POTASSIUM CHLORIDE- potassium chloride tablet, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Tillgänglig från:

Vensun Pharmaceuticals, Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska 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 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 have

Produktsammanfattning:

Potassium Chloride Extended-release Tablets, USP, 1500 mg of potassium chloride (20 mEq of potassium) are white to off-white capsule shape tablets debossed on upper side with “P” on left side of bisect and “265” on right side of bisect and are scored for flexibility of dosing, available as follows: NDC 42543-126-01: Bottles of 100 tablets NDC 42543-126-05: Bottles of 500 tablets NDC 42543-126-10: Bottles of 1000 tablets Potassium Chloride Extended-release Tablets, USP, 1125 mg of potassium chloride (15 mEq of potassium) are white to off-white capsule shape tablets debossed on upper side with “P” on left side of bisect and “264” on right side of bisect and are scored for flexibility of dosing, available as follows: NDC 42543-125-01: Bottles of 100 tablets NDC 42543-125-05: Bottles of 500 tablets NDC 42543-125-10: Bottles of 1000 tablets Potassium Chloride Extended-release Tablets, USP, 750 mg of potassium chloride (10 mEq of potassium) are white to off-white capsule shape tablets with “P263” debossed on upper side, available as follows: NDC 42543-124-01: Bottles of 100 tablets NDC 42543-124-05: Bottles of 500 tablets NDC 42543-124-10: Bottles of 1000 tablets Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).[See USP Controlled Room Temperature.] Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Pharmaceutics International, Inc. Hunt Valley, MD 21031 Rev. 00, March 2019

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
VENSUN PHARMACEUTICALS, INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
10 MEQ, 15 MEQ AND 20 MEQ
Rx only
DESCRIPTION
Potassium Chloride Extended -release Tablets, USP are an immediately
dispersing extended-release
oral dosage form of potassium chloride containing 750, 1125 or 1500 mg
of microencapsulated
potassium chloride, USP equivalent to 10, 15 or 20 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 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 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 begin 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, sodium
lauryl sulfate, triethyl citrate and
microcrystalline cellulose.
“USP Dissolution 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 impul