Potassium Citrate- Citric Acid Crystals

DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Potassium Citrate – Citric Acid Crystals (potassium citrate and citric acid for oral solution) is a pleasant-tasting oral systemic alkalizer containing potassium citrate and citric acid in a sugar-free base. Potassium Citrate – Citric Acid Crystals contains in each unit dose packet:

INACTIVE INGREDIENTS

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displayName: INACTIVE INGREDIENT SECTION
FDA Article Code: 51727-6

Blueberry Flavor and Sucralose and other ancillary ingredients as needed to ensure product stability. Potassium Citrate Monohydrate  has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its chemical structure is as follows: Citric Acid Monohydrate has the chemical name: 1,2,3-Propanetricarboxylic acid,
2-hydroxy-, monohydrate. Its chemical structure is as follows:

CLINICAL PHARMACOLOGY

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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Potassium citrate is absorbed and metabolized to potassium bicarbonate, thus acting as a systemic alkalizer.  The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently.  Oxidation is virtually complete so that less than 5% of the potassium citrate is excreted in the urine unchanged.

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Potassium Citrate – Citric Acid Crystals 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.  Potassium Citrate – Citric Acid Crystals 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.  Potassium Citrate – Citric Acid Crystals 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.

CONTRAINDICATIONS

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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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.

WARNINGS AND PRECAUTIONS

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displayName: WARNINGS AND PRECAUTIONS SECTION
FDA Article Code: 43685-7

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.

ADVERSE REACTIONS

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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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.

OVERDOSAGE

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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, hyperkalemia can result (see Contraindications and Warnings).  Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. Treatment:  Should hyperkalemia occur, treatment measures include the following: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 mL/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose.  (3) The 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 plasma potassium concentration can produce digitalis toxicity.

DOSAGE AND ADMINISTRATION

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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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.

HOW SUPPLIED

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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Potassium Citrate – Citric Acid Crystals – Unit Dose Packets, 100/box (NDC 76439-261-10).

STORAGE

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displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

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. R_x ONLY  Manufactured for:

Virtus Pharmaceuticals
Tampa, FL 33619
www.virtusRX.com
MADE IN CANADA Virtus
PHARMACEUTICALS Rev. 3/2014