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:

Amneal Pharmaceuticals

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 diarrhe

Product summary:

Potassium Chloride Extended-Release Capsules, USP, 10 mEq are clear transparent elongated hard gelatin capsule filled with white to off-white coated pellets and imprinting ‘AMNEAL’ on the cap and ‘542’ on the body, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K). They are available as follows: Bottles of 100: 65162-542-10 Bottles of 500: 65162-542-50 Bottles of 1000: 65162-542-11 Store at 20º to 25º C (68º to 77º F) [See USP Controlled Room Temperature]. Dispense in tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE - POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP,
10 MEQ
R ONLY
DESCRIPTION
Potassium Chloride Extended-Release Capsules, USP, 10 mEq are oral
dosage forms of
microencapsulated potassium chloride containing 750 mg of potassium
chloride USP equivalent to 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, 10 mEq
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.
The inactive ingredients are ethylcellulose, gelatin, sodium lauryl
sulfate and triethyl citrate.
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 impulses, the contraction of cardiac, skeletal,
and smooth muscle, and the
maintenance of normal renal function