POTASSIUM CHLORIDE- potassium capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (CHLORIDE ION - UNII:Q32ZN48698)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 750 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLEDRELEASE 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. 1. 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. 2. 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 diarrhea

Product summary:

Potassium Chloride Extended-release Capsules, USP, 10 mEq are dark blue opaque capsules, imprinted with Andrx logo on the cap and 560 on the body, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in blisterpacks of 30 (NDC 0615-1318-39), blisterpacks of 31 (NDC 0615-1318-31), blisterpacks of 15 (NDC 0615-1318-05). Store at controlled room temperature, 20° - 25°C (68° - 77°F). [See USP.] Dispense in tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CAPSULE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES
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, FD&C blue #1, FD&C red
# 40, gelatin, sodium lauryl sulfate, titanium oxide and triacetin.
CLINICAL PHARMACOLOGY
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 intracellular tonicity, the transmission of nerve impulses,
the contraction of cardiac, skeletal, an