LOTREL Capsule Ref.[10588] Active ingredients: Amlodipine Benazepril

Lotrel is a combination of amlodipine besylate and benazepril hydrochloride.

Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 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-1H1(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:

Its empirical formula is C₂₄H₂₈N₂O₅•HCl, and its molecular weight is 460.96.

Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl 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:

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 capsules are formulated in 4 different strengths for oral administration with a combination of amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 5/10 mg, 5/20 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 10/40 mg strength), iron oxides, lactose monohydrate, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.