POTASSIUM CHLORIDE- potassium chloride e-r capsule, coated, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

NuCare Pharmaceuticals,Inc.

INN (Nama Internasional):

POTASSIUM CHLORIDE

Komposisi:

POTASSIUM CHLORIDE 8 meq

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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. - For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, 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, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal s

Ringkasan produk:

NDC 68071-4078-3 Bottles of 30 NDC 68071-4078-6 Bottles of 60 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA October 2015 ID#: 226334

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE E-R CAPSULE, COATED, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS,INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES USP, 600 MG (8MEQ K)
AND 750 MG (10 MEQ K)
RX ONLY
DESCRIPTION
Potassium chloride extended-release capsules USP, 8 mEq and 10 mEq are
oral dosage
forms of microencapsulated potassium chloride containing 600 and 750
mg,
respectively, of potassium chloride USP equivalent to 8 and 10 mEq of
potassium.
Dispersibility of potassium chloride (KCl) is accomplished by
microencapsulation and a
dispersing agent. The resultant flow characteristics of the KCl
microcapsules and the
controlled release of K+ ions by the microcapsular membrane are
intended to avoid the
possibility that excessive amounts of KCl can be localized at any
point on the mucosa of
the gastrointestinal tract.
Each crystal of KCl is microencapsulated by a process with an
insoluble polymeric
coating which functions as a semi-permeable membrane; it allows for
the controlled
release of potassium and chloride ions over an eight-to-ten-hour
period. Fluids pass
through the membrane and gradually dissolve the potassium chloride
within the micro-
capsules. The resulting potassium chloride solution slowly diffuses
outward through the
membrane. Potassium chloride extended-release capsules USP, 600 mg (8
mEq K) and
750 mg (10 mEq K) are electrolyte replenishers. 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.
The inactive ingredients are ethyl cellulose, triethyl citrate, talc,
sodium lauryl sulfate,
gelatin, titanium dioxide, shellac, propylene glycol, potassium
hydroxide. In addition 600
mg [8 mEq K] capsule also contain black iron oxide and 750 mg [10 mEq
K] capsules
also contain FD&C blue #1 and FD&C red # 40.
CLINICAL PHARMACOLOGY
Potassium