Potassium Chloride
Generic: POTASSIUM CHLORIDE
Basic Information
Manufacturer
Lupin Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
fe08221d-74d5-490a-8db4-eaf3ed20b289
Indications & Usage
INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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.
1.
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.
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.
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.
1.
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.
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.
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.
Warnings
WARNINGS Voriconazole treatment-related visual disturbances are common.
In therapeutic trials, approximately 21% of patients experienced abnormal vision, color vision change and/or photophobia.
Visual disturbancesmay be associated with higher plasma concentrations and/or doses.
There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema [ see Warnings and Precautions (5.3)] .
The mechanism of action of the visual disturbance is unknown, although the site of action is most likely to be within the retina.
In a study in healthy subjects investigating the effect of 28-day treatment with voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude, a decrease in the visual field, and an alteration in color perception.
The ERG measures electrical currents in the retina.
The effects were noted early in administration of voriconazole and continued through the course of study drug dosing.
Fourteen days after end of dosing, ERG, visual fields and color perception returned to normal [ see Warnings and Precautions (5.7) ].
In therapeutic trials, approximately 21% of patients experienced abnormal vision, color vision change and/or photophobia.
Visual disturbancesmay be associated with higher plasma concentrations and/or doses.
There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema [ see Warnings and Precautions (5.3)] .
The mechanism of action of the visual disturbance is unknown, although the site of action is most likely to be within the retina.
In a study in healthy subjects investigating the effect of 28-day treatment with voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude, a decrease in the visual field, and an alteration in color perception.
The ERG measures electrical currents in the retina.
The effects were noted early in administration of voriconazole and continued through the course of study drug dosing.
Fourteen days after end of dosing, ERG, visual fields and color perception returned to normal [ see Warnings and Precautions (5.7) ].
Adverse Reactions
ADVERSE REACTIONS One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS and OVERDOSAGE ).
There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ).
The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.
These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.
There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ).
The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.
These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.