POTASSIUM CHLORIDE capsule, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Novel Laboratories, Inc.

INN (Kansainvälinen yleisnimi):

POTASSIUM CHLORIDE

Koostumus:

POTASSIUM CHLORIDE 8 meq

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Potassium Chloride Extended-Release Capsules USP, 8 mEq are hard gelatin capsules with white opaque cap and white opaque body, imprinted "NL 910" on the cap and "600 mg" on the body in black ink, filled with white to off white crystals. Bottles of 100 (NDC 40032-910-01) Bottles of 500 (NDC 40032-910-05) Potassium Chloride Extended-Release Capsules USP, 10 mEq are hard gelatin capsules with dark blue opaque cap and dark blue opaque body, imprinted "NL 911" on the cap and "750 mg" on the body in white ink, filled with white to off white crystals. Bottles of 90 (NDC 40032-911-09) Bottles of 500 (NDC 40032-911-05) Store at 20°- 25°C (68° - 77°F). [See USP Controlled Room Temperature] Dispense in tight container. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 USA PI9110000101 Rev. 07/2015

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
NOVEL LABORATORIES, INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP
NOVEL LABORATORIES, INC.
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.
Availability of potassium chloride (KCl) in extended-release manner is
accomplished by
microencapsulation of potassium chloride and a dispersing agent. The
resultant flow characteristics of
the KCI microcapsules and the controlled release of K+ ions by the
microcapsular membrane are
intended to avoid the possibility that excessive amounts of KCI can be
localized at any point on the
mucosa of the gastrointestinal tract.
Each crystal of KCI 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, 8 mEq
and 10 mEq are electrolyte replenishers. The chemical name of the
active ingredient is potassium
chloride and the structural formula is KCI. 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 ethylcellulose, triethyl citrate, sodium
lauryl sulfate, FD&C blue #1,
FD&C red # 40, gelatin, titanium dioxide, shellac, potassium hydroxide
and black iron oxide.
CLINICAL PHARMACOLOGY
Potassium ion is the principal intracellular cation of most body
tissues. Potassium ions participate in a
number of essential physi