Potassium Citrate-Citric Acid Crystals

Severe renal impairment with oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, and hyperkalemia from any cause.

There have been several reports, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts.  These lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or certain other oral diuretics.  These small-bowel lesions have caused obstruction, hemorrhage, and perforation.  Surgery was frequently required and deaths have occurred.  Based on a large survey of physicians and hospitals, both United States and foreign, the incidence of these lesions is low, and a causal relationship in man has not been definitely established.  Available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously.  Therefore, coated potassium-containing formulations should be administered only when indicated, and should be discontinued immediately if abdominal pain, distention, nausea, vomiting, or gastrointestinal bleeding occur.

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.

Do not exceed recommended dosage.  Discontinue use if adverse reactions occur.

Should be used with caution by patients with low urinary output unless under the supervision of a physician.  As with all liquids containing a high concentration of potassium, patients should be directed to dilute adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations; and preferably, to take each dose after meals to avoid saline laxative effect.

Potassium Citrate - Citric Acid Crystals 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.

Potassium Citrate - Citric Acid Crystals should be taken mixed in cool water or juice according to directions, followed by additional water or juice, if desired.  Proper dilution may help prevent gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations.

Usual Adult Dose:  Potassium Citrate - Citric Acid Crystals - Contents of 1 packet reconstituted with at least 6 ounces of cool water or juice, after meals and at bedtime, or as directed by physician.

Usual Pediatric Dose:  Potassium Citrate - Citric Acid Crystals is not recommended for pediatric use.

Usual Dosage Range:  Contents of 1 packet Potassium Citrate - Citric Acid Crystals, reconstituted as directed and taken four times a day, will usually maintain a urinary pH of 6.5-7.4.  To check urinary pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.

Store at controlled room temperature, 59° - 86° F (15° - 30°C). Protect from excessive heat or freezing.

Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088 Toll Free.

Rx ONLY 

Manufactured for:
Virtus Pharmaceuticals
Tampa, FL 33619
www.virtusRX.com
MADE IN CANADA

Virtus
PHARMACEUTICALS

Rev. 3/2014

VIRTUS
PHARMACEUTICALS       Rx Only

NDC: 76439-261-10

Potassium Citrate -
Citric Acid Crystals

Oral Solution

(Potassium Citrate and Citric Acid)

FRUIT FLAVORED • SUGAR FREE

100 Packets

Net wt. per packet 4.32 g