Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
Vensun Pharmaceuticals, Inc.
Potassium Chloride
Potassium Chloride 8 meq
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 8 mEq (600 mg) are white opaque/white opaque capsules, imprinted with "P" on the cap and "206" on the body of the capsule, each containing 600 mg microencapsulated potassium chloride (equivalent to 8 mEq K), supplied as follows: NDC 42543-103-01: Bottles of 100 capsules NDC 42543-103-05: Bottles of 500 capsules NDC 42543-103-10: Bottles of 1,000 capsules. Potassium Chloride Extended-release Capsules, USP 10 mEq (750 mg) are blue opaque/white opaque capsules, imprinted with "P" on the cap and "205" on the body of the capsule, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K), supplied as follows: NDC 42543-104-01: Bottles of 100 capsules NDC 42543-104-05: Bottles of 500 capsules NDC 42543-104-10: Bottles of 1,000 capsules. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Pharmaceutics International, Inc. Hunt Valley, MD 21031 Rev. 00, December 2015
Abbreviated New Drug Application
POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE VENSUN PHARMACEUTICALS, INC. ---------- POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP 8 MEQ AND 10 MEQ RX ONLY DESCRIPTION: Potassium Chloride Extended-release Capsules, USP 8 mEq (600 mg) and 10 mEq (750 mg) are oral dosage forms of microencapsulated potassium chloride containing 600 and 750 mg, respectively, of potassium chloride, USP equivalent to 8 and 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 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 micro-capsules. The resulting potassium chloride solution slowly diffuses outward through the membrane. Potassium Chloride Extended-release Capsules, USP 8 mEq (600 mg) and 10 mEq (750 mg) are electrolyte replenishers. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. Potassium chloride 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. The inactive ingredients are: ethyl cellulose, triethyl citrate, sodium lauryl sulfate, and sodium stearyl fumarate. The capsule shell contains gelatin and titanium dioxide. In addition, the 10 mEq (750 mg) capsule shell contains FD&C blue # 2, FD&C red # 3, and FDA/E172 black iron oxide. CLINICAL PHARMACOLOGY: Potassium ion is the principal intracellular cation সম্পূর্ণ নথি পড়ুন