Application Nr Approved Date Route Status External Links
ANDA206347 2016-01-21 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Because Of Reports Of Intestinal And Gastric Ulceration And Bleeding With Extended-Release Potassium Chloride Preparations, These Drugs Should Be Reserved For Those Patients Who Cannot Tolerate Or Refuse To Take Liquid Or Effervescent Potassium Preparations Or For Patients In Whom There Is A Problem Of Compliance With These Preparations. For The Treatment Of Patients With Hypokalemia With Or Without Metabolic Alkalosis, In Digitalis Intoxication And In Patients With Hypokalemic Familial Periodic Paralysis. If Hypokalemia Is The Result Of Diuretic Therapy, Consideration Should Be Given To The Use Of A Lower Dose Of Diuretic, Which May Be Sufficient Without Leading To Hypokalemia. For The Prevention Of Hypokalemia In Patients Who Would Be At Particular Risk If Hypokalemia Were To Develop, E.g., Digitalized Patients Or Patients With Significant Cardiac Arrhythmias. The Use Of Potassium Salts In Patients Receiving Diuretics For Uncomplicated Essential Hypertension Is Often Unnecessary When Such Patients Have A Normal Dietary Pattern And When Low Doses Of The Diuretic Are Used. Serum Potassium Should Be Checked Periodically, However, And If Hypokalemia Occurs, Dietary Supplementation With Potassium-Containing Foods May Be Adequate To Control Milder Cases. In More Severe Cases, And If Dose Adjustment Of The Diuretic Is Ineffective Or Unwarranted, Supplementation With Potassium Salts May Be Indicated.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Ethylcelluloses ETHYLCELLULOSES Unresolved
4. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Potassium Chloride

Comments