Schedule H

Oral

• Tablets: 75 mg, 150 mg, 300 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Essential Hypertension

Parameter Recommendation

Starting dose 150 mg once daily

Titration Increase to 300 mg once daily after 2–4 weeks if BP target not achieved

Usual maintenance dose 150–300 mg once daily

Maximum dose 300 mg/day

Clinical Notes:

• Effective as monotherapy or in combination with thiazide diuretics, calcium channel blockers

• Volume-depleted patients: Consider starting at 75 mg once daily

• Antihypertensive effect typically apparent within 1–2 weeks; maximal effect by 4–6 weeks

1. Diabetic Nephropathy in Type 2 Diabetes (Proteinuria ≥300 mg/day)

Parameter Recommendation

Starting dose 150 mg once daily

Titration Increase to 300 mg once daily after 2–4 weeks based on tolerability

Usual maintenance dose 300 mg once daily

Maximum dose 300 mg/day

Clinical Notes:

• Indicated to delay progression of nephropathy in hypertensive patients with type 2 diabetes

• Target BP: ≤130/80 mmHg as per ICMR guidelines

• Continue alongside optimal glycaemic control

• Evidence base: IDNT trial demonstrated renal protective benefit at 300 mg/day

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Heart Failure with Reduced Ejection Fraction (HFrEF) Starting: 75 mg once daily; Titrate to 150–300 mg once daily as tolerated Long-term OFF-LABEL — Specialist only. Use when ACE inhibitors not tolerated (e.g., persistent cough). Supported by RCT evidence; ARBs considered second-line to ACEIs in HFrEF

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Hypertension (Children ≥6 years)

Parameter Recommendation

Starting dose 75 mg once daily (children 6–12 years) OR 150 mg once daily (≥13 years/≥50 kg)

Titration Increase based on BP response; increments every 2–4 weeks

Usual maintenance dose 75–150 mg once daily

Maximum dose 150 mg/day (children 6–12 years); 300 mg/day (≥13 years) — not to exceed 300 mg/day

Clinical Notes:

• Use only under specialist supervision (paediatric nephrologist or cardiologist)

• Limited dosing data in children; extrapolated from adult studies and international guidance

• Not recommended in children <6 years due to insufficient safety/efficacy data

• Monitor renal function and serum potassium at baseline and during therapy

Minimum Age: Not recommended below 6 years

Secondary Indications — Paediatric Doses (Off-label)

Not established for other conditions in paediatric population.

OFF-LABEL use requires paediatric nephrologist or cardiologist supervision.

Clinical Notes:

• Monitor serum creatinine and potassium within 7–10 days of initiation in patients with renal impairment

• Avoid in bilateral renal artery stenosis (contraindicated)

• Hypersensitivity to irbesartan or any ARB

• Pregnancy (2nd and 3rd trimesters) — fetotoxic

• Concomitant use with aliskiren in patients with diabetes mellitus or eGFR <60 mL/min/1.73 m²

• Bilateral renal artery stenosis or stenosis in a solitary kidney

• Severe hepatic impairment

• Volume or sodium depletion (correct before initiation; risk of symptomatic hypotension)

• Unilateral renal artery stenosis

• Elderly patients with reduced renal reserve

• Pre-existing hyperkalaemia or concurrent potassium-elevating medications

• Aortic or mitral valve stenosis; hypertrophic cardiomyopathy

• Concomitant use with ACE inhibitors (dual RAAS blockade — monitor renal function closely)

• Black patients may have reduced antihypertensive response (consider combination therapy)

Aspect Details

Risk Category Contraindicated in 2nd and 3rd trimesters

1st Trimester Avoid unless no safer alternative available

Fetal Risks Oligohydramnios, fetal renal failure, pulmonary hypoplasia, limb contractures, skull hypoplasia, fetal/neonatal death

Preferred Alternatives Labetalol, methyldopa, nifedipine (as per Indian obstetric practice)

Monitoring If inadvertent exposure occurs, serial fetal ultrasound for amniotic fluid volume and renal development

Aspect Details

Compatibility Not recommended during breastfeeding

Excretion in Milk Unknown; presumed to be excreted based on animal data

Preferred Alternatives Enalapril, labetalol, nifedipine (safer profiles in lactation)

Infant Monitoring If used, monitor for hypotension, poor feeding, lethargy, inadequate weight gain

Aspect Recommendation

Starting dose 75–150 mg once daily

Titration Slower dose escalation; assess BP response over 4–6 weeks

Special Risks Increased sensitivity to hypotensive effects; higher risk of orthostatic hypotension, falls

Monitoring Renal function and serum potassium at baseline, 7–10 days post-initiation, then every 3–6 months

Interacting Drug Mechanism / Effect Recommendation

Aliskiren Dual RAAS blockade; increased risk of hyperkalaemia, hypotension, acute kidney injury Contraindicated in diabetics or eGFR <60; avoid in all patients

Potassium-sparing diuretics (spironolactone, amiloride, triamterene) Additive hyperkalaemia Avoid combination or monitor potassium very closely

Potassium supplements Additive hyperkalaemia Avoid unless documented hypokalaemia with close monitoring

Lithium Increased lithium levels; toxicity risk Monitor lithium levels frequently; consider alternative antihypertensive

NSAIDs (chronic use) Blunted antihypertensive effect; increased risk of acute kidney injury Avoid chronic NSAID use if possible; if essential, monitor renal function and BP

Interacting Drug Effect Recommendation

Thiazide/loop diuretics Risk of first-dose hypotension (especially if volume-depleted) Correct volume depletion before starting; consider lower initial dose

ACE inhibitors Dual RAAS blockade; additive hypotensive and renal effects Use with caution; generally avoid unless specialist supervision

Rifampicin CYP2C9 induction; may reduce irbesartan levels Monitor BP closely; may need dose adjustment

Antidiabetic agents (insulin, sulfonylureas) Possible enhanced hypoglycaemia Monitor blood glucose closely in diabetic patients

Trimethoprim Additive hyperkalaemia risk Monitor serum potassium

• Dizziness

• Fatigue

• Headache

• Nausea

• Hyperkalaemia (especially with renal impairment or potassium-elevating drugs)

• Orthostatic hypotension

• Upper respiratory tract infection

Adverse Effect Clinical Notes

Acute kidney injury Especially in volume-depleted, elderly, CKD patients; discontinue and hydrate

Angioedema Rare; less common than with ACE inhibitors; discontinue immediately if occurs

Severe hyperkalaemia (>6.0 mEq/L) May cause cardiac arrhythmias; discontinue and treat urgently

Severe hypotension with syncope More likely in salt/volume-depleted states

Fetal/neonatal toxicity If used in pregnancy — oligohydramnios, renal failure, death

7–10 days post-initiation or dose change Serum creatinine, eGFR, serum potassium

Long-term (every 3–6 months) Renal function, serum electrolytes, blood pressure

Diabetic nephropathy patients Urine albumin-to-creatinine ratio (UACR) or protein-to-creatinine ratio at intervals to assess progression

Brand Name Manufacturer

Irovel Sun Pharma

Aprovel Sanofi

Irbestar Torrent Pharmaceuticals

Irbey Zydus Cadila

Biovasartan Biochem Pharma

Xarb Cipla

Fixed-Dose Combinations (FDCs):

Notes:

• Prices vary by brand and region

• Not included in NLEM — not under NPPA price control

• FDC combinations priced higher

• Diabetic nephropathy: Irbesartan 300 mg/day is specifically evidence-based (IDNT trial) for delaying nephropathy progression in type 2 diabetes with proteinuria

• ACE inhibitor intolerance: Preferred alternative in patients with ACE inhibitor-induced cough; angioedema risk is lower but not zero

• First-dose hypotension: Correct volume depletion and reduce starting dose (75 mg) in diuretic-treated, elderly, or sodium-depleted patients

• Potassium monitoring: Essential when combining with potassium-sparing diuretics, trimethoprim, or in CKD patients

• No routine combination with ACE inhibitors — dual RAAS blockade increases adverse events without mortality benefit

• Avoid abrupt withdrawal in patients with heart failure or nephropathy; taper if discontinuation necessary

irbesartan; ARB; hypertension; diabetic nephropathy; antihypertensive; renal-protective; pregnancy-contraindicated; hyperkalaemia-risk; elderly-caution; Schedule-H

RxIndia v1.0 — 22 Apr 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Drug Formulary

• ICMR Guidelines for Management of Type 2 Diabetes

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• WHO Essential Medicines List (supportive for paediatric guidance)

• IDNT Trial (Lewis EJ et al., NEJM 2001) — for diabetic nephropathy indication