Benazepril Hydrochloride 40 mg/1

Benazepril Hydrochloride · TABLET, FILM COATED · A-S Medication Solutions

1 Recall on RecordCurrently in Shortage

Plain English

Benazepril hydrochloride is a prescription tablet taken by mouth that belongs to a class of medications called ACE inhibitors, which are commonly used to treat high blood pressure and heart failure. Your doctor will determine the right dose for your individual needs based on your medical condition and other factors.

Key Facts

Brand Name: Benazepril Hydrochloride
Generic Name: Benazepril Hydrochloride
NDC Code (Product): 50090-3359
Manufacturer: A-S Medication Solutions
Strength: 40 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: ANDA078212
Marketing Start: 05/22/2008

Recall History

1 Recall on Record

Class II04/09/2012

Dr. Reddy's Laboratories, Inc.

Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue288 reports

nausea256 reports

diarrhoea254 reports

drug ineffective234 reports

headache233 reports

dyspnoea228 reports

dizziness213 reports

pain211 reports

asthenia175 reports

pruritus168 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular mor…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Adult Patients: Initiate with 10 mg once daily (or 5 mg if patient is on diuretic). Titrate to 40 mg daily based on blood pressure response. ( 2.1 ) • Pediatric patients age 6 years and above with glomerular filtration rate (GFR) >30 mL/min/1.73 m 2 : Initiate with 0.2 mg/kg once daily. Maximum dose is 0.6 mg/kg once daily. • Renal Impairment: Initiate with 5 mg once daily in patients with GFR <30 mL/min/1.73 m 2 (serum creatinine >3 mg/dL) ( 2 .2) 2.1 Recommended Dosage ADULTS The recommended initial dose for patients not receiving a diuretic is 10 mg once a day. The usual maintenance dosage range is 20 to 40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited. The divided regimen was more effective in controlling trough (pre-dosing) blood pressure than the same dose given as a once-daily regimen. Use with diuretics in adults The recommended starting dose of benazepril hydrochloride tablets in a patient on a diuretic is 5 mg once daily. If blood pressure is not controlled with benazepril hydrochloride alone, a low dose of diuretic may be added. …

Contraindications

4 CONTRAINDICATIONS Benazepril hydrochloride tablets are contraindicated in patients: • who are hypersensitive to benazepril or to any other ACE inhibitor • with a history of angioedema with or without previous ACE inhibitor treatment Benazepril hydrochloride tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2)]. Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors; including benazepril hydrochloride tablets in patients with diabetes [see Drug Interactions ( 7.4 )] . • Angioedema or history of hereditary or idiopathic angioedema ( 4 ) • Hypersensitivity ( 4 ) • Co-administration with aliskiren in patients with diabetes ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Diuretics: Excessive drop in blood pressure ( 7.1 ) • Antidiabetics: Increased risk of hypoglycaemia ( 7.2 ) • NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy ( 7.3 ) • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ) • Lithium: Symptoms of lithium toxicity ( 7.6 ) • Neprilysin Inhibitor: Increased risk of angioedema ( Error! Hyperlink reference not valid. ) • Gold: Nitritoid reactions ( 7.8 ) 7.1 Diuretics Hypotension Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with benazepril hydrochloride. The possibility of hypotensive effects with benazepril hydrochloride can be minimized by either discontinuing or decreasing the dose of diuretic prior to initiation of treatment with benazepril hydrochloride [see Dosage and Administration ( 2.1 )]. Hyperkalemia Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is i…

Adverse Reactions

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Benazepril hydrochloride has been evaluated for safety in over 6000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in benazepril hydrochloride and placebo patients. The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 to 80 mg. Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with benazepril hydrochloride and in 3% of patients treated with placebo. The most common reasons for discontinuation were headache (0.6%) and cough (0.5%). Adverse reactions seen in at least 1% greater frequency in patients treated with benazepril hydrochloride than placebo were headache (6% vs. 4%), dizziness (4% vs. 2%), somnolence (2% vs. 0%)…

Frequently Asked Questions

What is Benazepril Hydrochloride used for?

Is Benazepril Hydrochloride a controlled substance?

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

What is the generic name for Benazepril Hydrochloride?

The generic name for Benazepril Hydrochloride is Benazepril Hydrochloride. There are 3 other brand versions of Benazepril Hydrochloride.

What is the NDC code for Benazepril Hydrochloride 40 mg/1?

The NDC (National Drug Code) for Benazepril Hydrochloride 40 mg/1 is 50090-3359, listed by A-S Medication Solutions.

Product NDC

50090-3359

Package NDC

50090-3359-0

Other Benazepril Hydrochloride Dosages

Other Benazepril Brands

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

Data from openFDA · Public domain (CC0 1.0)