Oral Citrate Solution
Sodium Citrate Solution Brandywine Pharmaceuticals, LLC
11c1130f-ed64-a303-e063-6394a90ab283
HUMAN PRESCRIPTION DRUG LABEL
Feb 19, 2024
Brandywine Pharmaceuticals, LLC
DUNS: 080581956
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Citric Acid and Sodium Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 71321-604-16
473 mL
ORAL CITRATE (SHOHL'S) SOLUTION
CONTAINS: Hydrous Sodium Citrate USP 490 mg/5 mL;
Citric Acid USP 640 mg/5 mL;
grape flavor, purified water, sodium
benzoate, sodium saccharin, sorbitol
USUAL DOSAGE: See package insert.
Dispense in a well-closed container.
Store at 20°-25°C (68°-77°F); excursions permitted
to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
GTIN: 00371321604162
Rx Only
Brandywine Pharmaceuticals, LLC
West Chester, PA USA
INDICATIONS & USAGE SECTION
INDICATIONS
Oral Citrate Solution is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long-term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). Oral Citrate Solution is also effective in treatment for acidosis of certain renal tubular disorders.
CONTRAINDICATIONS SECTION
CONTRAINDICATIONS
Oral Citrate Solution is contraindicated in patients with severe renal impairment, oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramp, anuria, severe myocardial damage, and hyperkalemia.
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS
Citrate solution is generally well tolerated when given in recommended doses when the patient has normal renal functions. To report suspected adverse reactions, contact Brandywine Pharmaceuticals, LLC at 610-314-7943 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
SPL UNCLASSIFIED SECTION
Brandywine Pharmaceuticals, LLC
West Chester, PA USA
Revised February 2024
DESCRIPTION SECTION
DESCRIPTION
The product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution.
CLINICAL PHARMACOLOGY SECTION
ACTION
Oral citrate solution is used as a systemic and urinary alkalinizer. Less than 5% of the citrate is excreted in the urine unchanged, since citrate oxidation is to a great extent complete.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
The dose of Oral Citrate Solution is 10 to 30 mL, diluted with water, after meals and at bedtime. The dose should be titrated to achieve the desired effects.
PRECAUTIONS SECTION
PRECAUTIONS
The citrate solution should be used with caution in patients with impaired renal function to avoid hypernatremia or alkalosis in the presence of hypocalcemia. Periodic determinations of serum electrolyte levels (especially bicarbonate levels) should be done in patients with renal disease to avoid cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. The solution should be diluted with water and preferably taken after meals to avoid saline laxative effects.
HOW SUPPLIED SECTION
HOW SUPPLIED
Oral Citrate Solution is supplied in a 473 mL bottle (NDC 71321-604-16).
PHARMACIST
Dispense in well-closed containers.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].