Amlodipine Besylate / Benazepril Hydrochloride

Pronunciation: (am-LOE-di-peen BES-i-late/ben-AZ-e-pril HYE-droe-KLOR-ide)

Class: Antihypertensive combination
Trade Names:
Lotrel
- Capsules amlodipine 2.5 mg/benazepril 10 mg
- Capsules amlodipine 5 mg/benazepril 10 mg
- Capsules amlodipine 5 mg/benazepril 20 mg
- Capsules amlodipine 5 mg/benazepril 40 mg
- Capsules amlodipine 10 mg/benazepril 20 mg
- Capsules amlodipine 10 mg/benazepril 40 mg
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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, an increase in diuresis, and a decrease in BP.

Indications and Usage

Treatment of hypertension.

Contraindications
History of angioedema, with or without previous ACE inhibitor treatment; hypersensitivity to
amlodipine, benazepril, or any other ACE inhibitor.

Dosage and Administration

Adults

PO 1 capsule (amlodipine 2.5 to 10 mg/benazepril 10 to 40 mg) per day.

Elderly
PO Initially, amlodipine 2.5 mg/day
Renal Function Impairment
CrCl less than 30 mL/min - amlodipine/benazepril not recommended.
Hepatic Function Impairment
PO Initially, amlodipine 2.5 mg/day.

Storage/Stability
Store capsules at 59 to 86F. Protect from moisture and light.
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Drug Interactions
Diuretics
Increased risk of excessive reduction of BP after initiation of amlodipine/benazepril therapy.
Gold therapy (eg, aurothiomalate)
Nitritoid reactions, including facial flushing, hypotension, nausea, and vomiting, may occur.
Potassium supplements, potassium-sparing diuretics (eg, spironolactone)
Increased risk of hyperkalemia.
Lithium
Plasma levels of lithium may be elevated, increasing the risk of toxicity.

Adverse Reactions
CNS
Headache (2%); dizziness (1%); anxiety, decreased libido, fatigue, insomnia, nervousness, tremor.

Dermatologic

Dermatitis, rash, skin nodule; Stevens-Johnson syndrome (postmarketing).

EENT
Esophagitis.

GI
Abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, nausea.

Genitourinary
Impotence, polyuria.

Hematologic
Neutropenia; hemolytic anemia, thrombocytopenia (postmarketing).

Hepatic
Jaundice and hepatic enzyme elevations (consistent with cholestasis) (postmarketing).

Metabolic
Hypokalemia.

Musculoskeletal
Back pain, muscle cramps, musculoskeletal pain.

Respiratory
Cough (3%); pharyngitis.

Miscellaneous
Edema (2%); angioedema, asthenia, cramps, flushing, hot flashes; pancreatitis (postmarketing).
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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
Periodically monitor electrolytes (eg, serum potassium), renal function, and hepatic function. Monitor
renal function more frequently during the first few weeks of therapy in patients with renal artery
stenosis.

Pregnancy
Category D . ACE inhibitors (eg, benazepril) can cause injury or death to the fetus if used during
second or third trimester and can increase the risk of birth defects in the first 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. Do not use in patients with severe renal disease (CrCl less than 30 mL/min).

Angioedema
Has been reported and may be fatal.

Cough
Persistent nonproductive cough, always resolving after discontinuation of therapy, has been reported
with ACE inhibitors.

CV effects

Increased frequency, duration, or severity of angina or acute MI has occurred rarely on initiation of
treatment with a calcium channel blocker or at time of dosage increases. More common among
patients with severe obstructive coronary artery disease.

Hepatic effects
ACE inhibitors have rarely been associated with a syndrome that starts with cholestatic jaundice and
progresses to fulminant hepatic necrosis and, sometimes, death. Discontinue therapy in patients that
develop jaundice or marked elevations of hepatic enzymes.

Hyperkalemia
Has been reported. Risk factors include renal impairment, diabetes mellitus, and concomitant use of
potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.

Hypotension
Has been reported, especially in patients who are volume- or salt-depleted (eg, those undergoing
dialysis, dietary salt restriction, or prolonged diuretic therapy; those who are experiencing diarrhea or
vomiting); use with caution. May also occur in patients undergoing surgery or during anesthesia;
usually corrected by volume expansion.

Neutropenia/Agranulocytosis
Has occurred with ACE inhibitors.

Renal effects
Benazepril use has been associated with oliguria or progressive azotemia and, rarely, acute renal
failure and/or death in patients with severe heart failure. Patients with renal artery stenosis may
experience increases in BUN and serum creatinine that are reversible upon discontinuation of
benazepril.

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 amlodipine/benazepril controls but does not cure hypertension and to
continue taking 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 if abnormal measurements are noted. Also advise patient to take record of BP and
pulse to each follow-up visit.

Instruct patient to sit or lie down if experiencing dizziness or light-headedness when

standing.

Caution patient that inadequate fluid intake, or excessive perspiration, diarrhea, or

vomiting can lead to a fall in BP, resulting in light-headedness or fainting.

Emphasize to patients with hypertension the 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 amlodipine/benazepril 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.

Tell women of childbearing age about the consequences of exposure of the fetus to ACE
inhibitors. Instruct patient to inform health care provider as soon as possible if she becomes
pregnant.
Copyright 2009 Wolters Kluwer Health.
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