POTASSIUM CITRATE AND CITRIC ACID solution

Drug Details [pdf]

DESCRIPTION

Potassium Citrate and Citric Acid Oral Solution, USP is a stable red colored and cherry flavored oral systemic alkalizer containing potassium citrate and citric acid in a sugar-free, non-alcoholic base.

Potassium Citrate and Citric Acid Oral Solution, USP contains in each teaspoonful (5 mL):

Potassium Citrate Monohydrate, USP 1100 mg

Citric Acid Monohydrate, USP 334 mg

Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq bicarbonate (HCO 3).

Inactive Ingredients: saccharin sodium, sodium benzoate, sorbitol solution, FD&C red # 40, purified water, and wild cherry flavor.

ACTIONS

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

Potassium citrate and citric acid oral solution 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.
CONTRAINDICATIONS

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

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.
PRECAUTIONS

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

Potassium citrate and citric acid oral solution 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

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 OF HYPERKALEMIA

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

Potassium Citrate and Citric Acid Oral Solution, USP should be taken diluted in water according to directions, followed by additional water, if desired. Palatability is enhanced if chilled before taking.

Usual Adult Dose

3 to 6 teaspoonfuls (15 to 30 mL), diluted with 1 glass of water, after meals and at bedtime, or as directed by a physician.

Usual Pediatric Dose

1 to 3 teaspoonfuls (5 to 15 mL), diluted with 1/2 glass of water, after meals and at bedtime, or as directed by a physician.

Usual Dosage Range

2 to 3 teaspoonfuls (10 to 15 mL), diluted with a glassful of water, taken four times a day. Potassium Citrate and Citric Acid Oral Solution USP, diluted with a glassful of water, taken four times a day will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects. 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

Potassium Citrate and Citric Acid Oral Solution, USP (Red color liquid with cherry flavor) is supplied in the following oral dosage form:

NDC: 62135-435-47: 16 fl oz (473 mL) bottle

STORAGE

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing.

Manufactured for:

Chartwell RX, LLC

Congers, NY 10920

L71146
Rev. 12/2022
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Potassium Citrate and Citric Acid Oral Solution, USP - NDC: 62135-435-47 - 16 fl oz (473 mL) Bottle Label

INGREDIENTS AND APPEARANCE

POTASSIUM CITRATE AND CITRIC ACID
potassium citrate and citric acid solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62135-435
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	POTASSIUM CITRATE	1100 mg in 5 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	334 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62135-435-47	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/08/2022

Labeler - Chartwell RX, LLC (079394054)

Registrant - Chartwell Pharmaceuticals Carmel, LLC (118673485)

Name	Address	ID/FEI	Business Operations
Establishment
Chartwell Pharmaceuticals Carmel, LLC		118673485	analysis(62135-435) , manufacture(62135-435) , pack(62135-435)

POTASSIUM CITRATE AND CITRIC ACID solution

Potassium Citrate and Citric Acid by

Drug Labeling and Warnings

Drug Details [pdf]