Lotrel (Amlodipine Besylate / Benazepril Hydrochloride) - Description

T2007-57/T2006-27

L otrel ^®

( 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

Rx only

Prescribing Information

DESCRIPTION

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-1 H -1-(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 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

      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.