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

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, 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 hav

Product summary:

Potassium chloride extended-release tablets, USP, 750mg of potassium chloride (equivalent to 10mEq of potassium) are white, oblong tablets and imprinted "KC M10". Potassium chloride extended-release tablets, USP, 1500 mg of potassium chloride (equivalent to 20 mEq of potassium) are white, oblong tablets, imprinted "KC M20" and scored for flexibility of dosing. They are supplied as follows: Bottles of 100 tablets, NDC 42291-507-01 Bottles of 500 tabletes, NDC 42291-507-50 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
MICRO-DISPERSIBLE TECHNOLOGY
RX ONLY
DESCRIPTION
The potassium chloride extended-release tablets, USP 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.
The potassium chloride extended-release tablets, USP product is an
immediately
dispersing extended-release oral dosage form of potassium chloride
containing 1,500
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 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 disintegrates within 1 minute. The
microencapsulated crystals
are formulated to provide an extended-release of potassium chloride.
_Inactive Ingredients_: croscarmellose sodium, 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 physiol