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Quinapril and Hydrochlorothiazide (Quinapril Hydrochloride / Hydrochlorothiazide) - Summary

 
 



USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, quinapril hydrochloride and hydrochlorothiazide should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

 

SUMMARY

Quinapril hydrochloride and hydrochlorothiazide is a fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide.

QUINAPRIL AND HYDROCHLOROTHIAZIDE (QUINAPRIL/HYDROCHLOROTHIAZIDE) is indicated for the following:

DOSAGE AND ADMINISTRATION).

WARNINGS: Neutropenia/Agranulocytosis).

Angioedema in Black Patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.


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NEWS HIGHLIGHTS

Media Articles Related to Quinapril and Hydrochlorothiazide (Quinapril / Hydrochlorothiazide)

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Portal Hypertension
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Title: Portal Hypertension
Category: Diseases and Conditions
Created: 1/31/2005 12:00:00 AM
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Published Studies Related to Quinapril and Hydrochlorothiazide (Quinapril / Hydrochlorothiazide)

Quinapril for treatment of hypertension in Turkey: dose titration and diuretic combination treatment strategies. [2007]
BACKGROUND and objective: Recently the PatenT (Prevalence, awareness, treatment and control of hypertension in Turkey) study showed that while the prevalence of hypertension in Turkey is high, effective control of BP is infrequently achieved. This study investigated the efficacy and safety of quinapril (as monotherapy or in combination with hydrochlorothiazide [HCTZ]) for achieving BP control (target <140/90 mm Hg) in Turkish subjects with mild to moderate hypertension... CONCLUSION: Quinapril was an effective and safe treatment for achieving and maintaining recommended BP targets in this sample population. These findings will provide clinicians in Turkey with valuable data on the use of quinapril for effective control and management of hypertension.

Beneficial effects of add-on hydrochlorothiazide in rats with myocardial infarction optimally treated with quinapril. [2005.12]
BACKGROUND: The antihypertensive and renoprotective effects of ACE inhibitor (ACEi) therapy are enhanced by inducing a negative sodium balance. Whether this strategy also improves outcome of chronic ACEi treatment after myocardial infarction (MI) is unknown. Therefore, we investigated whether hydrochlorothiazide (HCTZ) or dietary sodium restriction further improves survival in ACEi-treated rats with MI... CONCLUSIONS: Adding HCTZ, but not LS, to quinapril improved survival, neurohumoral status, and proteinuria during the early chronic phase of experimental post-MI LV dysfunction. Since no adverse effects were observed, HCTZ may safely be used to improve ACEi therapy.

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Clinical Trials Related to Quinapril and Hydrochlorothiazide (Quinapril / Hydrochlorothiazide)

Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension [Completed]
We will evaluate the combination of quinapril and alpha lipoic acid in patients with diabetes mellitus and hypertension. We will determine whether the combination of quinapril and lipoic acid as compared to quinapril and placebo provides benefit on systemic blood pressure and proteinuria.

A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension [Completed]
The purpose of this study is to determine the response rate for the therapeutic goal (diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week 6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20 mg plus hydrochlorothiazide 12. 5 mg; and to determine the mean decrease in diastolic and systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with baseline.

Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions [Completed]
This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc. (division of Ranbaxy Laboratories Limited) and Accuretic 20-25 mg tablets of Parke-Davis (division of Pfizer Inc.) in healthy, adult, human, male, subjects under fed conditions.

Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fasting Conditions [Completed]
The study was conducted as a open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing Quinapril hydrochloride and Hydrochlorothiazide tablets 20 mg/25 mg of OHM Laboratories Inc (a subsidiary of Ranbaxy pharmaceuticals Inc) with AccureticTM tablets 20 mg/ 25 mg (containing quinapril hydrochloride 20 mg and hydrochlorothiazide 25 mg) manufactured by Parke Davis Pharmaceuticals Limited, Vega Baja, PR 00694, Made in Germany and distributed by Parke-Davis, Division of Pfizer Inc. NY, NY 10017 in healthy, adult, male, human subjects under fasting condition.

QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia [Completed]
INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin converting enzyme) inhibition (quinapril) in improving coronary microvascular function. PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow reserve limitations and evidence for myocardial ischemia in the absence of significant coronary artery stenosis. STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific variables, and site by treatment effects. SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle Angina Questionnaire adjusting for baseline values, site, and site by treatment effects. SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and occurrence of adverse events. STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the study has been provided. Interim analyses are planned after 15 patients have been enrolled in each group. ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT EACH SITE Approximately 26

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Page last updated: 2017-09-19

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