Sodium Citrate Citric Acid Solution

Manufacturer PHARMACEUTICAL ASSOCIATES Active Ingredient Sodium Citrate and Citric Acid(SOW dee um SIT rate & SI trik AS id) Pronunciation SOW dee um SIT rate & SI trik AS id
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.
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Drug Class
Urinary alkalinizer; Systemic alkalinizer; Antilithic agent
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Pharmacologic Class
Alkalinizing agent; Electrolyte replacement
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a liquid that helps make your urine less acidic (more alkaline). This can help prevent certain types of kidney stones from forming or growing, and can also help treat conditions where your body has too much acid.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication after meals and at bedtime, or as directed by your doctor. It's essential to avoid taking aluminum products at the same time as this medication, so be sure to discuss this with your doctor.

Before using, shake the medication well. If you're taking the liquid form, mix it with water as instructed, and measure the dose carefully using the provided measuring device. If a device is not included, ask your pharmacist for one to ensure accurate measurement.

Storing and Disposing of Your Medication

Store this medication at room temperature, keeping the lid tightly closed, and protect it from heat. Do not freeze the medication.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Always dilute this medication in a full glass (4-8 ounces) of water or juice to prevent stomach upset and protect tooth enamel.
  • Take after meals or at bedtime to minimize stomach irritation.
  • Do not chew or crush tablets if a tablet form is prescribed (though this is typically a liquid).
  • Do not take antacids containing aluminum within 2 hours of this medication without consulting your doctor.
  • Follow your doctor's instructions regarding diet, especially if you are on a low-sodium or low-potassium diet.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 10-30 mL (equivalent to 10-30 mEq bicarbonate), 3-4 times daily, diluted in water
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

urinary_alkalinization: 10-30 mL, 3-4 times daily, adjusted to maintain urine pH 6.5-7.0
systemic_acidosis: Dosage individualized based on acid-base balance and electrolyte status
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Pediatric Dosing

Neonatal: Not established
Infant: 1-3 mEq/kg/day in divided doses, adjusted to desired urine pH or acid-base balance
Child: 5-15 mL, 3-4 times daily, adjusted to desired urine pH or acid-base balance
Adolescent: Same as adult dosing, 10-30 mL, 3-4 times daily, adjusted to desired urine pH or acid-base balance
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor electrolytes and acid-base status
Moderate: Use with caution; monitor electrolytes and acid-base status closely; consider dose reduction
Severe: Contraindicated due to risk of hyperkalemia, hypernatremia, and fluid overload
Dialysis: Contraindicated

Hepatic Impairment:

Mild: No specific adjustment needed; monitor electrolytes
Moderate: No specific adjustment needed; monitor electrolytes
Severe: No specific adjustment needed; monitor electrolytes

Pharmacology

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Mechanism of Action

Sodium citrate and citric acid are metabolized to bicarbonate. The bicarbonate ions increase the plasma bicarbonate concentration, buffering excess hydrogen ions, and raising blood pH. In the kidneys, bicarbonate is filtered and excreted, increasing urinary pH and the solubility of uric acid and cystine, while decreasing the solubility of calcium oxalate and calcium phosphate.
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Pharmacokinetics

Absorption:

Bioavailability: High (well absorbed orally)
Tmax: Approximately 1-2 hours (for bicarbonate effect)
FoodEffect: Food may delay absorption slightly but is recommended to minimize GI upset.

Distribution:

Vd: Distributed throughout the extracellular fluid
ProteinBinding: Not applicable (ions)
CnssPenetration: Limited

Elimination:

HalfLife: Not directly applicable for citrate/citric acid as they are metabolized; bicarbonate half-life is variable based on acid-base status.
Clearance: Renal excretion of bicarbonate and other ions
ExcretionRoute: Renal
Unchanged: Minimal (citrate is metabolized)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (urinary alkalinization)
PeakEffect: 1-2 hours
DurationOfAction: Approximately 4-6 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could be signs of a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat

Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Diarrhea
- Upset stomach
- Vomiting

Note: This list does not include all possible side effects. If you have concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, nausea, or vomiting
  • Diarrhea that is severe or persistent
  • Muscle weakness, numbness, or tingling in hands or feet
  • Unusual tiredness or fatigue
  • Swelling of ankles or feet
  • Irregular or slow heartbeat
  • Confusion or irritability
  • Difficulty breathing
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Dehydration (fluid loss)
+ Heat cramps
+ High potassium levels
+ Adynamia episodica hereditaria, a condition that causes periodic muscle weakness
+ Kidney disease
+ Heart disease
+ Inability to urinate
+ Untreated Addison's disease
If you are following a low-sodium or sodium-free diet
If you are taking any of the following medications:
+ Amiloride
+ Eplerenone
+ Spironolactone
+ Triamterene
* If you are taking or have recently taken any of the following medications:
+ Benazepril
+ Captopril
+ Enalapril
+ Fosinopril
+ Lisinopril
+ Moexipril
+ Perindopril
+ Quinapril
+ Ramipril
+ Trandolapril

Please note that this is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

Some formulations of this medication may contain benzyl alcohol. Due to the risk of serious side effects, it is recommended to avoid products containing benzyl alcohol in newborns and infants, especially when combined with other medications that also contain benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol and to discuss potential alternatives.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to notify your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Metabolic alkalosis (muscle cramps, twitching, irritability, confusion, slow shallow breathing)
  • Hyperkalemia (muscle weakness, fatigue, paresthesias, bradycardia, irregular heartbeat)
  • Hypernatremia (thirst, dry mouth, confusion, lethargy)
  • Fluid overload (edema, shortness of breath)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment may involve discontinuing the medication, correcting electrolyte imbalances, and supportive care.

Drug Interactions

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Contraindicated Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene) - increased risk of hyperkalemia
  • Severe renal impairment (anuria, oliguria, azotemia) - risk of hyperkalemia and fluid overload
  • Untreated Addison's disease
  • Acute dehydration
  • Adrenocortical insufficiency
  • Hyperkalemia of any etiology
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Major Interactions

  • ACE inhibitors (e.g., lisinopril, enalapril) - increased risk of hyperkalemia
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan) - increased risk of hyperkalemia
  • Aluminum-containing antacids (e.g., aluminum hydroxide) - increased absorption of aluminum, potentially leading to aluminum toxicity (especially in renal impairment)
  • Methenamine (e.g., methenamine hippurate, methenamine mandelate) - alkalinization of urine may inhibit the antibacterial action of methenamine
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Moderate Interactions

  • Quinidine - urinary alkalinization may decrease renal excretion of quinidine, leading to increased plasma levels and potential toxicity
  • Amphetamines - urinary alkalinization may decrease renal excretion of amphetamines, leading to increased plasma levels and potential toxicity
  • Salicylates (e.g., aspirin) - urinary alkalinization may increase renal excretion of salicylates, leading to decreased plasma levels and reduced efficacy
  • Lithium - urinary alkalinization may increase renal excretion of lithium, leading to decreased plasma levels and reduced efficacy
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Minor Interactions

  • Not many specific minor interactions; general caution with drugs sensitive to urinary pH changes.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Rationale: To establish baseline electrolyte status and identify pre-existing imbalances, especially hyperkalemia or hypernatremia, which are contraindications or require caution.

Timing: Prior to initiation of therapy

Renal Function (BUN, Serum Creatinine)

Rationale: To assess kidney function, as severe renal impairment is a contraindication and impaired function increases risk of electrolyte imbalances.

Timing: Prior to initiation of therapy

Urine pH

Rationale: To establish baseline urine pH and guide initial dosing for urinary alkalinization.

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Frequency: Periodically, especially during dose adjustments or in patients with renal impairment or other risk factors for electrolyte imbalance (e.g., every few days initially, then weekly to monthly for chronic therapy).

Target: Maintain within normal physiological range; specifically monitor potassium to prevent hyperkalemia.

Action Threshold: Discontinue or reduce dose if hyperkalemia, hypernatremia, or significant metabolic alkalosis develops.

Urine pH

Frequency: Daily or several times a week, especially during initial therapy or for stone prevention.

Target: Typically 6.5-7.0 for uric acid or cystine stones; adjust based on clinical goal.

Action Threshold: Adjust dose if target pH is not achieved or if pH becomes excessively alkaline (>7.5).

Renal Function (BUN, Serum Creatinine)

Frequency: Periodically, especially in patients with pre-existing renal impairment or on long-term therapy.

Target: Maintain within normal limits or stable for patient's baseline.

Action Threshold: Evaluate if renal function deteriorates.

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Symptom Monitoring

  • Signs of hyperkalemia (muscle weakness, fatigue, paresthesias, bradycardia, irregular heartbeat)
  • Signs of metabolic alkalosis (muscle cramps, twitching, irritability, confusion, slow shallow breathing)
  • Signs of hypernatremia (thirst, dry mucous membranes, confusion, lethargy)
  • Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal discomfort)
  • Edema or weight gain (suggesting fluid retention)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. While generally considered safe when used appropriately, close monitoring of electrolytes is crucial.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major malformations. Monitor electrolytes.
Second Trimester: Generally considered safe with appropriate monitoring.
Third Trimester: Generally considered safe with appropriate monitoring; risk of fluid overload or electrolyte imbalance in mother should be considered.
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Lactation

L3 (Moderately Safe). Citrate and its metabolites are normal body constituents. Small amounts may pass into breast milk, but significant adverse effects on the infant are unlikely with typical doses. Monitor infant for signs of electrolyte imbalance or GI upset.

Infant Risk: Low to moderate risk; generally considered compatible with breastfeeding with caution and monitoring.
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Pediatric Use

Dosing is weight-based and must be carefully calculated. Close monitoring of electrolytes and acid-base status is essential due to higher susceptibility to fluid and electrolyte imbalances.

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Geriatric Use

Use with caution due to increased likelihood of impaired renal function and polypharmacy. Start with lower doses and titrate slowly. Monitor electrolytes and renal function closely. Increased risk of hyperkalemia and fluid overload.

Clinical Information

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Clinical Pearls

  • Always dilute the solution in water or juice to prevent gastrointestinal irritation and protect tooth enamel. Rinse mouth after taking.
  • Take after meals or at bedtime to minimize GI upset.
  • Monitor urine pH regularly to ensure therapeutic efficacy and avoid over-alkalinization.
  • Patients should be advised to report any signs of muscle weakness, tingling, or irregular heartbeat, which could indicate hyperkalemia.
  • Avoid in patients with severe renal impairment, untreated Addison's disease, or acute dehydration due to the risk of severe electrolyte disturbances.
  • Caution is advised when co-administering with ACE inhibitors, ARBs, or potassium-sparing diuretics due to the increased risk of hyperkalemia.
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Alternative Therapies

  • Thiazide diuretics (for calcium stone prevention)
  • Allopurinol (for uric acid stone prevention)
  • Dietary modifications (e.g., increased fluid intake, reduced sodium/protein intake)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100 per 473 mL bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.