Application Nr Approved Date Route Status External Links
ANDA040807 2007-07-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hydrochlorothiazide Tablets Are Indicated As Adjunctive Therapy In Edema Associated With Congestive Heart Failure, Hepatic Cirrhosis, And Corticosteroid And Estrogen Therapy. Hydrochlorothiazide Tablets Have Also Been Found Useful In Edema Due To Various Forms Of Renal Dysfunction Such As Nephrotic Syndrome, Acute Glomerulonephritis, And Chronic Renal Failure. Hydrochlorothiazide Tablets Are Indicated In The Management Of Hypertension Either As The Sole Therapeutic Agent Or To Enhance The Effectiveness Of Other Antihypertensive Drugs In The More Severe Forms Of Hypertension. Use In Pregnancy Routine Use Of Diuretics During Normal Pregnancy 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 Toxemia. Edema During Pregnancy May Arise From Pathologic Causes Or From The Physiologic And Mechanical Consequences Of Pregnancy. Thiazides Are Indicated In Pregnancy When Edema Is Due To Pathologic Causes, Just As They Are In The Absence Of Pregnancy (see Precautions, Pregnancy). Dependent Edema In Pregnancy, Resulting From Restriction Of Venous Return By The Gravid Uterus, Is Properly Treated Through Elevation Of The Lower Extremities And Use Of Support Stockings. Use Of Diuretics To Lower Intravascular Volume In This Instance Is Illogical And Unnecessary. During Normal Pregnancy There Is Hypervolemia Which Is Not Harmful To The Fetus Or The Mother In The Absence Of Cardiovascular Disease. However, It May Be Associated With Edema, Rarely Generalized Edema. If Such Edema Causes Discomfort, Increased Recumbency Will Often Provide Relief. Rarely This Edema May Cause Extreme Discomfort Which Is Not Relieved By Rest. In These Instances, A Short Course Of Diuretic Therapy May Provide Relief And Be Appropriate.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Hydrochlorothiazide HYDROCHLOROTHIAZIDE ZINC896569

Comments