MICROZIDE
Details
- Status
- Prescription
- First Approved
- 1996-12-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MICROZIDE Approval History
What MICROZIDE Treats
3 indicationsMICROZIDE is approved for 3 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Stroke
- Myocardial Infarction
MICROZIDE Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue lisinopril and hydrochlorothiazide tablets 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 ....
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue lisinopril and hydrochlorothiazide tablets 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 .
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MICROZIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, s...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue lisinopril and hydrochlorothiazide tablets 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 ....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.