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:

Safecor Health, LLC

INN (International Name):

Potassium Chloride

Composition:

Potassium Chloride 750 mg

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. The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated. Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such pat

Product summary:

Potassium Chloride Extended-release Tablets, USP, 1500 mg of potassium chloride (20 mEq of potassium): Potassium Chloride Extended-release Tablets, USP, 750 mg of potassium chloride (10 mEq of potassium): For Institutional Use Only Ensure seal on pouch is tightly closed. Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
SAFECOR HEALTH, LLC
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POTASSIUM
CHLORIDE
EXTENDED-RELEASE
TABLETS, USP
MICROENCAPS ULATED
RX ONLY
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 are 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 are 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: _croscarmellose sodium, ethylcellulose and
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
The potassium ion is the principal intracellular cation of most body
tissues. Potassium ions participate