Drugplain

Amlodipine and Benazepril Hydrochloride 10 mg/1

Amlodipine and Benazepril Hydrochloride · CAPSULE · A-S Medication Solutions

No Recall HistoryCurrently in Shortage
Plain English

Amlodipine and Benazepril Hydrochloride is a capsule containing amlodipine and benazepril hydrochloride at 10 mg/1, taken oral. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
Amlodipine and Benazepril Hydrochloride
Generic Name
Amlodipine and Benazepril Hydrochloride
NDC Code (Product)
50090-2720
Manufacturer
A-S Medication Solutions
Strength
10 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA202239
Marketing Start
09/05/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

asthenia2 reports
back pain2 reports
cough2 reports
dizziness2 reports
fatigue2 reports
adrenocortical insufficiency acute1 reports
alopecia1 reports
arthralgia1 reports
cystitis1 reports
deep vein thrombosis1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

Dosage & Administration

2 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 ) 2.1 General Considerations The recommended initial dose is amlodipine 2.5 mg and 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 capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg and benazepril 40 mg once-daily. The dosing should be individualized and adjusted according to the patient’s clinical response. In clinical trials of amlodipine and bena…

Contraindications

4 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). 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) ]. 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 am…

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 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…

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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 tria…

Frequently Asked Questions

What is Amlodipine and Benazepril Hydrochloride used for?

Amlodipine and Benazepril Hydrochloride contains Amlodipine and Benazepril Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is Amlodipine and Benazepril Hydrochloride a controlled substance?

Amlodipine and Benazepril Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Amlodipine and Benazepril Hydrochloride?

The generic name for Amlodipine and Benazepril Hydrochloride is Amlodipine and Benazepril Hydrochloride. There are no other listed brand versions of Amlodipine and Benazepril Hydrochloride.

What is the NDC code for Amlodipine and Benazepril Hydrochloride 10 mg/1?

The NDC (National Drug Code) for Amlodipine and Benazepril Hydrochloride 10 mg/1 is 50090-2720, listed by A-S Medication Solutions.

Product NDC

50090-2720

Package NDC

50090-2720-0

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)