Amlodipine besylate and benazepril hydrochloride is the generic equivalent of the brand-name drug Amlodipine Besylate and Benazepril Hydrochloride. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Amlodipine besylate and benazepril hydrochloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
Clinical Identifiers
- RxCUI
- 898342898356
- Therapeutic Equivalence (TE) Code
ABTherapeutically equivalent — meets FDA bioequivalence requirements
- Pharmacologic Class
- ["Angiotensin Converting Enzyme Inhibitor [EPC]","Angiotensin-converting Enzyme Inhibitors [MoA]","Calcium Channel Antagonists [MoA]","Calcium Channel Blocker [EPC]","Cytochrome P450 3A Inhibitors [MoA]","Decreased Blood Pressure [PE]","Dihydropyridine Calcium Channel Blocker [EPC]","Dihydropyridines [CS]"]
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 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.
Adverse Reactions
6 ADVERSE REACTIONS 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 Dr. Reddy’s Laboratories Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical tr…
Drug Interactions
7 DRUG INTERACTIONS 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 syst…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 capsules is 1 capsule of…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION 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 th…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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