Potassium Cit 1080mg (10meq) Tabs

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.
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Drug Class
Urinary alkalinizer; Electrolyte replacement
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Pharmacologic Class
Mineral/electrolyte; Potassium salt
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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?

Potassium citrate is a medication used to make your urine less acidic and to increase the amount of a substance called citrate in your urine. This helps prevent certain types of kidney stones, especially calcium oxalate and uric acid stones, from forming or growing larger. It also helps treat a condition called renal tubular acidosis.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

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 if the tablet gets 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, avoiding 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.
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Lifestyle & Tips

  • Take this medication exactly as prescribed by your doctor, usually with meals or within 30 minutes after meals or a bedtime snack, to reduce stomach upset.
  • Swallow the tablets whole; do not chew, crush, or suck on them, as this can cause mouth or throat irritation.
  • Drink plenty of fluids throughout the day as recommended by your doctor to help prevent kidney stones.
  • Follow any dietary recommendations from your doctor, such as limiting sodium or animal protein intake.
  • Do not use salt substitutes or other potassium supplements unless specifically instructed by your doctor, as this can lead to dangerously high potassium levels.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose: 10-20 mEq (1080-2160 mg) orally twice daily with meals or within 30 minutes after meals or bedtime snack. Adjust dose to achieve desired urinary citrate levels (e.g., >320 mg/day) and/or urinary pH (e.g., 6.0-7.0).
Dose Range: 10 - 100 mg

Condition-Specific Dosing:

Hypocitraturic Calcium Oxalate Nephrolithiasis: Initial dose 20 mEq/day (10 mEq twice daily). May increase to 60-100 mEq/day in divided doses. Max 100 mEq/day.
Renal Tubular Acidosis (RTA) with Calcium Stones: Initial dose 40-60 mEq/day in divided doses. May increase to 100 mEq/day in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Dosing for specific conditions (e.g., RTA) should be individualized by a specialist. Generally, 1-2 mEq/kg/day in 3-4 divided doses, adjusted to urinary pH and citrate levels.
Adolescent: Similar to adult dosing for specific indications, but individualized based on weight and clinical response.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum potassium and renal function closely.
Moderate: Use with extreme caution; monitor serum potassium and renal function very closely. Consider lower doses. Contraindicated if GFR < 0.7 mL/kg/min.
Severe: Contraindicated (e.g., GFR < 30 mL/min or significant renal impairment) due to risk of hyperkalemia.
Dialysis: Contraindicated due to high risk of hyperkalemia.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor serum potassium if there are co-morbidities affecting renal function or potassium balance.

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: Well absorbed (approximately 90-95%)
Tmax: Approximately 1-1.5 hours
FoodEffect: Absorption is enhanced and gastrointestinal upset is minimized when taken with food or immediately after meals.

Distribution:

Vd: Not specifically quantified for citrate, but potassium is widely distributed throughout the body, primarily intracellularly.
ProteinBinding: Low (for potassium and citrate)
CnssPenetration: Limited

Elimination:

HalfLife: Potassium has a short half-life in plasma (minutes) as it rapidly equilibrates between intra- and extracellular compartments. Citrate is rapidly metabolized.
Clearance: Primarily renal for potassium not utilized; citrate is metabolized.
ExcretionRoute: Renal (as potassium and bicarbonate/CO2)
Unchanged: Minimal unchanged citrate excreted in urine; potassium excretion is highly regulated.
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Pharmacodynamics

OnsetOfAction: Within hours (urinary pH and citrate changes)
PeakEffect: Within 24 hours (stable urinary pH and citrate levels)
DurationOfAction: Approximately 8-12 hours per dose, requiring twice-daily dosing for sustained effect.

Safety & Warnings

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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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:

Diarrhea
Stomach pain
Upset stomach
Vomiting
* Note: You may notice the tablet shell in your stool, which is a normal and harmless occurrence.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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:

  • Signs of high potassium (hyperkalemia): unusual tiredness, muscle weakness, numbness or tingling in hands or feet, slow or irregular heartbeat, confusion.
  • Severe stomach pain, black or tarry stools, or vomiting blood (signs of gastrointestinal bleeding or ulceration).
  • Persistent nausea, vomiting, or diarrhea.
  • Signs of an allergic reaction: rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble 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 you experienced, including any 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 strenuous exercise without being physically conditioned
* Use of specific medications, including:
+ Amiloride
+ Eplerenone
+ Spironolactone
+ Triamterene

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust 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. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition. Some individuals may also require electrocardiogram (ECG) tests to check their heart rhythm.

Adhere to the dietary plan recommended by your doctor, which may involve reducing your salt intake. If you have questions or concerns about your diet, consult with your doctor. Additionally, you may need to perform a dipstick test 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. In the event that a tablet becomes lodged after swallowing, you may experience chest pain or pressure. If this occurs, contact your doctor immediately. Do not take another tablet unless instructed to do so by your doctor.

It is crucial to notify your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Symptoms of severe hyperkalemia: profound muscle weakness, flaccid paralysis, tingling sensations, confusion, irregular heartbeat (arrhythmias), slow heart rate, cardiac arrest.
  • Severe gastrointestinal irritation, nausea, vomiting, diarrhea.

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment for hyperkalemia may include intravenous calcium, insulin with glucose, sodium bicarbonate, or dialysis, depending on severity.

Drug Interactions

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Contraindicated Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of severe hyperkalemia.
  • ACE inhibitors (e.g., lisinopril, enalapril) and Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan) - increased risk of hyperkalemia, especially in patients with renal impairment.
  • Severe renal impairment (GFR < 30 mL/min) - risk of hyperkalemia.
  • Active urinary tract infection (UTI) - alkalinization may promote bacterial growth and stone formation (e.g., struvite stones).
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Major Interactions

  • Other potassium-containing medications or supplements - increased risk of hyperkalemia.
  • NSAIDs (e.g., ibuprofen, naproxen) - may impair renal potassium excretion, increasing hyperkalemia risk.
  • Immunosuppressants (e.g., cyclosporine, tacrolimus) - may increase serum potassium levels.
  • Digitalis glycosides (e.g., digoxin) - hyperkalemia can reduce the therapeutic effect of digoxin, while hypokalemia can potentiate its toxicity. Close monitoring is crucial.
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Moderate Interactions

  • Anticholinergics (e.g., atropine, dicyclomine) - may slow gastrointestinal transit, potentially increasing the risk of GI irritation or ulceration from potassium tablets.
  • Laxatives (especially those containing sodium phosphate) - may alter electrolyte balance.
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Minor Interactions

  • None commonly cited as minor interactions with significant clinical impact.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Potassium, Sodium, Chloride, Bicarbonate)

Rationale: To establish baseline potassium levels and assess overall electrolyte balance before initiating therapy, and to identify pre-existing hyperkalemia or other imbalances.

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 the risk of hyperkalemia.

Timing: Prior to initiation of therapy.

Urinalysis

Rationale: To rule out active urinary tract infection, which is a contraindication.

Timing: Prior to initiation of therapy.

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

Rationale: To establish baseline urinary parameters for stone formers and guide initial dosing.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Potassium

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 for hyperkalemia).

Renal Function (BUN, Serum Creatinine)

Frequency: Every 3-6 months or as clinically indicated, especially in elderly or those with risk factors for renal decline.

Target: Stable within normal limits for the patient.

Action Threshold: Significant increase in creatinine or decrease in eGFR (consider dose adjustment or discontinuation).

24-hour Urine Collection (for citrate, pH)

Frequency: After 1-2 weeks of stable dosing to assess response, then every 3-6 months or as needed to guide dose adjustments.

Target: Urinary citrate >320 mg/day; Urinary pH 6.0-7.0 (for calcium oxalate stones) or 6.5-7.0 (for uric acid stones).

Action Threshold: Citrate <320 mg/day (consider dose increase); pH outside target range (adjust dose).

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Symptom Monitoring

  • Symptoms of hyperkalemia (e.g., fatigue, muscle weakness, paresthesias, bradycardia, irregular heartbeat, confusion).
  • Gastrointestinal symptoms (e.g., abdominal discomfort, nausea, vomiting, diarrhea, black/tarry stools, severe abdominal pain - indicative of GI ulceration/bleeding).

Special Patient Groups

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Pregnancy

Potassium citrate is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data exist, but animal studies have not shown teratogenicity. Close monitoring of maternal potassium levels is essential.

Trimester-Specific Risks:

First Trimester: No specific data indicating increased risk, but generally avoided unless clearly needed.
Second Trimester: Use if clearly indicated and benefits outweigh risks; monitor maternal potassium.
Third Trimester: Use if clearly indicated and benefits outweigh risks; monitor maternal potassium, especially given potential for changes in renal function.
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Lactation

Potassium is a normal component of breast milk. While potassium citrate is generally considered compatible with breastfeeding (L3), caution is advised. Monitor the infant for any signs of electrolyte imbalance, though systemic absorption by the infant is unlikely to be significant.

Infant Risk: Low risk; monitor for signs of electrolyte imbalance, though unlikely to occur with maternal therapeutic doses.
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Pediatric Use

Safety and efficacy are not well-established for all pediatric age groups or indications. Use in children should be under the guidance of a specialist, with careful dose titration based on urinary parameters and close monitoring of serum potassium and renal function.

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Geriatric Use

Elderly patients are at increased risk for hyperkalemia due to age-related decline in renal function and potential for polypharmacy (e.g., concomitant use of ACE inhibitors, ARBs, NSAIDs). 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 take potassium citrate with food or immediately after a meal/snack to minimize gastrointestinal irritation and improve tolerability.
  • Do not crush, chew, or suck on the tablets, as this can cause local irritation or ulceration in the mouth or esophagus.
  • Regular monitoring of serum potassium and renal function is critical, especially during initiation and dose adjustments, and in patients with comorbidities or on interacting medications.
  • 24-hour urine collections are essential for guiding therapy, assessing response (urinary citrate and pH), and ensuring adequate stone prevention.
  • Patients should be advised to report any symptoms of hyperkalemia (e.g., muscle weakness, irregular heartbeat) or severe GI upset immediately.
  • Contraindicated in patients with severe renal impairment, active urinary tract infection, or conditions predisposing to hyperkalemia (e.g., uncontrolled diabetes, adrenal insufficiency).
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Alternative Therapies

  • Thiazide diuretics (for calcium stones, by reducing urinary calcium)
  • Allopurinol (for uric acid stones or hyperuricosuric calcium stones)
  • Dietary modifications (e.g., increased fluid intake, reduced sodium, reduced animal protein, increased fruit/vegetable intake)
  • Cystine-binding drugs (for cystine stones)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 30 tablets (10 mEq)
Generic Available: Yes
Insurance Coverage: Often Tier 1 or Tier 2 for generic formulations on most commercial and Medicare Part D plans.
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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.