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Fosinopril and Hydrochlorothiazide (Fosinopril Sodium / Hydrochlorothiazide) - Summary

 
 



WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue fosinopril and hydrochlorothiazide as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity
 

SUMMARY

Fosinopril sodium, USP is a white to off-white powder, freely soluble in methanol; soluble in chloroform and water.

Fosinopril sodium and hydrochlorothiazide tablets, USP is indicated for the treatment of hypertension.

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

In using fosinopril sodium and hydrochlorothiazide tablets, USP, 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 Angioedema).


See all Fosinopril and Hydrochlorothiazide indications & dosage >>

NEWS HIGHLIGHTS

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

ESC: Coffee, Naps, and Depression in Hypertension (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- Observations support naps but suggest risk with espresso and depression

Medical News Today: Could hypertension during pregnancy signal elevated risk for siblings?
Source: Featured Health News from Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Could hypertension during pregnancy signal elevated risk for siblings?
Source: Biology / Biochemistry News From Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Common 'heart attack' blood test may predict future hypertension
Source: Hypertension News From Medical News Today [2015.08.27]
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressureAnalysis of blood samples from more than 5,000 people suggests that a more sensitive...

ICD-10: Coding for Hypertension and Heart Disease
Source: Medscape Business of Medicine Headlines [2015.08.25]
There are some important elements to be aware of when coding for hypertension, heart disease, and kidney disease in ICD-10.
Medscape Business of Medicine

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)

Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions [Completed]
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under non-fasting conditions.

Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions [Completed]
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under fasting conditions.

Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting Conditions [Completed]
The objective of this study was to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12. 5 mg tablets by Ranbaxy Laboratories Limited with that of Monopril ®.-HCT 20-12. 5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1 x 20-12. 5 mg tablet) in healthy adult subjects under fasting conditions

Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3 [Active, not recruiting]
The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.

Bioequivalence Study of Fosinopril Sodium / Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fed Conditions [Completed]
The objective of this study is to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12. 5 mg tablets of Ranbaxy laboratories Limited with that of

Monopril ® - HCT 20-12. 5 mg tablets by Bristol Meyers Squibb following a single oral dose (1

x 20/12. 5 mg tablet) in healthy adult subjects under non-fasting conditions.

more trials >>


Page last updated: 2015-08-29

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