POTASSIUM CHLORIDE ER- potassium chloride tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Lastnosti izdelka Lastnosti izdelka (SPC)
30-10-2014

Aktivna sestavina:

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

Dostopno od:

Northwind Pharmaceuticals, LLC

INN (mednarodno ime):

POTASSIUM CHLORIDE

Sestava:

POTASSIUM CATION 20 meq

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. 1. 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. 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, 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 ha

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

                                POTASSIUM CHLORIDE ER- POTASSIUM CHLORIDE TABLET
NORTHWIND PHARMACEUTICALS, LLC
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POTASSIUM CHLORIDE
DESCRIPTION
The Potassium Chloride Extended Release Tablets USP, 20 mEq product is
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.
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, 20 mEq is 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, 20 mEq 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, 20 mEq begin
disintegrating into
microencapsulated crystals within seconds and completely disintegrates
within 1 minute. The
microencapsulated crystals are formulated to provide an extended
release of potassium chloride.
Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl
phthalate, ethyl-cellulose,
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 functio
                                
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