Potassium Citrate Citric Acid Sol

Manufacturer METHOD Active Ingredient Potassium Citrate and Citric Acid Solution(poe TASS ee um SIT rate & SI trik AS id) Pronunciation poe TASS ee um SIT rate & SI trik AS id
It is used to treat acid problems in the blood.It is used to lower acid levels in the urine.It is used to prevent gout attacks.
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Drug Class
Urinary alkalinizer; Nephrolithiasis agent
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Pharmacologic Class
Electrolyte; Alkalinizing agent
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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 combination of potassium and citrate, which helps to make your urine less acidic and increases the amount of citrate in your urine. This can help prevent certain types of kidney stones, like calcium oxalate and uric acid stones, from forming or growing larger.
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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 is essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

When taking this medication, mix it with water as instructed before consuming. Always shake the medication well before use. To ensure accurate dosing, measure the liquid carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one.

Storing and Disposing of Your Medication

Store this medication at room temperature, avoiding freezing temperatures. Protect the medication from heat sources and store it in a dry place. It is recommended to store the medication outside of the bathroom.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is 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.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually with or immediately after meals to reduce stomach upset.
  • Dilute the liquid solution in a full glass of water or juice to prevent irritation to the digestive tract.
  • Drink plenty of fluids throughout the day as directed by your doctor to help prevent kidney stones.
  • Follow any dietary recommendations from your doctor, such as limiting sodium or animal protein.
  • Do not stop taking this medication without consulting your doctor, even if you feel better.

Dosing & Administration

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Adult Dosing

Standard Dose: 10-30 mEq (1080-3240 mg) of potassium citrate, 3-4 times daily, with meals or within 30 minutes after meals or bedtime snack. Dosage should be adjusted to maintain urine pH between 6.0 and 7.0.
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

Hypocitraturic Calcium Oxalate Nephrolithiasis: 20-60 mEq/day in 2-4 divided doses
Uric Acid Nephrolithiasis: 40-80 mEq/day in 2-4 divided doses
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Dosing is individualized based on body weight and urine pH. Typically 1-2 mEq/kg/day in 3-4 divided doses, not to exceed adult dose.
Adolescent: Similar to adult dosing, individualized based on urine pH and condition.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum potassium and renal function closely.
Moderate: Use with caution; monitor serum potassium and renal function closely. Consider dose reduction.
Severe: Contraindicated (CrCl < 30 mL/min) due to risk of hyperkalemia.
Dialysis: Contraindicated due to risk of severe hyperkalemia.

Hepatic Impairment:

Mild: No specific adjustment required.
Moderate: No specific adjustment required.
Severe: No specific adjustment required, but caution if associated with significant renal dysfunction.

Pharmacology

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Mechanism of Action

Potassium citrate is metabolized to bicarbonate, which increases urinary pH and citrate excretion. Increased urinary citrate forms soluble complexes with calcium, reducing the saturation of calcium oxalate and calcium phosphate, thereby inhibiting the crystallization and aggregation of stone-forming salts. The increased urinary pH also helps to dissolve uric acid stones.
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Pharmacokinetics

Absorption:

Bioavailability: Well absorbed (citrate and potassium)
Tmax: Approximately 1-2 hours (for citrate)
FoodEffect: Absorption is enhanced and GI upset is minimized when taken with food.

Distribution:

Vd: Distributed throughout extracellular fluid
ProteinBinding: Not highly protein bound
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely defined for the combination; potassium is rapidly cleared, citrate is metabolized.
Clearance: Renal clearance for potassium; metabolic clearance for citrate.
ExcretionRoute: Renal (potassium, bicarbonate), metabolic (citrate)
Unchanged: Minimal unchanged citrate; potassium is primarily excreted renally.
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Pharmacodynamics

OnsetOfAction: Within hours (urinary alkalinization)
PeakEffect: Within 2-6 hours (peak urinary pH and citrate excretion)
DurationOfAction: Approximately 6-8 hours, requiring multiple daily doses to maintain effect.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high potassium levels, including:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Abdominal swelling

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Diarrhea
Stomach pain
Upset stomach
* Vomiting

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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, vomiting, or diarrhea
  • Muscle weakness, numbness or tingling in hands or feet
  • Slow or irregular heartbeat
  • Confusion or unusual tiredness
  • Black, tarry, or bloody stools (signs of GI bleeding)
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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 you experienced, including any symptoms that occurred.
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 currently taking any of the following medications:
+ Amiloride
+ Eplerenone
+ Spironolactone
+ Triamterene

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dosage 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. Regularly scheduled blood work and other laboratory tests should be performed as directed by your doctor to monitor your condition.

To minimize the risk of severe side effects, it is crucial to adhere to the prescribed dosage and not exceed the amount recommended by your doctor. Taking more than the prescribed dose may increase your chance of experiencing severe side effects.

If you follow a low-sodium diet or use a salt substitute, consult with your doctor to discuss any potential interactions. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication to both you and your baby. This will enable you to make an informed decision about your treatment.
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Overdose Information

Overdose Symptoms:

  • Hyperkalemia (high potassium levels): muscle weakness, fatigue, paresthesias, bradycardia, irregular heartbeat, EKG changes (peaked T waves, widened QRS)
  • Metabolic alkalosis: nausea, vomiting, muscle twitching, confusion, hypoventilation
  • Severe gastrointestinal irritation

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment may involve IV calcium (for cardiac effects), insulin/glucose, sodium bicarbonate, diuretics, or dialysis for severe hyperkalemia. Manage metabolic alkalosis symptomatically.

Drug Interactions

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Contraindicated Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Other potassium-containing medications or supplements
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Major Interactions

  • NSAIDs (e.g., ibuprofen, naproxen) - may increase risk of hyperkalemia, especially in patients with renal impairment
  • Digitalis glycosides (e.g., digoxin) - hyperkalemia can antagonize the effects of digitalis
  • Aluminum-containing antacids - may lead to increased aluminum absorption and toxicity
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Moderate Interactions

  • Magnesium-containing antacids - may lead to increased magnesium absorption and toxicity
  • Diuretics (other than potassium-sparing) - may alter potassium balance, requiring close monitoring
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Minor Interactions

  • None specifically noted as minor for this combination.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Potassium, Sodium, Chloride, Bicarbonate)

Rationale: To establish baseline electrolyte status and identify pre-existing imbalances, especially hyperkalemia or metabolic acidosis/alkalosis.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess kidney function, as impaired renal function is a contraindication due to hyperkalemia risk.

Timing: Prior to initiation of therapy.

Urinalysis and Urine pH

Rationale: To assess baseline urinary parameters and confirm the need for alkalinization.

Timing: Prior to initiation of therapy.

24-hour Urine Collection (for stone formers)

Rationale: To assess baseline urinary citrate, calcium, uric acid, and pH to guide dosing and monitor efficacy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Potassium

Frequency: Weekly initially, then monthly or every 3-6 months once stable, or as clinically indicated.

Target: 3.5-5.0 mEq/L

Action Threshold: >5.0 mEq/L (consider dose reduction or discontinuation); >5.5 mEq/L (urgent intervention for hyperkalemia).

Serum Bicarbonate (or CO2)

Frequency: Monthly initially, then every 3-6 months.

Target: 22-29 mEq/L

Action Threshold: >30 mEq/L (suggests metabolic alkalosis, consider dose reduction).

Renal Function (BUN, Creatinine)

Frequency: Every 3-6 months, or more frequently in patients with pre-existing renal impairment or on interacting medications.

Target: Stable within normal limits for patient.

Action Threshold: Significant increase in BUN/creatinine (re-evaluate therapy, consider discontinuation).

Urinary pH (spot or 24-hour)

Frequency: Daily (spot) or periodically (24-hour) to guide dose titration.

Target: 6.0-7.0 (for calcium oxalate/uric acid stones)

Action Threshold: <6.0 (consider dose increase); >7.5 (consider dose decrease to avoid calcium phosphate precipitation).

24-hour Urine Collection (for stone formers)

Frequency: Every 3-6 months after dose stabilization, or as clinically indicated.

Target: Increased urinary citrate (>320 mg/day), appropriate pH.

Action Threshold: Failure to achieve target urinary parameters (re-evaluate dose or adherence).

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Symptom Monitoring

  • Symptoms of hyperkalemia (fatigue, muscle weakness, paresthesias, bradycardia, irregular heartbeat)
  • Symptoms of metabolic alkalosis (nausea, vomiting, muscle twitching, confusion)
  • Gastrointestinal upset (abdominal discomfort, diarrhea, nausea, vomiting)
  • Signs of new stone formation or recurrence

Special Patient Groups

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Pregnancy

Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Use only if clearly needed and the benefit outweighs the risk.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, but data are limited.
Second Trimester: Limited data, monitor maternal electrolytes.
Third Trimester: Limited data, monitor maternal electrolytes.
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Lactation

Potassium and citrate are normal components of human milk. While generally considered compatible with breastfeeding, caution is advised. Monitor infant for any signs of electrolyte imbalance or GI upset.

Infant Risk: Low risk, but monitor for diarrhea or electrolyte disturbances.
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Pediatric Use

Used in children for nephrolithiasis, but dosing must be carefully individualized based on weight, urine pH, and underlying condition. Close monitoring of serum electrolytes and renal function is essential. Safety and efficacy are not as well-established as in adults.

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Geriatric Use

Elderly patients may have reduced renal function, increasing the risk of hyperkalemia. Close monitoring of serum potassium and renal function is crucial. Start with lower doses and titrate carefully.

Clinical Information

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Clinical Pearls

  • Always dilute the liquid solution in a full glass of water or juice (at least 4 oz) to prevent gastrointestinal irritation and potential ulceration.
  • Take with or immediately after meals to minimize GI upset and improve tolerability.
  • Regular monitoring of serum potassium and urine pH is critical to ensure efficacy and prevent adverse effects like hyperkalemia or over-alkalinization.
  • Advise patients to report any symptoms of hyperkalemia (e.g., muscle weakness, irregular heartbeat) immediately.
  • This medication is not effective for all types of kidney stones; it is primarily used for calcium oxalate and uric acid stones associated with hypocitraturia or acidic urine.
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Alternative Therapies

  • Increased fluid intake (general stone prevention)
  • Thiazide diuretics (for hypercalciuria-related calcium stones)
  • Allopurinol (for hyperuricosuria-related uric acid or calcium oxalate stones)
  • Dietary modifications (e.g., low sodium, low animal protein, increased fruit/vegetable intake)
  • Acetazolamide (less common, for urinary alkalinization)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$200+ per 473 mL bottle (solution)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it happened.