displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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, and smooth muscle, and the
maintenance of normal renal function.
The intracellular concentration of potassium is approximately 150 to
160 mEq per liter. The normal adult plasma concentration is 3.5 to
5 mEq per liter. An active ion transport system maintains this gradient
across the plasma membrane.
Potassium is a normal dietary constituent and under steady-state
conditions the amount of potassium absorbed from the gastrointestinal
tract is equal to the amount excreted in the urine. The usual
dietary intake of potassium is 50 to 100 mEq per day.
Potassium depletion will occur whenever the rate of potassium loss
through renal excretion and/or loss from the gastrointestinal tract
exceeds the rate of potassium intake. Such depletion usually develops
slowly as a consequence of therapy with diuretics, primary or secondary
hyperaldosteronisms, diabetic ketoacidosis, or inadequate replacement
of potassium in patients on prolonged parenteral nutrition.
Depletion can develop rapidly with severe diarrhea, especially if
associated with vomiting. Potassium depletion due to these causes
is usually accompanied by a concomitant loss of chloride and is
manifested by hypokalemia and metabolic alkalosis. Potassium
depletion may produce weakness, fatigue, disturbances of cardiac
rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram,
and in advanced cases, flaccid paralysis and/or
impaired ability to concentrate urine.
If potassium depletion associated with metabolic alkalosis cannot
be managed by correcting the fundamental cause of the deficiency,
e.g., where the patient requires long-term diuretic therapy, supplemental
potassium in the form of high potassium food or potassium
chloride may be able to restore normal potassium levels.
In rare circumstances (e.g., patients with renal tubular acidosis)
potassium depletion may be associated with metabolic acidosis and
hyperchloremia. In such patients potassium replacement should be
accomplished with potassium salts other than the chloride, such as
potassium bicarbonate, potassium citrate, potassium acetate, or
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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
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 diarrheal states.
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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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 potassiumsparing
diuretic (e.g., spironolactone, triamterene, amiloride) (see
Controlled-release formulations of potassium chloride have produced
esophageal ulceration in certain cardiac patients with
esophageal compression due to an enlarged left atrium. Potassium
supplementation, when indicated in such patients, should be given
as a liquid preparation.
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 anticholineric properties at sufficient
doses to exert anticholinergic effects) cause for arrest or delay in
capsule passage through the gastrointestinal tract.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Hyperkalemia (see OVERDOSAGE)
In patients with impaired mechanisms for excreting potassium, the
administration of potassium salts can produce hyperkalemia and
cardiac arrest. This occurs most commonly in patients given potassium
by the intravenous route but may also occur in patients given
potassium orally. Potentially fatal hyperkalemia can develop rapidly
and be asymptomatic. The use of potassium salts in patients with
chronic renal disease, or any other condition which impairs potassium
excretion, requires particularly careful monitoring of the serum
potassium concentration and appropriate dosage adjustments.
Interaction with Potassium-Sparing Diuretics
Hypokalemia should not be treated by the concomitant administration
of potassium salts and a potassium-sparing diuretic (e.g.,
spironolactone, triamterene, or amiloride), since the simultaneous
administration of these agents can produce severe hyperkalemia.
Interaction with Angiotensin Converting Enzyme Inhibitors
Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril,
enalapril) will produce some potassium retention by inhibiting
aldosterone production. Potassium supplements should be given to
patients receiving ACE inhibitors only with close monitoring.
Solid oral dosage forms of potassium chloride can produce ulcerative
and/or stenotic lesions of the gastrointestinal tract. Based on
spontaneous adverse reaction reports, enteric coated preparations
of potassium chloride are associated with an increased frequency of
small bowel lesions (40 – 50 per 100,000 patient years) compared
to sustained-release wax matrix formulations (less than one per
100,000 patient years). Because of the lack of extensive marketing
experience with microencapsulated products, a comparison
between such products and wax matrix or enteric coated products
is not available. Potassium Chloride Extended-release Capsules,
USP, 8 mEq and 10 mEq are microencapsulated capsules formulated
to provide a controlled rate of release of microencapsulated
potassium chloride and thus to minimize the possibility of high local
concentration of potassium near the gastrointestinal wall.
Prospective trials have been conducted in normal human volunteers
in which the upper gastrointestinal tract was evaluated by endoscopic
inspection before and after one week of solid oral potassium chloride
therapy. The ability of this model to predict events occurring in
usual clinical practice is unknown. Trials which approximated usual
clinical practice did not reveal any clear differences between the wax
matrix and microencapsulated dosage forms. In contrast, there was
a higher incidence of gastric and duodenal lesions in subjects receiving
a high dose of a wax matrix controlled-release formulation under
conditions which did not resemble usual or recommended clinical
practice (i.e., 96 mEq per day in divided doses of potassium chloride
administered to fasted patients, in the presence of an anticholinergic
drug to delay gastric emptying). The upper gastrointestinal lesions
observed by endoscopy were asymptomatic and were not accompanied
by evidence of bleeding (hemoccult testing). The relevance of
these findings to the usual conditions (i.e., non-fasting, no anticholinergic
agent, smaller doses) under which controlled-release
potassium chloride products are used is uncertain; epidemiologic
studies have not identified an elevated risk, compared to microencapsulated
products, for upper gastrointestinal lesions in patients
receiving wax matrix formulations. Potassium Chloride Extendedrelease
Capsules, USP, 8 mEq and 10 mEq should be discontinued
immediately and the possibility of ulceration, obstruction or perforation
considered if severe vomiting, abdominal pain, distention, or
gastrointestinal bleeding occur.
Hypokalemia in patients with metabolic acidosis should be treated
with an alkalinizing potassium salt such as potassium bicarbonate,
potassium citrate, potassium acetate, or potassium gluconate.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
One of the most severe adverse effects is
hyperkalemia (see CONTRAINDICATIONS, WARNINGS, AND OVERDOSAGE).
Gastrointestinal bleeding and ulceration have been
reported in patients treated with Potassium Chloride Extendedrelease
Capsules, USP, 8 mEq and 10 mEq (see CONTRAINDICATIONS
and WARNINGS). In addition to gastrointestinal bleeding and
ulceration, perforation and obstruction have been reported in
patients treated with other solid KCl dosage forms, and may occur
with Potassium Chloride Extended-release Capsules, USP, 8 mEq
and 10 mEq. The most common adverse reactions to the oral potassium
salts are nausea, vomiting, flatulence, abdominal discomfort,
and diarrhea. These symptoms are due to irritation of the gastrointestinal
tract and are best managed by taking the dose with meals,
or reducing the amount taken at one time. Skin rash has been
reported rarely with potassium preparations.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
The administration of oral potassium salts to persons
with normal excretory mechanisms for potassium rarely causes
serious hyperkalemia. However, if excretory mechanisms are
impaired or if potassium is administered too rapidly intravenously,
potentially fatal hyperkalemia can result (see CONTRAINDICATIONS
and WARNINGS). It is important to recognize that hyperkalemia is
usually asymptomatic and may be manifested only by an increased
serum potassium concentration (6.5-8.0 mEq/L) and characteristic
electrocardiographic changes (peaking of T-waves, loss of P-waves,
depression of ST segment, and prolongation of the QT interval).
Late manifestations include muscle paralysis and cardiovascular
collapse from cardiac arrest (9-12 mEq/L).
Treatment measures for hyperkalemia include the following: (1)
elimination of foods and medications containing potassium and of
any agents with potassium-sparing properties; (2) intravenous
administration of 300 to 500 mL/hr of 10% dextrose solution containing
10 to 20 units of crystalline insulin per 1,000 mL; (3) correction
of acidosis, if present, with intravenous sodium bicarbonate;
(4) use of exchange resins, hemodialysis, or peritoneal dialysis. In
treating hyperkalemia, it should be recalled that in patients who have
been stabilized on digitalis, too rapid a lowering of the serum potassium
concentration can produce digitalis toxicity.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
The usual dietary intake of potassium
by the average adult is 50 to 100 mEq per day. Potassium
depletion sufficient to cause hypokalemia usually requires the loss
of 200 or more mEq of potassium from the total body store.
Dosage must be adjusted to the individual needs of each patients.
The dose for the prevention of hypokalemia is typically in the range
of 20 mEq per day. Doses of 40 to 100 mEq per day or more are
used for the treatment of potassium depletion. Dosage should be
divided if more than 20 mEq per day is given such that no more than
20 mEq is given in a single dose. Because of the potential for gastric
irritation (see WARNINGS), Potassium Chloride Extendedrelease
Capsules, USP, 8 mEq and 10 mEq should be taken with
meals and with a full glass of water or other liquid.
Patients who have difficulty swallowing capsules may sprinkle the
contents of the capsule onto a spoonful of soft food. The soft food,
such as applesauce or pudding, should be swallowed immediately
without chewing and followed with a glass of cool water or juice to
ensure complete swallowing of the microcapsules. The food used
should not be hot and should be soft enough to be swallowed without
chewing. Any microcapsule/food mixture should be used immediately
and not stored for future use.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
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).
Dispense in tight container.
displayName: REFERENCES SECTION
FDA Article Code: 34093-5
Watson Laboratories, Inc.
Corona, CA 92880 USA
Watson Pharma, Inc.
Corona, CA 92880 USA
Rev. date: 10/09 192064
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Potassium Chloride ER Capsules,
USP 10mEq K (750 mg)