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:

Aphena Pharma Solutions - Tennessee, LLC

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, 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 patie

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Potassium Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10).  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 controlled room temperature, 20°-25°C (68°-77°F). [See USP.]  Manufactured by: Eurand, Inc. Vandalia, OH 45377 USA Distributed by: Watson Pharma, Inc. Rev. Date (01/09)        173714

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
POTASSIUM CHLORIDE
EXTENDED RELEASE
TABLETS USP
20 MEQ K
RX ONLY
173714
POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS USP 20 MEQ K
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.
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 Extended Release Tablets USP, 20 mEq 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 Extended Release Tablets USP, 20 mEq 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 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.
INACTIVE INGREDIENTS: Colloidal silicon dioxide, crospovidone, diethyl
phthalate, ethyl-cellulose,
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 ton