Drug Catalog - Product Detail
POTASSIUM CHLORIDE ER TAB 20MEQ 1000CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 43386-0917-10 | LUPIN PHARMACEUTICALS | 1000 | 20MEQ | NA |
PACKAGE FILES
Generic Name
POTASSIUM CHLORIDE
Substance Name
POTASSIUM CHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA206347
Description
DESCRIPTION Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients : microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.
How Supplied
HOW SUPPLIED Potassium chloride extended-release tablets USP 20 mEq K are supplied as oblong white to off-white colored, scored for flexibility of dosing, debossed "P 20" on one side and bisected on other side. Bottles of 90: 43386-917-09 Bottles of 100: 43386-917-01 Bottles of 400: 43386-917-04 Bottles of 500: 43386-917-05 Bottles of 1000: 43386-917-10 Potassium chloride extended-release tablets USP 10 mEq K are supplied as oblong, white to off-white colored tablets, debossed "P 10" on one side and plain on other side. Bottles of 90: 43386-915-09 Bottles of 100: 43386-915-01 Bottles of 500: 43386-915-05 Bottles of 1000: 43386-915-10 Keep tightly closed. Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted between 15 o to 30 o C (59 o to 86 o F) [See USP Controlled Room Temperature]. Manufactured by: Novel Laboratories, Inc Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc Baltimore, MD 21202 PI9170000202 Revised: 11/2016
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.
Dosage and 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.