POTASSIUM CHLORIDE tablet, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Dostupné z:

Zydus Lifesciences Limited

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

Potassium Chloride Extended-release Tablets, USP 10 mEq are white to off-white colored, capsule shaped, biconvex uncoated tablets debossed with "KCl 10" on one side and plain on the other side and are supplied as follows: NDC 70771-1599-1 in bottle of 100 tablets NDC 70771-1599-0 in bottle of 1000 tablets Potassium Chloride Extended-release Tablets, USP 20 mEq are white to off-white colored, capsule shaped, biconvex uncoated tablets debossed with "KCl" and "20" on either side of break line and plain on the other side and are supplied as follows: NDC 70771-1600-1 in bottle of 100 tablets NDC 70771-1600-5 in bottle of 500 tablets NDC 70771-1600-0 in bottle of 1000 tablets Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

POTASSIUM CHLORIDE - POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
ZYDUS LIFESCIENCES LIMITED
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POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
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, 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 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 extended-release tablets begin disintegrating into
microencapsulated
crystals within seconds and completely disintegrate within one minute.
The
microencapsulated crystals are formulated to provide an extended
release of potassium
chloride.
INACTIVE INGREDIENTS:
Colloidal silicon dioxide, croscarmellose sodium, ethylcellulose,
hyrpromellose,
microcrystalline cellulose, polyethylene glycol and povidone.
USP Assay preparation is pending.
CLINICAL PHARMACOLOGY
The potassium ion is the principal intracel