Label: TRICITRATES- potassium citrate, sodium citrate, and citric acid monohydrate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0677-1 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 0121-0677
- 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.
Drug Label Information
Updated August 21, 2018
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DESCRIPTION
Tricitrates SF Oral Solution is a stable and pleasant-tasting oral systemic alkalizer containing potassium citrate, sodium citrate, and citric acid in a sugar-free, non-alcoholic base.
Tricitrates SF Oral Solution contains in each teaspoonful (5 mL):
POTASSIUM CITRATE
Monohydrate550 mg SODIUM CITRATE
Dihydrate500 mg CITRIC ACID
Monohydrate334 mg Each mL contains 1 mEq potassium ion and 1 mEq sodium ion and is equivalent to 2 mEq bicarbonate (HCO3).
Inactive Ingredients: FD&C Yellow No. 6, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.
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ACTIONS
Potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalizers. 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 citrates are excreted in the urine unchanged.
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INDICATIONS AND ADVANTAGES
Tricitrates SF 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. 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. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urine 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 and sodium citrate do not neutralize the gastric juice or disturb digestion.
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CONTRAINDICATIONS
Severe renal impairment with oliguria or azotemia, untreated Addison's disease, or severe myocardial damage. In certain situations, when patients are on a sodium-restricted diet, the use of potassium citrate may be preferable; or, when patients are on a potassium-restricted diet, the use of sodium citrate may be preferable.
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PRECAUTIONS AND WARNINGS
Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy.
Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.
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ADVERSE REACTIONS
Tricitrates SF 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, especially in the presence of hypocalcemia. Potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.
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DOSAGE AND ADMINISTRATION
Tricitrates SF Oral Solution should be taken diluted in water, 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 in water, four times a day, after meals and at bedtime, or as directed by a physician.
Usual Pediatric Dose
1 to 3 teaspoonfuls (5 to 15 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician.
Usual Dosage Range
2 to 3 teaspoonfuls (10 to 15 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 6.5-7.4. 3 to 4 teaspoonfuls (15 to 20 mL), diluted with 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 urine pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.
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- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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INGREDIENTS AND APPEARANCE
TRICITRATES
potassium citrate, sodium citrate, and citric acid monohydrate solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0677(NDC:0121-0677) 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 550 mg in 5 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE 500 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 FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0677-1 50 in 1 BOX, UNIT-DOSE 08/21/2018 1 30 mL in 1 CUP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 08/21/2018 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 relabel(17856-0677) , repack(17856-0677)
