Schedule H

Oral

• Tablet: 5 mg

• Tablet: 10 mg

• Tablet: 20 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hypertension (Essential or Renovascular)

Adults:

Parameter Recommendation

Starting dose 5–10 mg once daily

Titration Increase by 5–10 mg every 1–2 weeks based on blood pressure response

Usual maintenance dose 10–20 mg once daily or in two divided doses

Maximum dose 40 mg/day

Key Clinical Notes:

• Use lower starting dose (5 mg) in patients currently on diuretics, elderly, or those with renal impairment

• Full antihypertensive effect may take 2–4 weeks to manifest

• Can be administered once daily or divided into two doses for better 24-hour control

• Consider withholding diuretic 2–3 days before initiation to reduce first-dose hypotension risk

1. Heart Failure (Adjunctive Therapy with Diuretics ± Beta-blockers)

Adults:

Parameter Recommendation

Starting dose 2.5–5 mg once daily

Titration Increase cautiously every 1–2 weeks as tolerated

Usual maintenance dose 10–20 mg once daily

Maximum dose 20 mg/day

Key Clinical Notes:

• Initiate under specialist supervision

• Assess renal function and serum potassium before starting and during up-titration

• Volume-depleted patients require careful dose initiation

• Symptomatic hypotension may occur; consider temporary diuretic dose reduction

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence Basis

Diabetic Nephropathy (with albuminuria) Starting: 10 mg once daily; Maintenance: 10–20 mg/day Chronic Specialist only; OFF-LABEL ACE inhibitor class effect; Indian nephrology practice; AIPRD data

Post-MI Left Ventricular Dysfunction Starting: 2.5–5 mg once or twice daily; Titrate to 10 mg twice daily Chronic Specialist only; OFF-LABEL Extrapolated from SAVE trial and ACE inhibitor class data

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Hypertension (Children ≥6 years)

Parameter Recommendation

Starting dose 0.2 mg/kg once daily (maximum initial dose: 10 mg/day)

Titration Increase based on blood pressure response every 1–2 weeks

Usual maintenance dose 0.2–0.4 mg/kg once daily

Maximum dose 0.6 mg/kg/day OR 40 mg/day (whichever is lower)

Safety Monitoring:

• Monitor blood pressure, serum creatinine, and potassium at baseline and regularly during therapy

• Avoid in patients with bilateral renal artery stenosis or solitary kidney with stenosis

• Tablet may need to be compounded into suspension for younger children unable to swallow tablets

Age Restrictions:

• Children <6 years: NOT recommended — safety and efficacy not established

• Neonates and infants: Contraindicated

Secondary Indications — Paediatric (Off-label)

Not recommended for any indication outside hypertension in Indian paediatric practice.

Additional Notes:

• Monitor serum creatinine and potassium within 1 week of initiation and after each dose change

• Bilateral renal artery stenosis: ACE inhibitors contraindicated (risk of acute renal failure)

• Avoid concurrent nephrotoxic agents

• Mild Impairment (Child-Pugh A): No dose adjustment required

• Moderate Impairment (Child-Pugh B): Start at lower dose (5 mg); titrate with caution; monitor for exaggerated hypotensive response

• Severe Impairment (Child-Pugh C): Use only if essential under close monitoring; hepatic conversion of benazepril to active metabolite (benazeprilat) may be reduced

• History of angioedema with previous ACE inhibitor use

• Hereditary or idiopathic angioedema

• Pregnancy (2nd and 3rd trimester — absolute; 1st trimester — avoid)

• Bilateral renal artery stenosis or stenosis in solitary kidney

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

• Hypersensitivity to benazepril or any component of formulation

• Renal impairment — requires dose adjustment and close monitoring of creatinine/potassium

• Hyperkalaemia risk — especially when used with potassium supplements, potassium-sparing diuretics, or in diabetics

• Volume or salt depletion — correct before initiating therapy to avoid severe first-dose hypotension

• Aortic or mitral stenosis, hypertrophic cardiomyopathy — risk of haemodynamic compromise

• Major surgery or anaesthesia — may cause hypotension; consider temporary discontinuation

• Patients with collagen vascular disease (e.g., SLE, scleroderma) — increased risk of neutropenia

• Black patients — may have reduced response and higher angioedema risk

Parameter Details

Overall Safety Contraindicated — Fetotoxic, particularly in 2nd and 3rd trimesters

Risk Fetal renal dysfunction, oligohydramnios, skull hypoplasia, neonatal hypotension, anuria, death

1st Trimester Avoid unless no alternative; discontinue immediately if pregnancy detected

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

Monitoring If inadvertent exposure: serial ultrasound for amniotic fluid, fetal growth, renal function

Parameter Details

Compatibility Not recommended

Drug Levels in Milk Low levels of benazepril and benazeprilat detected in breast milk

Preferred Alternatives Enalapril or captopril (if ACE inhibitor essential postpartum — more safety data available)

Infant Monitoring Hypotension, poor feeding, lethargy, oliguria if inadvertently used

• Recommended starting dose: 5 mg once daily or lower

• Titration: Slower titration at 2-week intervals; assess tolerance before each increment

• Extra Risks:

• Increased sensitivity to hypotensive effects — risk of falls

• Age-related decline in renal function — monitor creatinine and potassium closely

• Higher risk of first-dose hypotension, especially if on diuretics

• Consider renal function-based dosing even if serum creatinine appears normal

Interacting Drug Mechanism / Effect Clinical Advice

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

Potassium supplements / salt substitutes Increased potassium load Avoid unless documented hypokalaemia with monitoring

Lithium Reduced lithium clearance → toxicity Avoid combination; if essential, monitor lithium levels frequently

Aliskiren Dual RAAS blockade → renal impairment, hyperkalaemia Contraindicated in diabetics or eGFR <60

NSAIDs (including COX-2 inhibitors) Blunted antihypertensive effect + acute kidney injury risk Avoid prolonged use; monitor BP and renal function

Sacubitril/valsartan Increased angioedema risk Do not initiate benazepril within 36 hours of sacubitril/valsartan

Interacting Drug Effect Recommendation

Thiazide / loop diuretics First-dose hypotension; additive effect Reduce or hold diuretic 2–3 days before starting; resume cautiously

Other antihypertensives Additive blood pressure reduction Monitor BP; adjust doses as needed

Insulin / oral hypoglycaemics Enhanced hypoglycaemia risk Monitor blood glucose more frequently

Rifampicin May reduce benazepril efficacy (hepatic enzyme induction) Monitor BP; consider dose adjustment

Trimethoprim Additive hyperkalaemia risk Monitor potassium

Antacids May reduce benazepril absorption Separate administration by 2 hours

• Dry, persistent cough (5–10% — class effect, usually non-dose-dependent)

• Dizziness

• Headache

• Fatigue

• Hypotension (especially first-dose or with volume depletion)

• Hyperkalaemia

• Nausea, abdominal discomfort

• Elevated serum creatinine (transient, usually reversible)

Adverse Effect Clinical Notes

Angioedema (face, lips, tongue, larynx) May occur at any time during therapy — requires immediate discontinuation and emergency management; higher risk in Black patients

Severe hypotension Especially with first dose in volume-depleted or heart failure patients — may require IV fluids

Acute renal failure Particularly in bilateral renal artery stenosis, volume depletion, or concurrent nephrotoxics

Hyperkalaemia (severe) Life-threatening if >6.5 mEq/L — requires urgent treatment

Cholestatic jaundice / hepatic failure Rare; discontinue and do not rechallenge

Neutropenia / agranulocytosis Rare; higher risk in collagen vascular disease or concurrent immunosuppressants

Long-term (chronic use) BP, renal function, potassium every 3–6 months; more frequently in elderly, CKD, or diabetic patients

• Benace® (Abbott)

• Lotensin® (Novartis) — limited availability

• Generic benazepril (various regional manufacturers)

Note: Benazepril has limited market availability in India compared to other ACE inhibitors like enalapril or ramipril. Availability may vary by region.

• Not included in NLEM 2022

• Not NPPA price-controlled

• Less commonly stocked in government facilities; enalapril and ramipril more readily available

1. Dry cough: Occurs in up to 10% of patients and is not dose-related — if persistent and troublesome, switch to an ARB (e.g., losartan, telmisartan).

1. First-dose hypotension: Common in patients on high-dose diuretics, salt-restricted diets, or with heart failure — consider holding or reducing diuretic for 2–3 days before initiating benazepril.

1. Potassium vigilance: Monitor potassium closely in diabetics, CKD patients, and those on potassium supplements or spironolactone — hyperkalaemia can be life-threatening.

1. Angioedema awareness: Can occur even after months or years of stable therapy — counsel patients on warning symptoms (facial/lip swelling, throat tightness); requires permanent discontinuation.

1. Limited Indian availability: Consider enalapril or ramipril as alternatives if benazepril not readily available — similar efficacy within the ACE inhibitor class.

1. Women of childbearing potential: Counsel about fetotoxicity and need for reliable contraception; discontinue immediately if pregnancy is confirmed or planned.

benazepril; ACE-inhibitor; antihypertensive; heart-failure; hypertension; renal-protection; pregnancy-contraindicated; dry-cough; hyperkalaemia-risk; CKD-caution

RxIndia v1.0 — 10 Jun 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• NLEM 2022 (not listed)

• API Textbook of Medicine

• AIIMS Department of Medicine Prescribing Guidelines

• Indian Society of Hypertension Guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• SAVE trial data (off-label section — post-MI LV dysfunction)