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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LOTREL NEWS HIGHLIGHTS Media Articles Related to Lotrel (Amlodipine / Benazepril)
New Product For Pfizer Specialty Takes Pulmonary Arterial Hypertension To Heart
Source: Health News from Medical News Today [2009.07.02]
Pfizer Australia announced that it has signed an agreement to acquire the local distribution rights for THELIN® (Sitaxentan sodium), an oral, once-daily highly selective endothelin receptor antagonist, indicated for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA/WHO Functional Class III symptoms to improve exercise ability.
Rat Model Of Hepatic Encephalopathy And Prehepatic Portal Hypertension
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2009.06.30]
A research article published in the World Journal of Gastroenterology refers. The research team lead by Dr. Gabriela Beatriz Acosta, observed that the activity of GS was increased in the hippocampus in PH rats. There was a significant decrease in glutamate uptake in both brain areas, which was more marked in the hippocampus. The decrease in glutamate uptake might be caused by deficient transport function and persistent glutamate activity, which is not metabolized.
Sporadic Spikes in Blood Pressure Hike Chances of Hypertension
Source: MedicineNet Cholesterol Specialty [2009.06.30]
Title: Sporadic Spikes in Blood Pressure Hike Chances of Hypertension
Category: Health News
Created: 6/30/2009 7:00:00 AM
Last Editorial Review: 6/30/2009
White-Coat Hypertension Not Benign
Source: MedicineNet Exercise and Activity Specialty [2009.06.30]
Title: White-Coat Hypertension Not Benign
Category: Health News
Created: 6/30/2009
Last Editorial Review: 6/30/2009
'White-Coat' Hypertension May Persist Over Time (CME/CE)
Source: MedPage Today Cardiovascular [2009.06.29]
SAN FRANCISCO (MedPage Today) -- Sporadic hypertension, whether just in the doctor's office or only occasionally at home, substantially increases risk of later sustained hypertension, researchers found.
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 [generic for Lotrel] (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 [generic for Lotrel] 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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LOTREL 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: 2009-07-02
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