POTASSIUM CHLORIDE tablet, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Verfügbar ab:

BluePoint Laboratories

INN (Internationale Bezeichnung):

POTASSIUM CHLORIDE

Zusammensetzung:

POTASSIUM CHLORIDE 10 meq

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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. 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 p

Produktbesonderheiten:

Potassium chloride extended-release tablets, USP 10 mEq are off-white, capsule-shaped tablets, debossed "Andrx 710" on one side. Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured By: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA For BluePoint Laboratories Rev 10/16 234737

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
BLUEPOINT LABORATORIES
----------
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
RX ONLY
DESCRIPTION
The potassium chloride extended-release tablets, USP 10 mEq 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.
This formulation is 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 KCI. 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 disintegrate within 1
minute. The microencapsulated crystals are formulated to provide an
extended release of potassium
chloride.
INACTIVE INGREDIENTS:
Acetyltributyl citrate, crospovidone, 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 physiological processes including the
maintenance of intracellular tonicity; the
transmission of nerve impulses; the contraction of cardiac, skeletal,
and smooth muscle; and the
maintenance of normal renal function.
The intracellular concentration of potassium is approximately 150 to
160 mEq pe