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.
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LOTREL SUMMARY
Lotrel®
Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol.
Lotrel is indicated for the treatment of hypertension.
This fixed combination drug is not indicated for the ini-tial therapy of hypertension
(see DOSAGE AND ADMINISTRATION).
In using Lotrel, consideration should be given to the fact that an ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril does not have a similar risk
(see WARNINGS, Neutropenia/Agranulocytosis).
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks.
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NEWS HIGHLIGHTSMedia Articles Related to Lotrel (Amlodipine / Benazepril)
China Pharma Holdings, Inc. Completes Clinical Trials For Candesartan Anti-Hypertension Drug
Source: Hypertension News From Medical News Today [2010.01.23]
China Pharma Holdings, Inc. ("China Pharma") (NYSE Amex: CPHI), which develops, manufactures, and markets specialty pharmaceutical products in China, announced that the Company has completed clinical trials for Candesartan, an anti-hypertension drug, and submitted the generic drug production application to the SFDA...
Beta-Blockers Effective In Combination Therapies For Hypertension
Source: Hypertension News From Medical News Today [2010.01.20]
Using beta-blockers as a second-line therapy in combination with certain anti-hypertensive drugs significantly lowers blood pressure in patients with hypertension, according to a systematic review by Cochrane Researchers. This review also goes some way to explaining the differences in the way that patients respond to beta-blockers and other classes of blood pressure lowering drugs...
SunTech Medical's Oscar 2 ABPM Used In Study Linking Vitamin D Deficiency And Hypertension
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2010.01.19]
A study led by Dr. William White and Dr. Pooja Luthra at the University of Connecticut Health Center is using the Oscar 2™, 24 hour ambulatory blood pressure monitor (ABPM) to investigate a possible link between vitamin D deficiency and hypertension...
Hypertension Drugs May Cut Alzheimer's Risk
Source: MedicineNet Dementia Specialty [2010.01.13]
Title: Hypertension Drugs May Cut Alzheimer's Risk
Category: Health News
Created: 1/13/2010 9:57:00 AM
Last Editorial Review: 1/13/2010 9:57:27 AM
Hypertension Linked To Dementia In Older Women
Source: Hypertension News From Medical News Today [2010.01.12]
Older women with hypertension are at increased risk for developing brain lesions that cause dementia later in life, according to data from the Women's Health Initiative Memory Study (WHIMS). The findings were published in the December 2009 online issue of the Journal of Clinical Hypertension...
Published Studies Related to Lotrel (Amlodipine / Benazepril)
An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in chinese patients with mild to moderate hypertension. [2008.06]
CONCLUSIONS: In this group of patients, comparable antihypertensive effects were seen with the fixed-dose combination therapy, compared with amlodipine monotherapy. Both treatments appeared well tolerated in the studied population, but cough was more common in the fixed-dose combination group.
The effects of high-dose amlodipine/benazepril combination therapies on blood pressure reduction in patients not adequately controlled with amlodipine monotherapy. [2007.03]
BACKGROUND: This study compared the efficacy and safety of amlodipine/benazepril (10/40 mg/day and 10/20 mg/day) with amlodipine 10 mg/day in patients whose blood pressure (BP) was not adequately controlled with amlodipine monotherapy... CONCLUSION: Amlodipine/benazepril combinations were well tolerated and resulted in significant BP reductions and better BP responder rates than amlodipine monotherapy.
Efficacy of combination therapy with amlodipine besylate/benazepril hydrochloride for lowering systolic blood pressure in stage 2 hypertension. [2006.05]
The Systolic Evaluation of Lotrel Efficacy and Comparative Therapies (SELECT) study compared daily treatment with combination amlodipine besylate/benazepril hydrochloride 5/20 mg, amlodipine besylate 5 mg, and benazepril hydrochloride 20 mg in 505 patients aged 55 years of age or older with stage 2 hypertension (systolic blood pressure [BP] > or =160 and < or =200 mm Hg and diastolic BP > or =60 and < or =100 mm Hg)...
Efficacy of combination therapy for systolic blood pressure in patients with severe systolic hypertension: the Systolic Evaluation of Lotrel Efficacy and Comparative Therapies (SELECT) study. [2005.11]
Systolic hypertension is predominant among patients over 50 years of age, is a more important cardiovascular risk factor than diastolic blood pressure, and is more difficult to control than diastolic blood pressure. Consequently, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommends combination therapy as first-line treatment for patients with stage 2 hypertension...
Amlodipine/benazepril combination therapy for hypertensive patients nonresponsive to benazepril monotherapy. [2004.07]
BACKGROUND: Most patients with hypertension require two or more antihypertensive medications to achieve blood pressure (BP) goals. This double-blind study compared the efficacy and safety of high-dose combinations of amlodipine besylate (5 mg and 10 mg) and benazepril hydrochloride (40 mg) to benazepril hydrochloride (40 mg) alone in hypertensive patients not adequately controlled with benazepril hydrochloride (40 mg) monotherapy... CONCLUSION: High-dose amlodipine/benazepril combination therapy (5 mg/40 mg and 10 mg/40 mg) is an effective, safe, and well-tolerated treatment option for hypertensive patients who do not respond adequately to benazepril alone.
Clinical Trials Related to Lotrel (Amlodipine / Benazepril)
Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan amlodipine and
benazepril HCl 10 mg/20 mg to Novartis Lotrel® 10 mg/20 mg combination capsules following a
single, oral 10 mg/20 mg (1 x 10 mg/20 mg) dose administered under fed conditions.
Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and
benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a
single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.
Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM) [Active, not recruiting]
The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is
superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive
subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy
Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and
hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets
following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fed
conditions.
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and
hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets
following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting
conditions.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Lotrel has an overall score of 8. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Lotrel review by 57 year old male patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | blood pressure |
| Dosage & duration: | | 10/20 (dosage frequency: every nite) for the period of 2 years |
| Other conditions: | | hepatitis c |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | blodd pressure remained in the low area |
| Side effects: | | drowsiness, loss of libido |
| Comments: | | once a day |
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| | Lotrel review by 36 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Migraine headaches |
| Dosage & duration: | | 10mg/20mg taken once daily for the period of over two years |
| Other conditions: | | Borderline highblood pressure |
| Other drugs taken: | | Imitrex (as needed) | | |
Reported Results |
| Benefits: | | There was a huge reduction in the number of migraine headaches that I experienced. Before I started on the meds, I was getting migraines 3-4 times per week. Now I get them once or twice a year. I think the daily meds may even slightly reduce the rate at which a migraine (the rare times that I get them now) comes on. |
| Side effects: | | I do experience a slight cough. It isn't a major problem; it only happens maybe a couple times a week and it is sort of like a cough you would use to clear a tickle from your throat. |
| Comments: | | I take one pill daily and have to visit my physician every six months. |
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Page last updated: 2010-01-23
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