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:

Blenheim Pharmacal, Inc.

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. 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 s

Product summary:

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: 8 mEq Bottles of 100 NDC 68382-776-01 Bottles of 1000 NDC 68382-776-10 10 mEq Bottles of 30 NDC 68382-600-06 Bottles of 90 NDC 68382-600-16 Bottles of 100 NDC 68382-600-01 Bottles of 1000 NDC 68382-600-10 20 mEq Bottles of 30 NDC 68382-398-06 Bottles of 90 NDC 68382-398-16 Bottles of 100 NDC 68382-398-01 Bottles of 500 NDC 68382-398-05 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 Marketed/ Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131, (USA) 03-A996-R6 July, 2014

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
BLENHEIM PHARMACAL, INC.
----------
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
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 grad