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ACE inhibitor Pregnancy: Not recommended in the first trimester; contraindicated in the 2nd and 3rd trimesters (known human fetotoxicity/neonatal toxicity). Detectable in breast milk — not recommended during breast-feeding.

Fosinopril sodium

Brand names: Staril

Fosinopril is an angiotensin-converting enzyme (ACE) inhibitor used in the treatment of hypertension and heart failure.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Hypertension: 10 mg once daily initially; usual maintenance 10 mg up to a maximum of 40 mg once daily.
Route: Oral (single daily dose, at approximately the same time each day; not affected by food)
Frequency: Once daily
Max: 40 mg once daily
In patients at particular risk of hypotension (severe heart failure NYHA IV, patients over 75 y treated for heart failure, severe renal and/or hepatic impairment, or those on diuretics) initiate with a reduced 5 mg dose. Hypertensives on a diuretic that cannot be stopped: start 5 mg under medical supervision, monitor renal function and serum potassium. Heart failure: adjunct to diuretics (and digitalis where appropriate) — initial 10 mg once daily under close supervision, titrate up to 40 mg once daily by clinical response (10 mg dose not studied in NYHA IV or over 75 y). Children/adolescents: use not recommended (optimum dose not determined).

Dose adjustments

Renal

Renal insufficiency: initial dose of 10 mg per day recommended, but caution advised especially with GFR less than 10 mL/min; monitor renal function and serum potassium.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to fosinopril, other ACE inhibitors, or any component
  • History of angioedema associated with previous ACE inhibitor therapy
  • Hereditary or idiopathic angioneurotic oedema
  • Second and third trimester of pregnancy
  • Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²)
  • Concomitant use with sacubitril/valsartan (do not initiate earlier than 36 hours after the last dose of sacubitril/valsartan)

Side effects

  • Dizziness, headache, paraesthesia
  • Cough
  • Hypotension / orthostatic hypotension
  • Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia
  • Tachycardia, arrhythmia, palpitations
  • Rash, angioedema, dermatitis

Interactions

  • Aliskiren — concomitant use contraindicated in diabetes mellitus or renal impairment (GFR <60)
  • Sacubitril/valsartan — concomitant use contraindicated; fosinopril not to be started within 36 hours of the last dose
  • Diuretics — symptomatic hypotension may occur on initiation; if possible discontinue diuretic 2–3 days before starting, or begin at 5 mg (§4.5 not fully present in fetched bundle)

Clinical monograph

How it works

It is a prodrug hydrolysed to fosinoprilat, which inhibits ACE to reduce the conversion of angiotensin I to angiotensin II, causing vasodilatation and reducing aldosterone-mediated salt and water retention.

Prescribing in practice

  • It is contraindicated in pregnancy and in patients with a history of angioedema, including ACE-inhibitor-associated angioedema, and should be stopped if angioedema occurs.
  • Use with caution in renal impairment, renovascular disease and volume depletion, and avoid concurrent potassium-sparing diuretics or potassium supplements unless hyperkalaemia is monitored.
  • Symptomatic hypotension can occur, particularly with the first dose, in volume-depleted or diuretic-treated patients.

Monitoring

Check renal function and serum potassium before starting and after initiation or dose changes, and monitor blood pressure.

Counselling the patient

  • Report any swelling of the face, lips, tongue or throat, or difficulty breathing, urgently.
  • A dry persistent cough can occur; report it so alternatives can be considered.
  • Tell your clinician if you may be pregnant, and avoid potassium-containing salt substitutes unless advised.

Evidence & guidelines

ACE inhibitors have strong trial evidence for benefit in heart failure and hypertension, and NICE guidance includes them as core therapy in these conditions.

Reference: NICE NG136; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.