Drug Catalog - Product Detail
POTASSIUM CHLORIDE ER CAPS. CP 10MEQ 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68382-0701-05 | ZYDUS PHARMACEUTICALS (USA) | 500 | 10MEQ | CAPSULE |
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Description
DESCRIPTION Potassium chloride extended-release capsules, USP are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. Dispersibility of potassium chloride (KCl) is accomplished by microencapsulation and a dispersing agent. The resultant flow characteristics of the KCl microcapsules and the controlled release of K + ions by the microcapsular membrane are intended to avoid the possibility that excessive amounts of KCl can be localized at any point on the mucosa of the gastrointestinal tract. Each crystal of KCl is microencapsulated by a patented process with an insoluble polymeric coating which functions as a semi-permeable membrane; it allows for the controlled release of potassium and chloride ions over an eight- to ten-hour period. Fluids pass through the membrane and gradually dissolve the potassium chloride within the microcapsules. The resulting potassium chloride solution slowly diffuses outward through the membrane. Potassium chloride extended-release capsules, USP, are electrolyte replenishers. The chemical name of the active ingredient 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: edible ink, ethylcellulose, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide. May contain FD&C Red No. 40 and FD&C Yellow No. 6 aluminum lakes.
How Supplied
HOW SUPPLIED Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows: NDC 68382-702-01 bottle of 100 capsules NDC 68382-702-05 bottle of 500 capsules Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows: NDC 68382-701-01 bottle of 100 capsules NDC 68382-701-05 bottle of 500 capsules NDC 68382-701-30 unit dose packages of 100 capsules Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] Dispense in tight container as defined in the USP. Manufactured By: Nesher Pharmaceuticals USA LLC. St. Louis, MO 63044 Distributed By: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 P10083 10/11
Indications & Usage
INDICATIONS & 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. 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. 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.
Dosage and Administration
DOSAGE & 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 mEq or more 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. Because of the potential for gastric irritation (see WARNINGS ), potassium chloride extended-release capsules, USP, should be taken with meals and with a full glass of water or other liquid. Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of cool water or juice to ensure complete swallowing of the microcapsules. The food used should not be hot and should be soft enough to be swallowed without chewing. Any microcapsule/food mixture should be used immediately and not stored for future use.