POTASSIUM CHLORIDE- potassium chloride capsule, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Vensun Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

Potassium Chloride

Composição:

Potassium Chloride 8 meq

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Potassium Chloride Extended-release Capsules, USP 8 mEq (600 mg) are white opaque/white opaque capsules, imprinted with "P" on the cap and "206" on the body of the capsule, each containing 600 mg microencapsulated potassium chloride (equivalent to 8 mEq K), supplied as follows: NDC 42543-103-01: Bottles of 100 capsules NDC 42543-103-05: Bottles of 500 capsules NDC 42543-103-10: Bottles of 1,000 capsules. Potassium Chloride Extended-release Capsules, USP 10 mEq (750 mg) are blue opaque/white opaque capsules, imprinted with "P" on the cap and "205" on the body of the capsule, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K), supplied as follows: NDC 42543-104-01: Bottles of 100 capsules NDC 42543-104-05: Bottles of 500 capsules NDC 42543-104-10: Bottles of 1,000 capsules. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Pharmaceutics International, Inc. Hunt Valley, MD 21031 Rev. 00, December 2015

Status de autorização:

Abbreviated New Drug Application

Características técnicas

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
VENSUN PHARMACEUTICALS, INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP 8 MEQ AND 10 MEQ
RX ONLY
DESCRIPTION:
Potassium Chloride Extended-release Capsules, USP 8 mEq (600 mg) and
10 mEq (750 mg) 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 8 mEq
(600 mg) and 10 mEq (750 mg) are electrolyte replenishers. The
chemical name of the active ingredient
is potassium chloride and the structural formula is KCl. Potassium
chloride 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,
sodium lauryl sulfate, and sodium stearyl
fumarate. The capsule shell contains gelatin and titanium dioxide. In
addition, the 10 mEq (750 mg)
capsule shell contains FD&C blue # 2, FD&C red # 3, and FDA/E172 black
iron oxide.
CLINICAL PHARMACOLOGY:
Potassium ion is the principal intracellular cation