Schedule H

Oral, Intravenous

• Tablets: 5 mg, 10 mg, 20 mg, 40 mg

• Injections: 10 mg/mL (1 mL ampoule)

• It is also sometimes spelled torasemide, which is the recommended International Nonproprietary Name (rINN). In the United States, "torsemide" is the official United States Adopted Name (USAN).

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Congestive Heart Failure (CHF) – Edema

Parameter Details

Starting dose 10 mg once daily (oral or IV)

Titration Increase by 10–20 mg every 3–5 days based on volume status and renal response

Usual maintenance dose 10–40 mg once daily

Maximum dose 200 mg/day (specialist supervision only)

Clinical Notes:

• IV route preferred in hospitalised patients with acute decompensation

• Once-daily dosing in the morning to avoid nocturia

• Monitor daily weight to assess diuretic response

1. Essential Hypertension

Parameter Details

Starting dose 5 mg orally once daily

Titration May increase to 10 mg once daily after 2–4 weeks if blood pressure not controlled

Usual maintenance dose 5–10 mg once daily

Maximum dose 10 mg/day for hypertension indication

Clinical Notes:

• Not first-line antihypertensive therapy

• Reserved for patients with concurrent fluid overload or resistant hypertension

• Often combined with other antihypertensives

1. Chronic Kidney Disease (CKD) – Edema

Parameter Details

Starting dose 20 mg once daily

Titration May increase every 48–72 hours based on diuretic response and renal function

Usual maintenance dose 20–100 mg once daily

Maximum dose 200 mg/day (under specialist supervision)

Clinical Notes:

• More effective than furosemide in advanced CKD (eGFR <30 mL/min/1.73m²)

• Better oral bioavailability ensures more predictable response

• Higher doses often required as renal function declines

Secondary Indications – Adults Only

Indication Dose Duration Notes

Hepatic Cirrhosis – Ascites/Edema 10–20 mg orally once daily As long as edema persists Specialist only; must combine with spironolactone; OFF-LABEL for ascites management; risk of precipitating hepatic encephalopathy

Evidence basis: Indian hepatology specialist practice in tertiary centres; combination therapy with aldosterone antagonists is standard approach

PAEDIATRIC DOSING (Specialist Only)

Important: Use in children is off-label in India. Prescribing should be restricted to paediatric cardiologists or nephrologists only.

Primary Indications (Edema from Cardiac or Renal Causes)

Weight Category Initial Dose Route Frequency Maximum Dose

<20 kg 0.1–0.2 mg/kg Oral/IV Once or twice daily 0.4 mg/kg/dose or 10 mg/day (whichever is lower)

≥20 kg 2.5–5 mg Oral/IV Once or twice daily 0.4 mg/kg/dose or 20 mg/day (whichever is lower)

Safety Monitoring:

• Serum electrolytes (K⁺, Na⁺, Mg²⁺) every 48–72 hours initially

• Daily urine output and weight monitoring

• Blood pressure at each visit

• Hydration status assessment

Age Restrictions:

• Not recommended in neonates except under paediatric nephrologist/cardiologist supervision in tertiary care setting

• Limited safety data below 1 year of age

Secondary Indications – Paediatrics (Off-label)

Indication Dose Duration Notes

Nephrotic Syndrome – Refractory Edema 0.2 mg/kg orally once daily Until edema resolution OFF-LABEL; Specialist only; Evidence: paediatric nephrology practice in tertiary centres

Key Point: Loop diuretics including torasemide retain efficacy in advanced renal dysfunction, unlike thiazide diuretics which become ineffective at eGFR <30.

Caution: Risk of precipitating hepatic encephalopathy due to hypokalaemia and volume depletion – monitor mental status closely.

• Hypersensitivity to torasemide or sulfonamide derivatives

• Anuria or complete renal failure unresponsive to diuretics

• Hepatic coma or pre-coma (unless under specialist care)

• Severe uncorrected hypokalaemia (<3.0 mEq/L)

• Severe uncorrected hyponatraemia (<125 mEq/L)

• Severe hypovolaemia or dehydration

• Concomitant IV aminoglycoside administration (increased ototoxicity risk)

• Pre-existing electrolyte abnormalities (K⁺, Na⁺, Mg²⁺) — correct before initiation

• Elderly patients — higher risk of volume depletion and postural hypotension

• Gout or hyperuricaemia — may precipitate acute gout attacks

• Diabetes mellitus — may impair glycaemic control; monitor blood glucose

• History of ototoxicity or hearing impairment

• Concurrent use of nephrotoxic agents — monitor renal function closely

• Prostatic hypertrophy or urinary retention

• Systemic lupus erythematosus — may exacerbate disease

Aspect Details

Overall safety Not routinely recommended; limited human safety data

Indian practice Avoid unless maternal benefit clearly outweighs fetal risk (e.g., severe CHF unresponsive to safer alternatives)

Preferred alternatives Furosemide (if loop diuretic unavoidable, under specialist care)

When it may be used Life-threatening maternal fluid overload; specialist supervision mandatory

Monitoring required Fetal growth (serial USG), uteroplacental perfusion, amniotic fluid volume, maternal electrolytes

Aspect Details

Compatibility Not recommended; safety not well established

Expected levels in milk Likely excreted in small amounts; extent unknown

Preferred alternatives Furosemide (if loop diuretic essential)

If use unavoidable Use shortest possible duration; lowest effective dose

Infant monitoring Feeding adequacy, weight gain, signs of dehydration, urine output

Aspect Recommendation

Starting dose 5 mg once daily

Titration Slower than younger adults; increase every 5–7 days if needed

Additional risks Postural hypotension, falls, volume depletion, acute kidney injury, electrolyte disturbances

Monitoring More frequent BP checks, renal function, and electrolytes (every 3–5 days during titration)

Special considerations Avoid concurrent NSAID use; assess baseline renal function before initiation

Interacting Drug Effect Recommendation

Aminoglycosides (gentamicin, amikacin) Increased risk of ototoxicity and nephrotoxicity Avoid concurrent use, especially IV

Lithium Increased lithium levels and toxicity (reduced renal clearance) Avoid combination; if unavoidable, monitor lithium levels closely

Digoxin Hypokalaemia increases risk of digoxin toxicity and arrhythmias Monitor K⁺ and digoxin levels; supplement potassium if needed

High-dose NSAIDs (chronic use) Blunts diuretic effect; increases nephrotoxicity Avoid chronic concurrent use

Cisplatin Additive ototoxicity and nephrotoxicity Avoid combination

Interacting Drug Effect Recommendation

ACE inhibitors / ARBs Enhanced hypotensive effect; risk of first-dose hypotension and renal impairment Monitor BP and renal function; consider holding diuretic before first ACE inhibitor dose

Antidiabetic agents Potential for altered glycaemic control Monitor blood glucose; adjust antidiabetic dose if needed

Other antihypertensives Additive blood pressure lowering Monitor for symptomatic hypotension

Corticosteroids Additive hypokalaemia Monitor potassium levels

Ketoconazole, Fluconazole May increase torasemide levels (CYP2C8/2C9 inhibition) Monitor for enhanced diuretic effect

Rifampicin May reduce torasemide levels (CYP induction) May need higher diuretic dose

Probenecid Reduced diuretic efficacy (competes for tubular secretion) May need dose adjustment

• Hypokalaemia

• Polyuria

• Dizziness

• Headache

• Postural hypotension

• Muscle cramps

• Nausea

• Transient increase in serum creatinine

• Hyperuricaemia

Adverse Effect Action Required

Severe hypokalaemia or hyponatraemia May cause cardiac arrhythmias; requires immediate electrolyte replacement; discontinue or reduce dose

Ototoxicity (tinnitus, hearing loss) More common with IV use or renal impairment; discontinue immediately

Stevens-Johnson syndrome / Toxic epidermal necrolysis Rare; immediate discontinuation and hospitalisation

Hepatic encephalopathy (in cirrhotic patients) Discontinue; correct electrolytes; specialist management

Anaphylaxis Rare; immediate discontinuation and emergency management

Severe volume depletion / Hypovolaemic shock Discontinue; IV fluid resuscitation

Phase Parameters Frequency

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

After initiation / dose change BP, electrolytes, renal function, weight Every 3–7 days

Stable long-term therapy Electrolytes, renal function Monthly (more frequent in elderly or comorbid conditions)

CHF patients Daily weight Ongoing self-monitoring by patient

Cirrhotic patients Mental status, electrolytes Frequently; as per specialist guidance

• Dytor (Cipla)

• Torsid (Unichem)

• Torsinex (Zuventus)

• Torvate (Intas)

• Torfix (Indoco)

• Tide (Micro Labs)

• Diutor (Cadila)

• Torasemide injection available from multiple manufacturers

Fixed-Dose Combinations:

Note: NPPA-regulated under NLEM for CHF and CKD indications; prices may vary by brand and region.

1. Bioavailability advantage: Torasemide has 80–100% oral bioavailability compared to 40–60% for furosemide, providing more predictable diuresis in outpatient settings.

1. Longer duration of action: Half-life of 3–4 hours versus 1–2 hours for furosemide; once-daily dosing is usually sufficient.

1. CKD efficacy: Preferred over furosemide in advanced CKD (eGFR <30) due to more reliable absorption and response.

1. Morning dosing: Administer in the morning to minimise nocturia and improve patient compliance.

1. Potassium monitoring: Consider adding potassium-sparing diuretic (spironolactone) for chronic use to prevent hypokalaemia, especially in CHF and cirrhosis.

1. Cirrhosis caution: Never use as monotherapy in cirrhotic ascites — always combine with spironolactone and start at low doses to prevent encephalopathy.

loop diuretic; heart failure; edema; hypertension; CKD-safe; NLEM India; cirrhosis; IV diuretic; furosemide alternative

RxIndia v1.0 — 25 Jan 2025

• CDSCO Formulations Database

• Indian Pharmacopoeia (latest edition)

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine (2022)

• AIIMS Drug Formulary

• ICMR CKD Management Guidelines

• IAP Drug Formulary — Paediatric Loop Diuretics

• Goodman & Gilman — The Pharmacological Basis of Therapeutics

• Indian nephrology and cardiology specialist protocols