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:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 750 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. 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 diarrh

Product summary:

Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body. Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows: NDC  0615-7694-39 blistercards of 30 capsules NDC  0615-7694-31 blistercards of 31 capsules NDC  0615-7694-05 blistercards of 15 capsules NDC 0615-7694-14 blistercards of 14 capsules NDC 0615-7694-30 unit-dose boxes of 30 capsules Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] Dispense in tight container as defined in the USP. Manufactured By: Nesher Pharmaceuticals USA LLC. St. Louis, MO 63044 Distributed By: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 P10107 11/13

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP
8 MEQ (600 MG) AND 10 MEQ (750 MG)
RX ONLY
DESCRIPTION
Potassium chloride extended-release capsules, USP are an oral dosage
form of microencapsulated
potassium chloride containing 600 mg and 750 mg of potassium chloride,
USP, equivalent to 8 mEq and
10 mEq of potassium, respectively.
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 patented 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 microcapsules. The
resulting potassium chloride solution
slowly diffuses outward through the membrane. Potassium chloride
extended-release capsules, USP,
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.
Inactive ingredients: edible ink, ethylcellulose, FD&C Blue No. 2
aluminum lake, FD&C Yellow No. 6,
gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide.
May contain FD&C Red No. 40 and
FD&C Yellow No. 6 aluminum lakes.
CLINICAL PHARMACOLOGY
Potassium ion is the principal intracellular cation of most body
tissues. Potassium ions participate in a
number of essent