Hyperlipidemia Type 3 Treatments
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Generic Name
Atorvastatin
Brand Names
Amlodipine, Amlodipine Besylate, Atorvaliq, Azor, Benazepril, Benicar, Caduet, Katerzia, Lipitor, Lotensin, Lotrel, Norliqva, Norvasc, Olmesartan Medoxomil, Olmesartan Medoxomil Amlodipine, Sdamlo, Tribenzor
FDA approval date: June 21, 1991
Classification: HMG-CoA Reductase Inhibitor
Form: Tablet, Suspension, Capsule, Solution
What is Amlodipine (Atorvastatin)?
Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker and benazepril, an angiotensin-converting enzyme inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
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Related Latest Advances
Brand Information
Amlodipine and Benazepril Hydrochloride (Amlodipine and Benazepril Hydrochloride)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride as soon as possible
1DOSAGE FORMS AND STRENGTHS
Amlodipine and benazepril hydrochloride capsules USP are available as follows:
2CONTRAINDICATIONS
- Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, including amlodipine and benazepril hydrochloride capsules in patients with diabetes.
- Amlodipine and benazepril hydrochloride capsules are contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules.
- Amlodipine and benazepril hydrochloride capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan
3OVERDOSAGE
Only a few cases of human overdose with amlodipine have been reported. One patient was asymptomatic after a 250 mg ingestion; another, who combined 70 mg of amlodipine with an unknown large quantity of a benzodiazepine, developed refractory shock and died.
4DESCRIPTION
Amlodipine and benazepril hydrochloride capsules USP are a combination of amlodipine besylate and benazepril hydrochloride.
Benazepril hydrochloride USP 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-1
Its molecular formula is C
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 USP is a white or almost white 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 molecular formula is C
Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker.
5CLINICAL STUDIES
Over 950 patients received amlodipine and benazepril hydrochloride once-daily in 6 double-blind, placebo-controlled studies. The antihypertensive effect of a single dose persisted for 24 hours, with peak reductions achieved 2 to 8 hours after dosing.
6HOW SUPPLIED/STORAGE AND HANDLING
Amlodipine and benazepril hydrochloride is available as capsules containing amlodipine besylate USP (13.9 mg, equivalent to 10 mg of amlodipine respectively), with 20 mg of benazepril hydrochloride USP providing for the following available combinations: 10 mg/20 mg. They are available as follows:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Pregnancy:Advise female patients of childbearing age about the consequences of exposure to amlodipine and benazepril hydrochloride during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible [see
Symptomatic Hypotension:Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider. Tell patients that if syncope occurs to discontinue amlodipine and benazepril hydrochloride capsules until the physician has been consulted. Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see .
Hyperkalemia:Advise patients not to use salt substitutes without consulting their healthcare provider [see .
Distributed by:
Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited Hyderabad-500 032, India
Revised: 11/2021
Distributed by:
Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited Hyderabad-500 032, India
Revised: 11/2021
8Patient Information
Amlodipine and Benazepril Hydrochloride Capsules USP Read this Patient Information leaflet before you start taking amlodipine and benazepril hydrochloride capsules and each time you get a refill. There may be new information. This leaflet does not replace talking with your doctor. If you have any questions, ask your doctor or pharmacist.
9PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg/20 mg
Rx only
Amlodipine and
10 mg*/20 mg
Amlodipine and
10 mg*/20 mg
