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Fosinopril and Hydrochlorothiazide (Fosinopril Sodium / 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, fosinopril sodium and hydrochlorothiazide tablets should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

 

SUMMARY

Fosinopril sodium is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol, and slightly soluble in hexane.

Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension.

These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION.)

In using fosinopril sodium-hydrochlorothiazide tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis).

ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angiodema.)


See all Fosinopril and Hydrochlorothiazide indications & dosage >>

NEWS HIGHLIGHTS

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

Treating Mild Hypertension With Drugs May Be Misdirected
Source: Medscape Medical Students Headlines [2014.09.23]
Experts have suggested that treating mild hypertension with drugs has unclear benefits and huge costs; priorities should shift to society-wide measures that promote lifestyle modification.
Medscape Medical News

Hypertension may be initiated by an autoimmune response
Source: Hypertension News From Medical News Today [2014.09.19]
High blood pressure is a major risk factor for heart attack, stroke, chronic heart failure, and kidney disease.

Dementia risk reduction through tobacco control and better prevention, detection and control of hypertension and diabetes
Source: Diabetes News From Medical News Today [2014.09.18]
The World Alzheimer Report 2014 'Dementia and Risk Reduction: An analysis of protective and modifiable factors', calls for dementia to be integrated into both global and national public health...

Men who improve their fitness levels can hold off development of hypertension
Source: Hypertension News From Medical News Today [2014.09.17]
A man's cardiorespiratory fitness can drastically delay the natural, age-associated increase of his blood pressure over his adult life span.

Experts raise concern over unnecessary treatment of mild hypertension in low risk people
Source: Hypertension News From Medical News Today [2014.09.15]
Lowering the drug threshold for high blood pressure (hypertension) has exposed millions of low-risk people around the world to drug treatment of uncertain benefit at huge cost to health systems...

more news >>

Published Studies Related to Fosinopril and Hydrochlorothiazide (Fosinopril / Hydrochlorothiazide)

Different effects of antihypertensive regimens based on fosinopril or hydrochlorothiazide with or without lipid lowering by pravastatin on progression of asymptomatic carotid atherosclerosis: principal results of PHYLLIS--a randomized double-blind trial. [2004.12]
BACKGROUND AND PURPOSE: The Plaque Hypertension Lipid-Lowering Italian Study (PHYLLIS) tested whether (1) the angiotensin-converting enzyme (ACE) inhibitor fosinopril (20 mg per day) was more effective on carotid atherosclerosis progression than the diuretic hydrochlorothiazide (25 mg per day), (2) pravastatin (40 mg per day) was more effective than placebo when added to either hydrochlorothiazide or fosinopril, and (3) there were additive effects of ACE inhibitor and lipid-lowering therapies... CONCLUSIONS: Progression of carotid atherosclerosis occurred with hydrochlorothiazide but not with fosinopril. Progression could also be avoided by associating pravastatin with hydrochlorothiazide.

[Comparison of the antihypertensive activity of fosinopril and irbesartan] [2002.11]
OBJECTIVE: To compare the antihypertensive effect of two daily single dose drugs acting on the renin-angiotensin axis by two different ways... CONCLUSIONS: Fosinopril and irbesartan seems to be equally effective to reduce DBP. Irbesartan might have higher effectiveness on systolic blood pressure. Irbesartan act more gradually than fosinopril and this may be useful to prevent from acute blood pressure falls.

Fixed combinations of delapril plus indapamide vs fosinopril plus hydrochlorothiazide in mild to moderate essential hypertension. [2002.05]
This 12-week randomized, parallel-group, multicenter study compared fixed combinations of delapril (D) 30 mg plus indapamide (I) 2.5 mg and fosinopril (F) 20 mg plus hydrochlorothiazide (H) 12.5 mg in 171 adult patients with mild to moderate essential hypertension... In this study, the efficacy and safety of D + I were comparable to those of F + H in patients with mild to moderate essential hypertension.

Antihypertensive effect of the combination of fosinopril and HCTZ is resistant to interference by nonsteroidal antiinflammatory drugs. [1999.09]
Nonsteroidal antiinflammatory drugs (NSAID) are frequently reported to interfere with the blood pressure lowering actions of various antihypertensive medications. We studied 17 women with arthritis and hypertension who were receiving fosinopril and HCTZ, and administered sequentially in random order ibuprofen, sulindac, and nabumetone for 1 month each, with an intervening 2-week washout period between each treatment period...

Fosinopril and hydrochlorothiazide combination versus individual components: lack of a pharmacokinetic interaction. [1999.05]
OBJECTIVE: To evaluate the pharmacokinetic interaction and bioequivalence of a combination formulation of the angiotensin-converting enzyme inhibitor fosinopril and the diuretic hydrochlorothiazide (HCTZ)... CONCLUSIONS: Fosinopril and HCTZ in a combination tablet display pharmacokinetic profiles similar to those achieved when either drug is administered alone or when coadministered in separate tablets. When used with HCTZ, the favorable pharmacokinetic feature of fosinopril, dual and compensatory pathways of renal and hepatic elimination, is preserved.

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

Eplerenone, ACE Inhibition and Albuminuria [Recruiting]
The purpose of this study is to determine whether eplerenone is more effective than doubling the dose of ACE inhibitor in reducing urinary protein (albumin) loss in diabetes mellitus

Angiotensin-converting Enzyme (ACE)-Inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease (COPD) [Recruiting]
A double blind randomised placebo controlled parallel trial of the effect of fosinopril, an angiotensin converting enzyme inhibitor, on the quadriceps muscle in 80 COPD patients who have quadriceps weakness. Patients will have a baseline assessment including measures of quadriceps strength and endurance and a quadriceps biopsy. Patients with weakness will be randomised to ACE inhibitor or placebo and re-assessed after three months of treatment.

The investigators aim to show that ACE-inhibition will alter the IGF-1/AKT/FoXO/atrogene pathways involved in muscle wasting in COPD.

ACE Inhibition and Novel Cardiovascular Risk Factors [Completed]

Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery [Not yet recruiting]
Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of an intermediate risk surgery will experience more intraoperative hypotension than those who hold their chronic ACEI perioperatively.

Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of an intermediate risk surgery will experience better postoperative control of hypertension than those who hold their chronic ACEI perioperatively.

Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of an intermediate risk surgery will experience less acute renal failure than those who hold their chronic ACEI perioperatively.

Secondary research hypothesis #3: Patients with a preoperative systolic blood pressure less than 110 mmHg who are continued on their chronicACEI therapy perioperatively will have a significant decrease in blood pressure during anesthesia compared to those who have a preoperative systolic blood pressure greater than 110 who are continued on their chronic ACEI.

Secondary research hypothesis #4: Patients above the age of 64 who are continued on their chronic ACEI therapy perioperatively will have a significant decrease in blood pressure during anesthesia compared to those aged 64 or younger who are continued on their chronic ACEI.

Is There an Adverse Drug Reaction Between Renin-Angiotensin System Blockade and Inhaled Anesthetics [Recruiting]
It is controversial whether or not patients whose Renin Angiotensin System is blocked for the treatment of hypertension suffer increased risk when undergoing surgery and anaesthesia.

The investigators wish to test the hypothesis: Blockade of the Renin Angiotensin System causes altered dose response under general anaesthesia in a dose dependant manner. The investigators wish to look for altered responses across the usual anaesthetic dosing range as measured by blood pressure and heart responses.

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Page last updated: 2014-09-23

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