Benazepril

What is Benazepril?

• Benazepril (Lotensin) is an angiotensin-converting enzyme (ACE) inhibitor used for the treatment of hypertension, to lower blood pressure.

Benazepril structure

Benazepril-3D-balls

Benazeprilat

What are the uses of this medicine?

• Benazepril (Lotensin) is used 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.
• It may be used alone or in combination with thiazide diuretics.

How does this medicine work?

• Benazepril (ben az' e pril) is an ACE inhibitor which is widely used in the therapy of hypertension.
• Like other ACE inhibitors, benazepril inhibits the conversion of angiotensin I, a relatively inactive molecule, to angiotensin II which is the major mediator of vasoconstriction and volume expansion induced by the renin-angiotensin system.
• Other host enzymes besides that which converts angiotensin I to II may be inhibited as well, which may account for some of the side effects of the ACE inhibitors.

Who Should Not Use this medicine ?

This medicine cannot be used 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
• in combination with a neprilysin inhibitor (e.g., sacubitril)
• co-administration with aliskiren in patients with diabetes

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• diuretics ('water pills'), lithium (Lithobid), and potassium supplements
• valsartan and sacubitril (Entresto) or if you have stopped taking it within the last 36 hours

Is this medicine FDA approved?

• Benazepril was approved for use in the United States in 1991 and current indications are for therapy of hypertension, either alone or in combination with other agents.

How should this medicine be used?

Recommended dosage: Adult Patients:

• The recommended initial dose for patients not receiving a diuretic is 10 mg once a day.
• The usual maintenance dosage range is 20 mg to 40 mg per day administered as a single-dose or in two equally divided doses.

Use with diuretics in adults:

• The recommended starting dose of benazepril HCl tablets in a patient on a diuretic is 5 mg once daily.

Pediatric patients age 6 years and above with glomerular filtration rate (GFR) > 30 mL/min/1.73 m2:

• The recommended starting dose for pediatric patients is 0.2 mg/kg once per day.
• Titrate as needed to 0.6 mg/kg once per day.
• Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied in pediatric patients.

Renal Impairment:

• Initiate with 5 mg once daily in patients with GFR < 30 mL/min/1.73 m2 (serum creatinine > 3 mg/dL).

Administration:

• Benazepril comes as a tablet to take by mouth.
• It is usually taken once or twice a day with or without food.
• To help you remember to take benazepril, take it around the same time every day.
• Your doctor will probably start you on a low dose of benazepril and gradually increase your dose.
• Benazepril controls high blood pressure but does not cure it.
• Continue to take benazepril even if you feel well.
• Do not stop taking benazepril without talking to your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg, 10 mg, 20 mg, 40 mg

This medicine is available in fallowing brand namesː

• Lotensin

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• fatigue
• headache
• cough
• gastrointestinal upset
• skin rash

Benazepril may cause serious side effects include:

• Stevens-Johnson syndrome
• pemphigus
• apparent hypersensitivity reactions
• Thrombocytopenia
• hemolytic anemia
• Anxiety
• decreased libido
• hypertonia
• insomnia
• nervousness
• paresthesia
• asthma
• bronchitis
• dyspnea
• sinusitis
• urinary tract infection
• frequent urination
• infection
• arthritis
• impotence
• alopecia
• arthralgia
• myalgia
• asthenia
• sweating

What special precautions should I follow?

• Benazepril can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue benazepril HCl as soon as possible
• Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx including some fatal reactions, have occurred in patients treated with benazepril. Patients receiving co-administration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.
• Intestinal angioedema has occurred in patients treated with ACE inhibitors.
• Benazepril HCl can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure, or death. In such patients, follow closely for the first 2 weeks of treatment and whenever the dose of benazepril or diuretic is increased. Avoid use of benazepril HCl in patients who are hemodynamically unstable after acute MI.
• In patients undergoing major surgery or during anesthesia with agents that produce hypotension, benazepril HCl may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs, correct by volume expansion.
• Serum potassium should be monitored periodically in patients receiving benazepril. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia.
• ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
• Benazepril is associated with a low rate of transient serum aminotransferase elevations and has been linked to rare instances of acute liver injury.
• Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• hypotension
• Hypotension can be associated with electrolyte disturbances and renal failure

Management of overdosage:

• Benazepril is only slightly dialyzable, but consider dialysis to support patients with severely impaired renal function.
• If ingestion is recent, consider activated charcoal.
• Consider gastric decontamination (e.g., vomiting, gastric lavage) in the early period after ingestion.
• Monitor for blood pressure and clinical symptoms.
• Supportive management should be employed to ensure adequate hydration and to maintain systemic blood pressure.
• In the case of marked hypotension, infuse physiological saline solution; as needed, consider vasopressors (e.g., catecholamines i.v.).

Can this medicine be used in pregnancy?

• Benazepril can cause fetal harm when administered to a pregnant woman.
• When pregnancy is detected, discontinue benazepril HCl as soon as possible.

Can this medicine be used in children?

• Safety and effectiveness of benazepril HCl have not been established in pediatric patients less than 6 years of age or in children with glomerular filtration rate < 30 mL/min/1.73 m².
• Infants below the age of 1 year should not be given benazepril HCl because of the risk of effects on kidney development.

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• Benazepril HCl

Inactive Ingredients:

• crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and talc

Who manufactures and distributes this medicine?

Distributed by:

• Amneal Pharmaceuticals LLC
• Bridgewater, NJ

What should I know about storage and disposal of this medication?

* Store at 20º to 25°C (68° to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF).

• Dailymed label info on Benazepril
• FDA Benazepril

Benazepril Resources
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Common ACE inhibitors include the following:

• Benazepril
• Captopril
• Enalapril
• Fosinopril
• Lisinopril
• Moexipril
• Perindopril
• Quinapril
• Ramipril
• Trandolapril