Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
Major Pharmaceuticals
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 1500 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 WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 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. Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in suc
Potassium chloride extended-release tablets, USP contain 600 mg, 750 mg and 1500 mg of potassium chloride (equivalent to 8 mEq, 10 mEq and 20 mEq, respectively). Potassium chloride extended-release tablets, USP are provided as extended-release, film-coated tablets. Potassium chloride extended-release 600 mg tablets are round in shape, yellow in color and are debossed with the trademark K-TAB on one side. Potassium chloride extended-release 750 mg tablets are ovaloid in shape, yellow in color and are debossed with the “a” logo on one side and the trademark K-TAB on the other side. Potassium chloride extended-release 1500 mg tablets are ovaloid in shape, white in color and are debossed with the trademark K-TAB on one side. Potassium chloride extended-release tablets are supplied as follows: 20 mEq 100 tablets in blister packs per box , NDC 0904-6507-61 (10 cards of 10 tablets each) Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Manufactured by: AbbVie LTD Barceloneta, PR 00617 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Distributed By: Major® Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 03-A996-R6 July, 2014 REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBER
New Drug Application Authorized Generic
POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE MAJOR PHARMACEUTICALS ---------- POTASSIUM CHLORIDE EXTENDED - RELEASE TABLETS, USP DESCRIPTION Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 600 mg, 750 mg and 1500 mg of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. These formulations are 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. The expended inert, porous, wax/polymer matrix is not absorbed and may be excreted intact in the stool. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name 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 8 mEq and 10 mEq Tablets Castor oil, cellulosic polymers, colloidal silicon dioxide, D&C Yellow No. 10, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin and vitamin E. 20 mEq Tablets Castor oil, cellulosic polymers, colloidal silicon dioxide, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin and vitamin E. 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 muscle, and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport syst Les hele dokumentet