MICROZIDE SUMMARY
MICROZIDE® (hydrochlorothiazide 12.5 mg) is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-Chloro-3,4-dihydro-2 H- 1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
MICROZIDE is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, MICROZIDE may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.
Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.
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NEWS HIGHLIGHTS
Published Studies Related to Microzide (Hydrochlorothiazide)
A randomized, comparative study evaluating the efficacy and tolerability of losartan-low dose chlorthalidone (6.25 mg) combination with losartan-hydrochlorothiazide (12.5 mg) combination in Indian patients with mild-to-moderate essential hypertension. [2009.07]
OBJECTIVE: The relationship of blood pressure (BP) to cardiovascular risk is linear, positive, and continuous. Lowering elevated BP reduces the risk of cardiovascular events. The primary objective of this randomized, multicenter, comparative, 3-month, open-label study was to evaluate the antihypertensive efficacy of losartan/chlorthalidone versus losartan/hydrochlorothiazide in mild-to-moderate essential hypertension... CONCLUSIONS: The losartan/low-dose chlorthalidone (6.25 mg) combination is as effective as the widely used losartan/hydrochlorothiazide combination in lowering BP and is well tolerated, thus providing a useful therapeutic option for treating mild-to-moderate hypertension.
Triple antihypertensive therapy with amlodipine, valsartan, and hydrochlorothiazide: a randomized clinical trial. [2009.07]
Many patients with hypertension require > or =3 agents to achieve target blood pressure (BP). The efficacy/safety of the dual combinations of valsartan (Val)/hydrochlorothiazide (HCTZ) and amlodipine (Aml)/Val in hypertension are well established... In conclusion, this study demonstrates the efficacy/safety of treating moderate and severe hypertension with Aml/Val/HCTZ 10/320/25 mg.
Aliskiren-based therapy lowers blood pressure more effectively than hydrochlorothiazide-based therapy in obese patients with hypertension: sub-analysis of a 52-week, randomized, double-blind trial. [2009.07]
OBJECTIVES: To compare the long-term efficacy, safety and tolerability of the direct renin inhibitor aliskiren against the diuretic hydrochlorothiazide (HCTZ) in obese patients with hypertension... CONCLUSION: Aliskiren-based therapy provided superior BP reductions to HCTZ-based therapy with good tolerability in obese patients with hypertension.
Combination therapy with various combinations of aliskiren, valsartan, and hydrochlorothiazide in hypertensive patients not adequately responsive to hydrochlorothiazide alone. [2009.06]
This study investigated the efficacy and safety of several different multi-drug regimens including aliskiren, valsartan, and hydrochlorothiazide (HCTZ) in patients not adequately responsive to HCTZ as monotherapy. After 4 weeks of HCTZ treatment, patients (N=641) whose diastolic blood pressure (DBP) was > or =95 mm Hg were treated for 8 weeks with either aliskiren/valsartan/HCTZ, aliskiren/HCTZ, valsartan/HCTZ, or HCTZ alone...
Effects of force-titrated valsartan/hydrochlorothiazide versus amlodipine/hydrochlorothiazide on ambulatory blood pressure in patients with stage 2 hypertension: the EVALUATE study. [2009.06]
BACKGROUND: Previous studies using the combination of angiotensin-receptor blockers and hydrochlorothiazide (HCTZ) have shown superior ambulatory blood pressure (ABP) reduction in study participants with stage 2 hypertension compared with monotherapy. OBJECTIVE: This multicenter, double-blind, parallel group, forced-titration study of individuals with stage 2 hypertension, compared the efficacy of valsartan and amlodipine in combination with HCTZ on ABP reduction... CONCLUSION: On the basis of ABP monitoring but not office measurements, the fixed-dose combination of valsartan/HCTZ is a significantly more effective treatment regimen than amlodipine/HCTZ, with similar tolerability.
Clinical Trials Related to Microzide (Hydrochlorothiazide)
Fasting Study of Hydrochlorothiazide Tablets 50 mg to Hydrochlorothiazide Tablets 50 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's
hydrochlorothiazide 50 mg tablets to Ivax's Hydrochlorothiazide 50 mg tablets following a
single, oral 50 mg (1 x 50 mg) dose administered under fasting conditions.
Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension [Completed]
Study Objectives :
- To demonstrate the reduction in office Blood Pressure following a 8-week regimen of
irbesartan / hydrochlorothiazide using irbesartan as a reference.
- To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan
/ hydrochlorothiazide using irbesartan as a reference.
- To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood
Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week
regimen of irbesartan / hydrochlorothiazide versus irbesartan.
- To compare the proportion of patients requiring titration after 4-week regimen of
irbesartan/hydrochlorothiazide versus irbesartan
- To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus
irbesartan when administered once daily
A Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg [Micardis HCT] Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg [Diovan HCT] Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension. [Completed]
A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. (ATHOS Study) [Completed]
The primary objective of this clinical trial was to show that the combination of telmisartan
80 mg + hydrochlorothiazide (HCTZ) 12. 5 mg was not inferior to and was possibly superior to
amlodipine 10 mg + HCTZ 12. 5 mg in reducing the systolic blood pressure (SBP) in the last six
hours of the 24-hour dose period [as measured by 24-hour ambulatory blood pressure monitoring
( ABPM)] in elderly patients with predominantly systolic hypertension. The primary endpoint
was the change from baseline in SBP in the last six hours of the 24-hour dose period (as
measured by 24-hour ABPM) at the end-of-study visit.
Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension [Completed]
This study is designed to evaluate the efficacy and safety of the combination valsartan with
hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan
with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken
comparing two different possible ways to achieve the higher dosage of the triple combination,
i. e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.
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