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, ZESTORETIC should be discontinued as soon as possible. See WARNINGS, Pregnancy, Lisinopril, Fetal/Neonatal Morbidity and Mortality.
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ZESTORETIC SUMMARY
ZESTORETIC® (lisinopril and hydrochlorothiazide)
ZESTORETIC® (Lisinopril and Hydrochlorothiazide) combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor.
ZESTORETIC is indicated for the treatment of hypertension.
These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
In using ZESTORETIC, 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 the use of ZESTORETIC, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).
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NEWS HIGHLIGHTS
Published Studies Related to Zestoretic (Lisinopril / Hydrochlorothiazide)
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...
Clinical Trials Related to Zestoretic (Lisinopril / Hydrochlorothiazide)
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions [Completed]
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence
between Test Product and the corresponding Reference Product under fed condition in normal,
healthy, adult, human subjects.
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions [Completed]
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence
between Test Product and the corresponding Reference Product under fasting condition in
normal, healthy, adult, human subjects.
Action to Control Cardiovascular Risk in Diabetes (ACCORD) [Completed]
The purpose of this study is to prevent major cardiovascular events (heart attack, stroke,
or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic
control, intensive blood pressure control, and multiple lipid management.
Reports of Suspected Zestoretic (Lisinopril / Hydrochlorothiazide) Side Effects
Hypertension (11),
Hypokalaemia (8),
Transient Ischaemic Attack (8),
Headache (7),
Hyponatraemia (7),
Mental Status Changes (6),
Polymedication (6),
Cerebrovascular Accident (6),
Dysarthria (6),
Ear Haemorrhage (5), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Zestoretic has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| Zestoretic review by 49 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | No Side Effects | | Treatment Info |
Condition / reason: | | High blood pressure |
Dosage & duration: | | 20/12.5 x 2 (dosage frequency: once per day) for the period of three years |
Other conditions: | | None |
Other drugs taken: | | None | | Reported Results |
Benefits: | | After trying a variety of high blood pressure medicines my doctor prescribed Zestoretic. Zestoretic lowered my blood pressure to acceptable levels of 100/70 from 130/90. The difference between this medicine and prior ones seems to be the diuretic. After experiencing the positive benefits of the diuretic I began watching my sodium intake. I avoid any food that contains 900 or over mgs of sodium per serving. This pretty much eliminates most canned soups, dry packaged side dishes and frozen foods. After 16 months of watching my sodium intake I have become much more sensitive to sodium and no longer use table salt |
Side effects: | | None |
Comments: | | I take two tablets once a day at breakfast. |
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Page last updated: 2006-11-04
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