POTASSIUM CHLORIDE- potassium chloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Potassium Chloride Extended-release Capsules, USP, 8 mEq are white opaque capsules, imprinted with Andrx logo on the cap and 559 on the body, each containing 600 mg microencapsulated potassium chloride (equivalent to 8 mEq K) in bottles of 30 NDC 68071-3274-3 bottles of 60 NDC 68071-3274-6 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: February 2015 192064-2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
NUCARE 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 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 (KCI) is accomplished by
microencapsulation 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, FD&C blue #1, FD&C red #
40, gelatin, sodium lauryl
sulfate, titanium oxide and triacetin.
CLINICAL PHARMACOLOGY:
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 impu