POTASSIUM CHLORIDE tablet, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Novel Laboratories, Inc.

INN (International Name):

POTASSIUM CHLORIDE

Sammensætning:

POTASSIUM CHLORIDE 8 meq

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 therapeutic use 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 patien

Produkt oversigt:

Potassium Chloride Extended-release Tablets, USP 8 mEq are round, beveled edge, light blue colored film coated tablets debossed with "n8" on one side and plain on the other side. Bottles of 100: 40032-912-01 Bottles of 500: 40032-912-05 Bottles of 750: 40032-912-11 Potassium Chloride Extended-release Tablets, USP 10 mEq are round, beveled edge, yellow colored film coated tablets debossed with "n10" on one side and plain on the other side. Bottles of 100: 40032-913-01 Bottles of 500: 40032-913-05 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight container with child resistant closure. Manufactured by:   Novel Laboratories, Inc. Somerset, NJ 08873. PI9130000101 Iss. 05/2016

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
NOVEL LABORATORIES, INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
DESCRIPTION
Potassium Chloride Extended-release Tablets, USP are a solid oral
dosage form of potassium chloride.
Each contains 600 mg or 750 mg of potassium chloride equivalent to 8
mEq or 10 mEq of potassium in
a wax matrix tablet. This formulation is intended to provide an
extended-release of potassium from the
matrix to minimize the likelihood of producing high, localized
concentrations of potassium within the
gastrointestinal tract.
Potassium Chloride Extended-release Tablets are an electrolyte
replenisher. The chemical name is
potassium chloride, and the structural formula is KCl. Potassium
chloride, USP is a white, granular
powder or 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.
_Inactive Ingredients:_ Hydrogenated vegetable oil, Magnesium
Stearate, Colloidal Silicon Dioxide.
The 8 mEq tablets also contain polyvinyl alcohol, titanium dioxide,
polyethylene glycol, talc, FD&C
blue #1/brilliant blue FCF Aluminum Lake, FD&C blue #2/indigo carmine
Aluminum Lake.
The 10 mEq tablets also contain polyvinyl alcohol, polyethylene
glycol, titanium dioxide, talc, D&C
yellow #10 Aluminum Lake, and FD&C yellow #6 /sunset yellow FCF
Aluminum Lake.
USP Dissolution Test Pending.
USP Assay Test Pending.
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 per liter. The normal
adult plasma concentration is 3.5 to 5 mEq per liter. An active ion
transport system maintains this gradient
across t