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Benazepril

Lotensin · ACE inhibitor

An oral ACE inhibitor for hypertension, with age- and kidney-specific dosing. Pregnancy exposure, angioedema, potassium changes and interacting renin–angiotensin medicines require active review.

Therapeutic class
ACE inhibitor antihypertensive
Common brand
Lotensin
Reference focus
Selected U.S. single-agent tablets and labeled pharmacy suspension
Essential safety

Stop promptly when pregnancy is detected; angioedema needs urgent care.

The label carries a fetal-toxicity boxed warning. Do not combine with sacubitril-containing treatment or give within 36 hours of switching to / from it. Check kidney function and potassium, particularly with diuretics, dehydration or interacting medicines.

Warnings and precautions
01

Indications

Hypertension treatment is the selected labeled indication.

Labeled use

Benazepril treats hypertension to lower blood pressure and may be used alone or with thiazide diuretics. Blood-pressure lowering reduces cardiovascular events, primarily stroke and myocardial infarction; this is not a separate acute heart-attack treatment claim. Pediatric antihypertensive use has age and renal limitations.

Scope and related products

This profile reviews single-agent tablets and the label-described pharmacy-prepared suspension. Benazepril / hydrochlorothiazide and amlodipine / benazepril combinations have their own strengths and prescribing instructions. Heart failure or kidney-protection protocols are outside the selected labeled hypertension regimen; no universal BP target or class-derived dose is asserted.

02

Dosage and administration

Starting dose differs with diuretics, age and renal function.

Selected oral dosing

Population / situationLabel regimen and limit
Adult not receiving a diureticStart 10 mg once daily; usual maintenance 20–40 mg / day as one dose or two equal doses. The full label mentions greater response at 80 mg but limited experience
Adult receiving a diureticStart 5 mg once daily; review volume status / diuretic plan and BP response
Adult renal impairment, §2 GFR below 30 mL / min / 1.73 m²Start 5 mg once daily; titrate to BP response, maximum 40 mg / day for this renal regimen
Child age 6 or olderStart 0.2 mg / kg once daily; titrate to 0.6 mg / kg once daily. Above 0.6 mg / kg or 40 mg / day has not been studied; observe renal eligibility

Renal boundary and pediatric limits

The adult dose section specifies GFR below 30 mL / min / 1.73 m², while §8.6 requires adjustment with dialysis or creatinine clearance at or below 30 mL / min. These measures and exact boundaries are not interchangeable; obtain clinician clarification at the boundary rather than selecting a dose automatically. Pediatric highlights specify GFR greater than 30, while full text does not recommend below 30; clarify exact 30 eligibility. Do not use below age 6; infants below 1 should not receive it because of kidney-development risk.

Pharmacy-prepared suspension

The label describes 150 mL of 2 mg / mL suspension from fifteen 20 mg tablets: add 75 mL Ora-Plus in an amber PET bottle and shake at least 2 minutes; stand at least 1 hour, then shake at least 1 minute; add 75 mL Ora-Sweet and shake to disperse. This is a verified pharmacy preparation, not a claim of a ready-made approved liquid. Refrigerate 2–8°C up to 30 days in the specified child-resistant PET bottle and shake before each use. Use a calibrated oral measure and the prescribed milligram dose.

Titration and organ considerations

Titrate from BP response and tolerability, checking trough control when appropriate. Volume depletion, diuretics or severe renal disease increase hypotension risk. The label reports essentially unchanged benazeprilat kinetics in studied cirrhosis and supplies no separate numerical hepatic adjustment; new jaundice or marked enzyme elevation requires stopping and evaluation. Do not invent a universal missed-dose doubling, titration interval or combined renal / hepatic algorithm.

03

Safety

Fetal toxicity, angioedema and renal / potassium changes require prompt action.

Warnings and precautions

Stop as soon as pregnancy is detected and arrange an alternative clinical plan. Renin–angiotensin blockade can reduce fetal renal function and cause oligohydramnios, skeletal / lung abnormalities, neonatal renal failure or death.

Head, neck or intestinal angioedema can occur. Stop and obtain urgent assessment for swelling of face / lips / tongue, breathing difficulty or unexplained significant abdominal pain; airway involvement can be fatal. ACE inhibitor angioedema is more frequent in Black patients. Venom desensitization, certain high-flux dialysis membranes and dextran-sulfate LDL apheresis can provoke serious anaphylactoid reactions.

Monitor kidney function, potassium and BP. Volume / salt depletion, high-dose diuretics, dialysis, renal artery stenosis and other conditions can increase hypotension or acute-kidney-injury risk. Follow high-risk patients closely during the first 2 weeks and after dose increases; avoid use when hemodynamically unstable after acute MI.

Potassium-raising drugs or supplements can cause hyperkalemia. Stop and evaluate jaundice or markedly increased liver enzymes because a rare cholestatic syndrome can progress to hepatic necrosis. Tell surgical / anesthesia teams about ACE inhibitor treatment; perioperative hypotension needs clinical management.

Contraindications

Hypersensitivity to benazepril or another ACE inhibitor; angioedema history with or without prior ACE treatment, including hereditary / idiopathic history; concomitant neprilysin inhibitor. Do not administer within 36 hours of switching to or from sacubitril / valsartan. Aliskiren coadministration in diabetes is contraindicated. Pregnancy-related stopping is also mandatory under the box; do not reinterpret the absence of pregnancy in this formal list as permission.

Boxed warning

Fetal toxicity: discontinue promptly when pregnancy is detected because drugs acting directly on the renin–angiotensin system can injure or kill the developing fetus. Discuss planned pregnancy and alternatives before exposure.

Adverse reactions

Reported effects include cough, headache, dizziness, postural dizziness and somnolence. Serious reactions include angioedema, severe hypotension, renal dysfunction, hyperkalemia and hepatic injury; less common reports include skin, GI and hematologic events. Trial and postmarketing data do not define one universal incidence for every population.

04

Drug interactions

Review potassium, renal toxicity and other renin–angiotensin blockers.

Neprilysin inhibitors, aliskiren and dual blockade

Do not combine with a neprilysin inhibitor and keep at least 36 hours when switching to / from sacubitril / valsartan. Aliskiren with benazepril is contraindicated in diabetes and should be avoided with renal impairment (GFR below 60 mL / min per label). ACE inhibitor / ARB / aliskiren combinations generally should be avoided because renal injury, hypotension and hyperkalemia increase without typical added benefit.

Diuretics, potassium and NSAIDs

Diuretics can magnify initial hypotension; adjust the plan with the clinician rather than stop them independently. Potassium-sparing diuretics, supplements or potassium salt substitutes raise hyperkalemia risk. NSAIDs, including COX-2 inhibitors, can reduce BP benefit and cause kidney injury, especially with older age, volume depletion or impaired renal function; monitor renal function.

Lithium, diabetes drugs and other reactions

Monitor lithium levels because toxicity may occur. Insulin or oral glucose-lowering medicines can increase hypoglycemia risk; monitor closely, especially during the first month of combined use. mTOR inhibitors increase angioedema risk. Injectable gold has rarely caused flushing, nausea, vomiting and hypotension with ACE inhibitors. Reconcile all medicines without inventing a fixed interaction-adjustment percentage.

05

Use in specific populations

Pediatric eligibility, kidney function and pregnancy need distinct decisions.

Pregnancy and breastfeeding

Discontinue when pregnancy is detected; second / third-trimester exposure can cause profound fetal / neonatal injury. Exposed newborns need clinical monitoring for hypotension, oliguria and hyperkalemia. Small amounts of benazepril / benazeprilat are excreted in milk; the label estimates an exclusively breastfed infant receives less than 0.1% of the maternal weight-adjusted dose. This exposure estimate is not a universal safety guarantee; individualize maternal treatment and infant considerations.

Children and older adults

Pediatric antihypertensive dosing applies from age 6 with the stated renal eligibility and studied dose ceiling; below 6 effectiveness is unestablished, and below 1 the label says not to give. Clarify exact GFR 30 wording before use. Older patients may be more sensitive and more likely to have kidney impairment; select doses cautiously and monitor renal function.

Renal, hepatic and population response

Adults receiving dialysis or with severely reduced renal function require reduced initial dosing and close monitoring; resolve the GFR versus creatinine-clearance boundary language. Cirrhosis did not substantially alter studied active-metabolite kinetics, but hepatic failure symptoms require stopping. Average monotherapy BP response was lower in Black than non-Black patients; use measured response and individualized treatment, not a race-based dose formula.

06

Clinical pharmacology

The active metabolite inhibits ACE and alters angiotensin / aldosterone signaling.

Mechanism

Benazepril is converted mainly in the liver to benazeprilat, which has much greater ACE-inhibitory activity. Reduced angiotensin II and aldosterone contribute to vasodilation and possible potassium increase. ACE also degrades bradykinin; this pathway relates to ACE-inhibitor adverse effects, while the label does not fully resolve bradykinin’s contribution to BP benefit.

Pharmacokinetics

After oral dosing, benazepril peaks around 0.5–1 hour and benazeprilat 1–2 hours; food delays metabolite peak without changing benazepril bioavailability. Renal excretion predominates, with some biliary elimination. Active-metabolite effective half-life is 10–11 hours during repeated daily dosing; severe renal impairment raises / delays exposure. Limited dialysis removal does not replace careful clinical organ management.

07

Monitoring and counseling

Measure response and catch renal, potassium or allergic complications.

Monitoring

Assess BP / volume status, creatinine or kidney-function estimate, potassium, pregnancy plans and interacting medicines before and during treatment. Reassess after dose changes or intercurrent dehydration and monitor high-risk hypotension patients closely for the first 2 weeks. Check glucose more closely with diabetes drugs and lithium levels when coadministered. The label specifies periodic testing but no universal laboratory interval or BP target.

Counseling

Report pregnancy immediately, avoid unsupervised potassium supplements / salt substitutes and discuss vomiting, diarrhea or heavy sweating that could cause dehydration. Seek urgent care for angioedema and take no further dose pending assessment; report fainting or jaundice. Follow the pharmacy suspension’s refrigeration, 30 day limit and shaking instructions. Do not independently change combination products or double an uncertain dose.

Overdose or severe hypotension

Obtain medical / Poison Control assessment for overdose or severe symptoms; management includes BP, fluids / electrolytes and kidney support as clinically indicated. Dialysis removes little drug but may be needed for organ support. Do not treat historical charcoal / emesis / lavage descriptions as home instructions or use an unverified replacement-dose algorithm.

08

Product identification

Selected Lotensin lists 10, 20 and 40 mg; the generic also lists 5 mg.

Representative tablet

Product
Lotensin 20 mg benazepril hydrochloride tablet
Route
Oral; prescription
Appearance
Pink; 20 and LOTENSIN engraving
Example package
100 tablets · NDC 30698-449-01

Dosage forms and strengths

Current selected Lotensin label lists 10, 20 and 40 mg tablets. Selected Solco generic lists 5, 10, 20 and 40 mg; its 5 mg tablet is round white with S / 341, NDC 43547-335-03 (30). The labeled 2 mg / mL suspension is pharmacy-prepared from 20 mg tablets using specified vehicles. Fixed-dose combinations and other manufacturers require separate checking; a lower-dose instruction does not prove a brand 5 mg tablet is currently supplied.

Storage and handling

Lotensin tablets: do not store above 30°C; protect from moisture and dispense tight. Solco tablets: 20–25°C, protect from moisture and dispense tight. The specified 2 mg / mL suspension: refrigerate 2–8°C for up to 30 days in the prescribed amber PET child-resistant container and shake before every use. Follow the dispensed product; do not apply suspension refrigeration or discard limits to tablets.

09

References

Original sources for the clinical and product information.

  1. DailyMed / ValidusLotensin · Single-agent prescribing information

    Current SPL version 10, effective 2025-09-30. Current September 2025 SPL retains January 2019 clinical PI; actual brand strengths 10 / 20 / 40 mg.

  2. DailyMed / SolcoBenazepril hydrochloride · Generic tablet prescribing information

    Current SPL version 11, effective 2024-06-30. Current June 2024 label verifies 5 / 10 / 20 / 40 mg strengths, including lower-dose product.

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