POTASSIUM CHLORIDE tablet, extended release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152)

Disponible desde:

Sandoz Inc

Designación común internacional (DCI):

Potassium Chloride

Composición:

Potassium Chloride 750 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Potassium chloride extended-release tablets, USP 750 mg of potassium chloride (equivalent to 10 mEq of potassium) are white, oblong tablets and imprinted "US 10". They are supplied as follows: Potassium chloride extended-release tablets, USP 1,500 mg of potassium chloride (equivalent to 20 mEq of potassium) are white, oblong tablets, imprinted "US 20" and scored for flexibility of dosing. They are supplied as follows: 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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
SANDOZ INC
----------
POTAS S IUM
CHLORIDE
EXTENDED-RELEAS E
TABLETS, USP
MICRO-DISPERSIBLE TECHNOLOGY
RX ONLY
DESCRIPTION
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.
Potassium chloride extended-release tablets, USP are an immediately
dispersing extended-release oral
dosage form of potassium chloride containing 1,550 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 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 partic