POTASSIUM CHLORIDE tablet, film coated, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

NCS HealthCare of KY, Inc dba Vangard Labs

SNN (starptautisko nepatentēto nosaukumu):

POTASSIUM CHLORIDE

Kompozīcija:

POTASSIUM CHLORIDE 10 meq

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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. - 1.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. - 2.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 pa

Produktu pārskats:

Potassium Chloride Extended-release Tablets, USP are available containing 600 mg of potassium chloride, USP (equivalent to 8 mEq) or 750 mg of potassium chloride, USP (equivalent to 10 mEq). The 8 mEq (600 mg) tablet is a light brown film-coated, round, unscored tablet debossed with M on one side of the tablet and PC2 on the other side. The 10 mEq (750 mg) tablet is a peach film-coated, round, unscored tablet debossed with M on one side of the tablet and PC1 on the other side. They are available as follows: NDC 0615-7867-39 blistercards of 30 tablets NDC 0615-7867-05 blistercards of 15 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured in India by: Mylan Laboratories Limited Hyderabad—500 034, India Code No. MH/DRUGS/25/NKD/89 REVISED OCTOBER 2013 MX:KCHLER:R2 75052349

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
8 MEQ AND 10 MEQ
RX ONLY
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 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.
_ USP Assay Test Pending._
INACTIVE INGREDIENTS
Ethylcellulose, magnesium stearate, polyethylene glycol, polyvinyl
alcohol, red iron oxide, stearic
acid, talc, titanium dioxide, and yellow iron oxide.
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 mEq
to 160 mEq per liter. The
normal adult plasma concentration is 3.5 mEq to 5 mEq per liter. An
active ion transport system maintains
this gradient across the plasma membrane.
Potassium is a normal dietary constituent and under steady state
conditions the amount of potassium
absorbed from the gastrointestinal tract is equal to the amount
excreted in the urine. The usual dietary
intake of potassium is 50 mEq t