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Lotrel (Amlodipine Besylate / Benazepril Hydrochloride) - Summary

 
 



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.

 

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.
See all Lotrel indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Lotrel (Amlodipine / Benazepril)

Deaths from pulmonary hypertension have increased, say CDC
Source: Cardiovascular / Cardiology News From Medical News Today [2014.04.04]
A study from the CDC finds that deaths from pulmonary hypertension - high blood pressure in the arteries leading from the heart to the lungs - have increased over the past decade.

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Source: MedicineNet Brain Aneurysm Specialty [2014.04.02]
Title: Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Category: Diseases and Conditions
Created: 11/8/1998 8:47:00 PM
Last Editorial Review: 4/2/2014 12:00:00 AM

Children with glomerular kidney disease more likely to have hypertension as adults
Source: Hypertension News From Medical News Today [2014.03.20]
Men who as children had glomerular disease, a disorder of the portion of the kidney that filters blood and one that usually resolves with time, were more likely than men without childhood...

First guidelines for patients with pulmonary hypertension in sickle cell disease
Source: Blood / Hematology News From Medical News Today [2014.03.19]
Boston Medical Center (BMC) and Boston University School of Medicine (BUSM) physicians have helped create the first set of clinical guidelines for treating patients with pulmonary hypertension in...

Guidelines on the management of pulmonary hypertension of sickle cell disease
Source: Hypertension News From Medical News Today [2014.03.18]
The American Thoracic Society has developed clinical practice guidelines to help clinicians identify and manage patients with sickle cell disease who are at increased risk for mortality from...

more news >>

Published Studies Related to Lotrel (Amlodipine / Benazepril)

Comparative efficacy and safety of amlodipine/benazepril combination therapy and amlodipine monotherapy in severe hypertension. [2010.06]
This multicentre, double-blind, trial in subjects with severe hypertension compared the efficacy and tolerability of two parallel drug regimens: A/B (amlodipine/benazepril: 5/20 or 10/40 mg daily, if necessary) with A (amlodipine: 5 or 10 mg daily, if necessary)... We conclude that titration of amlodipine and benazepril in single-pill combinations is more effective than titration of amlodipine alone for rapid BP control in patients with severe hypertension.

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...

more studies >>

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.

more trials >>

Reports of Suspected Lotrel (Amlodipine / Benazepril) Side Effects

Drug Ineffective (5)Blood Pressure Increased (5)Headache (4)Dizziness (4)Cough (4)Rash (4)LIP Swelling (3)Urticaria (3)Drug Hypersensitivity (3)Cerebrovascular Accident (3)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Lotrel has an overall score of 7.67. The effectiveness score is 9.33 and the side effect score is 6.67. 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

 

Lotrel review by 45 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   High Blood Pressure
Dosage & duration:   5mg./10mg taken 1 x daily for the period of 30 days
Other conditions:   Celiac Disease
Other drugs taken:   Trazadone
  
Reported Results
Benefits:   I have slightly high blood pressure on the diastolic side. Lotrel did a good job at maintaining good levels without increasing my pulse which I experienced with other BP meds.
Side effects:   After introducing Lotrel within two weeks I notices small red dots appear on my ankles which I thought was just a heat rash. I developed Petechiae which is the bleeding of small capillaries in the skin or mucous membrane. It appears as round pinpoint sized dots that vary in colour from red to blue or purple. These dots most commonly appear on the legs but can appear all over the body. Also an onset on Acne developed on my back at about the same time which was quite severe, and I have never had Acne related problems, even in my youth.
Comments:   Currently my physician has taken me off of my BP meds to allow the Petechiae to fade, and to ensure that the reaction was indeed related to the Lotrel. It has been 4 days and slowly the rash and redness is mellowing.

 

Lotrel review by 45 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   High Blood Pressure
Dosage & duration:   5mg./10mg taken 1 x daily for the period of 30 days
Other conditions:   Celiac Disease
Other drugs taken:   Trazadone
  
Reported Results
Benefits:   I have slightly high blood pressure on the diastolic side. Lotrel did a good job at maintaining good levels without increasing my pulse which I experienced with other BP meds.
Side effects:   After introducing Lotrel within two weeks I notices small red dots appear on my ankles which I thought was just a heat rash. I developed Petechiae which is the bleeding of small capillaries in the skin or mucous membrane. It appears as round pinpoint sized dots that vary in colour from red to blue or purple. These dots most commonly appear on the legs but can appear all over the body. Also an onset on Acne developed on my back at about the same time which was quite severe, and I have never had Acne related problems, even in my youth.
Comments:   Currently my physician has taken me off of my BP meds to allow the Petechiae to fade, and to ensure that the reaction was indeed related to the Lotrel. It has been 4 days and slowly the rash and redness is mellowing.

See all Lotrel reviews / ratings >>

Page last updated: 2014-04-04

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