Lotrel
Lotrel®
(amlodipine besylate and benazepril hydrochloride) Combination Capsules
2.5 mg/10 mg
5 mg/10 mg
5 mg/20 mg
5 mg/40 mg
10 mg/20 mg
10 mg/40 mg
USE IN PREGNANCY
When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Lotrel should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
DRUG DESCRIPTION
Lotrel Oral (amlodipine / benazepril - oral)
This medication is a combination of two drugs, a calcium channel blocker (amlodipine) and an ACE inhibitor (benazepril). It is used to treat high blood pressure (hypertension). It works by relaxing blood vessels, causing them to widen. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems.
Benazepril hydrochloride is a white to off-white crystalline powder, soluble ( > 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3- phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is
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Its empirical formula is C24H28N2O5•HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group.
Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4- (2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is
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Its empirical formula is C20H25ClN2O5•C6H6O3S, and its molecular weight is 567.1.
Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker.
Lotrel is a combination of amlodipine besylate and benazepril hydrochloride. The capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.
Generic Name: Amlodipine Besylate and Benazepril HCl
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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