Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, oral:
Cytra-2: Sodium citrate 500 mg and citric acid 334 mg per 5 mL (480 mL) [alcohol free, dye free, sugar free; contains propylene glycol and sodium benzoate; grape flavor; contains sodium 1 mEq/mL equivalent to bicarbonate 1 mEq /mL]
Oracit: Sodium citrate 490 mg and citric acid 640 mg per 5 mL (15 mL, 30 mL, 500 mL) [contains sodium 1 mEq/mL equivalent to bicarbonate 1 mEq /mL]
Shohl's Solution (Modified): Sodium citrate 500 mg and citric acid 300 mg per 5 mL (480 mL) [contains alcohol; contains sodium 1 mEq/mL equivalent to bicarbonate 1 mEq /mL]
Virtrate-2: Sodium citrate 500 mg and citric acid 334 mg per 5 mL (480 mL [DSC]) [sugar free; contains propylene glycol and sodium benzoate; grape flavor; contains sodium 1 mEq/mL equivalent to bicarbonate 1 mEq /mL]
Generic: Sodium citrate 500 mg and citric acid 334 mg per 5 mL (30 mL, 480 mL)
Pharmacokinetics/Pharmacodynamics
Metabolism
≥95% via hepatic oxidation to bicarbonate; may be impaired in patients with hepatic failure, shock, or severe illness
Excretion
Urine (<5% as sodium citrate)
Use: Labeled Indications
Acidosis: Treatment of metabolic acidosis or acidosis in certain renal tubular disorders.
Gastric acid buffer: Buffer agent to neutralize gastric acidity.
Systemic alkalinizer: Alkalinizing agent in conditions where long-term maintenance of alkaline urine is desirable.
Use: Off Label
Aspiration prophylaxis in patients undergoing anesthesiabyes
Data from studies of varying methodologies support the use of sodium citrate and citric acid with H2-receptor antagonists and/or metoclopramide for the prevention of aspiration in patients undergoing anesthesia (O'Reardon 2011, Stuart 1996). Clinical experience and case reports also suggest use may be especially beneficial in patients at high risk for aspiration (eg, patients with a full stomach, severe GERD, gastroparesis, and/or pregnant patients undergoing anesthesia for electroconvulsive therapy) Berkow 2019, Hagberg 2019, Kellner 2019, Nixon 2019.
Based on the American Society of Anesthesiologists practice guidelines for obstetric anesthesia, sodium citrate and citric acid with H2-receptor antagonist and/or metoclopramide is an effective and recommended prophylactic agent for the prevention of aspiration during surgical procedures (eg, cesarean delivery, postpartum tubal ligation) in pregnant patients.
Contraindications
Hypersensitivity to sodium citrate, citric acid, or any component of the formulation; severe renal impairment; oliguria; azotemia; untreated Addison disease; adynamia episodica hereditaria; acute dehydration; heat cramp; anuria; severe myocardial damage; hyperkalemia; sodium-restricted diet.
Dosage and Administration
Dosing: Adult
Acidosis or systemic alkalization: Oral: 10 to 30 mL 4 times daily.
Aspiration prophylaxis in patients undergoing anesthesia (off-label use): Note: May be considered in patients at high risk for aspiration (ASA 2016; Berkow 2019; Hagberg 2019; Lovas 2011; O'Reardon 2011; Rabheru 2001).
Oral: 30 mL given immediately before surgery in conjunction with other appropriate agents (eg, IV H2 antagonist and/or IV metoclopramide given ~30 to 90 minutes prior to surgery) (Abir 2019; ASA 2017; Berkow 2019).
Gastric acid buffer: Oral: 15 mL as a single dose.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Individualize dose as determined by disease and patient-specific targets. 1 mL of oral solution contains 1 mEq of bicarbonate and 1 mEq of sodium.
Renal tubular acidosis (RTA), distal (Type 1): Limited data available: Note: Dose requirements may vary with age. Infants, Children, and Adolescents: Oral: Usual dose: 2 to 4 mEq bicarbonate/kg/day (2 to 4 mL/kg/day) in divided doses; reported range: 1 to 7 mEq bicarbonate/kg/day; adjust dose to maintain target serum CO2 (Chan 2001; Kliegman 2016; Rodríguez Soriano 2002; Santos 1986).
Renal tubular acidosis (RTA), proximal (Type 2): Limited data available: Note: Dose requirements may vary with age; for Type 2 RTA, bicarbonate doses are higher than those required for other types of RTA. Infants, Children, and Adolescents: Oral: Usual range: 10 to 20 mEq bicarbonate/kg/day in divided doses (Chan 2001; Kliegman 2016; Rodríguez Soriano 2002); Note: May be used in combination with potassium citrate formulations to meet bicarbonate requirement.
Systemic alkalinization; chronic:
Volume-based dosing: Children ≥2 years and Adolescents: Oral: 5 to 15 mL (5 to 15 mEq bicarbonate) per dose after meals and at bedtime
Weight-based dosing (mEq bicarbonate/kg): Limited data available: Infants, Children, and Adolescents: Oral: 2 to 3 mEq bicarbonate/kg/day (2 to 3 mL/kg/day) in 3 to 4 divided doses; adjust dose to targeted serum bicarbonate levels; typical adult doses do not exceed 30 mEq/dose (30 mL/dose) (Kliegman 2007)
Reconstitution
Shake well. Chill solution prior to administration to enhance palatability.
Acidosis or systemic alkalization: Dilute dose with 30 to 90 mL of water.
Gastric acid buffer: Dilute dose with 15 mL of water.
Administration
Administer after meals. When used for acidosis/systemic alkalinization, administer after meals and at bedtime.
Dietary Considerations
Take after meals to minimize laxative effect.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze.
Drug Interactions
Alpha-/Beta-Agonists (Indirect-Acting): Alkalinizing Agents may increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy
Aluminum Hydroxide: Citric Acid Derivatives may increase the absorption of Aluminum Hydroxide. Monitor therapy
Amantadine: Alkalinizing Agents may increase the serum concentration of Amantadine. Monitor therapy
Amphetamines: Alkalinizing Agents may decrease the excretion of Amphetamines. Management: Consider alternatives to using amphetamines and alkalinizing agents in combination. If these agents must be used together, patients should be monitored closely for excessive amphetamine effects. Consider therapy modification
Mecamylamine: Alkalinizing Agents may increase the serum concentration of Mecamylamine. Monitor therapy
Memantine: Alkalinizing Agents may increase the serum concentration of Memantine. Monitor therapy
QuiNINE: Alkalinizing Agents may increase the serum concentration of QuiNINE. Monitor therapy
Adverse Reactions
Frequency not defined. Generally well tolerated with normal renal function.
Central nervous system: Tetany
Endocrine & metabolic: Metabolic alkalosis
Gastrointestinal: Diarrhea, nausea, vomiting
Warnings/Precautions
Disease-related concerns:
- Cardiovascular disease: Use with caution in patients with heart failure or hypertension; contains sodium.
- Edema: Use with caution in patients with peripheral or pulmonary edema; contains sodium.
- Hepatic impairment: Use with caution in patients with hepatic failure; conversion to bicarbonate may be impaired.
- Renal impairment: Use with caution in patients with renal impairment; contains sodium. Contraindicated in patients with severe impairment, oliguria, azotemia or anuria.
- Severely ill: Use with caution in patients who are severely ill; conversion to bicarbonate may be impaired.
- Shock: Use with caution in patients who are in shock; conversion to bicarbonate may be impaired.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
- Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
- Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).
Other warnings/precautions:
- Administration: Dilute with water to minimize GI injury; administer after meals to minimize saline laxative effect.
Monitoring Parameters
Serum creatinine, BUN, LFTs, serum bicarbonate and urinary pH at baseline and as clinically indicated during therapy; periodic serum electrolytes (especially bicarbonate) in patients with renal disease.
Pregnancy
Pregnancy Considerations
Use caution with toxemia of pregnancy.
Patient Education
What is this drug used for?
- It is used to treat high acid levels in the blood.
- It is used to lower acid levels in the urine.
- It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
- Diarrhea
- Nausea
- Vomiting
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
