Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
Aphena Pharma Solutions - Tennessee, LLC
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 WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. - 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. - 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 patient
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. K-TAB (potassium chloride extended-release tablets, USP) contain 750 mg and 1500 mg of potassium chloride (equivalent to 10 mEq and 20 mEq, respectively). K-TAB tablets are provided as ovaloid, extended-release Filmtab® tablets. K-TAB 750 mg are yellow in color and are debossed with the “a” logo on one side and the trademark K-TAB on the other side. K-TAB 1500 mg are white in color and are debossed with the trademark K-TAB on one side. K-TAB Tablets are supplied as follows: 10 mEq 20 mEq Do not store above 77°F (25°C). Filmtab® - Film-sealed tablets, AbbVie Inc. ©2013 AbbVie Inc. Manufactured by: AbbVie LTD Barceloneta, PR 00617 For: AbbVie Inc. North Chicago, IL 60064 03-A823 November, 2013
New Drug Application
K-TAB- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- K-TAB® (POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP) DESCRIPTION K-TAB (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 750 mg and 1500 mg of potassium 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. K-TAB 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 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 system maintains this gradient across the plasma mem Læs hele dokumentet