Application Nr Approved Date Route Status External Links
ANDA074461 1997-03-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Indapamide Tablets Are Indicated For The Treatment Of Hypertension, Alone Or In Combination With Other Antihypertensive Drugs. Indapamide Tablets Are Also Indicated For The Treatment Of Salt And Fluid Retention Associated With Congestive Heart Failure. Usage In Pregnancy The Routine Use Of Diuretics In An Otherwise Healthy Woman Is Inappropriate And Exposes Mother And Fetus To Unnecessary Hazard (see Precautions Below). 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. Indapamide Is Indicated In Pregnancy When Edema Is Due To Pathologic Causes, Just As It Is In The Absence Of Pregnancy (however, See Precautions Below). 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 Not Harmful To Either The Fetus Or 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 (8 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Indapamide INDAPAMIDE ZINC601305