POTASSIUM CHLORIDE tablet, 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:

Preferred Pharmaceuticals Inc.

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CATION 20 meq

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 IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 1. 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. 2. 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, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing. Storage Conditions: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Contains: MICROCAPS drug delivery product RX Only Manufactured by: Adare Pharmaceuticals, Inc. Vandalia, OH 45377 USA Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Repackaged By: Preferred Pharmaceuticals Inc. Revised: 04/2021 MICROCAPS is a registered trademark of Adare Pharmaceuticals S.r.l., an affiliate of Adare Pharmaceuticals, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
PREFERRED PHARMACEUTICALS INC.
----------
POTASSIUM CHLORIDE
EXTENDED RELEASE
TABLETS, USP
20 MEQ K
REVISED: 04/2021
RX ONLY
DESCRIPTION
The Potassium Chloride Extended Release Tablets, USP, 20 mEq product
is an
immediately dispersing extended release oral dosage form of potassium
chloride
containing 1500 mg of microencapsulated potassium chloride, USP
equivalent to 20 mEq
of potassium in a tablet.
This formulation is 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.
Potassium Chloride Extended Release Tablets, USP, 20 mEq are an
electrolyte
replenisher. The chemical name of the active ingredient 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.
Potassium Chloride Extended Release Tablets, USP, 20 mEq are tablet
formulations (not
enteric coated or wax matrix) containing individually
microencapsulated potassium
chloride crystals which disperse upon tablet disintegration. In
simulated gastric fluid at
37°C and in the absence of outside agitation, Potassium Chloride
Extended Release
Tablets, USP, 20 mEq begin disintegrating into microencapsulated
crystals within
seconds and completely disintegrates within 1 minute. The
microencapsulated crystals
are formulated to provide an extended release of potassium chloride.
FDA approved dissolution test specifications differ from USP.
INACTIVE INGREDIENTS: Colloidal silicon dioxide, crospovidone, diethyl
phthalate,
ethylcellulose, microcrystalline cellulose.
CLINICAL PHARMACOLOGY
The 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 toni