Amlodipine 10 mg / Olmesartan 20 mg Tablets — Generic For Azor — Aurobindo

These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES.

AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use

Initial U.S. Approval: 1995

Warning: Fetal Toxicity

See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride as soon as possible (5.1).

Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus (5.1).

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)

Dosage And Administration

Usual starting dose is 2.5 mg/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)

Dosage Forms And Strengths

Capsules (amlodipine and benazepril hydrochloride): 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. (3)

Contraindications

Do not coadminister aliskiren with ACE inhibitors, including amlodipine and benazepril hydrochloride capsules, in patients with diabetes. (4)

Amlodipine and benazepril hydrochloride capsules are contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to amlodipine. (4)

Amlodipine and benazepril hydrochloride capsules are 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. (4)

Warnings And Precautions

Anaphylactoid reactions, including angioedema. (5.2)

Myocardial infarction or increased angina in patients with obstructive coronary artery disease. (5.3)

Assess for hypotension and hyperkalemia. (5.4, 5.6)

Titrate slowly in patients with impaired hepatic or severely impaired renal function. (5.5, 5.7)

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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 RAS: Increased risk of renal impairment, hypotension, and hyperkalemia (7.1)

Neprilysin inhibitors: increased risk of angioedema (7.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2021