Application Nr Approved Date Route Status External Links
ANDA078391 2008-02-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Hydrochlorothiazide Capsules Are Indicated In The Management Of Hypertension Either As The Sole Therapeutic Agent, Or In Combination With Other Antihypertensives. Unlike Potassium Sparing Combination Diuretic Products, Hydrochlorothiazide Capsules 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.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

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