POTASSIUM CHLORIDE- 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:

REMEDYREPACK INC.

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 10 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. - 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, eg, 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 have

Product summary:

Potassium Chloride Extended-Release Tablets, USP 20 mEq are available in bottles of 100 (NDC 62037-720-01), bottles of 500 (NDC 62037-720-05), and bottles of 1000 (NDC 62037-720-10). Potassium Chloride Extended-Release Tablets, USP 20 mEq are off-white, capsule-shaped tablets, debossed "Andrx 720" on one side and scored on the other for flexibility of dosing. Potassium Chloride Extended-Release Tablets, USP 10 mEq are available in bottles of 100 (NDC 62037-710-01). Potassium Chloride Extended-Release Tablets, USP 10 mEq are off-white, capsule-shaped tablets, debossed "Andrx 710" on one side. Keep tightly closed. Store at  20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 3/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
REMEDYREPACK INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
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.
The Potassium Chloride Extended-Release Tablets, USP 10 mEq product is
an immediately dispersing
extended release oral dosage form of potassium chloride containing 750
mg of microencapsulated
potassium chloride, USP equivalent to 10 mEq of potassium in a 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.
Potassium chloride is 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 is a tablet formulation (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 tablets begin
disintegrating into microencapsulated crystals within seconds and
completely disintegrate within 1
minute. The microencapsulated crystals are formulated to provide an
extended release of potassium
chloride.
INACTIVE INGREDIENTS:
Acetyltributyl citrate, crospovidone, ethylcellulose, and
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