Fosinopril
Regulatory sources consulted
- openfda-label-e39b61db-42b8-4ddf-89d1-549c08d49e71
- aemps-ft-83239
- ansm-rcp-64622680
- PubMed PMID:37417783 ↗
- PubMed PMID:38771738 ↗
- PubMed PMID:41323461 ↗
- professional-knowledge
- OpenFDA · C09AA09
- RxNorm rxcui 50166 ↗
- PubMed PMID:36853224 ↗
Approved indications
- Treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
- Management of heart failure as adjunctive therapy to conventional therapy including diuretics with or without digitalis.
Contraindications
Absolute
- Hypersensitivity to fosinopril or to any other angiotensin-converting enzyme (ACE) inhibitor.
- History of angioedema related to previous ACE inhibitor therapy.
- Concomitant use with aliskiren in patients with diabetes.
- Second and third trimesters of pregnancy.
Clinical warnings
- Boxed warning · FETAL TOXICITY: When pregnancy is detected, discontinue fosinopril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. — FDA
- Major warning · Angioedema: Head and neck angioedema, as well as intestinal angioedema, have been reported. Angioedema involving the larynx may be fatal. Discontinue treatment immediately. — FDA
Drug interactions
- HighPotassium-sparing diuretics or potassium supplementsC03D
Mechanism: Additive hyperkalemic effects. Fosinopril (ACEI) reduces aldosterone production, decreasing potassium excretion.
Recommendation: Monitor serum potassium frequently. Avoid combination unless documented hypokalemia is present.
FDA labelANSM RCP
- ModerateNSAIDs (Nonsteroidal anti-inflammatory drugs)M01A
Mechanism: Inhibition of renal vasodilatory prostaglandins, which can lead to deterioration of renal function. May also reduce the antihypertensive effect.
Recommendation: Monitor renal function periodically, especially in elderly, volume-depleted, or patients with pre-existing renal impairment. Monitor blood pressure.
FDA label
- HighLithiumN05AN01
Mechanism: ACE inhibitors reduce the renal clearance of lithium, increasing its serum levels and risk of toxicity.
Recommendation: Coadministration with caution. Frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity is increased.
FDA label
Adverse events
Common (≥1%)
cough · dizziness · nausea/vomiting
Rare but serious
angioedema · agranulocytosis · hyperkalemia · acute renal failure · hepatotoxicity
Pregnancy and lactation
FDA category: D
Pregnancy: Contraindicated in the second and third trimesters due to fetal toxicity (renal injury, oligohydramnios, delayed cranial ossification). Discontinue as soon as pregnancy is detected. Lactation: No information is available on its use. An alternative drug may be preferred, especially while nursing a newborn or preterm infant.
Recent literature (PubMed)
Revisión sistemática y metaanálisis en red que evalúa el riesgo de tos inducida por IECA. Fosinopril se clasificó con un riesgo relativamente alto de tos (SUCRA 72.5%) en comparación con otros IECA como captopril o spirapril, aunque el estudio concluye que todos los IECA tienen un riesgo similar.
Revisión que destaca la falta de datos sobre el uso de fosinopril durante la lactancia, recomendando preferir un fármaco alternativo, especialmente en recién nacidos o prematuros.
Revisión sistemática y metaanálisis que evalúa el impacto de antihipertensivos en estenosis carotídea asintomática. Menciona que fosinopril demostró beneficios duales en la reducción de la presión arterial y la remodelación vascular, aunque el metaanálisis no mostró mejoras significativas en el flujo sanguíneo cerebral regional.