Application Nr Approved Date Route Status External Links
ANDA072011 1988-06-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage This Fixed Combination Drug Is Not Indicated For The Initial Therapy Of Edema Or Hypertension Except In Individuals In Whom The Development Of Hypokalemia Cannot Be Risked. Triamterene And Hydrochlorothiazide Tablets Are Indicated For The Treatment Of Hypertension Or Edema In Patients Who Develop Hypokalemia On Hydrochlorothiazide Alone. Triamterene And Hydrochlorothiazide Is Also Indicated For Those Patients Who Require A Thiazide Diuretic And In Whom The Development Of Hypokalemia Cannot Be Risked (e.g., Patients On Concomitant Digitalis Preparations, Or With A History Of Cardiac Arrhythmias, Etc.). Triamterene And Hydrochlorothiazide May Be Used Alone Or In Combination With Other Antihypertensive Drugs Such As Beta-Blockers. Since Triamterene And Hydrochlorothiazide May Enhance The Actions Of These Drugs, Dosage Adjustments May Be Necessary. 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 In 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. Thiazides Are Indicated In Pregnancy When Edema Is Due To Pathologic Causes, Just As They Are In 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 (5 Total)

Name Structure Kind Function Status
1. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 2 Total)

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