Potassium Citrate and Citric Acid
Generic: POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE
Basic Information
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
ce42122f-8087-471f-b0a3-5524bdbd4526
Indications & Usage
INDICATIONS AND USAGE Potassium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated.
In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine.
It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable.
This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M.
dose.
This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage.
It is highly palatable, pleasant tasting and tolerable, even when administered for long periods.
Potassium citrate does not neutralize the gastric juice or disturb digestion.
In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine.
It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable.
This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M.
dose.
This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage.
It is highly palatable, pleasant tasting and tolerable, even when administered for long periods.
Potassium citrate does not neutralize the gastric juice or disturb digestion.
Warnings
WARNINGS Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.
Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity.
Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity.
Adverse Reactions
ADVERSE REACTIONS Potassium Citrate and Citric Acid Oral Solution USP is generally well tolerated without any unpleasant side effects when given in recommended doses to patients with normal renal function and urinary output.
However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis.
Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentration of potassium in the serum.
Periodic determinations of serum electrolytes should be carried out in those patients with renal disease in order to avoid these complications.
Hyperkalemia may exhibit the following electrocardiographic abnormalities: Disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves, etc.
To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc.
at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis.
Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentration of potassium in the serum.
Periodic determinations of serum electrolytes should be carried out in those patients with renal disease in order to avoid these complications.
Hyperkalemia may exhibit the following electrocardiographic abnormalities: Disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves, etc.
To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc.
at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.