Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Gastrointestinal Adverse Reactions
(Physician Labeling Rule (PLR)
Conversion)
Solid oral dosage forms of potassium chloride can produce ulcerative
and/or stenotic lesions of the gastrointestinal tract, particularly if the drug
is in contact with the gastrointestinal mucosa for a prolonged period of time.
Consider the use of liquid potassium in patients with dysphagia, swallowing
disorders, or severe gastrointestinal motility disorders.
If severe vomiting, abdominal pain, distention, or gastrointestinal
bleeding occurs, discontinue potassium chloride extended-release capsules and
consider possibility of ulceration, obstruction or perforation.
Potassium chloride extended-release capsules should not be taken on an
empty stomach because of its potential for gastric irritation.
6
Adverse Reactions
(Physician Labeling Rule (PLR) Conversion)
The following
adverse reactions have been identified with use of oral potassium salts.
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.
The most common
adverse reactions to oral potassium salts are nausea, vomiting, flatulence,
abdominal pain/discomfort, and diarrhea
There have been
reports of hyperkalemia and of upper and lower gastrointestinal conditions
including, obstruction, bleeding, ulceration, and perforation.
Skin rash has been
reported rarely.
7
Drug Interactions
7.1 Amiloride and Triamterene
(Physician Labeling Rule (PLR) Conversion)
Use with triamterene or amiloride can produce severe hyperkalemia.
Concomitant use is contraindicated.
7.2 Renin-Angiotensin-Aldosterone Inhibitors
(Physician Labeling Rule (PLR)
Conversion)
Drugs that inhibit the renin-angiotensin-aldosternone system (RAAS)
including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor
blockers (ARBs), spironolactone, eplerenone, or aliskiren produces potassium
retention by inhibiting aldosterone production. Closely monitor potassium in
patients taking drugs that inhibit RAAS.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
(Physician Labeling Rule (PLR)
Conversion)
NSAIDs may produce potassium retention by reducing renal synthesis of
prostaglandin E and impairing the renin-angiotensin system. Closely monitor
potassium in patients taking NSAIDS.
8
Use in Specific Populations
8.1 Pregnancy
(Physician Labeling Rule (PLR)
Conversion)
Risk Summary
There are no human data related to use of potassium chloride
extended-release capsules during pregnancy and animal reproductive studies have
not been conducted. Potassium
supplementation that does not lead to hyperkalemia is not expected to cause
fetal harm.
The background risk for major birth defects and miscarriage in the
indicated population is unknown. All pregnancies have a background risk of
birth defect, loss, or other adverse outcomes. In the U.S. general population,
the estimated background risk of major birth defects and miscarriage in
clinically recognized pregnancies is 2-4% and 15-20%, respectively.
8.2 Lactation
(Physician Labeling Rule (PLR)
Conversion, additions and/or revisions are underlined)
Risk Summary
The normal potassium ion content of human milk is about 13 mEq per
liter. Since oral potassium becomes part of the body potassium pool, as long
as body potassium is not excessive, the contribution of potassium chloride
supplementation should have little or no effect on the level in human milk.
8.4 Pediatric Use
(Physician Labeling Rule (PLR)
Conversion)
Clinical trial data from published literature have demonstrated the
safety and effectiveness of potassium chloride in children with diarrhea and
malnutrition from birth to 18 years.
8.5 Geriatric Use
(Physician Labeling Rule (PLR)
Conversion, additions and/or revisions are underlined)
Clinical studies of potassium chloride did not include
sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy.
...
8.6 Cirrhotics
(Physician Labeling Rule (PLR)
Conversion)
Based on publish literature, the baseline corrected serum
concentrations of potassium measured over 3 hours after administration in
cirrhotic subjects who received an oral potassium load rose to approximately
twice that of normal subjects who received the same load. Patients with
cirrhosis should usually be started at the low end of the dosing range, and the
serum potassium level should be monitored frequently.
8.7 Renal Impairment
(Physician Labeling Rule (PLR) Conversion)
Patients with renal impairment have reduced urinary excretion of
potassium and are at substantially increased risk of hyperkalemia. Patients
with impaired renal function, particularly if the patient is on RAAS inhibitors
or nonsteroidal anti-inflammatory drugs, should usually be started at the low
end of the dosing range because of the potential for development of
hyperkalemia. The serum potassium level should be monitored frequently. Renal
function should be assessed periodically.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(Physician Labeling Rule (PLR)Conversion)
- Inform patients to take each dose with meals and
with a full glass of water or other liquid.
- Advise patients seek medical attention if tarry
stools or other evidence of gastrointestinal toxicity is noticed.
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