Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
NuCare Pharmaceuticals, Inc.
POTASSIUM CHLORIDE
POTASSIUM CATION 20 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. 1. 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. 2. 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 patien
Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing. Bottles of 30 NDC 68071-1933-3 Bottles of 60 NDC 68071-1933-6 Bottles of 90 NDC 68071-1933-9 Bottles of 180 NDC 68071-1933-8 Storage Conditions: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Contains: MICROCAPS drug delivery product Manufactured by: Adare Pharmaceuticals, Inc. Vandalia, OH 45377 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: October 2015 MICROCAPS is a registered trademark of Adare Pharmaceuticals S.r.l., an affiliate of Adare Pharmaceuticals, Inc.
Abbreviated New Drug Application
POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE NUCARE PHARMACEUTICALS, INC. ---------- POTASSIUM CHLORIDE - ADARE 076368 POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 MEQ K Revised: October 2015 RX ONLY DESCRIPTION The Potassium Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. This formulation is 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. Potassium Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. 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. Potassium Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. INACTIVE INGREDIENTS: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl cellulose, microcrystalline cellulose. CLINICAL PHARMACOLOGY The 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 nerv Läs hela dokumentet