertensive efficacy; increased risk of AKI Avoid chronic concurrent use; monitor BP and renal function

ACE inhibitors / ARBs Risk of first-dose hypotension; potential for renal impairment Monitor BP and renal function; may need to reduce diuretic dose initially

Digoxin Hypokalaemia increases digoxin toxicity risk Monitor potassium levels; supplement if needed

Antidiabetic agents May impair glycaemic control Monitor blood glucose; adjust antidiabetic dose if needed

Corticosteroids Additive hypokalaemia Monitor potassium levels

Carbamazepine Additive hyponatraemia risk Monitor sodium levels closely

Loop diuretics Additive electrolyte disturbances and dehydration Use with caution; monitor electrolytes and hydration

• Hypokalaemia

• Hyponatraemia

• Dizziness

• Orthostatic hypotension

• Fatigue

• Headache

• Hyperuricaemia

• Mild gastrointestinal disturbances (nausea, constipation)

• Muscle cramps

• Photosensitivity

Adverse Effect Action Required

Severe electrolyte imbalance (profound hypokalaemia/hyponatraemia) May cause life-threatening arrhythmias; requires hospitalisation and electrolyte replacement

Torsades de pointes Discontinue immediately; cardiac monitoring; correct electrolytes

Severe hypersensitivity reactions (angioedema, anaphylaxis) Discontinue immediately; emergency management

Stevens-Johnson syndrome / Toxic epidermal necrolysis Rare; immediate discontinuation and specialist dermatology care

Acute pancreatitis Rare; discontinue and provide supportive care

Thrombocytopenia / Agranulocytosis Rare; discontinue and monitor blood counts

Hepatic encephalopathy (in cirrhotic patients) Discontinue; supportive management

Phase Parameters Frequency

Baseline Serum electrolytes (Na⁺, K⁺, Mg²⁺), renal function (creatinine, eGFR), uric acid, fasting glucose, lipid profile, blood pressure Before initiation

After initiation / dose change Electrolytes, renal function, blood pressure 1–2 weeks after starting or any dose change

Stable long-term therapy Electrolytes, renal function Every 3–6 months

Annual Uric acid, fasting glucose, lipid profile Yearly

Elderly / High-risk patients All above parameters More frequently (every 1–3 months)

• Natrilix SR (Serdia)

• Indapin (Zydus)

• Lorvas SR (Torrent)

• Indicontin (Sun Pharma)

• Indalol (Lupin)

Fixed-Dose Combinations:

Note: Indapamide 1.5 mg SR is included in NLEM 2022; NPPA price-controlled formulation.

1. Metabolic advantage: Indapamide has a more favourable metabolic profile than hydrochlorothiazide — less impact on glucose tolerance, lipid profile, and potassium levels at antihypertensive doses.

1. Elderly preference: First-choice thiazide-like diuretic for elderly hypertensives in Indian practice due to better tolerability and lower electrolyte disturbance risk.

1. Dose ceiling: Antihypertensive efficacy plateaus at 1.5 mg SR or 2.5 mg IR; higher doses increase adverse effects without additional BP benefit.

1. SR vs IR: Sustained-release formulation provides smoother BP control and may have better tolerability; preferred over IR where available.

1. CKD limitation: Ineffective and potentially harmful when eGFR <30 mL/min/1.73m²; switch to loop diuretics in advanced CKD.

1. Potassium monitoring: Consider potassium-sparing agent (amiloride) or dietary potassium supplementation in patients at high risk of hypokalaemia.

hypertension; thiazide-like diuretic; elderly-safe; NLEM India; sustained-release; metabolic-favourable; renal-caution; potassium-loss; first-line antihypertensive

RxIndia v1.0 — 25 Jan 2025

• CDSCO Product Database

• Indian Pharmacopoeia (latest edition)

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine

• AIIMS Hypertension Management Guidelines

• Indian Society of Nephrology Expert Consensus

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• ADVANCE and HYVET trial data (for off-label evidence)