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Drug Catalog - Product Detail

POTASSIUM CHLORIDE TB 10MEQ 100

NDC Mfr Size Str Form
68382-0600-01 ZYDUS PHARMACEUTICALS (USA) 100 10MEQ TABLET
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Description
DESCRIPTION Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 600 mg, 750 mg and 1500 mg of potassium, respectively, in a film-coated (not enteric-coated), wax matrix 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. The expended inert, porous, wax/polymer matrix is not absorbed and may be excreted intact in the stool. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients 8 mEq and 10 mEq Tablets Castor oil, cellulosic polymers, colloidal silicon dioxide, D&C Yellow No. 10, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin and vitamin E. 20 mEq Tablets Castor oil, cellulosic polymers, colloidal silicon dioxide, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin and vitamin E.
How Supplied
HOW SUPPLIED Potassium chloride extended-release tablets, USP contain 600 mg, 750 mg and 1500 mg of potassium chloride (equivalent to 8 mEq, 10 mEq and 20 mEq, respectively). Potassium chloride extended-release tablets, USP are provided as extended-release, film-coated tablets. Potassium chloride extended-release 600 mg (8 mEq) tablets are round in shape, yellow in color, debossed with the trademark K-TAB on one side, and are supplied as follows: Bottles of 100 – NDC 68382-776-01 Bottles of 1000 – NDC 68382-776-10 Potassium chloride extended-release 750 mg tablets (10 mEq) are ovaloid in shape, yellow in color, and are supplied and debossed as follows: Bottles of 100 – NDC 68382-320-01 (10 on one side and the trademark K‑TAB on the other side) Bottles of 100 – NDC 68382-600-01 (the “a” logo on one side and the trademark K‑TAB on the other side) Bottles of 1000 – NDC 68382-320-10 (10 on one side and the trademark K‑TAB on the other side) Bottles of 1000 – NDC 68382-600-10 (the “a” logo on one side and the trademark K‑TAB on the other side) Potassium chloride extended-release 1500 mg tablets (20 mEq) are ovaloid in shape, white in color, debossed with the trademark K-TAB on one side, and are supplied as follows: Bottles of 100 – NDC 68382-398-01 Bottles of 500 – NDC 68382-398-05 Recommended Storage Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Manufactured by: AbbVie LTD Barceloneta, PR 00617 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 03-B464 January, 2017
Indications & Usage
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 WITH 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION The usual dietary potassium intake 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 40-100 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. Potassium chloride extended-release tablets provide 8 mEq, 10 mEq and 20 mEq of potassium chloride. 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 ). NOTE: Potassium chloride extended-release tablets are to be swallowed whole without crushing, chewing or sucking the tablets.