Application Nr Approved Date Route Status External Links
ANDA200185 2011-05-18 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 Controlled-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. 1. For The Treatment Of Patients With Hypokalemia With Or Without Metabolic Alkalosis, In Digitalis Intoxications, 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. 2. 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, Hepatic Cirrhosis With Ascites, States Of Aldosterone Excess With Normal Renal Function, Potassium-Losing Nephropathy, And Certain Diarrheal States. 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 (7 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. Dibutyl Sebacate DIBUTYL SEBACATE 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.
5. 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.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Potassium Chloride