Label: POTASSIUM CITRATE AND CITRIC ACID- potassium citrate and citric acid monohydrate solution
- NDC Code(s): 0121-0676-16
- Packager: Pharmaceutical Associates, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated August 2, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Potassium Citrate and Citric Acid Oral Solution USP is a stable and pleasant-tasting 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 1100 mg
CITRIC ACID Monohydrate 334 mg
Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq bicarbonate (HCO 3).
Inactive Ingredients: FD&C Red No. 40, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.
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 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.
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 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.
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.
Potassium Citrate and Citric Acid Oral Solution USP (clear pink to red colored; berry-citrus flavored) is supplied in the following oral dosage form:
NDC 0121-0676-16: 16 fl oz (473 mL) bottle
- MANUFACTURED BY
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
and Citric Acid
Oral Solution USP
1100 mg/334 mg per 5 mL
A SUGAR-FREE SYSTEMIC ALKALIZER
Each teaspoonful (5 mL) contains:
Potassium Citrate Monohydrate…..1100 mg
Citric Acid Monohydrate…..334 mg
Each mL contains 2 mEq Potassium Ion, and is
equivalent to 2 mEq Bicarbonate (HCO3).
16 fl oz (473 mL)
Greenville, SC 29605
INDICATIONS AND USAGE: Potassium
Citrate and Citric Acid Oral Solution USP
is a stable and pleasant-tasting oral
systemic alkalizer. It is effective for long-
term maintenance of an alkaline urine,
especially when the administration of
sodium salts is undesirable or contra-
SEE ACCOMPANYING LITERATURE
DOSAGE AND ADMINISTRATION:
Usual Adult Dosage: 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.
SHAKE WELL BEFORE USING.
STORAGE: Keep tightly closed. Store at
controlled room temperature. 20° -25° C
(68° -77° F). Protect from excessive heat or
Dispense in a tight, light-resistance container
with a child-resistant closure.
INGREDIENTS AND APPEARANCE
POTASSIUM CITRATE AND CITRIC ACID
potassium citrate and citric acid monohydrate solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0676 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0676-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/07/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/07/1997 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0676)