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Sodium Citrate and Citric Acid


General


Pronunciation

(SOW dee um SIT rate & SI trik AS id)


Brand Names: U.S.

  • Cytra-2
  • Oracit
  • Shohls Solution (Modified)
  • Virtrate-2

Indications


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.


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.


Dosing and Administration


Dosing: Adult

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

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


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Acidosis or systemic alkalization:

Manufacturers recommendation: Children ≥2 years and Adolescents: Oral: 5 to 15 mL 4 times daily

Alternative dosing: Note: 1 mL of oral solution contains bicarbonate 1 mEq:

Infants and Children (off-label dosing): Oral: Bicarbonate 2 to 3 mEq/kg/day in 3 to 4 divided doses (Kliegman 2007)

Gastric acid buffer: Children and Adolescents: Oral: Refer to adult dosing.


Dosing: Renal Impairment

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: Hepatic Impairment

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


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.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

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]

Oracit � �: Sodium citrate 490 mg and citric acid 640 mg per 5 mL (15 mL, 30 mL, 500 mL, 3840 mL)

Shohls Solution (Modified): Sodium citrate 500 mg and citric acid 300 mg per 5 mL (480 mL) [contains alcohol]

Virtrate-2: Sodium citrate 500 mg and citric acid 334 mg per 5 mL (480 mL) [sugar free; contains propylene glycol and sodium benzoate; grape flavor]

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


Drug Interactions

Aluminum Hydroxide: Citric Acid Derivatives may increase the absorption of Aluminum Hydroxide. Consider therapy modification


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.


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.


Pregnancy Considerations

Use caution with toxemia of pregnancy.


Actions


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)


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience nausea or vomiting. Have patient report immediately to prescriber severe diarrhea; black, tarry, or bloody stools; severe abdominal pain; vomiting blood; weakness; numbness or tingling; or confusion (HCAHPS).

- Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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