POTASSIUM CHLORIDE tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 ha

Περίληψη προϊόντος:

Potassium chloride extended-release tablets, USP 10 mEq are available in NDC: 70518-2234-00 PACKAGING: 30 in 1 BLISTER PACK Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Keep tightly closed. 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].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
REMEDYREPACK INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
10 MEQ AND 20 MEQ
RX ONLY
DESCRIPTION
The potassium chloride extended-release tablets, USP 20 mEq product is
an immediately
dispersing extended-release oral dosage form of potassium chloride
containing 1500 mg
of microencapsulated potassium chloride, USP equivalent to 20 mEq of
potassium in a
tablet.
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 is 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, crystalline powder. It is odorless and has a
saline taste. It is
freely soluble in water and practically insoluble in ethanol.
Potassium chloride is 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 tablets begin disintegrating into microencapsulated
crystals within
seconds and completely disintegrate within 1 minute. The
microencapsulated crystals
are formulated to provide an extended-release of potassium chloride.
This product complies with USP assay preparation 2.
INACTIVE INGREDIENTS: crospovidone, ethylcellulose, hydroxypropyl
cellulose,
magnesium stearate, microcrystalline cellulose and talc.
CLINICAL PHARMACOLOGY
The potassium ion is the principal intracellular cation of most body
tissues. Potassium
ions participate in a numb