Potassium Cit 540mg (5meq) Tablets

Manufacturer ZYDUS PHARMACEUTICALS (USA) Active Ingredient Potassium Citrate(poe TASS ee um SIT rate) Pronunciation poe TASS ee um SIT rate
It is used to treat kidney stones.It is used to treat acid problems in the blood.
🏷️
Drug Class
Urinary alkalinizer; Nephrolithiasis agent
🧬
Pharmacologic Class
Electrolyte; Potassium salt
🤰
Pregnancy Category
Category C
FDA Approved
Jan 1970
⚖️
DEA Schedule
Not Controlled

Overview

ℹ️

What is this medicine?

Potassium citrate is a medication used to prevent certain types of kidney stones. It works by making your urine less acidic and increasing a substance called citrate in your urine, which helps prevent stones from forming.
📋

How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food to help your body absorb it properly.
Swallow your medication whole with a full glass of water. Do not chew, break, or crush the tablet.
Avoid sucking on the tablet.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

If you experience difficulty swallowing or feel like the tablet is getting stuck in your throat, consult your doctor for guidance.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

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.
💡

Lifestyle & Tips

  • Drink plenty of fluids (e.g., water) throughout the day to help prevent kidney stones, as advised by your doctor.
  • Take this medication with meals or within 30 minutes after meals or a bedtime snack to reduce stomach upset and improve absorption.
  • Swallow tablets whole; do not chew, crush, or suck on them, as this can cause mouth or throat irritation and lead to a rapid release of potassium.
  • Avoid excessive intake of high-potassium foods or salt substitutes unless directed by your doctor.
  • Report any unusual symptoms, especially muscle weakness, tingling, or irregular heartbeat, to your doctor immediately.

Dosing & Administration

👨‍⚕️

Adult Dosing

Standard Dose: Initial: 2 tablets (10 mEq) orally twice daily with meals or within 30 minutes after meals or bedtime snack. Maintenance: Adjusted to achieve target urine pH (6.0-7.0) and serum potassium levels, typically 2 to 4 tablets (10-20 mEq) two to three times daily.
Dose Range: 10 - 60 mg

Condition-Specific Dosing:

Hypocitraturic calcium oxalate nephrolithiasis: Initial: 10 mEq (two 540mg tablets) orally twice daily. Adjust dose to maintain urine citrate excretion >320 mg/day and urine pH between 6.0 and 7.0. Max: 100 mEq/day in divided doses.
Uric acid nephrolithiasis: Initial: 10 mEq (two 540mg tablets) orally twice daily. Adjust dose to maintain urine pH between 6.5 and 7.0. Max: 100 mEq/day in divided doses.
👶

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Use in children is generally not recommended unless under strict medical supervision and specific indications (e.g., severe hypocitraturia). Dosing must be individualized based on weight, serum potassium, and urine pH. Typically 1-2 mEq/kg/day in divided doses.
Adolescent: Similar to adult dosing, but individualized based on weight, serum potassium, and urine pH.
⚕️

Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum potassium and creatinine closely.
Moderate: Contraindicated if GFR < 30 mL/min/1.73m² due to risk of hyperkalemia. If GFR 30-60 mL/min/1.73m², use with extreme caution and frequent monitoring.
Severe: Contraindicated (GFR < 30 mL/min/1.73m²) due to high risk of life-threatening hyperkalemia.
Dialysis: Contraindicated.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor serum potassium if underlying conditions predispose to hyperkalemia.
Moderate: No specific dose adjustment required, but monitor serum potassium if underlying conditions predispose to hyperkalemia.
Severe: No specific dose adjustment required, but monitor serum potassium if underlying conditions predispose to hyperkalemia.

Pharmacology

🔬

Mechanism of Action

Potassium citrate is metabolized to bicarbonate, which alkalinizes the urine. This increases urinary pH, increases urinary citrate excretion, and decreases urinary calcium 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. Alkalinization of urine also increases the solubility of uric acid, preventing uric acid stone formation.
📊

Pharmacokinetics

Absorption:

Bioavailability: Well absorbed (potassium and citrate ions)
Tmax: Varies by formulation: Immediate release: 1-2 hours; Extended release: 4-6 hours (for peak plasma potassium concentration)
FoodEffect: Absorption is enhanced and gastrointestinal upset is reduced when taken with food.

Distribution:

Vd: Not readily quantifiable for potassium and citrate ions as they are ubiquitous in the body.
ProteinBinding: Not significantly protein bound.
CnssPenetration: Limited

Elimination:

HalfLife: Potassium: Rapidly distributed and excreted; Citrate: Rapidly metabolized (plasma half-life minutes). The therapeutic effect (urinary alkalinization) is sustained by continuous release from extended-release formulations.
Clearance: Primarily renal for potassium; metabolic for citrate.
ExcretionRoute: Renal (potassium), Metabolic (citrate)
Unchanged: Minimal (citrate); Varies (potassium, depending on body needs)
⏱️

Pharmacodynamics

OnsetOfAction: Within hours (for urinary alkalinization)
PeakEffect: Within 24 hours (for stable urinary pH and citrate excretion with regular dosing)
DurationOfAction: Varies by formulation: Immediate release: 4-6 hours; Extended release: 8-12 hours

Safety & Warnings

⚠️

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:

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
Extreme fatigue or weakness
Abdominal swelling
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

Diarrhea
Stomach pain
Upset stomach
Vomiting
* Note: You may notice the tablet shell in your stool, but this is normal and not a cause for concern.

Reporting Side Effects

This is not an exhaustive list of all possible side effects. If you have questions or concerns 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, nausea, vomiting, or diarrhea
  • Black, tarry, or bloody stools
  • Vomiting blood or material that looks like coffee grounds
  • Muscle weakness or numbness/tingling in hands or feet
  • Slow, fast, or irregular heartbeat
  • Confusion or unusual tiredness
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
📋

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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Fluid loss (dehydration)
+ High blood sugar (diabetes)
+ Elevated potassium levels
+ Kidney disease
+ Stomach ulcers
+ Urinary tract infections
+ Adrenal gland disease
Other health conditions, such as:
+ Bowel blockage
+ Slow-moving gastrointestinal (GI) tract
+ Delayed stomach emptying
Plans to engage in intense exercise, especially if you are not physically fit
* Use of specific medications, including:
+ Amiloride
+ Eplerenone
+ Spironolactone
+ Triamterene

Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
⚠️

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 work and laboratory tests, as directed by your doctor, are crucial to monitor your condition. Additionally, some individuals may require electrocardiogram (ECG) tests to check their heart rhythm.

To ensure optimal treatment outcomes, adhere to the diet plan recommended by your doctor, which may involve reducing your salt intake. If you have any questions or concerns about your diet, consult with your doctor. You may also need to perform dipstick tests to check the acid content (pH) of your urine.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor to avoid any potential interactions. In the event that a tablet becomes lodged after swallowing, you may experience chest pain or pressure. If this occurs, contact your doctor immediately and do not take another tablet unless instructed to do so by your doctor.

It is crucial to inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will discuss the benefits and risks of this medication with you, considering both your health and the well-being of your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Hyperkalemia (high potassium levels): muscle weakness, fatigue, paresthesia (tingling/numbness), bradycardia (slow heart rate), irregular heartbeat, confusion, flaccid paralysis, cardiac arrest.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment involves measures to lower serum potassium, such as IV calcium (for cardiac stability), insulin and glucose, sodium bicarbonate, potassium-binding resins, or hemodialysis in severe cases.

Drug Interactions

🚫

Contraindicated Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - severe hyperkalemia risk.
  • Conditions predisposing to hyperkalemia (e.g., severe renal impairment, uncontrolled diabetes mellitus, acute dehydration, adrenal insufficiency, extensive tissue breakdown).
🔴

Major Interactions

  • ACE inhibitors (e.g., lisinopril, enalapril) - increased risk of hyperkalemia.
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan) - increased risk of hyperkalemia.
  • Other potassium-containing medications or supplements - increased risk of hyperkalemia.
  • NSAIDs (e.g., ibuprofen, naproxen) - may reduce renal potassium excretion, increasing hyperkalemia risk.
🟡

Moderate Interactions

  • Digoxin - hyperkalemia can worsen digoxin toxicity (though hypokalemia is more commonly associated with toxicity, rapid shifts can be problematic).
  • Anticholinergic drugs - may increase risk of gastrointestinal irritation/ulceration due to prolonged contact with tablet.
🟢

Minor Interactions

  • Not available

Monitoring

🔬

Baseline Monitoring

Serum Potassium (K+)

Rationale: To establish baseline and identify pre-existing hyperkalemia or risk factors.

Timing: Prior to initiation of therapy.

Serum Creatinine (Cr) and Blood Urea Nitrogen (BUN)

Rationale: To assess renal function, as impaired renal function is a contraindication or requires dose adjustment.

Timing: Prior to initiation of therapy.

24-hour Urine Collection (for pH, citrate, calcium, oxalate, uric acid, sodium, creatinine)

Rationale: To characterize stone type, assess baseline urinary parameters, and guide initial dosing.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Serum Potassium (K+)

Frequency: Weekly for the first month, then monthly for 3-6 months, then every 3-6 months 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)

Serum Creatinine (Cr)

Frequency: Periodically (e.g., every 3-6 months) or as clinically indicated.

Target: Within normal limits for age/sex

Action Threshold: Significant increase from baseline (investigate renal function)

Urinary pH (first morning void or 24-hour collection)

Frequency: Daily (patient self-monitoring with pH paper) or periodically (24-hour collection, e.g., every 3-6 months).

Target: 6.0-7.0 (for calcium oxalate/phosphate stones); 6.5-7.0 (for uric acid stones)

Action Threshold: <6.0 or >7.5 (adjust dose)

24-hour Urine Citrate Excretion

Frequency: Every 3-6 months or as needed to assess therapeutic efficacy.

Target: >320 mg/day

Action Threshold: <320 mg/day (consider dose increase)

👁️

Symptom Monitoring

  • Symptoms of hyperkalemia (e.g., fatigue, muscle weakness, paresthesia, bradycardia, irregular heartbeat)
  • Gastrointestinal upset (e.g., nausea, vomiting, diarrhea, abdominal discomfort)
  • Signs of gastrointestinal ulceration/bleeding (e.g., black, tarry stools; severe abdominal pain; vomiting blood)

Special Patient Groups

🤰

Pregnancy

Potassium citrate is classified as 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 potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data; theoretical risk of electrolyte imbalance.
Second Trimester: Limited data; theoretical risk of electrolyte imbalance.
Third Trimester: Limited data; theoretical risk of electrolyte imbalance.
🤱

Lactation

Potassium is a normal component of breast milk. While potassium citrate is generally considered safe during breastfeeding due to its natural presence in the body and low risk of adverse effects in the infant, caution is advised. Monitor the infant for any signs of electrolyte imbalance.

Infant Risk: Low risk (L1)
👶

Pediatric Use

Safety and efficacy have not been fully established in pediatric patients. Use in children should be under strict medical supervision and only when clearly indicated, with careful monitoring of serum potassium and urine pH. Dosing must be individualized.

👴

Geriatric Use

Elderly patients may be more susceptible to hyperkalemia due to age-related decline in renal function. Initiate therapy with lower doses and monitor serum potassium and renal function more frequently. Avoid use in elderly patients with significant renal impairment.

Clinical Information

💎

Clinical Pearls

  • Potassium citrate is the preferred alkalinizing agent for hypocitraturic calcium oxalate nephrolithiasis and uric acid nephrolithiasis.
  • Always take with food to minimize gastrointestinal irritation and improve tolerability.
  • Patients should be instructed not to chew, crush, or suck on the tablets to prevent rapid potassium release and local irritation.
  • Regular monitoring of serum potassium and urine pH is crucial to ensure efficacy and safety.
  • Patients should be advised to maintain adequate hydration while on therapy.
  • Contraindicated in patients with conditions that predispose to hyperkalemia, such as severe renal impairment, uncontrolled diabetes, or adrenal insufficiency.
🔄

Alternative Therapies

  • Sodium bicarbonate (less preferred due to sodium load and less effective citrate excretion)
  • Thiazide diuretics (for hypercalciuria)
  • Allopurinol (for hyperuricosuria)
  • Increased fluid intake (general stone prevention)
  • Dietary modifications (e.g., reduced sodium, animal protein, oxalate; increased calcium for some stone types)
💰

Cost & Coverage

Average Cost: $20 - $50 per 90 tablets (generic 540mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations) by most commercial and Medicare Part D plans.
📚

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.