Benazepril
Regulatory sources consulted
- openfda-label-4ec5fd64-ed88-4751-be23-71c9a83da0ab
- aemps-ft-59553
- ansm-rcp-69695547
- PubMed PMID:37432701 ↗
- PubMed PMID:37417783 ↗
- PubMed PMID:38771738 ↗
- PubMed PMID:38496070 ↗
- OpenFDA · C09AA07
- RxNorm rxcui 18867 ↗
Approved indications
- Treatment of hypertension, to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Contraindications
Absolute
- Hypersensitivity to benazepril or any other ACE inhibitor.
- History of angioedema (hereditary, idiopathic, or due to previous ACE inhibitor treatment).
- Concomitant use with sacubitril/valsartan. Do not initiate until 36 hours after the last dose of sacubitril/valsartan.
- Concomitant use with aliskiren in patients with diabetes.
- Second and third trimesters of pregnancy.
Clinical warnings
- Boxed warning · Fetal Toxicity: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as pregnancy is detected. — FDA
- Major warning · Angioedema: Risk of angioedema of the face, extremities, lips, tongue, glottis and/or larynx. Higher risk in Black patients and with concomitant use of mTOR inhibitors or neprilysin inhibitors. — FDA
- Hypotension: Excessive blood pressure reduction may occur, especially in volume-depleted or diuretic-treated patients. — FDA
- Hyperkalemia: Risk of increased serum potassium, especially in patients with renal impairment, diabetes, or on concomitant potassium-sparing diuretics or potassium supplements. — FDA
Drug interactions
- HighSacubitril/ValsartanC09DX04
Mechanism: Increased risk of angioedema due to additive inhibition of neprilysin (NEP) by sacubitrilat and ACE inhibition by benazepril.
Recommendation: Contraindicated. Do not co-administer. Allow a washout period of at least 36 hours when switching between these drugs.
FDA labelANSM RCP
- HighAliskirenC09XA02
Mechanism: Dual blockade of the renin-angiotensin-aldosterone system (RAAS), which increases the risk of hypotension, hyperkalemia, and renal impairment.
Recommendation: Contraindicated in patients with diabetes. Not recommended in patients with renal impairment (GFR < 60 ml/min).
FDA labelANSM RCP
- ModeratePotassium-sparing diureticsC03D
Mechanism: Additive effect on serum potassium, increasing the risk of hyperkalemia.
Recommendation: If concomitant use is necessary, monitor serum potassium frequently.
FDA label
- ModerateNSAIDs (Non-Steroidal Anti-Inflammatory Drugs)M01A
Mechanism: May attenuate the antihypertensive effect and increase the risk of renal function deterioration, including acute renal failure.
Recommendation: Monitor blood pressure and renal function periodically, especially in elderly, volume-depleted, or renally-impaired patients.
FDA label
- ModerateLithiumN05AN01
Mechanism: Decreased renal excretion of lithium, which can lead to lithium toxicity.
Recommendation: Combination is not recommended. If necessary, monitor serum lithium levels closely.
FDA label
Adverse events
Common (≥1%)
headache · dizziness · dry cough · somnolence
Rare but serious
angioedema · acute renal failure · hyperkalemia · agranulocytosis · pancreatitis
Pregnancy and lactation
FDA category: X
Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal toxicity (fetal injury and death). Discontinue as soon as pregnancy is detected. During lactation, levels in breastmilk are low and adverse effects in the infant are not expected.
Recent literature (PubMed)
Revisión sistemática y metaanálisis en red que compara el riesgo de tos inducida por IECA. Confirma que los IECA tienen un riesgo de tos 2.2 veces mayor que el placebo y 3.2 veces mayor que los ARA-II. Benazepril se clasifica en una posición intermedia entre los IECA en cuanto al riesgo de tos.
Revisión sistemática que compara IECA y ARA-II. Concluye que ambos tienen una eficacia similar en la reducción de la presión arterial, pero los IECA podrían ser superiores en la reducción de eventos cardiovasculares y mortalidad por todas las causas, mientras que los ARA-II son mejor tolerados (menos efectos adversos como la tos).
Nota breve que indica que debido a los bajos niveles de benazepril en la leche materna, las cantidades ingeridas por el lactante son pequeñas y no se espera que causen efectos adversos, considerándolo seguro durante la lactancia.
Metaanálisis en red que evalúa la eficacia de varias combinaciones a dosis fija (single-pill combination). Incluye la combinación amlodipino/benazepril. Los resultados sugieren que las combinaciones de ARA-II/BCC pueden tener ventajas sobre otras combinaciones en la reducción de la presión arterial.