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Fixed-dose combination

Amlodipine and Benazepril

Also known as amlodipine besylate, benazepril hydrochloride
Available on request
Presentations
6
Brands
0
Manufacturers
0
Available from stock
0

Amlodipine and Benazepril is a fixed-dose combination of an angiotensin converting enzyme inhibitor, a calcium channel blocker and a dihydropyridine calcium channel blocker. It is available as capsules for oral use. MedsAcross supplies Amlodipine and Benazepril for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Angiotensin Converting Enzyme Inhibitor, Calcium Channel Blocker, Dihydropyridine Calcium Channel Blocker, Angiotensin-converting Enzyme Inhibitors, Calcium Channel Antagonists, Cytochrome P450 3A Inhibitors, Decreased Blood Pressure
US FDA first approval
3 March 1995
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Capsule
Fixed-dose combination of
Amlodipine, Benazepril
Identifiers
RxCUI 214223CAS 357437-90-2Q4747074

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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

Source: US FDA prescribing information

How it works

Benazepril Benazepril and benazeprilat inhibit 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. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. Hypertensive patients treated with benazepril and amlodipine for up to 56 weeks had elevations of serum potassium up to 0.2 mEq/L. Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.

Source: US FDA prescribing information

Dosing overview

Usual starting dose is 2.5/10 mg. May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor. Patients who experience edema with amlodipine may be switched to amlodipine and benazepril hydrochloride capsules containing a lower dose of amlodipine.

Source: US FDA prescribing information

Contraindications

Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, including amlodipine and benazepril hydrochloride capsules in patients with diabetes. Amlodipine and benazepril hydrochloride capsules are 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 capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. Anaphylactoid reactions, including angioedema. Myocardial infarction or increased angina in patients with obstructive coronary artery disease. Assess for hypotension and hyperkalemia. Titrate slowly in patients with impaired hepatic or severely impaired renal function.

Source: US FDA prescribing information

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.

Source: US FDA prescribing information

Interactions

Potassium supplements/potassium-sparing diuretics: hyperkalemia. Lithium: Increased serum lithium levels, toxicity symptoms. Injectable gold: facial flushing, nausea, vomiting, hypotension. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Risk of renal dysfunction, loss of antihypertensive effect. Do not exceed doses greater than 20 mg daily of simvastatin mTOR inhibitors: increased risk of angioedema. Dual inhibition of the RAS: Increased risk of renal impairment, hypotension, and hyperkalemia. Neprilysin inhibitors: increased risk of angioedema

Source: US FDA prescribing information

Storage

Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture, heat and light.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

6 presentations of Amlodipine and Benazepril, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Amlodipine and Benazepril 10 mg/20 mg capsuleOralGeneric nameAmlodipine and Benazepril—US FDAAvailable on request
Amlodipine and Benazepril 5 mg/20 mg capsuleOralGeneric nameAmlodipine and Benazepril—US FDAAvailable on request
Amlodipine and Benazepril 5 mg/10 mg capsuleOralGeneric nameAmlodipine and Benazepril—US FDAAvailable on request
Amlodipine and Benazepril 10 mg/40 mg capsuleOralGeneric nameAmlodipine and Benazepril—US FDAAvailable on request
Amlodipine and Benazepril 5 mg/40 mg capsuleOralGeneric nameAmlodipine and Benazepril—US FDAAvailable on request
Amlodipine and Benazepril 2.5 mg/10 mg capsuleOralGeneric nameAmlodipine and Benazepril—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 3 March 1995Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Amlodipine and Benazepril in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Amlodipine and Benazepril available for export from India?

Yes, on request. MedsAcross lists 6 presentations of Amlodipine and Benazepril and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Amlodipine and Benazepril approved by the US FDA?

Yes. The US FDA first approved Amlodipine and Benazepril on 3 March 1995, according to Drugs@FDA.

Does Amlodipine and Benazepril need cold chain shipping?

No listed presentation of Amlodipine and Benazepril is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. Amlodipine and Benazepril Hydrochloride prescribing information (Avet Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 6 October 2026

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