POTASSIUM CHLORIDE EXTENDED-RELEASE- potassium chloride tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Sun Pharmaceutical Industries, Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 intoxication, 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. 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 enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Potassium Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections). 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 tablet passage through the gastrointestinal tract.

Přehled produktů:

Potassium Chloride Extended Release Tablets, USP, 10mEq are available in bottles of 100 tablets (NDC 63304-076-01), bottles of 500 tablets (NDC 63304-076-05) and bottles of 1000 tablets (NDC 63304-076-10). Potassium Chloride Extended Release Tablets, USP, 10mEq are capsule shaped, white to off-white tablets, with “Q10” imprinted on one side and plain on the other side. Storage Conditions: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Contains: MICROCAPS drug delivery product. Manufactured by: Adare Pharmaceuticals, Inc. Vandalia, OH 45377 USA Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Iss. 07/2019 MICROCAPS is a registered trademark of Adare Pharmaceuticals S.r.l., an affiliate of Adare Pharmaceuticals, Inc.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

POTASSIUM CHLORIDE EXTENDED-RELEASE- POTASSIUM CHLORIDE TABLET,
EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS, USP 10 MEQ K
RX ONLY
DESCRIPTION
The Potassium Chloride Extended Release Tablets, USP, 10 mEq product
is an
immediately dispersing extended release oral dosage form of potassium
chloride
containing 750 mg of microencapsulated potassium chloride, USP
equivalent to 10 mEq
of potassium in a tablet.
These formulations are intended to slow the release of potassium so
that the likelihood
of a high localized concentration of potassium chloride within the
gastrointestinal tract is
reduced.
Potassium Chloride Extended Release Tablets, USP, 10mEq are an
electrolyte
replenisher. 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.
Potassium Chloride Extended Release Tablets, USP, 10mEq are a tablet
formulation (not
enteric coated or wax matrix) containing individually
microencapsulated potassium
chloride crystals which disperse upon tablet disintegration.
In simulated gastric fluid at 37°C and in the absence of outside
agitation, Potassium
Chloride Extended Release Tablets, USP, 10 mEq begin disintegrating
into micro-
encapsulated crystals within seconds and completely disintegrates
within 1 minute. The
microencapsulated crystals are formulated to provide an extended
release of potassium
chloride.
FDA approved dissolution test specifications differ from USP.
INACTIVE INGREDIENTS:Colloidal silicon dioxide, crospovidone, diethyl
phthalate,
ethylcellulose, microcrystalline cellulose.
CLINICAL PHARMACOLOGY
The 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 intracellul