DrugindexOnline^{2nd edition}

Pronouncation: (am-LOW-dih-PEEN BEH-sih-LATE/BEN-AZE-uh-pril HIGH-droe-CLOR-ide)
Class: Antihypertensive combination

Trade Names:
Lotrel
- Capsule 2.5 mg amlodipine/10 mg benazepril
- Capsule 5 mg amlodipine/10 mg benazepril
- Capsule 5 mg amlodipine/20 mg benazepril
- Capsule 10 mg amlodipine/20 mg benazepril

Mechanism of Action

Pharmacology

Amlodipine: Inhibits movement of calcium ions across cell membrane in systemic and coronary vascular smooth muscle; 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 blood pressure.

Indications and Usage

Treatment of hypertension.

Contraindications

Hypersensitivity to amlodipine, benazepril, or any other ACE inhibitor.

Dosage and Administration

Adults

PO 1 capsule (2.5 to 10 mg amlodipine/10 to 20 mg benazepril)/day.

Storage/Stability

Store capsules at controlled room temperature (59° to 86°F). Protect from moisture and light.

Drug Interactions

Diuretics

Increased risk of excessive reduction of blood pressure after initiation of amlodipine/benazepril therapy.

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

Increased risk of hyperkalemia.

Lithium

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

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Palpitations.

CNS

Headache; dizziness; somnolence; fatigue; insomnia; nervousness; anxiety; tremor; decreased libido.

Dermatologic

Rash; skin nodule; dermatitis; Stevens-Johnson syndrome.

EENT

Esophagitis.

GI

Dry mouth; nausea; abdominal pain; constipation; diarrhea; dyspepsia.

Genitourinary

Impotence; polyuria.

Hematologic

Hemolytic anemia; thrombocytopenia.

Hepatic

Jaundice; hepatic enzyme elevations consistent with cholestasis.

Metabolic

Hypokalemia.

Respiratory

Cough; pharyngitis.

Miscellaneous

Edema; flushing; hot flashes; angioedema; asthenia; back pain; musculoskeletal pain; cramps; muscle cramps.

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.

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

Amlodipine: Undetermined; benazepril: excreted in breast milk.

Children

Safety and efficacy not established.

Renal Function

Use with caution.

Angioedema

Has been reported and may be fatal.

Hypotension

Has been reported, especially in patients who are volume or salt depleted (eg, those undergoing dialysis, dietary salt restriction, or prolonged diuretic therapy, or who are experiencing diarrhea or vomiting); use with caution.

Neutropenia/agranulocytosis

Has occurred with ACE inhibitors.

Patient Information

• Advise patient to take once daily as prescribed, 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.
• 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.
• Emphasize to hypertensive patient importance of other modalities on BP: weight control, regular exercise, smoking cessation, and moderate intake of alcohol and salt.
• Caution patient to not take any salt substitutes unless advised by health care provider.
• Instruct patient to stop taking drug and immediately report any of these symptoms to health care provider: fainting, swelling of the face, lips, eyelids, or tongue.
• Instruct patient to inform health care provider if a persistent cough or swelling of the ankles or feet develop while taking this medication.