Benazepril Hydrochloride / Hydrochlorothiazide

Pronunciation: (BEN-AZE-uh-pril HIGH-droe-CLOR-ide/high-droe-klor-oh-THIGH-uh-zide)Class: Antihypertensive

Trade Names:Lotensin HCT- Tablets 5 mg benazepril/6.25 mg hydrochlorothiazide- Tablets 20 mg benazepril/25 mg hydrochlorothiazide- Tablets 20 mg benazepril/12.5 mg hydrochlorothiazide- Tablets 10 mg benazepril/12.5 mg hydrochlorothiazide

Pharmacology

Benazepril

Competitively inhibits angiotensin I-converting enzyme, resulting in the prevention of angiotensin I conversion to angiotensin II, a potent vasoconstrictor that stimulates aldosterone secretion. This action results in a decrease in sodium and fluid retention, increase in diuresis and a decrease in BP.

Hydrochlorothiazide

Increases chloride, sodium, and water excretion by interfering with transport of sodium ions across renal tubular epithelium.

Indications and Usage

Treatment of hypertension. This fixed combination drug is not intended for the initial therapy of hypertension.

Contraindications

Anuric patients; patients hypersensitive to benazepril or any other ACE inhibitor; hydrochlorothiazide or other sulfonamide derivative.

Dosage and Administration

Adults

PO Combination therapy with once-daily doses of 5 to 20 mg benazepril and 6.25 to 25 mg of hydrochlorothiazide in the morning and evening; take this medicine with or without food.

Storage/Stability

Store tablets at controlled room temperature (less than 86°F). Keep container tightly closed. Protect from moisture and light.

Drug Interactions

Cholestyramine, colestipol

May impair the absorption of hydrochlorothiazide.

Insulin

In diabetic patients, requirements of insulin may be increased, decreased, or unchanged.

Lithium

Plasma levels of lithium may be elevated, increasing the risk of toxicity.

Potassium supplements, potassium-sparing diuretics (eg, spironolactone)

Increased risk of hyperkalemia.

Tubocurarine

Effects may be increased.

Laboratory Test Interactions

Hydrochlorothiazide may decrease serum protein-bound iodine levels without signs of thyroid disturbances.

Adverse Reactions

Cardiovascular

Postural dizziness; hypotension; palpitations; syncope; tachycardia; peripheral vascular disorder; orthostatic hypotension.

CNS

Dizziness; headache; fatigue; somnolence; insomnia; nervousness; vertigo; lightheadedness; weakness; restlessness.

Dermatologic

Rash; sweating; photosensitivity; purpura; urticarial rash; Stevens-Johnson syndrome.

EENT

Tinnitus; rhinitis; sinusitis; transient blurred vision; xanthopsia.

GI

Nausea; vomiting; diarrhea; dyspepsia; anorexia; constipation; dry mouth; paresthesia; taste perversion; pancreatitis; sialadenitis; cramping; gastric irritation.

Genitourinary

Impotence; urinary frequency; decreased libido.

Hematologic

Aplastic anemia; agranulocytosis; leukopenia; thrombocytopenia.

Hepatic

Intrahepatic cholestatic jaundice.

Metabolic

Gout; hyperglycemia; glucosuria.

Respiratory

Cough; upper respiratory infection; respiratory distress (including pneumonitis, pulmonary edema).

Miscellaneous

Hypertonia; angioedema (including edema of lips and face); flushing; arthralgia; myalgia; asthenia; pain (including chest and abdominal); back pain; flu-like syndrome; muscle spasm; necrotizing angiitis.

Precautions

Warnings When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, discontinue therapy as soon as possible.

Monitor Ensure that volume and/or salt depletion have been corrected before initiating therapy. Monitor and record BP and pulse. Should hypotension result, hold medication and notify health care provider. Monitor blood sugar in diabetic patient when drug is started or dose is changed. Report significant changes to health care provider.

Pregnancy

Category D (second and third trimester); Category C (first trimester). ACE inhibitors (eg, benazepril) can cause injury or death to fetus if used during second or third trimester. When pregnancy is detected, discontinue as soon as possible.

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Renal Function

Use with caution.

Hepatic Function

Use with caution.

Angioedema

Use with extreme caution in patients with hereditary angioedema. Angioedema associated with laryngeal edema may be fatal.

Hypotension

Decreases in BP may occur, especially in salt- or volume-depleted patients as a result of dialysis, prolonged diuretic therapy, dietary salt restriction, diarrhea, or vomiting. Volume and salt depletion should be corrected before initiating therapy with benazepril/hydrochlorothiazide.

Neutropenia/agranulocytosis

Has occurred with other ACE inhibitors.

Overdosage

Symptoms

Dehydration, electrolyte disturbances, hypotension.

Patient Information

• Advise patient to take prescribed dose once daily without regard to meals.
• Advise patient to try to take each dose at about the same time each day.
• Inform patient that drug controls, but does not cure, hypertension and to continue taking drug as prescribed even when BP is not elevated.
• Caution patient not to change the dose or stop taking unless advised by health care provider.
• Instruct patient to continue taking other BP medications as prescribed by health care provider.
• Instruct patient in BP and pulse measurement skills.
• Advise patient to monitor and record BP and pulse at home and to inform health care provider should abnormal measurements be noted. Also advise patient to take record of BP and pulse to each follow-up visit.
• Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
• Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing.
• Caution patient that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to excessive fall in BP resulting in lightheadedness or fainting.
• Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
• Caution patient to avoid unnecessary exposure to UV light (eg, sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light to avoid photosensitivity reaction.
• Emphasize to hypertensive patient importance of other modalities on BP: Weight control, regular exercise, smoking cessation, moderate intake of alcohol and salt.
• Caution patient to not take any potassium-containing salt substitutes or potassium supplements unless advised by health care provider.
• Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: fainting, swelling of the face, lips, eyelids, or tongue, difficulty breathing.
• Instruct patient to inform health care provider if a persistent cough develops while taking this medication.

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