Drug Facts
Composition & Profile
Identifiers & Packaging
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].; 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 Label
- 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].
- 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 Label
Overview
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.
Indications & Usage
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.
Dosage & 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.
Warnings & Precautions
No warnings available yet.
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
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
Storage & Handling
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.