"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
(amlodipine besylate and benazepril hydrochloride) Tablets
When pregnancy is detected, discontinue Lotrel as soon as possible.
Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus
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-1H-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 capsules are formulated in 6 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 monohydrate, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.
What are the possible side effects of amlodipine and benazepril (Lotrel)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.
Some side effects of amlodipine and benazepril may not occur until after you have been using the medication for several months.
Call your doctor at once if you have:
- feeling like you might pass out;
- nausea, upper stomach pain, itching, unusual weakness or tired feeling, jaundice...
What are the precautions when taking amlodipine besylate and benazepril hcl (Lotrel)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to amlodipine or benazepril; or to other dihydropyridine calcium channel blockers (such as nisoldipine, nifedipine); or to other ACE inhibitors (such as captopril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), liver disease, a certain structural heart problem (aortic stenosis), collagen vascular...
Last reviewed on RxList: 2/6/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Lotrel Information
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