Amiloride Schedule (India)

Schedule H

Amiloride Routes

Oral

Amiloride Formulations

Tablets: 5 mg

Amiloride Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Hypertension (usually in combination with thiazides)

Parameter Recommendation

Starting dose 5 mg once daily

Titration Increase to 5 mg twice daily after 1–2 weeks if response inadequate

Usual maintenance dose 5–10 mg/day in 1–2 divided doses

Maximum dose 20 mg/day

Clinical notes Typically combined with hydrochlorothiazide or other thiazides to offset potassium loss; not recommended as monotherapy

Oedema (cardiac failure, hepatic cirrhosis, nephrotic syndrome)

Parameter Recommendation

Starting dose 5 mg once daily

Titration Increase by 5 mg increments every 1–2 weeks based on clinical response

Usual maintenance dose 5–10 mg/day

Maximum dose 20 mg/day

Clinical notes Use lowest effective dose to minimise hyperkalemia risk; combine with loop or thiazide diuretic for synergistic effect

Hypokalemia Prevention/Treatment (diuretic-induced)

Parameter Recommendation

Starting dose 5 mg once daily, given alongside thiazide or loop diuretic

Titration Adjust based on serum potassium levels (recheck within 3–5 days)

Usual maintenance dose 5–10 mg/day

Maximum dose 15 mg/day

Clinical notes Do not initiate if baseline serum potassium >5.0 mEq/L; discontinue if hyperkalemia develops

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Lithium-induced nephrogenic diabetes insipidus (OFF-LABEL) 5–10 mg once daily Long-term under supervision Specialist only; Evidence: Case series, nephrology specialist practice; Reduces urine output by blocking ENaC in collecting duct

Amiloride Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

⚠️ Not routinely used in paediatric practice. Use ONLY under specialist supervision (paediatric nephrology/cardiology) when potassium-sparing diuresis is specifically indicated.

Primary Indications

Edematous States with Hypokalemia (e.g., nephrotic syndrome, cardiac failure)

Age Group	Dose (mcg/kg/day)	Typical Total Daily Dose	Clinical Notes

≥1 year to 12 years 0.3 mg/kg/day PO once daily Increase by 0.1 mg/kg/day based on serum K+ response 0.6 mg/kg/day OR 20 mg/day (whichever is lower)

≥12 years 5 mg once daily As per adult dosing 20 mg/day

Safety Monitoring:

Serum potassium and creatinine at baseline, within 3–5 days of initiation, then weekly during titration

Use short-term alongside loop/thiazide diuretics

Discontinue promptly if serum K+ exceeds 5.5 mEq/L

Secondary Indications — Paediatrics (Off-label)

Indication Status

Hypertension in children Not routinely recommended; use only under nephrology/cardiology guidance if strong indication exists

Other off-label uses NOT AVAILABLE — insufficient paediatric data in Indian sources

Age Restriction: Not recommended below 1 year of age except under direct paediatric nephrology supervision with documented justification.

Amiloride Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation

60 No dose adjustment required

30–60 Use with caution; start at lowest dose; monitor potassium within 3–5 days and weekly thereafter

<30 Avoid — high risk of severe hyperkalemia

Haemodialysis Contraindicated

Peritoneal dialysis Contraindicated

Amiloride Hepatic adjustment

Severity	Recommendation
Mild impairment	No dose adjustment; monitor serum potassium regularly
Moderate impairment	Use with caution; consider dose reduction; close monitoring of electrolytes and mental status
Severe impairment (e.g., decompensated cirrhosis)	Avoid unless benefit clearly outweighs risk — increased risk of hyperkalemia and precipitation of hepatic encephalopathy

Amiloride Contraindications

Hyperkalemia (serum K+ >5.5 mEq/L) or conditions predisposing to hyperkalemia

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

Anuria

Concurrent use with other potassium-sparing diuretics (spironolactone, triamterene, eplerenone)

Concurrent potassium supplementation

Known hypersensitivity to amiloride or any excipient

Addison's disease (untreated)

Amiloride Cautions

Diabetes mellitus — impaired potassium excretion increases hyperkalemia risk

Elderly patients — higher susceptibility to electrolyte disturbances

Concurrent ACE inhibitor or ARB therapy — additive hyperkalemia risk

Metabolic or respiratory acidosis — shifts potassium extracellularly

Hepatic cirrhosis — risk of electrolyte derangement precipitating encephalopathy

Dehydration or hypovolaemia

Pregnancy and lactation (limited human safety data)

Amiloride Pregnancy

Parameter Recommendation

Risk category Limited human data; use only if potential benefit justifies risk to fetus

Preferred alternatives Labetalol, methyldopa, or nifedipine for hypertension; loop diuretics for severe refractory oedema under specialist supervision

When it may be used Refractory oedema not responding to safer diuretics — specialist obstetric/nephrology input mandatory

What to monitor Maternal serum potassium, creatinine, blood pressure; fetal growth monitoring via ultrasound

Amiloride Lactation

Parameter Recommendation

Compatibility Unknown; likely excreted in breast milk in small quantities — avoid prolonged use

Expected drug levels in milk Low (estimated, based on pharmacokinetic profile)

Preferred alternatives Low-dose thiazides if diuretic necessary during breastfeeding

What to monitor in infant Adequate weight gain, signs of dehydration, urine output

Amiloride Elderly

Parameter Recommendation

Starting dose 2.5–5 mg once daily

Titration Slow — increase dose no more frequently than every 2 weeks

Key risks Hyperkalemia (due to age-related decline in renal function), hyponatraemia, orthostatic hypotension

Monitoring Serum potassium and creatinine within 3–5 days of initiation and after any dose change; more frequent if combined with ACE inhibitors/ARBs

Dose recommendation Maintain at lower end of therapeutic range

Amiloride Major drug interactions

Interacting Drug Mechanism / Effect Action

ACE inhibitors (enalapril, ramipril) / ARBs (losartan, telmisartan) Additive hyperkalemia due to reduced aldosterone effect Avoid combination or use only with strict K+ monitoring (within 3–5 days and regularly)

Potassium supplements Additive increase in serum potassium Contraindicated — risk of severe, life-threatening hyperkalemia

Other potassium-sparing diuretics (spironolactone, triamterene, eplerenone) Additive hyperkalemia Contraindicated

Ciclosporin / Tacrolimus Both cause hyperkalemia via renal tubular effects Avoid combination

Trimethoprim (especially high-dose) Blocks ENaC-mediated potassium excretion Monitor potassium closely; avoid if possible in elderly or renal impairment

Amiloride Moderate drug interactions

Interacting Drug Mechanism / Effect Action

Lithium Reduced lithium clearance; risk of lithium toxicity Monitor lithium levels; consider dose reduction of lithium

NSAIDs (ibuprofen, diclofenac, naproxen) Reduce renal perfusion; may worsen renal function and increase serum potassium Monitor renal function and potassium; use short-term if unavoidable

Loop diuretics (furosemide) / Thiazides (hydrochlorothiazide) Used together therapeutically but risk of excessive volume depletion Monitor blood pressure, volume status, and electrolytes

Beta-blockers Additive hypotensive effect; beta-blockers can mask hypoglycaemia and impair potassium regulation Monitor blood pressure and potassium

Digoxin Amiloride may alter digoxin renal clearance Monitor digoxin levels if co-administered

Amiloride Common Adverse effects

Hyperkalemia (especially in renal impairment or with interacting drugs)

Nausea

Abdominal discomfort / flatulence

Headache

Dizziness

Muscle cramps

Fatigue

Amiloride Serious Adverse effects

Adverse Effect Clinical Significance

Severe hyperkalemia May cause cardiac arrhythmias (peaked T waves, widened QRS, ventricular fibrillation) — potentially fatal; requires immediate discontinuation and urgent correction

Severe electrolyte imbalances Hyponatraemia, hypochloraemia — may cause confusion, weakness, cardiac dysfunction

Hepatic encephalopathy In patients with cirrhosis — triggered by electrolyte shifts; requires discontinuation

Aplastic anaemia / Neutropenia Rare; requires blood count monitoring if unexplained fever or infection

Amiloride Monitoring requirements

Timing	Parameters
Baseline	(before initiation) Serum potassium, creatinine, eGFR, blood pressure
After initiation / dose change	Serum potassium and creatinine within 3–5 days

Long-term maintenance Serum potassium, creatinine, and eGFR every 4–6 weeks; more frequently in elderly, diabetics, or patients on ACE inhibitors/ARBs

Additional Blood pressure, volume status, symptoms of hyperkalemia (muscle weakness, palpitations)

Amiloride Brands in India

Brand Name	Composition	Manufacturer
*	Amifru (Amiloride + Furosemide —	FDC)
*	Frumil (Amiloride + Furosemide —	FDC)
*	Moduretic (Amiloride + Hydrochlorothiazide —	FDC)

Enamide

Lymin

Note: Plain amiloride 5 mg tablets have limited standalone availability; most commonly available as fixed-dose combinations with thiazide or loop diuretics.

Amiloride Price range (INR)

Formulation	Approximate Price (per tablet)
Amiloride 5 mg (plain) ₹4–₹8 per tablet
FDC with Hydrochlorothiazide ₹3–₹6 per tablet
FDC with Furosemide ₹4–₹7 per tablet

NPPA Status: Not currently under DPCO price control as plain amiloride.

Amiloride Clinical pearls

Rarely used as monotherapy — almost always combined with thiazide or loop diuretic to counterbalance potassium loss while enhancing natriuresis

Always check baseline serum potassium before initiating; do not start if K+ >5.0 mEq/L

Recheck potassium within 3–5 days of initiation, especially in elderly, diabetics, or those on ACE inhibitors/ARBs — this is when hyperkalemia is most likely to manifest

HYPERKALEMIA is the most dangerous adverse effect — educate patients about symptoms (muscle weakness, fatigue, palpitations) and importance of follow-up

Avoid in dialysis-dependent patients — drug accumulates and hyperkalemia risk is unacceptable

In cirrhotic patients, use with extreme caution — electrolyte shifts can precipitate hepatic encephalopathy

Amiloride Tags

Amiloride; potassium-sparing; diuretic; ENaC-inhibitor; hypertension; edema; hyperkalemia-risk; renal-caution; cirrhosis; Schedule H; NLEM

Amiloride Version

RxIndia v1.0 — 14 May 2025

Amiloride Reference

CDSCO approved product information

Indian Pharmacopoeia

National Formulary of India

API Textbook of Medicine

AIIMS Drug Formulary

NLEM 2022

Goodman & Gilman's: The Pharmacological Basis of Therapeutics

Indian nephrology and cardiology consultant protocols

Indian package inserts (Frumil, Amifru, Moduretic)

RxIndia

The Drug Registry

Amiloride