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:

AvPAK

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 diarrheal states. The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated. Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium sparing diuretic (e.g., spironolactone, triamterene, amiloride) (see OVERDOSAGE ). Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation. All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis) or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in capsule passage through the gastrointestinal tract.

Product summary:

Potassium Chloride Extended-Release Capsules, USP, 10 mEq are blue opaque elongated hard gelatin capsule filled with white to off-white coated pellets and imprinting ‘amneal’ on the cap and ‘542’ on the body with white ink, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K). They are available as follows: NDC 50268-671-13 10 capsules per card, 3 cards per carton Dispensed in blister punch material. For Institutional Use Only. Store at 20 º to 25 º C (68 º to 77 º 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
AVPAK
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP
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, sodium lauryl sulfate and
triethyl
citrate. Additionally capsule shell contains following inactive
ingredients: FD&C blue 1,
FD&C red 40, gelatin and titanium dioxide.
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
contra