POTASSIUM CHLORIDE tablet, extended release

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

BluePoint Laboratories

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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.

Ապրանքի ամփոփագիր:

Potassium chloride extended-release tablets, USP 10 mEq - white to off-white, capsule-shaped biconvex tablets debossed with ‘471’ on one side and plain on the other side. Potassium chloride extended-release tablets, USP 10 mEq are supplied as follows: NDC 68001-367-00 Bottles of 100 NDC 68001-367-03 Bottles of 500 Potassium chloride extended-release tablets, USP 20 mEq - white to off-white, capsule-shaped biconvex tablets debossed with ‘472’ on one side and scored on the other side. Potassium chloride extended-release tablets, USP 20 mEq are supplied as follows: NDC 68001-445-00 Bottles of 100 NDC 68001-445-03 Bottles of 500 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].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
BLUEPOINT LABORATORIES
----------
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP10 MEQ AND 20MEQ
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. This product
follows USP
Dissolution test 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