Sodium Citrate and Citric Acid Oral Solution
Dosage Form: solution
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.
Sodium Citrate and Citric Acid Oral Solution Description
Sodium Citrate-Citric Acid Solution is a stable and pleasant-tasting systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. It is a nonparticulate neutralizing buffer.
Sodium Citrate-Citric Acid Solution contains in each teaspoonful (5 mL):
Sodium Citrate Dihydrate ............................ 500 mg
Citric Acid Monohydrate ............................. 334 mg
Each mL contains 1 mEq Sodium Ion, and is equivalent to 1 mEq Bicarbonate (HC03).
propylene glycol, sorbitol, polyethylene glycol 400, sodium benzoate, sodium saccharin, grape flavor, and purified water.
Sodium Citrate and Citric Acid Oral Solution - Clinical Pharmacology
Sodium citrate is absorbed and metabolized to sodium 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 sodium citrate is excreted in the urine unchanged.
Indications and Usage for Sodium Citrate and Citric Acid Oral Solution
Sodium Citrate-Citric Acid Solution is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively.
Sodium Citrate-Citric Acid Solution is 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 the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.
Contraindicated in patients with sodium- restricted diets, with severe renal impairment, or known hypersensitivity to any of the ingredients.
Do not exceed recommended dosage. Discontinue use if adverse reactions occur.
Sodium Citrate-Citric Acid Solution should be used with caution by patients with low urinary output unless under the supervision of a physician. This product should not be administered concurrently with aluminum-based antacids. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary edema, and toxemia of pregnancy. Periodic examinations 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.
Sodium Citrate-Citric Acid 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 alkalosis, especially in the presence of hypocalcemia.
Overdosage with sodium salts may cause diarrhea, nausea, and vomiting, hypernoia, and convulsions.
Sodium Citrate and Citric Acid Oral Solution Dosage and Administration
Sodium Citrate-Citric Acid Solution should be administered by diluting in water, followed by additional water, if desired. SHAKE WELL BEFORE USING.
For Systemic Alkalization:
Usual Adult Dosage: 2 to 6 teaspoonfuls (10 to 30 mL), diluted in 1 to 3 ounces 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 in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician.
As a neutralizing buffer: 3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician.
How is Sodium Citrate and Citric Acid Oral Solution Supplied
Sodium Citrate-Citric Acid Solution is a (colorless, grape flavor) solution and is supplied in the following oral dosage form: NDC 58657-410-16 (16 fl oz bottles).
Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing.
To report a serious adverse event or to obtain product information, call (877) 250-3427.
Method Pharmaceuticals, LLC
Arlington, TX 76006
PRINCIPAL DISPLAY PANEL
500 mg/334 mg per 5 mL
SHAKE WELL BEFORE USE
16 fl oz (473 mL)
|SODIUM CITRATE-CITRIC ACID
trisodium citrate dihydrate and citric acid monohydrate solution
|Labeler - Method Pharmaceuticals, LLC (060216698)|
More about citric acid/sodium citrate
- Other brands: Oracit