POTASSIUM CHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Available from:

DIRECT RX

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 750 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 patients

Product summary:

Potassium chloride extended-release tablets, USP contain 750 mg and 1500 mg of potassium chloride (equivalent to 10 mEq and 20 mEq, respectively). Potassium chloride extended-release tablets, USP are provided as ovaloid, extended-release, film-coated tablets. Potassium chloride extended-release tablets 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. Potassium chloride extended-release tablets 1500 mg are white in color and are debossed with the trademark K-TAB on one side. Potassium chloride extended-release tablets are supplied as follows: 10 mEq 20 mEq Recommended Storage Do not store above 77°F (25°C). Manufactured by: AbbVie LTD Barceloneta, PR 00617 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 03-A826 November, 2013 NDC 68382–600–01 ZyGenerics POTASSIUM CHLORIDE EXTENDED— RELEASE TABLETS, USP 10 mEq (750 mg) 100 Film-Coated Tablets

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
DIRECT RX
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POTASSIUM CHLORIDE
DESCRIPTION SECTION
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.
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
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 SECTION
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 membrane.
Potassium is