POTASSIUM CHLORIDE EXTENDED-RELEASE- 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:

Par Pharmaceutical, Inc.

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 8 meq

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. - 1.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. - 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, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrhe

Product summary:

Potassium Chloride Extended-Release Capsules, USP, 8 mEq (600 mg) in a hard gelatin capsule with white opaque cap imprinted with “par” and white opaque body imprinted with “C219” in black ink containing white to off white spherical shaped coated pellets. Bottles of 100 (NDC 10370-219-01) Bottles of 500 (NDC 10370-219-05) Potassium Chloride Extended-Release Capsules, USP, 10 mEq (750 mg) in a hard gelatin capsule with dark blue opaque cap imprinted with “par” and dark blue opaque body imprinted with “C220” in black ink containing white to off white spherical coated pellets. Bottles of 100 (NDC 10370-220-01) Bottles of 500 (NDC 10370-220-05) Potassium chloride extended-release capsules are store at controlled room temperature, 20º to 25ºC (68º to 77ºF). [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Manufactured by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 I04/13

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE EXTENDED-RELEASE- POTASSIUM CHLORIDE CAPSULE,
EXTENDED
RELEASE
PAR PHARMACEUTICAL, INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP 8 MEQ AND 10 MEQ
R Only
DESCRIPTION
Potassium Chloride Extended-Release Capsules, USP, are 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 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, ethylcellulose, gelatin, sodium lauryl
sulfate, FD&C Blue #1, FD&C Red
#40, titanium oxide, triacetin, shellac, iron oxide black, isopropyl
alcohol, n-butyl alcohol, propylene
glycol, ammonium hydroxide, FD&C Blue #2, FD&C Red #40, FD&C Blue #1
and D&C Yellow #10.
CLINICAL PHARMACOLOGY
Potassium ion is the principal intracellular cation of most body
tissues. Potassium io