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Sodium citrate and citric acid (oral solution): Drug information

Sodium citrate and citric acid (oral solution): Drug information
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Brand Names: US
  • Cytra-2;
  • Oracit
Brand Names: Canada
  • PMS-Dicitrate
Pharmacologic Category
  • Alkalinizing Agent, Oral
Dosing: Adult
Acidosis or systemic alkalization

Acidosis or systemic alkalization: Oral: 10 to 30 mL 4 times daily.

Aspiration prophylaxis in patients undergoing anesthesia

Aspiration prophylaxis in patients undergoing anesthesia (off-label use): Note: May be considered in patients at high risk for aspiration (Ref).

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) (Ref).

Gastric acid buffer

Gastric acid buffer: Oral: 15 mL as a single dose.

Metabolic acidosis in patients with chronic kidney disease

Metabolic acidosis in patients with chronic kidney disease: Note: KDIGO guidelines suggest oral replacement when plasma HCO3- concentrations are <22 mEq/L (Ref).

Oral (off-label dose): Initial: 15 to 22.5 mL/day in 2 to 3 divided doses; titrate to normal serum bicarbonate concentrations (eg, 23 to 29 mEq/L although a more targeted range of 24 to 26 mEq/L for patients with non–dialysis-dependent chronic kidney disease [CKD] has been suggested by observational studies (Ref)) (Ref). Avoid exceeding serum bicarbonate concentrations >29 mEq/L since this has been associated with increased mortality in patients with CKD (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Contains sodium; use with caution, especially in patients with concomitant hypertension, heart failure, or volume overload (Ref).

Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (Ref).

Hemodialysis, intermittent (thrice weekly): No dosage adjustment necessary (Ref).

Peritoneal dialysis: No dosage adjustment necessary (Ref).

CRRT: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Sodium citrate and citric acid (oral solution): Pediatric drug information")

Dosage guidance:

Dosing: 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

Renal tubular acidosis (RTA): Limited data available: Note: Dose should be individualized based on urinary bicarbonate excretion (degree depends on type of RTA), serum bicarbonate, and possibly age-related factors.

Infants, Children, and Adolescents:

Distal (type 1): Oral: Usual dose: 2 to 4 mEq bicarbonate/kg/day in divided doses; titrate to maintain normal electrolyte concentrations; younger patients require more bicarbonate replacement due to acid production during growth; some data suggest infants require a higher dose of 5 to 10 mEq bicarbonate/kg/day and growing children need 4 to 8 mEq bicarbonate/kg/day (Ref).

Proximal (type 2): Oral: Usual dose: 10 to 15 mEq/kg/day in divided doses; titrate as necessary to maintain normal electrolyte concentrations; doses as high as 20 mEq bicarbonate/kg/day have been described (Ref).

Systemic alkalinization; chronic

Systemic alkalinization; chronic:

Fixed dosing: Children ≥2 years and Adolescents: Oral: 5 to 15 mEq bicarbonate per dose after meals and at bedtime.

Weight-directed dosing (mEq bicarbonate/kg): Limited data available: Infants, Children, and Adolescents: Oral: 2 to 3 mEq bicarbonate/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) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; use is contraindicated in patients with anuria, severe renal impairment, oliguria, or azotemia.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Generally well tolerated with normal renal function.

Central nervous system: Tetany

Endocrine & metabolic: Metabolic alkalosis

Gastrointestinal: Diarrhea, nausea, vomiting

Contraindications

Hypersensitivity to sodium citrate, citric acid, or any component of the formulation; untreated Addison disease; adynamia episodica hereditaria; acute dehydration; heat cramp; severe myocardial damage; sodium-restricted diet. Note: Although the manufacturer's labeling states use in severe renal impairment, oliguria, azotemia, anuria, or hyperkalemia is contraindicated, use in these patients may be considered under close medical supervision.

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.

• 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.

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.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms Considerations

Each mL provides 1 mEq sodium, and is equivalent to 1 mEq bicarbonate

Dosage Forms: US

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]

Generic: Sodium citrate 500 mg and citric acid 334 mg per 5 mL (15 mL, 30 mL, 480 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Oracit Oral)

490-640 mg/5 mL (per mL): $0.25

Solution (Sod Citrate-Citric Acid Oral)

500-334 mg/5 mL (per mL): $0.32 - $7.56

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Administer after meals. When used for acidosis/systemic alkalinization, administer after meals and at bedtime.

Administration: Pediatric

Oral: Shake well before use. Dose must be diluted prior to administration; administer after meals and at bedtime to avoid saline laxative effect; chilling solution prior to dosing helps to enhance palatability.

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: Adult

Aspiration prophylaxis in patients undergoing anesthesia

Medication Safety Issues
Sound-alike/look-alike issues:

Bicitra may be confused with Polycitra

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Aluminum Hydroxide: Citric Acid Derivatives may increase absorption of Aluminum Hydroxide. Risk C: Monitor

Amantadine: Alkalinizing Agents may increase serum concentration of Amantadine. Risk C: Monitor

Amphetamines: Alkalinizing Agents may decrease 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. Risk D: Consider Therapy Modification

Flecainide: Alkalinizing Agents may decrease excretion of Flecainide. Risk C: Monitor

Mecamylamine: Alkalinizing Agents may increase serum concentration of Mecamylamine. Risk C: Monitor

Memantine: Alkalinizing Agents may increase serum concentration of Memantine. Risk C: Monitor

QuiNIDine: Alkalinizing Agents may increase serum concentration of QuiNIDine. Risk C: Monitor

QuiNINE: Alkalinizing Agents may increase serum concentration of QuiNINE. Risk C: Monitor

Pregnancy Considerations

Use caution with toxemia of pregnancy.

Dietary Considerations

Take after meals to minimize 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.

Reference Range

Note: Reference ranges may vary depending on the laboratory

Urinary pH: 4.6 to 8.0

Pharmacokinetics (Adult Data Unless Noted)

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)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (IN) India: Carmicide;
  • (PR) Puerto Rico: Virtrate 2;
  • (ZA) South Africa: Pneucid
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