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:

Contract Pharmacy Services-PA

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 EXTENDED-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 digitais 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 have a

Product summary:

Potassium Chloride Extended-release Tablet, USP, 1500 mg of potassium chloride (20 mEq of potassium) are available in: Potassium Chloride Extended-release Tablets, USP 20 mEq are white, oblong, imprinted US 20 and scored for flexibility of dosing. Potassium Chloride Extended-release Tablet, USP, 750 mg of potassium chloride (10 mEq of potassium) are available in: Potassium Chloride Extended-release Tablets, USP 10 mEq are white, oblong imprinted US 10.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
CONTRACT PHARMACY SERVICES-PA
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POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP MICROENCAPSULATED
DESCRIPTION
Potassium Chloride Extended-release Tablets, USP are 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.
Potassium Chloride Extended-release Tablets, USP are 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 Extended-release Tablets, USP is an electrolyte
replenisher. The chemical name of
the active ingredient is potassium chloride, and the structural
formula is KCl (molecular weight: 74.55).
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 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 begins disintegrating into
microencapsulated crystals within
seconds and completely disintegrates within one minute. The
microencapsulated crystals are formulated
to provide an extended release of potassium chloride.
Inactive Ingredients: croscamellose sodium, ethylcellulose and
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
The potassium ion is the principal intracellular cation of most body
tissues. Pota