Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
Contract Pharmacy Services-PA
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 750 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 diarrheal
Potassium chloride extended-release capsules, USP, 10 mEq (750 mg) are dark blue opaque capsules, imprinted with Andrx logo on the cap and 560 on the body, packaged as follows: NDC 67046-589-30 blisters of 30 Capsules Store at controlled room temperature 15° - 30°C (59° - 86°F). Dispense in tight container. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Revised: 08/08 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW
Abbreviated New Drug Application
POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE CONTRACT PHARMACY SERVICES-PA ---------- POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES USP 10 MEQ (750 MG) RX ONLY Rev. 09/09 DESCRIPTION Potassium chloride extended-release capsules, USP is an oral dosage form of microencapsulated potassium chloride containing 750 mg of potassium chloride, USP, equivalent to 10 mEq of potassium. 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 Ethylcellulose, FD&C Blue #1, FD&C red # 40, Gelatin, Sodium Lauryl Sulfate, Titanium Oxide and T riacetin. CLINICAL PHARMACOLOGY Potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes, including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal and smooth Citiți documentul complet