Potassium Cit ER 1620mg (15meq) Tab

Manufacturer CAMBER PHARMACEUTICALS 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
Potassium salt; Alkalinizing agent
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Pregnancy Category
C
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FDA Approved
Jan 1985
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DEA Schedule
Not Controlled

Overview

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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 the amount of a substance called citrate in your urine, which helps prevent calcium from forming stones.
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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 with a full glass of water.
Swallow the tablet whole - do not chew, break, or crush it.
Do not suck 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

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe 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.
If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are any 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 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 a missed dose.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually with meals or within 30 minutes after meals, to reduce stomach upset.
  • Swallow the tablet whole; do not chew, crush, or suck on the tablet, as this can cause irritation or ulceration in the mouth or throat.
  • Maintain adequate fluid intake (e.g., 2-3 liters per day) unless otherwise instructed by your doctor.
  • Follow any dietary recommendations provided by your doctor or dietitian, especially regarding sodium, calcium, and oxalate intake.
  • Avoid potassium-rich foods or salt substitutes unless approved by your doctor, as this can increase your potassium levels.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mEq (1620 mg) orally two to three times daily with meals or within 30 minutes after meals.
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

Hypocitraturia with calcium oxalate nephrolithiasis: Initial dose 10-20 mEq/day, adjusted based on 24-hour urinary citrate and pH. Typical dose 30-60 mEq/day in 2-3 divided doses. Max 100 mEq/day.
Renal tubular acidosis (RTA) with calcium stones: Initial dose 30-60 mEq/day in 2-3 divided doses, adjusted to maintain urinary pH between 6.0-7.0.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Limited data; typically 1-2 mEq/kg/day in 2-3 divided doses, adjusted based on urinary citrate and pH. Max 100 mEq/day.
Adolescent: Similar to adult dosing, adjusted based on urinary parameters.
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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 lower doses. (CrCl 30-60 mL/min)
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 needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but caution if associated with renal impairment or conditions predisposing to hyperkalemia.

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 decreasing the saturation of calcium oxalate and calcium phosphate, and inhibiting the crystallization and aggregation of calcium salts. The increased urinary pH also decreases the crystallization of uric acid.
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Pharmacokinetics

Absorption:

Bioavailability: Well absorbed (citrate portion)
Tmax: Approximately 1-1.5 hours (for citrate component from ER formulation)
FoodEffect: Should be taken with food to minimize gastrointestinal upset and to slow absorption, which may reduce peak potassium levels.

Distribution:

Vd: Not specifically quantified for citrate; potassium is widely distributed intracellularly.
ProteinBinding: Not significantly protein bound.
CnssPenetration: Limited

Elimination:

HalfLife: Not applicable for citrate (rapidly metabolized); potassium homeostasis is tightly regulated.
Clearance: Citrate is rapidly metabolized; potassium is primarily renally excreted.
ExcretionRoute: Renal (potassium), metabolic (citrate)
Unchanged: Minimal (citrate); potassium excretion is regulated based on body needs.
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Pharmacodynamics

OnsetOfAction: Within hours (urinary alkalinization)
PeakEffect: Within 24 hours (stable urinary pH and citrate excretion)
DurationOfAction: Approximately 8-12 hours (due to extended-release formulation)

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, contact your doctor for advice:

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

Reporting Side Effects

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

  • Signs of high potassium (hyperkalemia): unusual tiredness, muscle weakness, numbness or tingling, slow or irregular heartbeat.
  • Severe stomach pain, black or tarry stools, or vomiting blood (signs of GI bleeding or ulceration).
  • Persistent nausea, vomiting, or diarrhea.
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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.
Certain health conditions, including:
+ Dehydration (fluid loss)
+ Diabetes (high blood sugar)
+ High potassium levels
+ Kidney disease
+ Stomach ulcers
+ Urinary tract infections
+ Adrenal gland disease
Other health conditions, such as:
+ Bowel blockage
+ Slow-moving gastrointestinal (GI) tract
+ Slow stomach emptying
If you plan to engage in intense exercise, especially if you are not physically fit
* If you are 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 your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, 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 consulting your doctor first.
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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 diet 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 stuck after swallowing, you may experience chest pain or pressure. If this occurs, immediately contact your doctor. Do not take another tablet unless instructed to do so by your doctor.

It is crucial to notify your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. 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:

  • Severe hyperkalemia (muscle weakness, paralysis, confusion, tingling in hands/feet, irregular heartbeat, slow heart rate, low blood pressure)
  • Cardiac arrhythmias (potentially fatal)

What to Do:

Seek immediate medical attention or call poison control (1-800-222-1222). Treatment involves measures to lower serum potassium (e.g., IV calcium, insulin/glucose, sodium bicarbonate, potassium-binding resins, dialysis).

Drug Interactions

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Contraindicated Interactions

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

  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (e.g., ibuprofen, naproxen) - especially with renal impairment
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Moderate Interactions

  • Anticholinergics (e.g., atropine, dicyclomine) - may increase risk of GI irritation/ulceration due to slowed GI transit with ER formulation.
  • Digitalis glycosides (e.g., digoxin) - hyperkalemia can antagonize the effects of digoxin.
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Minor Interactions

  • Not many specific minor interactions; general caution with other potassium-containing products.

Monitoring

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Baseline Monitoring

Serum electrolytes (Potassium, Sodium, Chloride, Bicarbonate)

Rationale: To assess baseline electrolyte status and identify pre-existing hyperkalemia or other imbalances.

Timing: Prior to initiation of therapy.

Renal function (BUN, Serum Creatinine)

Rationale: To assess kidney function, as impaired renal function increases the risk of hyperkalemia.

Timing: Prior to initiation of therapy.

Urinalysis

Rationale: To assess baseline urinary parameters and rule out infection.

Timing: Prior to initiation of therapy.

24-hour urine collection (for pH, citrate, calcium, oxalate, uric acid, creatinine)

Rationale: To establish baseline stone risk factors 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 or 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).

Serum Creatinine and BUN

Frequency: Monthly for the first month, then every 3-6 months, or as clinically indicated.

Target: Within normal limits for patient's age/sex.

Action Threshold: Significant increase (e.g., >25% above baseline or above upper limit of normal) may indicate worsening renal function and increased hyperkalemia risk.

24-hour urine collection (for pH, citrate, calcium)

Frequency: Every 4-6 weeks initially until desired urinary parameters are achieved, then every 6-12 months.

Target: Urinary pH 6.0-7.0; Urinary citrate >320 mg/day (or target based on stone type).

Action Threshold: Urinary pH <6.0 or >7.0 (adjust dose); inadequate citrate excretion (increase dose); hypercalciuria (re-evaluate stone prevention strategy).

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Symptom Monitoring

  • Symptoms of hyperkalemia (e.g., fatigue, muscle weakness, paresthesias, bradycardia, irregular heartbeat)
  • Gastrointestinal upset (e.g., nausea, vomiting, diarrhea, abdominal pain)
  • Signs of GI bleeding or ulceration (e.g., black, tarry stools; severe abdominal pain; coffee-ground emesis)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. While potassium is an essential electrolyte, high doses or hyperkalemia could pose risks.

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, especially if maternal renal function is compromised.
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Lactation

L1 (Safest). Potassium is a normal component of breast milk. Therapeutic doses are generally considered compatible with breastfeeding, but monitor infant for any signs of electrolyte imbalance if maternal doses are very high.

Infant Risk: Low risk; potassium is naturally present in breast milk. No adverse effects expected with typical maternal doses.
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Pediatric Use

Use with caution and close monitoring. Dosing is typically weight-based and adjusted according to 24-hour urinary parameters. Risk of hyperkalemia is higher in children with impaired renal function.

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Geriatric Use

Use with caution due to increased likelihood of impaired renal function and polypharmacy (e.g., ACE inhibitors, ARBs, NSAIDs) which can increase the risk of hyperkalemia. Monitor serum potassium and renal function more frequently.

Clinical Information

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Clinical Pearls

  • Always take potassium citrate with food or immediately after a meal to minimize gastrointestinal irritation and improve tolerability.
  • Instruct patients to swallow the extended-release tablets whole without crushing, chewing, or sucking, as this can lead to rapid potassium release, local irritation, and potential ulceration.
  • Regular monitoring of serum potassium, renal function, and 24-hour urinary parameters (pH, citrate, calcium) is crucial for safe and effective therapy.
  • Educate patients on the symptoms of hyperkalemia and to seek immediate medical attention if they occur.
  • Ensure patients maintain adequate hydration throughout therapy to help prevent stone formation and aid in drug excretion.
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Alternative Therapies

  • Sodium bicarbonate (less preferred due to sodium load)
  • Thiazide diuretics (for hypercalciuric stone formers)
  • Allopurinol (for uric acid stone formers)
  • Dietary modifications (e.g., increased fluid intake, reduced sodium, reduced animal protein, increased fruit/vegetable intake)
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Cost & Coverage

Average Cost: $30 - $150 per 90 tablets (generic)
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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.