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, lisinopril and hydrochlorothiazide tablets should be discontinued as soon as possible. See WARNINGS, Pregnancy, Lisinopril, Fetal/Neonatal morbidity and mortality.
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SUMMARY
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg
Rx only
Lisinopril and hydrochlorothiazide tablets combine an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor.
Lisinopril 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 lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.)
In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema.)
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NEWS HIGHLIGHTS
Published Studies Related to Lisinopril and Hydrochlorothiazide (Lisinopril / Hydrochlorothiazide)
Aggressive antihypertensive strategies based on hydrochlorothiazide, candesartan or lisinopril decrease left ventricular mass and improve arterial compliance in patients with type II diabetes mellitus and hypertension. [2006.08]
We investigated the effects of aggressive antihypertensive therapy based on hydrochlorothiazide, candesartan or lisinopril on left ventricular mass (LVM) index and arterial stiffness in hypertensive type II diabetic individuals. Seventy hypertensive type II diabetic individuals were treated with three antihypertensive strategies in a randomized, double-blind, double-dummy design...
Effect of telmisartan/hydrochlorothiazide vs lisinopril/hydrochlorothiazide combination on ambulatory blood pressure and cognitive function in elderly hypertensive patients. [2006.03]
The aim of this study was to compare the effects of telmisartan/hydrochlorothiazide (HCTZ) vs lisinopril/HCTZ combination on ambulatory blood pressure and cognitive function in elderly hypertensive patients. A total of 160 patients, 76 men and 84 women, aged 61-75 years, with sitting diastolic blood pressure (DBP)>90 mmHg and <110 mmHg and systolic blood pressure (SBP)>140 mmHg were randomized to receive temisartan 80 mg/HCTZ 12.5 mg o.d...
Aggressive antihypertensive therapy based on hydrochlorothiazide, candesartan or lisinopril as initial choice in hypertensive type II diabetic individuals: effects on albumin excretion, endothelial function and inflammation in a double-blind, randomized clinical trial. [2005.06]
We investigated the effects of aggressive antihypertensive therapy based on hydrochlorothiazide, candesartan or lisinopril on urinary albumin excretion, endothelial function and inflammatory activity in hypertensive type II diabetic individuals. A total of 70 hypertensive type II diabetic individuals were treated with three antihypertensive strategies in a randomized, double-blind, double-dummy design...
Clarithromycin suspension: bioequivalence studies on two different strengths. [2004.09]
Two studies were performed in different groups of volunteers, with the aim to prove the bioequivalence of test (Klaromin) and reference clarithromycin (CAS 81103-11-9) suspensions containing in 5 mL either 125 mg (study 1) or 250 mg (study 2) of the drug, administered as an oral dose of 10 mL...
Comparison of valsartan 160 mg with lisinopril 20 mg, given as monotherapy or in combination with a diuretic, for the treatment of hypertension: the Blood Pressure Reduction and Tolerability of Valsartan in Comparison with Lisinopril (PREVAIL) study. [2004.06]
BACKGROUND: The goal of antihypertensive therapy is to provide good blood pressure (BP) control without eliciting adverse effects. OBJECTIVE: This study compared the risk-benefit profile of the angiotensin II receptor blocker valsartan with that of the angiotensin-converting enzyme inhibitor lisinopril in patients with mild to severe hypertension. The primary objective was to show that the equipotent BP-lowering effect of the valsartan-based treatment is accompanied by a better tolerability profile... CONCLUSIONS: Valsartan and lisinopril were both highly effective in controlling BP in these patients with mild to severe hypertension, but valsartan was associated with a significantly reduced risk for AEs, especially cough.
Clinical Trials Related to Lisinopril and Hydrochlorothiazide (Lisinopril / Hydrochlorothiazide)
Research Study To Test Coreg CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure [Active, not recruiting]
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2
essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline.
Subjects will be randomized to received either COREG CR + lisinopril or lisinopril + placebo.
Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg)
is met. The primary objective of the study is to compare the proportion of subjects who
achieve target blood pressure after 6 weeks of treatment.
Antiproteinuric Effect of Valsartan and Lisinopril [Completed]
Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in
non-diabetic and diabetic renal disease: a randomized (3: 3:1), double blind, parallel group,
controlled trial, 5 months follow-up.
Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo
treatment in no-diabetic and diabetic patients.
Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin
ratio more than monotherapies.
Design: Multicentric, randomized, double blind, parallel group, active controlled.
Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20
A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL. [Completed]
This study will be a randomized study investigating the bioequivalence of COREG CR to its
components, COREG and Lisinopril (ZESTRIL). PK samples will be obtained throughout the study
to investigate the PK of COREG CR FDC to COREG and Lisinopril
Antialbuminuric Effects of Valsartan and Lisinopril [Terminated]
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in
non-diabetic and diabetic renal disease: a randomized (3: 3:1), open label, parallel group,
20 weeks follow-up.
Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril
vs combo treatment in non-diabetic and diabetic patients.
Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more
than monotherapies..
Design: Multicentric, randomized, open label, parallel group, active controlled.
Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20
Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus
lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up.
Description % of change in albuminuria from baseline at 20 weeks.
Secondary Endpoint : To investigate the effect of 5 months treatment with
valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to
investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus
lisinopril on blood pressure and the effect on left ventricular mass index using
electrocardiogram and Cornell-Sokolow method.
VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria [Completed]
The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20
mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater
decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in
the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria
(MAU).
Reports of Suspected Lisinopril and Hydrochlorothiazide (Lisinopril / Hydrochlorothiazide) Side Effects
Angioedema (36),
Renal Failure Acute (22),
Cough (21),
Dyspnoea (19),
Swollen Tongue (18),
Dizziness (16),
Nausea (16),
Dysphagia (15),
Drug Ineffective (14),
Vomiting (13), more >>
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Page last updated: 2007-02-12
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