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:

TYA Pharmaceuticals

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 patient

Product summary:

NDC:64725-0600-1 in a CONTAINER of 30 TABLET, FILM COATED, EXTENDED RELEASES Do not store above 77°F (25°C). AbbVie LTD Barceloneta, PR 00617 Manufactured by: Pennington, NJ 08534 Distributed by: Zydus Pharmaceuticals USA Inc. 03-A828 June 2014

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
TYA 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 system