Schedule H

Oral

• Tablets: 10 mg, 20 mg, 40 mg

• Fixed-Dose Combinations (FDCs): with hydrochlorothiazide (HCTZ), with amlodipine, with amlodipine + HCTZ

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hypertension (Essential or Secondary)

Parameter Recommendation

Starting dose 20 mg once daily (10 mg once daily if elderly, volume-depleted, or on diuretics)

Titration May increase after 2 weeks based on blood pressure response

Usual maintenance dose 20–40 mg once daily

Maximum dose 40 mg once daily

Clinical notes:

• Once-daily administration provides 24-hour blood pressure control

• Full antihypertensive effect typically achieved within 2 weeks

• Can be used as monotherapy or combined with other antihypertensives (thiazides, CCBs)

• No significant effect on heart rate

1. Chronic Kidney Disease with Hypertension and/or Proteinuria

Parameter Recommendation

Starting dose 20 mg once daily

Titration Increase to 40 mg once daily if blood pressure or proteinuria inadequately controlled

Usual maintenance dose 20–40 mg once daily

Maximum dose 40 mg once daily

Clinical notes:

• Particularly useful in diabetic nephropathy with albuminuria

• Monitor serum creatinine and potassium closely during initiation and titration

• Specialist input advised for CKD stage 4 or higher

• Initial rise in creatinine up to 30% may be acceptable if stabilises

Secondary Indications — Adults Only (Off-label)

Indication Dose Evidence Basis Notes

Heart failure (HFpEF or HFrEF) 20–40 mg once daily RCTs showing ARB benefits in heart failure; not first-line per Indian HF guidelines OFF-LABEL; Cardiologist supervision only

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Hypertension (Children ≥6 years)

Weight Category Starting Dose Usual Maintenance Maximum Dose

20 kg to <35 kg 10 mg once daily 10–20 mg once daily 20 mg once daily

≥35 kg 20 mg once daily 20–40 mg once daily 40 mg once daily

Clinical notes:

• Not approved for children below 6 years of age

• Not recommended in children with eGFR <30 mL/min/1.73m²

• Monitor blood pressure, renal function, and serum potassium regularly

• Specialist supervision mandatory

• Titrate at 2-week intervals based on blood pressure response

Secondary Indications — Paediatric Doses (Off-label)

Indication Recommendation

Heart failure Not routinely used in Indian paediatric practice

Proteinuric kidney disease Not established; specialist-directed only; OFF-LABEL

Statement: Not recommended for use below 6 years of age except under specialist supervision with clear justification.

• Known hypersensitivity to olmesartan or any excipient

• Pregnancy (especially 2nd and 3rd trimester) — absolute contraindication

• Biliary obstruction or severe cholestatic disorders

• Concurrent use with aliskiren in patients with diabetes mellitus

• Concurrent use with aliskiren in patients with renal impairment (eGFR <60 mL/min)

• Severe hepatic impairment

• Volume or sodium depletion (risk of first-dose hypotension)

• Pre-existing renal impairment — risk of deterioration

• Hyperkalaemia risk (concurrent potassium-sparing agents, potassium supplements, CKD)

• Renovascular hypertension or renal artery stenosis

• Aortic or mitral valve stenosis (haemodynamically significant)

• Hypertrophic cardiomyopathy

• Primary aldosteronism — may have reduced response

• History of angioedema

• Elderly patients — heightened sensitivity to blood pressure and renal effects

Aspect Recommendation

Overall safety Contraindicated, especially in 2nd and 3rd trimesters

Risk Fetal renal dysfunction, oligohydramnios, limb contractures, pulmonary hypoplasia, neonatal death

Preferred alternatives Labetalol, nifedipine, methyldopa (standard in Indian obstetric practice)

If exposure occurs Discontinue immediately; monitor fetal renal development and amniotic fluid volume

When may be used Never — discontinue as soon as pregnancy is confirmed

Aspect Recommendation

Compatibility Not recommended; insufficient human data

Expected drug levels in milk Unknown

Preferred alternatives Enalapril (if tolerated), labetalol, nifedipine

Monitoring in infant Not applicable — avoid use during lactation

• Starting dose: 10 mg once daily recommended

• Titration: Slow and cautious; increase at intervals of 2–4 weeks

• Risks: Increased susceptibility to first-dose hypotension, postural hypotension, electrolyte disturbances, reduced renal reserve

• Monitoring: Close blood pressure and renal function monitoring essential

• Avoid concurrent use with NSAIDs

Interacting Drug Effect / Risk Recommendation

Potassium-sparing diuretics (spironolactone, amiloride, triamterene) Increased risk of hyperkalaemia Avoid combination or monitor potassium frequently

Potassium supplements Additive hyperkalaemia risk Avoid unless hypokalaemia documented

Aliskiren Dual RAAS blockade — increased risk of hypotension, hyperkalaemia, renal impairment Contraindicated in diabetics and renal impairment

ACE inhibitors Dual RAAS blockade — similar risks Avoid unless specialist-supervised

Lithium Increased lithium plasma levels; toxicity risk Avoid if possible; if essential, monitor lithium levels closely

NSAIDs (including COX-2 inhibitors) Reduced antihypertensive effect; increased risk of acute kidney injury Avoid prolonged concurrent use; monitor renal function

Interacting Drug Effect / Risk Recommendation

Loop diuretics, thiazide diuretics Volume depletion may enhance first-dose hypotension Consider reducing diuretic dose or starting olmesartan at 10 mg

Other antihypertensives Additive blood pressure lowering Adjust doses accordingly; monitor for hypotension

Rifampicin Enzyme induction may reduce olmesartan efficacy Monitor blood pressure; dose adjustment may be required

Antidiabetic agents ARBs may potentiate insulin sensitivity Monitor blood glucose

Trimethoprim Additive hyperkalaemia risk Monitor serum potassium

Colesevelam May reduce olmesartan absorption Administer olmesartan at least 4 hours before colesevelam

• Dizziness

• Headache

• Fatigue

• Hypotension (especially first-dose or in volume-depleted patients)

• Hyperkalaemia

• Nausea

• Diarrhoea

• Back pain

• Upper respiratory tract infection symptoms

Adverse Effect Clinical Note

Sprue-like enteropathy Chronic severe diarrhoea, weight loss, villous atrophy; unique to olmesartan among ARBs; requires immediate discontinuation

Acute kidney injury Especially in bilateral renal artery stenosis, volume depletion, or concurrent NSAIDs/diuretics

Severe hyperkalaemia May be life-threatening; risk increased with K+-sparing agents

Angioedema Rare with ARBs; discontinue immediately if occurs

Rhabdomyolysis Very rare; reported in post-marketing surveillance

Phase Parameters

Baseline Blood pressure, serum creatinine, eGFR, serum potassium, volume status assessment

After initiation or dose change Recheck blood pressure, renal function, potassium within 1–2 weeks

Long-term (stable patients) Monitor blood pressure, renal function, electrolytes every 3–6 months

Special monitoring If unexplained chronic diarrhoea develops, evaluate for sprue-like enteropathy

• Olmesar (MacLeods)

• Olsar (Unichem)

• Olmy (Ipca)

• Winbp (Tablets India)

• Olmat (Micro Labs)

• Olvance (Intas)

Fixed-dose combinations:

• Olmesar-A, Olmy-AM (with amlodipine)

• Olmesar-H, Olsar-H (with hydrochlorothiazide)

Note: Not currently listed in NLEM 2022 (Losartan is the listed ARB); not under NPPA price control as single entity

• Olmesartan is uniquely associated with sprue-like enteropathy among ARBs — consider this diagnosis in patients with unexplained chronic diarrhoea and weight loss; symptoms typically resolve upon discontinuation

• Preferred over ACE inhibitors in patients with persistent dry cough or ACE inhibitor-induced angioedema

• Once-daily dosing provides consistent 24-hour blood pressure control, improving adherence

• In volume-depleted patients or those on high-dose diuretics, start at 10 mg to prevent symptomatic hypotension

• Can be continued in CKD stages 3–4 if potassium and creatinine remain stable; initial creatinine rise up to 30% may be acceptable

• Avoid the "triple whammy" combination (ARB + diuretic + NSAID) particularly in elderly patients — high risk of acute kidney injury

Olmesartan; ARB; hypertension; proteinuria; CKD; diabetic nephropathy; sprue-like enteropathy; pregnancy-contraindicated; once-daily; antihypertensive

RxIndia v1.0 — 05 Jun 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• API Textbook of Medicine, 11th Edition

• ICMR Guidelines on Hypertension Management

• AIIMS Hypertension Management Protocols

• IAP Paediatric Hypertension Guidelines

• Manufacturer product inserts (MacLeods, Unichem, Ipca)

• FDA Drug Safety Communication on sprue-like enteropathy (for adverse effect documentation)