POTASSIUM CHLORIDE EXTENDED RELEASE- potassium chloride capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Pieejams no:

Adare Pharmaceuticals Inc

SNN (starptautisko nepatentēto nosaukumu):

POTASSIUM CHLORIDE

Kompozīcija:

POTASSIUM CHLORIDE 600 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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. - 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. - 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 anticholineric properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in capsule passage through the gastrointestinal tract.

Produktu pārskats:

Potassium Chloride Extended-release Capsules, USP, 8 mEq are white to ivory opaque capsules printed with “102” and containing 600 mg microencapsulated potassium chloride (equivalent to 8 mEq K) in bottles of 100 (NDC 59917-102-01), bottles of 500 (NDC 59917-102-05) and bottles of 1000 (NDC 59917-102-10). Potassium Chloride Extended-release Capsules, USP, 10 mEq are light blue opaque capsules printed with “103” and containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in bottles of 100 (59917-103-01) , bottles of 500 (NDC 59917-103-05) and bottles of 1000 (NDC 59917-103-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured by: Adare Pharmaceuticals, Inc. Vandalia, OH 45377 USA Rev. date: 6/2016

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

POTASSIUM CHLORIDE EXTENDED RELEASE- POTASSIUM CHLORIDE CAPSULE
ADARE PHARMACEUTICALS INC
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP, 8 MEQ AND 10 MEQ
RX ONLY
DESCRIPTION:
Potassium Chloride Extended-release Capsules, USP, 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, USP, 8 mEq and
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, magnesium
stearate, sodium lauryl
sulfate, titanium dioxide and edible black ink. The 10 mEq capsules
also contain black
iron oxide, FD&C blue No. 1 and FD&C red No. 3.
CLINICAL PHARMACOLOGY:
Potassium ion is the principal intracellular cation of most body
tissues. Potassium ions
participate in a number of essential physiological processes,
i