POTASSIUM CHLORIDE capsule, coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

LUPIN LIMITED

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 10 meq

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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. - 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 diarrheal s

Product summary:

Potassium Chloride Extended-Release Capsules USP, 600 mg (8 mEq K) are size '00' opaque white color hard gelatin capsules imprinted with 'LU' on cap and 'R51' on body in black ink containing white to off white coated pellets (equivalent to 8 mEq K) in bottles of 100 (NDC 68180-798-01) and bottles of 500 (NDC 68180-798-02). Potassium Chloride Extended-Release Capsules USP, 750 mg (10 mEq K) are size '00 EL' opaque blue color hard gelatin capsules imprinted with 'LU' on cap and 'R52' on body in white ink containing white to off white coated pellets (equivalent to 10 mEq K) in bottles of 100 (NDC 68180-799-01), bottles of 500 (68180-799-02) and bottles of 1000 (68180-799-03). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA October 2015                                                                                      ID#: 226334

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, COATED, EXTENDED
RELEASE
LUPIN LIMITED
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES USP, 600 MG (8MEQ K) AND
750 MG (10 MEQ K)
RX ONLY
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, 600 mg (8
mEq K) and 750 mg (10 mEq K) 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 ethyl cellulose, triethyl citrate, talc,
sodium lauryl sulfate, gelatin, titanium
dioxide, shellac, propylene glycol, potassium hydroxide. In addition
600 mg [8 mEq K] capsule also
contain black iron oxide and 750 mg [10 mEq K] capsules also contain
FD&C blue #1 and FD&C red #
40.
CLINICAL PHARMACOLOGY
Potassium ion is the principa