Medicine guide

Amlodipine Besylate and Benazepril Hydrochloride

5 mg + 10 mg · Capsule

Prescription only
Angiotensin Converting Enzyme Inhibitor

Active substance: Amlodipine Besylate and Benazepril Hydrochloride
Used in: Heart, blood pressure and circulation
Made by: Lupin Pharmaceuticals, Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-10-03

This product has an FDA recall

Class II Completed · 2025-07-02 — Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027Using the product could cause temporary or medically reversible harm.

A recall usually covers specific lots. Check the lot number on your pack against the notice, and ask your pharmacist before you stop a medicine. FDA recalls

What it is

Angiotensin Converting Enzyme Inhibitor

Used for

Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor.

The label’s usual adult dose

Usual starting dose is 2.5/10 mg.

Full directions ↓

Serious warning

FETAL TOXICITY See full prescribing information for complete boxed warning.

All warnings ↓

Good to know

Prescription only

45other products contain Amlodipine Besylate and Benazepril Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor.
Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1 ).
1.1 Hypertension Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.

From the official label · 2025-10-03 · DailyMed

How it works

From this product’s own US prescribing label.

Benazepril Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and in animals.
ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance angiotensin II.

Peak level after6–12 h

Half-life30–50 h

Mostly cleared after≈ 8 daysfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

On the basis of in vitro studies, benazeprilat's degree of protein binding should be unaffected by age, by hepatic dysfunction, or—over the therapeutic concentration range—by concentration Metabolism Amlodipine is extensively (approximately 90%) metabolized in the liver to inactive metabolites.

How it leaves the body

Ten percent of unchanged drug and 60% of amlodipine metabolites are excreted in urine.

With food

Absorption from the individual tablets is not influenced by the presence of food in the gastrointestinal tract; food effects on absorption from amlodipine and benazepril hydrochloride capsules have not been studied.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-03

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

FETAL TOXICITY See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible ( 5.5 ).
Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.5 ) WARNING:
FETAL TOXICITY When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible ( 5.5 ).
Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.5 )

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Do not coadminister aliskiren with ACE inhibitors, including amlodipine and benazepril hydrochloride, in patients with diabetes.
( 4 ) Amlodipine and benazepril hydrochloride is contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to amlodipine.
( 4 ) Amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).
Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan.
( 5.1 ) Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), ACE inhibitors, including amlodipine and benazepril hydrochloride in patients with diabetes.
Amlodipine and benazepril hydrochloride is contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules.
Amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).
Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see Warnings and Precautions ( 5.1 )] .

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Usual starting dose is 2.5/10 mg.
( 2.1 ) May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor.
( 2.2 ) Patients who experience edema with amlodipine may be switched to amlodipine and benazepril hydrochloride capsules, containing a lower dose of amlodipine.
( 2.1 )
2.1 General Considerations The recommended initial dose of amlodipine and benazepril hydrochloride capsule is 1 capsule of amlodipine 2.5 mg/benazepril 10 mg orally once-daily.
Begin therapy with amlodipine and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.
The antihypertensive effect of amlodipine and benazepril hydrochloride capsule is largely attained within 2 weeks.
If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once-daily.
The dosing should be individualized and adjusted according to the patient's clinical response.
In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.
2.2 Replacement Therapy Amlodipine and benazepril hydrochloride capsules may be substituted for the titrated components.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Anaphylactoid reactions, including angioedema ( 5.1 ).
Myocardial infarction or increased angina in patients with obstructive coronary artery disease ( 5.2 ).
Assess for hypotension and hyperkalemia ( 5.4 , 5.8 ).
Titrate slowly in patients with impaired hepatic or severely impaired renal function ( 5.6 , 5.7 ).
5.1 Fetal Toxicity Amlodipine and benazepril hydrochloride can cause fetal harm when administered to a pregnant woman.
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsule as soon as possible [see Use in Specific Populations ( 8.1 )].
5.2 Angioedema and Anaphylactoid Reactions Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with benazepril.
This may occur at any time during treatment.
Angioedema associated with edema of the larynx, tongue, or glottis can compromise the airway and be fatal.
If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, discontinue treatment with amlodipine and benazepril hydrochloride capsule and treat immediately.
When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, appropriate therapy, e.g., administer subcutaneous epinephrine injection 1:1000 (0.3 to 0.5 mL), promptly [ see Adverse Reactions ( 6 ) ].
Patients with a history of angioedema may be at increased risk for angioedema while receiving amlodipine and benazepril hydrochloride capsules.
Black patients receiving ACE inhibitors have a higher incidence of angioedema compared to nonblacks.
Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema [see Drug Interactions ( 7 )].
Intestinal Angioedema Intestinal angioedema has been reported in patients treated with ACE inhibitors.
These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.
The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor.
Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Anaphylactoid Reactions During Desensitization Two patients undergoing desensitizing treatment with hymenoptera (wasp sting) venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.
Anaphylactoid Reactions During Membrane Exposure Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor.
Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
5.3 Increased Angina and/or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
5.4 Hypotension Amlodipine and benazepril hydrochloride can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure, or death.
Symptomatic hypotension is most likely to occur in patients who have heart failure, severe aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy or have been volume or salt depleted as a result of diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.
Correct volume and salt depletion before starting therapy with benazepril.
If hypotension occurs, place the patient in the supine position and give physiological saline intravenously if needed.
Continue treatment with benazepril once blood pressure and volume have returned to normal.
In patients with congestive heart failure, start amlodipine and benazepril hydrochloride capsules therapy under close medical supervision; follow closely for the first 2 weeks of treatment and whenever the dose of the benazepril component is increased or a diuretic is added or its dose increased.
In patients undergoing surgery or during anesthesia with agents that produce hypotension, benazepril will block the angiotensin II formation that could otherwise occur secondary to compensatory renin release.
Hypotension that occurs as a result of this mechanism can be corrected by volume expansion.
5.5 Impaired Renal Function Monitor renal function periodically in patients treated with amlodipine and benazepril hydrochloride.
Changes in renal function, including acute renal failure, can be caused by drugs that affect the RAS.
Patients whose renal function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, severe heart failure, post-myocardial infarction or volume depletion) or who are on NSAIDS or ARBs may be at particular risk of developing acute renal failure on amlodipine and benazepril hydrochloride.
Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on amlodipine and benazepril hydrochloride.
5.6 Hyperkalemia Monitor serum potassium periodically in patients receiving amlodipine and benazepril hydrochloride.
Drugs that affect the RAS can cause hyperkalemia.
Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.
In U.S. placebo-controlled trials of amlodipine and benazepril hydrochloride, hyperkalemia [serum potassium at least 0.5 mEq/L greater than the upper limit of normal (ULN)] not present at baseline occurred in approximately 1.5% of hypertensive patients receiving amlodipine and benazepril hydrochloride.
Increases in serum potassium were generally reversible.
5.7 Hepatitis and Hepatic Failure There have been rare reports of predominantly cholestatic hepatitis and isolated cases of acute liver failure, some of them fatal, in patients on ACE inhibitors.
The mechanism is not understood.
Patients receiving ACE inhibitors who develop jaundice or marked elevation of hepatic enzymes should discontinue the ACE inhibitor and be kept under medical surveillance.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Amlodipine and benazepril hydrochloride capsules can cause fetal harm when administered to a pregnant woman.
Use of drugs that act on the RAS during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the RAS from other antihypertensive agents.
When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.
Pregnant women with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following:
reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death.
Perform serial ultrasound examinations to assess the intra-amniotic environment.
Fetal testing may be appropriate, based on the week of gestation.
Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
If oligohydramnios is observed, consider alternative drug treatment.
Closely observe neonates with histories of in utero exposure to amlodipine and benazepril hydrochloride for hypotension, oliguria, and hyperkalemia.
In neonates with a history of in utero exposure to amlodipine and benazepril hydrochloride, if oliguria or hypotension occurs, support blood pressure and renal perfusion.
Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function.
Data Animal Data Benazepril and Amlodipine:
When rats received benazepril:amlodipine at doses ranging from 5:2.5 to 50:25 mg/kg/day, dystocia was observed at an increasing dose-related incidence at all doses tested.
On a body surface area basis, the 2.5 mg/kg/day dose of amlodipine is twice the amlodipine dose delivered when the maximum recommended dose of amlodipine and benazepril hydrochloride capsules is given to a 60 kg patient.
Similarly, the 5 mg/kg/day dose of benazepril is approximately equivalent with the benazepril dose delivered when the maximum recommended dose of amlodipine and benazepril hydrochloride capsules is given to a 60 kg patient.
No teratogenic effects were seen when benazepril and amlodipine were administered in combination to pregnant rats or rabbits.
Rats received doses of up to 50:25 mg (benazepril:amlodipine)/kg/day (12 times the MRHD on a body surface area basis, assuming a 60 kg patient).
Rabbits received doses of up to 1.5:0.75 mg/kg/day (equivalent to the maximum recommended dose of amlodipine and benazepril hydrochloride capsules given to a 60 kg patient).
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary Amlodipine and benazepril hydrochloride capsules can cause fetal harm when administered to a pregnant woman.
Use of drugs that act on the RAS during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the RAS from other antihypertensive agents.
When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.
Pregnant women with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following:
reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death.
Perform serial ultrasound examinations to assess the intra-amniotic environment.
Fetal testing may be appropriate, based on the week of gestation.
Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
If oligohydramnios is observed, consider alternative drug treatment.
Closely observe neonates with histories of in utero exposure to amlodipine and benazepril hydrochloride for hypotension, oliguria, and hyperkalemia.
In neonates with a history of in utero exposure to amlodipine and benazepril hydrochloride, if oliguria or hypotension occurs, support blood pressure and renal perfusion.
Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function.
Data Animal Data Benazepril and Amlodipine:
When rats received benazepril:amlodipine at doses ranging from 5:2.5 to 50:25 mg/kg/day, dystocia was observed at an increasing dose-related incidence at all doses tested.
On a body surface area basis, the 2.5 mg/kg/day dose of amlodipine is twice the amlodipine dose delivered when the maximum recommended dose of amlodipine and benazepril hydrochloride capsules is given to a 60 kg patient.
Similarly, the 5 mg/kg/day dose of benazepril is approximately equivalent with the benazepril dose delivered when the maximum recommended dose of amlodipine and benazepril hydrochloride capsules is given to a 60 kg patient.
No teratogenic effects were seen when benazepril and amlodipine were administered in combination to pregnant rats or rabbits.
Rats received doses of up to 50:25 mg (benazepril:amlodipine)/kg/day (12 times the MRHD on a body surface area basis, assuming a 60 kg patient).
Rabbits received doses of up to 1.5:0.75 mg/kg/day (equivalent to the maximum recommended dose of amlodipine and benazepril hydrochloride capsules given to a 60 kg patient).
8.2 Lactation Risk Summary Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril, so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of the maternal doses of benazepril and benazeprilat.
Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%.
No adverse effects of amlodipine on the breastfed infant have been observed.
There is no available information on the effects of amlodipine or benazepril on milk production.
8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use In geriatric patients, exposure to amlodipine is increased, thus consider lower initial doses of amlodipine and benazepril hydrochloride [see Clinical Pharmacology ( 12.3 )].
Of the total number of patients who received amlodipine and benazepril hydrochloride in U.S. clinical studies of amlodipine and benazepril hydrochloride, over 19% were 65 years or older while about 2% were 75 years or older.
Overall differences in effectiveness or safety were not observed between these patients and younger patients.
Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
8.6 Hepatic Impairment Exposure to amlodipine is increased in patients with hepatic insufficiency, thus consider using lower doses of amlodipine and benazepril hydrochloride capsules [see Clinical Pharmacology ( 12.3 )] .
8.7 Renal Impairment In patients with severe renal impairment systemic exposure to benazepril is increased.
The recommended dose of benazepril in this subgroup is 5 mg which is not an available strength with amlodipine and benazepril hydrochloride capsules.
Amlodipine and benazepril hydrochloride capsules are not recommended in patients with severe renal impairment.
No dose adjustment of amlodipine and benazepril hydrochloride capsules is needed in patients with mild or moderate impairment of renal function [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.7 ) and Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Potassium supplements/potassium-sparing diuretics: hyperkalemia.
( 7.1 ) Lithium: Increased serum lithium levels; toxicity symptoms.
( 7.1 ) Injectable gold: facial flushing, nausea, vomiting, hypotension.
( 7.1 ) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs):
Risk of renal dysfunction, loss of antihypertensive effect.
( 7.1 ) Do not exceed doses greater than 20 mg daily of simvastatin.
( 7.1 ) mTOR inhibitors: increased risk of angioedema.
( 7.1 ) Dual inhibition of the renin-angiotensin system (RAS):
Increased risk of renal impairment, hypotension, and hyperkalemia.
( 7.1 ) Neprilysin inhibitors: increased risk of angioedema.
( 7.1 )
7.1 Drug/Drug Interactions Amlodipine Simvastatin:
Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin.
Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
CYP3A4 Inhibitors:
Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction.
Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A4 inhibitors to determine the need for dose adjustment.
CYP3A4 Inducers:
No information is available on the quantitative effects of CYP3A4 inducers on amlodipine.
Blood pressure should be monitored when amlodipine is coadministered with CYP3A4 inducers (e.g. rifampicin, St.
John's Wort).
Benazepril Potassium Supplements and Potassium-Sparing Diuretics:
Benazepril can attenuate potassium loss caused by thiazide diuretics.
Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia.
If concomitant use of such agents is indicated, the patient's serum potassium should be monitored frequently.
Lithium:
Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium.
When coadministering amlodipine and benazepril hydrochloride capsules and lithium, frequent monitoring of serum lithium levels is recommended.
Gold:
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including benazepril, may result in deterioration of renal function, including possible acute renal failure.
These effects are usually reversible.
Monitor renal function periodically in patients receiving benazepril and NSAID therapy.
The antihypertensive effect of ACE inhibitors, including benazepril, may be attenuated by NSAIDs.
Antidiabetic Agents:
In rare cases, diabetic patients receiving an ACE inhibitor (including benazepril) concomitantly with insulin or oral antidiabetics may develop hypoglycemia.
Such patients should therefore be advised about the possibility of hypoglycemic reactions and should be monitored accordingly.
Mammalian Target of Rapamycin (mTOR) Inhibitors:
The risk of angioedema may be increased in patients receiving coadministration of ACE inhibitors and mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus).
Dual Blockade of the Renin-Angiotensin System (RAS):
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy.
In general, avoid combined use of RAS inhibitors.
Closely monitor blood pressure, renal function and electrolytes in patients on amlodipine and benazepril hydrochloride and other agents that block the RAS.
Do not coadminister aliskiren with amlodipine and benazepril hydrochloride in patients with diabetes.
Avoid use of aliskiren with amlodipine and benazepril hydrochloride in patients with renal impairment [glomerular filtration rate (GFR) ˂ 60 mL/min].
Neprilysin Inhibitor:
Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema. [see Warnings and Precautions ( 5.1 )].

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Only a few cases of human overdose with amlodipine have been reported.
One patient was asymptomatic after a 250 mg ingestion; another, who combined 70 mg of amlodipine with an unknown large quantity of a benzodiazepine, developed refractory shock and died.
Human overdoses with any combination of amlodipine and benazepril have not been reported.
In scattered reports of human overdoses with benazepril and other ACE inhibitors, there are no reports of death.
Treatment Patients should be admitted to hospital and, generally, should be managed in an intensive care setting, with continuous monitoring of cardiac function, blood gases, and blood biochemistry.
Emergency supportive measures such as artificial ventilation or cardiac pacing should be instituted if appropriate.
In the event of a potentially life-threatening oral overdose, use induction of vomiting or gastric lavage and/or activated charcoal to remove the drug from the gastrointestinal tract (only if presented within 1 hour after ingestion of amlodipine and benazepril hydrochloride).
Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care.
To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison-Control Center.
Telephone numbers of certified poison-control centers are listed in the Physicians' Desk Reference (PDR).
In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.
The most likely effect of overdose with amlodipine and benazepril hydrochloride capsule is vasodilation, with consequent hypotension and tachycardia.
Simple repletion of central fluid volume (Trendelenburg positioning, infusion of crystalloids) may be sufficient therapy, but pressor agents (norepinephrine or high-dose dopamine) may be required.
With abrupt return of peripheral vascular tone, overdoses of other dihydropyridine calcium channel blockers have sometimes progressed to pulmonary edema, and patients must be monitored for this complication.
Analyses of bodily fluids for concentrations of amlodipine, benazepril, or their metabolites are not widely available.
Such analyses are, in any event, not known to be of value in therapy or prognosis.
No data are available to suggest physiologic maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of amlodipine, benazepril, or their metabolites.
Benazeprilat is only slightly dialyzable; attempted clearance of amlodipine by hemodialysis or hemo-perfusion has not been reported, but amlodipine's high protein binding makes it unlikely that these interventions will be of value.
Angiotensin II could presumably serve as a specific antagonist-antidote to benazepril, but angiotensin II is essentially unavailable outside of scattered research laboratories.

Quoted from the official label, section “Overdosage”.

Use in children

Risk Summary Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril, so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of the maternal doses of benazepril and benazeprilat.
Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%.
No adverse effects of amlodipine on the breastfed infant have been observed.
There is no available information on the effects of amlodipine or benazepril on milk production.

Quoted from the official label, section “Pediatric Use”.

Use in older people

In geriatric patients, exposure to amlodipine is increased, thus consider lower initial doses of amlodipine and benazepril hydrochloride [see Clinical Pharmacology ( 12.3 )].
Of the total number of patients who received amlodipine and benazepril hydrochloride in U.S. clinical studies of amlodipine and benazepril hydrochloride, over 19% were 65 years or older while about 2% were 75 years or older.
Overall differences in effectiveness or safety were not observed between these patients and younger patients.
Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

Discontinuation because of adverse reactions occurred in 4% of amlodipine and benazepril hydrochloride-treated patients and 3% of placebo-treated patients.
The most common reasons for discontinuation of therapy with amlodipine and benazepril hydrochloride were cough and edema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Amlodipine and benazepril hydrochloride has been evaluated for safety in over 2,991 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 400 were treated for more than 1 year.
In a pooled analysis of 5 placebo-controlled trials involving amlodipine and benazepril hydrochloride capsules doses up to 5 mg/20 mg, the reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy.
Discontinuation of therapy due to side effects was required in approximately 4% of patients treated with amlodipine and benazepril hydrochloride capsules and in 3% of patients treated with placebo.
The most common reasons for discontinuation of therapy with amlodipine and benazepril hydrochloride capsules in these studies were cough and edema (including angioedema).
The peripheral edema associated with amlodipine use is dose-dependent.
When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced.
The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans.
However, all patient groups benefit from the reduction in amlodipine-induced edema.
The side effects considered possibly or probably related to study drug that occurred in these trials in more than 1% of patients treated with amlodipine and benazepril hydrochloride are shown in the table below.
Cough was the only adverse event with at least possible relationship to treatment that was more common on amlodipine and benazepril hydrochloride capsules (3.3%) than on placebo (0.2%).
Percent Incidence in U.
S.
Placebo-controlled Trials Benazepril/Amlodipine N = 760 Benazepril N = 554 Amlodipine N = 475 Placebo N = 408 Cough 3.3 1.8 0.4
0.2 Headache 2.2 3.8 2.9
5.6 Dizziness 1.3 1.6 2.3
1.5 Edema Edema refers to all edema, such as dependent edema, angioedema, facial edema. 2.1 0.9 5.1
2.2 The incidence of edema was greater in patients treated with amlodipine monotherapy (5.1%) than in patients treated with amlodipine and benazepril hydrochloride capsules (2.1%) or placebo (2.2%).
Other side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials of patients treated with amlodipine and benazepril hydrochloride capsules or in postmarketing experience were the following:
Body as a Whole Asthenia and fatigue.
CNS Insomnia, nervousness, anxiety, tremor, and decreased libido.
Dermatologic Flushing, hot flashes, rash, skin nodule, and dermatitis.
Digestive Dry mouth, nausea, abdominal pain, dyspepsia, and esophagitis.
Hematologic Neutropenia Musculoskeletal Cramps, and muscle cramps.
Urogenital Sexual problems such as impotence, and polyuria.
Monotherapies of benazepril and amlodipine have been evaluated for safety in clinical trials in over 6,000 and 11,000 patients, respectively.
The observed adverse reactions to the monotherapies in these trials were similar to those seen in trials of amlodipine and benazepril hydrochloride.
6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In postmarketing experience with benazepril, there have been rare reports of Stevens-Johnson syndrome, pancreatitis, hemolytic anemia, pemphigus, thrombocytopenia, paresthesia, dysgeusia, orthostatic symptoms and hypotension, angina pectoris and arrhythmia, pruritus, photosensitivity reaction, arthralgia, arthritis, myalgia, blood urea nitrogen (BUN) increase, serum creatinine increase, renal impairment, vision impairment, agranulocytosis, neutropenia.
Rare reports in association with use of amlodipine:
gingival hyperplasia, tachycardia, jaundice, and hepatic enzyme elevations (mostly consistent with cholestasis severe enough to require hospitalization) , leukocytopenia, allergic reaction, hyperglycemia, dysgeusia, hypoesthesia, paresthesia, syncope, peripheral neuropathy, hypertonia, visual impairment, diplopia, hypotension, vasculitis, rhinitis, gastritis, hyperhidrosis, pruritus, skin discoloration, urticaria, erythema multiform, muscle spasms, arthralgia, micturition disorder, nocturia, erectile dysfunction, malaise, weight decrease or gain.
Other potentially important adverse experiences attributed to other ACE inhibitors and calcium channel blockers include:
eosinophilic pneumonitis (ACE inhibitors) and gynecomastia (CCBs).

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Pregnancy:
Advise female patients of childbearing age about the consequences of exposure to amlodipine and benazepril hydrochloride during pregnancy.
Discuss treatment options with women planning to become pregnant.
Ask patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations (8.1 )].
Symptomatic Hypotension:
Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider.
Tell patients that if syncope occurs to discontinue amlodipine and benazepril hydrochloride capsules until the physician has been consulted.
Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see Warnings and Precautions ( 5.3 )] .
Hyperkalemia:
Advise patients not to use salt substitutes without consulting their healthcare provider [see Drug Interactions ( 7) ] .
LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.
Manufactured for: Lupin Pharmaceuticals, Inc.
Naples, FL 34108 United States MADE IN INDIA Revised: October 2024 Image

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Capsules (amlodipine/benazepril mg):
2.5/10, 5/10, 5/20, 5/40, 10/20, 10/40 ( 3 ) Amlodipine and benazepril hydrochloride capsules, USP are available as follows:
2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Amlodipine and benazepril hydrochloride capsules USP are available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations:
2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg.
Amlodipine and benazepril hydrochloride capsules USP, 2.5 mg/10 mg are size '2' capsules with white opaque cap and white opaque body, imprinted with 'LU' (in black ink) on cap and 'E11' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet, debossed with '1' on one side and plain on the other side.
NDC 68180-755-01 Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 5 mg/10 mg are size '2' capsules with yellow opaque cap and yellow opaque body, imprinted with 'LU' (in black ink) on cap and 'E12' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet, debossed with '1' on one side and plain on the other side.
NDC 68180-756-01 Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 5 mg/20 mg are size '2' capsules with flesh opaque cap and flesh opaque body, imprinted with 'LU' (in black ink) on cap and 'E13' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet, plain on both sides.
NDC 68180-459-01 Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 5 mg/40 mg are size '2' capsules with dark green cap and white body, imprinted with 'LU' (in black ink) on cap and 'E15' (in black ink) on body, containing white to off-white powder and two white to off-white, circular tablets, plain on both sides.
NDC 68180-463-01 Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 10 mg/20 mg are size '2' capsules with brown cap and brown body, imprinted with 'LU' (in black ink) on cap and 'E14' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet, plain on both sides.
NDC 68180-472-01 Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 10 mg/40 mg are size '2' capsules with dark blue cap and white body, imprinted with 'LU' (in black ink) on cap and 'E16' (in black ink) on body, containing white to off-white powder and two white to off-white, circular tablets, plain on both sides.
NDC 68180-473-01 Bottles of 100 capsules Storage :
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature.] Protect from moisture.
Dispense in tight container (USP).

Quoted from the official label, section “How Supplied”.

What is in it

Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is Its empirical formula is C 24 H 28 N 2 O 5
HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is Its empirical formula is C 20 H 25 ClN 2 O 5
C 6 H 6 O 3 S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations:
2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide. image image

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose anhydrousMilk sugar: matters with lactose intolerance or a milk allergy.
Colour dyesD&C Yellow #10 (present in 5 mg/40 mg strength); FD&C Blue #1 (present in 10 mg/40 mg strength); FD&C Blue #2 (present in 10 mg/20 mg strength); FD&C Green #3 (present in 5 mg/40 mg strength); FD&C Red #40 (present in 10 mg/40 mg strength); FD&C Yellow #6 (present in 5 mg/ 40 mg strength)Some people react to dyes such as tartrazine (Yellow 5) or carmine.
GelatingelatinAnimal-derived: matters for vegetarian, vegan, halal and kosher diets.
Titanium dioxidetitanium dioxide (not present in 10 mg/20 mg strength)A whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (14)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 14 of 14

Details

Made by	Lupin Pharmaceuticals, Inc.
Active substance	Amlodipine Besylate and Benazepril Hydrochloride
Used in	Heart, blood pressure and circulation
Strength	5 mg + 10 mg
Form	Capsule
Route	Oral
Packs	100 CAPSULE in 1 BOTTLE
NDC	68180-756

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

42 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Capsule42 products
- 2.5 mg + 10 mg4
  2.5 mg + 10 mg · 4 companies
- 5 mg + 10 mg8
  5 mg + 10 mg · 8 companies
  - A-S Medication Solutions
  - Amneal Pharmaceuticals NY LLC
  - BluePoint Laboratories
  - Bryant Ranch Prepack
  - Dr.Reddy's Laboratories Limited
  - Lupin Pharmaceuticals, Inc. · this page
  - PD-Rx Pharmaceuticals, Inc.
  - REMEDYREPACK INC.
- 5 mg + 40 mg6
  5 mg + 40 mg · 6 companies
- 5 mg + 20 mg7
  5 mg + 20 mg · 7 companies
- 10 mg + 20 mg10
  10 mg + 20 mg · 10 companies
  +2 more
- 10 mg + 40 mg6
  10 mg + 40 mg · 6 companies
- 20 mg + 5 mg

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Amlodipine Besylate and Benazepril Hydrochloride