Schedule H

Oral

• Tablets: 4 mg, 8 mg, 16 mg, 32 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hypertension (Essential or Secondary)

Parameter Recommendation

Starting dose 8 mg once daily (4 mg once daily if volume-depleted or on diuretics)

Titration Increase after 2–4 weeks based on blood pressure response

Usual maintenance dose 8–16 mg once daily

Maximum dose 32 mg once daily

Clinical notes:

• Suitable as monotherapy or in combination with other antihypertensives

• Volume or salt-depleted patients require lower starting dose to prevent symptomatic hypotension

• Full antihypertensive effect typically seen within 4 weeks

1. Heart Failure with Reduced Ejection Fraction (HFrEF)

Parameter Recommendation

Starting dose 4 mg once daily

Titration Double dose at 2-week intervals as tolerated

Usual maintenance dose 16–32 mg once daily

Maximum dose (target dose) 32 mg once daily

Clinical notes:

• Used as add-on to standard heart failure therapy (diuretics, beta-blockers)

• Suitable for NYHA class II–IV patients

• Initiation preferably under specialist supervision

• Close monitoring required during uptitration, particularly in elderly and renal-impaired patients

• If intolerant to ACE inhibitors (cough), candesartan is a valid alternative

Secondary Indications — Adults Only (Off-label)

Indication Dose Evidence Basis Notes

Diabetic nephropathy (Type 2 diabetes with albuminuria) 8–16 mg once daily RCTs demonstrating albuminuria reduction; Indian nephrology practice OFF-LABEL; Specialist only

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Hypertension (Children ≥1 year, weight ≥8 kg)

Weight Category Starting Dose Titration Maximum Dose

8 kg to <35 kg 0.2 mg/kg once daily Adjust at 2-week intervals based on BP response 0.4 mg/kg/day (absolute max 8 mg/day)

≥35 kg 4 mg once daily Adjust at 2-week intervals based on BP response 16 mg once daily

Clinical notes:

• Monitor renal function and serum potassium after initiation and during dose adjustments

• Not recommended in children below 1 year of age

• Specialist supervision mandatory

Secondary Indications — Paediatric Doses (Off-label)

Indication Recommendation

Paediatric heart failure Not routinely used; specialist-directed only; OFF-LABEL

• Known hypersensitivity to candesartan or any excipient

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

• Severe hepatic impairment with cholestasis

• Bilateral renal artery stenosis or stenosis in a solitary functioning kidney

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

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

• Pre-existing renal impairment — risk of deterioration

• Conditions predisposing to hyperkalaemia (concurrent potassium-retaining agents, potassium supplements)

• Aortic or mitral valve stenosis (haemodynamically significant)

• Hypertrophic cardiomyopathy

• Elderly patients — heightened sensitivity to BP and renal effects

• Primary aldosteronism — may have reduced response

Trimester Recommendation

1st trimester Avoid if possible; switch to safer alternatives (labetalol, methyldopa, nifedipine)

2nd and 3rd trimester Contraindicated — associated with fetal renal dysfunction, oligohydramnios, limb contractures, pulmonary hypoplasia, neonatal death

Additional notes:

• If exposure occurs during pregnancy, monitor fetal growth and amniotic fluid volume closely

• Specialist referral mandatory if inadvertent exposure occurs

• Neonates exposed in utero require monitoring for hypotension, oliguria, and hyperkalaemia

Parameter Recommendation

Excretion in breast milk Likely excreted in low levels (limited human data)

Preferred alternatives Enalapril, nifedipine (longer safety track record in lactation)

If used Monitor infant for poor feeding, lethargy, hypotension

Overall recommendation Avoid if possible; use alternative agents with established lactation safety

• Starting dose: 4 mg once daily recommended

• Titration: Slow and careful; increase at 4-week intervals

• Monitoring: Close blood pressure and renal function monitoring essential

• Risks: Increased susceptibility to first-dose hypotension, renal insufficiency, and electrolyte disturbances

• Avoid concurrent use with nephrotoxic agents and NSAIDs

Interacting Drug Effect / Risk Recommendation

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

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

ACE inhibitors Dual RAAS blockade — similar risks as above Avoid unless specialist-supervised (e.g., proteinuric nephropathy)

Lithium Increased lithium levels and toxicity Avoid if possible; if used, monitor lithium levels frequently

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, thiazides Volume depletion may enhance first-dose hypotension Consider reducing diuretic dose or starting candesartan at 4 mg

Rifampicin Enzyme induction may reduce candesartan plasma levels Monitor BP; dose adjustment may be needed

Antidiabetic agents (including SGLT2 inhibitors) Overlapping effects on renal function; glucose changes Monitor blood glucose and renal function

Other antihypertensives Additive blood pressure lowering Adjust doses accordingly

Trimethoprim Additive hyperkalaemia risk Monitor serum potassium

• Dizziness

• Headache

• Hyperkalaemia

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

• Transient elevation in serum creatinine

• Fatigue

• Back pain

Adverse Effect Clinical Note

Acute kidney injury Especially in bilateral renal artery stenosis or with concurrent NSAIDs/diuretics

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

Angioedema Rare; may be delayed; discontinue immediately

Hepatic dysfunction Rare; monitor if symptoms suggestive of liver injury

Fetal/neonatal toxicity If used during 2nd/3rd trimester — renal failure, death

Phase Parameters

Baseline Blood pressure, serum creatinine, eGFR, serum potassium

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

Long-term (stable patients) Monitor potassium and renal function every 3–6 months

Heart failure patients More frequent monitoring during uptitration; watch for hypotension and renal deterioration

• Atacand

• Candesar

• Candepar

• Cansartan

• Candisar

• Candelong

Fixed-dose combinations (FDCs):

• Candesar-H (Candesartan + Hydrochlorothiazide)

• Candepar-H (Candesartan + Hydrochlorothiazide)

Note: Not currently under NPPA price control / NLEM price cap

• Preferred ARB option in patients intolerant to ACE inhibitors due to dry cough

• Target dose of 32 mg daily in heart failure has demonstrated mortality benefit (CHARM trials)

• Initial rise in serum creatinine up to 30% may be acceptable and does not necessarily warrant discontinuation — reassess if rise exceeds 30% or continues to increase

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

• When initiating in patients already on diuretics, consider temporary diuretic dose reduction or starting candesartan at 4 mg

• Once-daily dosing improves adherence compared to multiple-dose antihypertensives

Candesartan; ARB; hypertension; heart failure; HFrEF; renal-safe; diabetic nephropathy; pregnancy-contraindicated; paediatrics-specialist; RAAS blocker

RxIndia v1.0 — 05 Jun 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• National List of Essential Medicines (NLEM) India

• API Textbook of Medicine

• AIIMS Guidelines on Hypertension Management

• ICMR Guidelines on Hypertension and Heart Failure

• IAP Recommendations for Paediatric Hypertension

• CHARM trial data (for heart failure dosing and outcomes)