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:

Northstar Rx LLC

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. 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 hard gelatin capsules with opaque white body with ‘357’ imprinted in black and opaque orange cap with ‘G’ imprinted in black, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in bottles of 100 (NDC 16714-824-01) and bottles of 500 (NDC 16714-824-02). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. May 2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
NORTHSTAR RX LLC
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP, 10 MEQ
RX ONLY
DESCRIPTION
Potassium chloride extended-release capsules, USP, 10 mEq is an oral
dosage form 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 USP and
the structural formula is KCl. Potassium chloride USP occurs as a
granular crystalline powder. It is
freely soluble in water and practically insoluble in ethanol.
The inactive ingredients are, ethylcellulose, FD&C red #3, FD&C yellow
# 6, gelatin, magnesium
stearate, sodium lauryl sulfate, talc and titanium dioxide.
The imprinting ink contains the following: black iron oxide, potassium
hydroxide and shellac.
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, skelet