Benazepril hydrochloride and hydrochlorothiazide

What is Benazepril hydrochloride and hydrochlorothiazide?

• Benazepril hydrochloride and hydrochlorothiazide (Lotensin HCT) is combination of benazepril a angiotensin-converting enzyme (ACE) inhibitor and hydrochlorothiazide a diuretic used to treat high blood pressure.

Benazepril structure

Benazepril-3D-balls

Hydrochlorothiazide-2D-skeletal

Hydrochlorothiazide-3D-balls

What are the uses of this medicine?

• Benazepril hydrochloride and hydrochlorothiazide (Lotensin HCT) is used for the treatment of hypertension.
• This fixed combination drug is not indicated for the initial therapy of hypertension.

How does this medicine work?

• A combination preparation of the synthetic angiotensin-converting enzyme (ACE) inhibitor prodrug benazepril and the thiazide diuretic hydrochlorothiazide, with antihypertensive activity.
• Benazepril is de-esterified by the liver into its active form benazeprilat, which competitively inhibits ACE.
• ACE inhibition prevents the formation of angiotensin II, and blocks angiotensin II-mediated activities, including vasoconstriction and stimulation of synthesis and secretion of aldosterone, which leads to an increase in sodium excretion and increases water outflow.
• Hydrochlorothiazide inhibits electrolyte reabsorption via binding to the Na-Cl cotransporter on the renal distal tubules, thereby increasing excretion of sodium, potassium, chloride, bicarbonate and water.
• Together, these agents lead to a reduction in blood pressure.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who are anuric
• who are hypersensitive to benazepril, to any other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs
• with a history of angioedema with or without previous ACE inhibitor treatment
• in combination with a neprilysin (e.g., sacubitril)
• coadministration with aliskiren in patients with diabetes

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• cholestyramine (Prevalite)
• colestipol (Colestid)
• insulin
• lithium (Lithobid)
• oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos)
• other diuretics ('water pills')
• other medications for high blood pressure
• potassium supplements
• valsartan
• sacubitril (Entresto) or if you have stopped taking it within the last 36 hours
• have diabetes and you are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT)

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:

• A patient whose blood pressure is not adequately controlled with benazepril alone or with hydrochlorothiazide alone may be switched to combination therapy with Benazepril HCl and Hydrochlorothiazide.
• The usual recommended starting dose is 10/12.5 mg once daily to control blood pressure.
• The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals.
• The maximum recommended dose is 20/25 mg.

Administration:

• The combination of benazepril and hydrochlorothiazide comes as a tablet to take by mouth.
• It is usually taken once a day.
• To help you remember to take benazepril and hydrochlorothiazide, take it around the same time every day.
• Benazepril and hydrochlorothiazide controls high blood pressure but does not cure it.
• Continue to take benazepril and hydrochlorothiazide even if you feel well.
• Do not stop taking benazepril and hydrochlorothiazide 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 for oral administration with a combination of 10 or 20 mg of benazepril and 12.5 or 25 mg of hydrochlorothiazide USP.

This medicine is available in fallowing brand namesː

• Lotensin HCT

What side effects can this medication cause?

The most common side effects of this medicine include:

• Dizziness
• Fatigue
• Postural Dizziness
• Headache
• Cough
• Hypertonia
• Vertigo
• Nausea
• Impotence
• Somnolence

What special precautions should I follow?

• Angioedema, including laryngeal edema, can occur at any time with treatment with ACE inhibitors. A patient receiving Benazepril HCl and Hydrochlorothiazide should be told to report immediately any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to take no more drugs until after consulting with the prescribing physician.
• Female patients of childbearing age should be told about the consequences of exposure to Benazepril HCl and Hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
• Patients receiving Benazepril HCl and Hydrochlorothiazide should be cautioned that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. The patient should be told that if syncope occurs, Benazepril HCl and Hydrochlorothiazide should be discontinued until the physician has been consulted.
• All patients should be cautioned that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.
• Patients receiving Benazepril HCl and Hydrochlorothiazide should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.
• Patients should be told to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia.
• Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
• Minimal amounts of unchanged benazepril and benazeprilat are excreted into the breast milk of lactating women treated with benazepril. Because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide and the unknown effects of benazepril in infants, a decision should be made whether to discontinue nursing or to discontinue Benazepril HCl and Hydrochlorothiazide.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dehydration
• electrolyte depletion (hypokalemia, hypochloremia, hyponatremia)
• hypotension
• hypokalemia
• cardiac arrhythmias

Management of overdosage:

• No specific information is available on the treatment of overdosage with Benazepril HCl and Hydrochlorothiazide; treatment should be symptomatic and supportive.
• Benazeprilat is only slightly dialyzable, but dialysis might be considered in overdosed patients with severely impaired renal function.
• Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of benazepril overdose.
• Because the hypotensive effect of benazepril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat benazepril overdose by infusion of normal saline solution.

Can this medicine be used in pregnancy?

• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
• Female patients of childbearing age should be told about the consequences of exposure to Benazepril HCl and Hydrochlorothiazide during pregnancy.
• Discuss treatment options with women planning to become pregnant.
• Patients should be asked to report pregnancies to their physicians as soon as possible.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BENAZEPRIL HYDROCHLORIDE
• HYDROCHLOROTHIAZIDE

Inactive ingredients:

• MICROCRYSTALLINE CELLULOSE
• CROSPOVIDONE
• HYDROGENATED CASTOR OIL
• FERRIC OXIDE RED
• LACTOSE, UNSPECIFIED FORM
• POLYETHYLENE GLYCOL, UNSPECIFIED
• TALC
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

Distributed by:

• Padagis
• Allegan, MI

Manufactured for:

• Validus Pharmaceuticals LLC
• Parsippany, NJ

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

• Do not store above 86°F (30°C).
• Protect from moisture and light.
• Dispense in a tight, light‑resistant container (USP).

• Dailymed label info on Benazepril hydrochloride and hydrochlorothiazide
• FDA Benazepril hydrochloride and hydrochlorothiazide

Common ACE inhibitors include the following:

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