POTASSIUM CHLORIDE ER 20MEQ 1000 TABLETS
Generic: Potassium Chloride
POTASSIUM CHLORIDE ER 20MEQ 1000 TABLETS
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Identification
Potassium Chloride
Potassium Chloride
Lupin Pharmaceuticals,Inc.
HUMAN PRESCRIPTION DRUG
Administration
TABLET, EXTENDED RELEASE
ORAL
ANDA206347
Active Ingredients
| Ingredient | Strength |
|---|---|
| POTASSIUM CHLORIDE | 20 meq/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
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. 1. 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. 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. 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.
Warnings
WARNINGS Voriconazole treatment-related visual disturbances are common. In therapeutic trials, approximately 21% of patients experienced abnormal vision, color vision change and/or photophobia. Visual disturbancesmay be associated with higher plasma concentrations and/or doses. There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema [ see Warnings and Precautions (5.3)] . The mechanism of action of the visual disturbance is unknown, although the site of action is most likely to be within the retina. In a study in healthy subjects investigating the effect of 28-day treatment with voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude, a decrease in the visual field, and an alteration in color perception. The ERG measures electrical currents in the retina. The effects were noted early in administration of voriconazole and continued through the course of study drug dosing. Fourteen days after end of dosing, ERG, visual fields and color perception returned to normal [ see Warnings and Precautions (5.7) ].
Dosage & Administration
DOSAGE AND ADMINISTRATION The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store. Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose. Each potassium chloride extended-release tablet 20 mEq provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium. Each potassium chloride extended-release tablet 10 mEq provides 750 mg of potassium chloride equivalent to 10 mEq of potassium. Potassium chloride extended-release tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS ). Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration: 1. Break the tablet in half and take each half separately with a glass of water. 2. Prepare an aqueous (water) suspension as follows: 1. Place the whole tablet(s) in approximately one-half glass of water (4 fluid ounces). 2. Allow approximately 2 minutes for the tablet(s) to disintegrate. 3. Stir for about half a minute after the tablet(s) has disintegrated. 4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw. 5. Add another one fluid ounce of water, swirl, and consume immediately. 6. Then, add an additional one fluid ounce of water, swirl, and consume immediately. Aqueous suspension of potassium chloride extended-release tablet that is not taken immediately should be discarded. The use of other liquids for suspending potassium chloride extended-release tablets is not recommended.
Adverse Reactions
ADVERSE REACTIONS One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS and OVERDOSAGE ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ). The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.