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:

Actavis Pharma, 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 a bisect on the other side 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. Store at  20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. B 8/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
ACTAVIS PHARMA, 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.
USP dissolution test is pending.
CLINICAL PHARMACOLOGY
The potassium ion is the principal intracellular cation of most body
tissues. Potassium
ions participate in a number of essenti