מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
Nesher Pharmaceuticals (USA) LLC
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 600 mg
ORAL
PRESCRIPTION DRUG
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 diarrhea
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 51477-002-04 bottle of 100 capsules NDC 51477-002-03 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 51477-001-04 bottle of 100 capsules NDC 51477-001-03 bottle of 500 capsules NDC 51477-001-11 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. Nesher Pharmaceuticals Inc. St. Louis, MO 63044 P10009-1 08/11
New Drug Application Authorized Generic
POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE NESHER PHARMACEUTICALS (USA) LLC ---------- POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP 8 MEQ (600 MG) AND 10 MEQ (750 MG) RX ONLY P10009-1 08/11 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. CLINICAL PHARMACOLOGY Potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of e קרא את המסמך השלם