Schedule H

Oral

• Tablets: 40 mg, 80 mg, 160 mg, 320 mg

• Fixed-dose combinations:

– Valsartan + Hydrochlorothiazide (various strengths)

– Valsartan + Amlodipine (various strengths)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Essential Hypertension

Parameter Adult Dose

Starting dose 80 mg once daily

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

Usual maintenance dose 80–160 mg once daily

Maximum dose 320 mg once daily

Key Clinical Notes:

• Once-daily dosing preferred for better adherence

• May be combined with thiazide diuretics or amlodipine for enhanced blood pressure control

• Correct volume depletion before initiation

1. Heart Failure with Reduced Ejection Fraction (HFrEF)

Parameter Adult Dose

Starting dose 40 mg twice daily

Titration Double dose every 1–2 weeks as tolerated

Usual maintenance dose 80–160 mg twice daily

Maximum dose 160 mg twice daily

Key Clinical Notes:

• Alternative to ACE inhibitors in patients intolerant to ACEi

• Twice-daily dosing essential for sustained RAAS blockade in heart failure

• Monitor renal function and potassium closely during titration

• Evidence basis: Val-HeFT trial

1. Post-Myocardial Infarction with Left Ventricular Dysfunction

Parameter Adult Dose

Starting dose 20 mg twice daily

Titration Double dose every few days as tolerated

Usual maintenance dose 160 mg twice daily

Maximum dose 160 mg twice daily

Key Clinical Notes:

• Initiate within 12 hours to 10 days post-MI in clinically stable patients

• Alternative to ACE inhibitor in ACEi-intolerant patients

• Evidence basis: VALIANT trial

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes Evidence Basis

Diabetic nephropathy in Type 2 Diabetes Mellitus — OFF-LABEL 80–160 mg once daily Chronic use Specialist only; adjunct to standard antidiabetic and renoprotective therapy International RCTs (MARVAL trial); Indian nephrology specialist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Indication: Hypertension in Children ≥6 years

Body Weight Starting Dose Maximum Dose

18–35 kg 40 mg once daily 80 mg once daily

35–80 kg 80 mg once daily 160 mg once daily

80 kg 80–160 mg once daily 320 mg once daily

Monitoring:

• Blood pressure at each visit

• Serum creatinine and potassium within 1–2 weeks of initiation and after each dose increase

• Growth parameters at regular intervals

Statement: Not recommended for children below 6 years of age. Use only under paediatric cardiology or nephrology supervision.

Secondary Indications — Paediatric Doses (Off-label)

Not applicable.

Valsartan is not established for heart failure or nephropathy in paediatric population. Use for these indications only under specialist supervision within institutional protocols.

• Known hypersensitivity to valsartan or any ARB

• Pregnancy (especially 2nd and 3rd trimesters)

• Severe hepatic impairment or biliary cirrhosis

• Concomitant use with aliskiren in patients with diabetes mellitus

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

• History of angioedema related to previous ARB or ACE inhibitor therapy

• Bilateral renal artery stenosis or stenosis of artery to a solitary kidney

• Volume or salt depletion (from diuretics, dietary restriction, diarrhoea, vomiting) — risk of symptomatic hypotension

• Hyperkalaemia — use caution with concurrent ACE inhibitors, potassium supplements, or potassium-sparing diuretics

• Aortic or mitral valve stenosis

• Hypertrophic obstructive cardiomyopathy

• Concomitant NSAID therapy — may reduce antihypertensive efficacy and worsen renal function

• Primary hyperaldosteronism — generally unresponsive to ARBs

Parameter Guidance

Safety category Contraindicated — especially in 2nd and 3rd trimesters

Fetal risks Oligohydramnios, fetal renal dysfunction, skull hypoplasia, limb contractures, pulmonary hypoplasia, neonatal death

Action if pregnancy detected Discontinue immediately

Preferred alternatives Labetalol, methyldopa, nifedipine (extended-release)

Monitoring (if inadvertent exposure) Serial ultrasound for amniotic fluid volume, fetal growth, and renal function

Parameter Guidance

Compatibility Not recommended during breastfeeding

Excretion in milk Unknown; likely low but data insufficient

Preferred alternatives Enalapril (low milk excretion, established safety data), labetalol, nifedipine

Infant monitoring Not applicable — avoid use during lactation

• Starting dose: 40–80 mg once daily (lower end of range)

• Titration: Slower titration intervals (every 4 weeks) due to increased sensitivity to hypotensive effects

• Additional risks:

– Postural hypotension and falls

– Reduced renal reserve — monitor renal function closely

– Dehydration from concurrent diuretic therapy

• Monitoring: Blood pressure (including orthostatic), serum creatinine, and potassium more frequently

Interacting Drug Effect / Risk Recommendation

ACE inhibitors Dual RAAS blockade increases risk of hypotension, hyperkalaemia, and acute kidney injury Avoid concurrent use unless specifically indicated under specialist supervision

Aliskiren (in diabetics or eGFR <60) Increased risk of hypotension, hyperkalaemia, and renal dysfunction Contraindicated

Potassium-sparing diuretics (spironolactone, eplerenone, amiloride) Additive hyperkalaemia risk Avoid or monitor potassium closely

Potassium supplements Risk of severe hyperkalaemia Avoid unless hypokalaemia documented; monitor closely

Lithium Increased lithium plasma concentration and toxicity Avoid if possible; if essential, monitor lithium levels frequently

NSAIDs (chronic use) Reduced antihypertensive effect; increased risk of acute kidney injury Avoid prolonged concurrent use; if necessary, monitor BP and renal function

Interacting Drug Effect / Risk Recommendation

Thiazide/loop diuretics Augmented antihypertensive effect; increased risk of hypotension and volume depletion Monitor blood pressure; may need to reduce diuretic dose before starting valsartan

Metformin Potential for renal function deterioration affecting metformin clearance Monitor renal function periodically

Rifampicin May reduce valsartan plasma levels via OATP transporter induction Monitor blood pressure; dose adjustment may be needed

Trimethoprim Additive hyperkalaemia risk Monitor serum potassium

Other antihypertensives Additive blood pressure lowering Monitor for symptomatic hypotension

• Dizziness

• Headache

• Fatigue

• Hypotension (especially first-dose)

• Diarrhoea

• Back pain

• Upper respiratory tract infection

• Arthralgia

Adverse Effect Clinical Action

Angioedema (rare but potentially life-threatening) Discontinue immediately; secure airway; administer adrenaline/antihistamines as needed

Severe hyperkalaemia (with cardiac arrhythmias) Discontinue; treat with calcium gluconate, insulin-dextrose, sodium polystyrene sulfonate

Acute kidney injury Hold therapy; investigate precipitating factors; reassess after renal recovery

Hepatic dysfunction (elevated transaminases, rarely hepatitis) Monitor LFTs; discontinue if significant elevation

Severe hypotension Reduce dose or discontinue; IV fluids if volume-depleted

Long-term (chronic therapy) Blood pressure, renal function, and potassium every 3–6 months; more frequently in elderly, CKD, or patients on interacting drugs

Monotherapy:

• Diovan® (Novartis)

• Valzaar® (Cipla)

• Valent® (Sun Pharma)

• Valsartan (Zydus, Torrent, and other generics)

Fixed-dose combinations:

• Valsartan is listed in NLEM — NPPA price control applicable for standalone formulations

• Government supply available through public health facilities

• Valsartan is a preferred alternative to ACE inhibitors in patients who develop cough or angioedema with ACEi

• Once-daily dosing suffices for hypertension; twice-daily dosing is required for heart failure and post-MI indications to maintain adequate RAAS blockade

• Always correct volume depletion before initiating therapy to minimise first-dose hypotension

• Periodic monitoring of potassium is mandatory, especially in patients with CKD or on concurrent RAAS-affecting drugs

• Combination with thiazide or amlodipine provides enhanced blood pressure control in resistant hypertension

• Do not combine with ACE inhibitors or aliskiren in diabetic patients — dual RAAS blockade increases adverse outcomes

valsartan; ARB; hypertension; heart failure; HFrEF; post-MI; renal-protective; NLEM India; pregnancy-contraindicated; Schedule H

RxIndia v1.0 — 04 Apr 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia (IP)

• NLEM 2022

• API Textbook of Medicine

• ICMR Guidelines for Hypertension and Diabetes

• Indian Heart Journal Heart Failure Recommendations

• Val-HeFT trial (evidence for HFrEF indication)

• VALIANT trial (evidence for post-MI indication)

• AIIMS Treatment Protocols

• PGI Chandigarh Hospital Formulary