Schedule H

Oral

• Tablets: 1.25 mg, 2.5 mg, 5 mg, 10 mg

• Capsules (soft gelatin): 1.25 mg, 2.5 mg, 5 mg, 10 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hypertension

Parameter Recommendation

Starting dose 2.5 mg once daily

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

Usual maintenance dose 2.5–10 mg once daily (may be given in divided doses)

Maximum dose 10 mg/day

Clinical Notes:

• In volume-depleted or diuretic-treated patients, initiate at 1.25 mg to minimise first-dose hypotension risk

• Evening dosing may be preferred for non-dippers

1. Heart Failure (NYHA Class II–IV)

Parameter Recommendation

Starting dose 1.25 mg once or twice daily

Titration Double dose at 1–2 week intervals as tolerated

Usual maintenance dose 5 mg/day in 1–2 divided doses

Maximum dose 10 mg/day

Clinical Notes:

• Initiate only after haemodynamic stabilisation with diuretics

• Hold or reduce dose if symptomatic hypotension or rising creatinine (>30% from baseline)

• Aim for target dose where tolerated; partial dosing still beneficial

1. Post-Myocardial Infarction with Left Ventricular Dysfunction

Parameter Recommendation

Starting dose 2.5 mg twice daily (starting 3–10 days post-MI)

Titration Increase over subsequent days toward target

Usual maintenance dose 5 mg twice daily

Maximum dose 10 mg/day

Clinical Notes:

• Start only when patient is haemodynamically stable

• Proven mortality benefit in post-MI LV systolic dysfunction (EF ≤40%)

1. Diabetic Nephropathy and Proteinuric Chronic Kidney Disease

Parameter Recommendation

Starting dose 1.25–2.5 mg once daily

Titration Adjust every 2–4 weeks based on BP, proteinuria, and renal function

Usual maintenance dose 2.5–10 mg once daily

Maximum dose 10 mg/day

Clinical Notes:

• Provides renoprotection independent of blood pressure lowering

• Acceptable to continue if creatinine rises <30% from baseline and potassium remains <5.5 mEq/L

• Also beneficial in non-diabetic proteinuric CKD

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Secondary stroke prevention (in hypertensive patients) 5–10 mg once daily Long-term OFF-LABEL — Evidence from HOPE trial; used in Indian practice for high-risk cardiovascular patients with hypertension

Atrial fibrillation with LVH (stroke risk reduction adjunct) 2.5–10 mg/day Long-term OFF-LABEL — Benefit from BP lowering and LVH regression; does NOT replace anticoagulation

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Indication: Hypertension in children ≥1 year (specialist-supervised use only)

Weight/Age Category Starting Dose Titration Usual Maintenance Maximum Dose

Children ≥1 year, <10 kg 0.05 mg/kg once daily Increase at intervals ≥1 week 0.05–0.2 mg/kg/day 0.625 mg/day

Children ≥1 year, ≥10 kg 0.05 mg/kg once daily Increase at intervals ≥1 week 0.05–0.2 mg/kg/day 2.5–5 mg/day

Safety and Monitoring:

• Monitor blood pressure, serum creatinine, and potassium at baseline, 1 week after initiation, and regularly thereafter

• Crushed tablets may be mixed with water for administration if needed

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

Heart failure secondary to congenital heart disease 0.05–0.1 mg/kg/day in 1–2 doses Long-term OFF-LABEL — Specialist only — Used in paediatric cardiology units; requires preserved baseline renal function

Age Restriction Statement:

• NOT RECOMMENDED in infants <1 year except under paediatric nephrology or cardiology specialist supervision due to immature renal physiology and limited safety data

• History of angioedema (idiopathic or associated with prior ACE inhibitor/ARB use)

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

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

• Hypersensitivity to ramipril or any ACE inhibitor

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

• Concomitant use with sacubitril/valsartan within 36 hours

• Severe hypotension or cardiogenic shock

• Volume depletion or concurrent diuretic therapy — increased risk of first-dose hypotension

• Hyperkalaemia risk — particularly in CKD, diabetes, elderly, or those on potassium-sparing agents

• Aortic or mitral stenosis — risk of reduced coronary perfusion with hypotension

• Hypertrophic cardiomyopathy with outflow obstruction

• Pre-existing renal impairment — monitor closely for deterioration

• Dual RAS blockade with ARBs — avoid unless under specialist supervision

• Collagen vascular diseases (e.g., SLE, scleroderma) — increased risk of neutropenia

• Black African patients — may have reduced efficacy and higher angioedema risk

Aspect Recommendation

Overall safety Contraindicated in 2nd and 3rd trimesters — teratogenic effects include renal agenesis, skull hypoplasia, oligohydramnios, limb contractures

First trimester Avoid unless no alternative exists; discontinue immediately upon confirmation of pregnancy

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

If inadvertently exposed Serial ultrasound for fetal growth, renal function, amniotic fluid volume; neonatal monitoring post-delivery

Aspect Recommendation

Compatibility Not recommended — limited human data; low-level excretion in breast milk expected

Preferred alternatives Enalapril (if ACE inhibitor needed), labetalol, nifedipine

Drug levels in milk Low (based on limited studies)

Infant monitoring If exposure occurs: monitor for poor feeding, inadequate weight gain, hypotension, lethargy

Aspect Recommendation

Starting dose 1.25 mg once daily

Titration Slower than standard; increase at 2–4 week intervals

Special risks Orthostatic hypotension, falls, pre-existing renal impairment, hyperkalaemia

Monitoring Renal function and serum potassium within 1 week of initiation and after each dose change

Drug/Class Interaction Management

Potassium-sparing diuretics (spironolactone, eplerenone, amiloride) Significantly increased hyperkalaemia risk Monitor potassium closely; avoid combination in renal impairment

Aliskiren Dual RAS blockade increases hypotension, hyperkalaemia, AKI Contraindicated in diabetes or eGFR <60

Sacubitril/valsartan Markedly increased angioedema risk Do not initiate ramipril within 36 hours of sacubitril/valsartan; washout required

Lithium Increased lithium levels leading to toxicity Avoid combination; if essential, monitor lithium levels frequently

ARBs (dual RAS blockade) Hypotension, renal impairment, hyperkalaemia Avoid unless specialist-directed in specific heart failure scenarios

Drug/Class Interaction Management

NSAIDs (including COX-2 inhibitors) Reduced antihypertensive effect; increased renal impairment risk Use lowest NSAID dose for shortest duration; monitor BP and renal function

Thiazide/loop diuretics Enhanced hypotensive effect, especially initially Consider temporary diuretic dose reduction before starting ramipril

Antidiabetic agents (insulin, sulfonylureas) Enhanced hypoglycaemic effect Monitor blood glucose, especially early in therapy

Allopurinol, immunosuppressants Increased risk of leucopenia Monitor complete blood count periodically

Potassium supplements Additive hyperkalaemia risk Avoid routine supplementation; monitor potassium

Antacids Minor reduction in ramipril absorption Separate administration by 2 hours if clinically significant

• Dry persistent cough (5–10%; class effect)

• Dizziness and lightheadedness

• Postural hypotension

• Headache

• Fatigue and asthenia

• Hyperkalaemia

• Transient rise in serum creatinine (initial)

• Nausea, diarrhoea

Adverse Effect Clinical Action

Angioedema (face, lips, tongue, larynx) Immediate discontinuation; emergency airway management; do not rechallenge with any ACE inhibitor

Severe hypotension (especially first-dose) Supine positioning, IV fluids, dose reduction or discontinuation

Acute kidney injury Hold therapy; investigate reversible causes; may need specialist referral

Neutropenia/agranulocytosis Monitor CBC in collagen vascular disease patients; discontinue if confirmed

Cholestatic jaundice/hepatitis Rare; discontinue if liver enzymes significantly elevated

Anaphylactoid reactions Reported during haemodialysis with high-flux membranes or LDL apheresis; avoid concomitant use

1–2 weeks post-initiation or dose change Repeat creatinine, potassium, blood pressure

Long-term (every 3–6 months) Renal function, potassium, blood pressure; assess for cough, symptoms of angioedema

Special populations More frequent monitoring in elderly, CKD, heart failure, diabetes

• Cardace (Sanofi)

• Ramcor (Cipla)

• Ramistar (Lupin)

• Hopace (Emcure)

• Aceten (Zydus Cadila)

• Odipril (Sun Pharma)

• Ramace (Glenmark)

Fixed-Dose Combinations (FDCs):

• Ramipril + Hydrochlorothiazide

• Ramipril + Amlodipine

Notes:

• Included in NLEM 2022; select brands under NPPA price control

• Generic formulations widely available at lower cost

• Government supply available through public health facilities

1. First-dose precaution: Always initiate at 1.25–2.5 mg in elderly, diuretic-treated, or volume-depleted patients to avoid significant first-dose hypotension.

1. Cough management: Dry cough occurs in 5–10% of patients; if persistent and distressing, switching to an ARB is appropriate rather than reducing dose.

1. Renal function changes: A rise in creatinine up to 30% from baseline is acceptable and does not mandate discontinuation, particularly in heart failure and CKD with proteinuria.

1. Target dosing in heart failure: Aim for evidence-based target doses (5 mg BD) where tolerated; undertreating reduces mortality benefit.

1. Avoid abrupt discontinuation: In stable heart failure or post-MI patients, abrupt cessation may precipitate clinical deterioration.

1. Potassium vigilance: Always check potassium within 1–2 weeks of starting therapy, especially in diabetics, CKD patients, and those on concomitant potassium-sparing agents.

hypertension; ACE inhibitor; heart failure; post-MI; diabetic nephropathy; CKD; pregnancy-contraindicated; dry cough; renal adjustment; NLEM India

RxIndia v1.1 — 13 Jun 2025

• CDSCO-approved product information

• Indian Pharmacopoeia 2022

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine (11th Edition)

• ICMR Guidelines on Hypertension Management

• AIIMS Cardiology and Nephrology protocols

• HOPE Trial (N Engl J Med 2000) — for off-label cardiovascular usage

• IAP Drug Formulary — for paediatric dosing reference