Cytra-K Oral Solution

Manufacturer CYPRESS PHARMACEUTICAL 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 replacement; 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?

Cytra-K Oral Solution is a liquid medicine that helps make your urine less acidic. This can help prevent certain types of kidney stones from forming, especially calcium oxalate and uric acid stones. It works by increasing the amount of a substance called citrate in your urine and making your urine less acidic, which helps dissolve or prevent stone formation.
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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.

To prepare your dose, mix the medication with water as instructed by your doctor before consuming it. Always shake the medication well before use. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.

If you find the taste unpleasant, you can chill the medication in the refrigerator to make it more palatable.

Storing and Disposing of Your Medication

Store your medication at room temperature, avoiding freezing temperatures. Protect the medication from heat sources and store it in a dry place. It is recommended to keep the medication away from bathrooms.

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 to make up for the missed one.
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Lifestyle & Tips

  • Drink plenty of fluids throughout the day, as directed by your doctor, to help prevent kidney stones.
  • Take this medicine with or immediately after meals to reduce stomach upset.
  • Do not stop taking this medicine without consulting your doctor, even if you feel better.
  • Avoid high-potassium foods or salt substitutes unless advised by your doctor, as this medicine already contains potassium.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 10-20 mEq (1080-2160 mg potassium citrate) three to four times daily, or as directed by physician. Dosage should be adjusted to maintain urinary pH between 6.0 and 7.0.
Dose Range: 30 - 100 mg

Condition-Specific Dosing:

renal tubular acidosis with calcium stones: 60-100 mEq/day in 3-4 divided doses
hypocitraturic calcium oxalate nephrolithiasis: 30-60 mEq/day in 3-4 divided doses
uric acid lithiasis: 40-80 mEq/day in 3-4 divided doses
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Dosing is individualized based on body weight and urinary pH. Typically 1-2 mEq/kg/day in 3-4 divided doses, not to exceed adult dose. Close monitoring of serum potassium and urinary pH is essential.
Adolescent: Similar to adult dosing, individualized based on urinary pH and stone type.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum potassium and renal function closely.
Moderate: Contraindicated in patients with severe renal impairment (GFR < 0.7 mL/kg/min) due to risk of hyperkalemia. For moderate impairment, significant dose reduction and frequent monitoring are required.
Severe: Contraindicated.
Dialysis: Contraindicated.

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor for electrolyte imbalances if underlying conditions exist.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended.

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. Increased urinary pH also decreases the solubility of uric acid, preventing uric acid stone formation. Citric acid contributes to the overall alkalinizing effect.
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Pharmacokinetics

Absorption:

Bioavailability: Well absorbed orally (potassium citrate)
Tmax: Not precisely defined for solution, but onset of action is relatively rapid.
FoodEffect: Should be taken with or after meals to minimize gastrointestinal upset.

Distribution:

Vd: Not available
ProteinBinding: Not available
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely defined for the combination; potassium is rapidly excreted renally. Citrate metabolism is rapid.
Clearance: Renal (potassium); metabolic (citrate)
ExcretionRoute: Renal (potassium, bicarbonate)
Unchanged: Minimal (citrate); significant portion of potassium is excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Within hours (urinary alkalinization)
PeakEffect: Within 24 hours (sustained urinary pH elevation)
DurationOfAction: Dependent on dosing frequency (e.g., 6-8 hours for qid dosing)

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 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
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. 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

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.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
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Seek Immediate Medical Attention If You Experience:

  • Unusual tiredness or weakness
  • Numbness or tingling in hands or feet
  • Slow or irregular heartbeat
  • Muscle cramps or pain
  • Severe stomach pain, nausea, vomiting, or diarrhea
  • 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 taking any of the following medications:
+ Amiloride
+ Eplerenone
+ Spironolactone
+ Triamterene

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication with your existing medications and health conditions. Never 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 undergo blood tests and other laboratory examinations as instructed by your doctor to ensure safe and effective treatment. Adhere strictly to the prescribed dosage, as taking more than recommended may increase your risk of experiencing severe side effects. If your diet consists of low-salt foods or you are using a salt substitute, consult with your doctor to discuss any potential interactions. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Hyperkalemia (high potassium levels): muscle weakness, fatigue, paresthesias, bradycardia, irregular heartbeat, confusion, paralysis.
  • Severe gastrointestinal irritation: nausea, vomiting, diarrhea, abdominal pain, potentially GI bleeding.
  • Metabolic alkalosis (less common with oral administration).

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management involves discontinuing the drug, administering calcium gluconate for cardiac stability, insulin/glucose, sodium bicarbonate, or potassium-binding resins. Dialysis may be necessary in severe cases.

Drug Interactions

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Contraindicated Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - severe hyperkalemia risk
  • Patients with hyperkalemia or conditions predisposing to hyperkalemia (e.g., chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, adrenal insufficiency, extensive tissue breakdown)
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Major Interactions

  • ACE inhibitors (e.g., lisinopril, enalapril) - increased risk of hyperkalemia
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan) - increased risk of hyperkalemia
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (e.g., ibuprofen, naproxen) - may reduce renal potassium excretion, increasing hyperkalemia risk
  • Digitalis glycosides (e.g., digoxin) - hyperkalemia can exacerbate cardiac arrhythmias
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine) - may increase GI transit time, potentially increasing local irritation from potassium salts
  • Aluminum-containing antacids - may increase aluminum absorption
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Minor Interactions

  • None commonly cited for significant clinical impact.

Monitoring

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Baseline Monitoring

Serum Potassium

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

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine, GFR)

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

Timing: Prior to initiation of therapy.

Urinary pH

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Potassium

Frequency: Initially within 1-2 weeks of starting therapy or dose adjustment, then every 3-6 months or as clinically indicated.

Target: 3.5-5.0 mEq/L

Action Threshold: If >5.0 mEq/L, reduce dose or discontinue; if >5.5 mEq/L, discontinue immediately and manage hyperkalemia.

Urinary pH

Frequency: Daily (patient self-monitoring) or periodically in clinic.

Target: 6.0-7.0 (for stone prevention)

Action Threshold: If consistently <6.0, consider dose increase; if consistently >7.0, consider dose decrease.

Renal Function (BUN, Creatinine)

Frequency: Every 6-12 months, or more frequently in patients with risk factors for renal decline.

Target: Within normal limits for age/sex

Action Threshold: Significant decline may necessitate dose adjustment or discontinuation.

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Symptom Monitoring

  • Symptoms of hyperkalemia (e.g., muscle weakness, fatigue, paresthesias, bradycardia, irregular heartbeat)
  • Gastrointestinal upset (e.g., nausea, vomiting, diarrhea, abdominal discomfort)
  • Signs of urinary tract infection (e.g., dysuria, frequency, urgency)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit outweighs the potential risk to the fetus. While potassium is an essential electrolyte, high doses or electrolyte imbalances could theoretically pose risks. Close monitoring of maternal potassium levels is crucial.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk if maternal electrolytes are stable.
Second Trimester: Generally considered low risk if maternal electrolytes are stable.
Third Trimester: Generally considered low risk if maternal electrolytes are stable, but close monitoring for hyperkalemia is important, especially near term.
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Lactation

Potassium is a normal component of breast milk. While specific data for Cytra-K are limited, it is generally considered compatible with breastfeeding when used at therapeutic doses, provided maternal potassium levels are monitored and remain within normal limits. Infant monitoring for signs of hyperkalemia is prudent, though unlikely.

Infant Risk: Low risk, but theoretical risk of electrolyte imbalance in the infant with very high maternal doses or pre-existing infant renal issues.
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Pediatric Use

Used in pediatric patients for nephrolithiasis, particularly in conditions like renal tubular acidosis. Dosing must be carefully individualized based on weight, urinary pH, and serum potassium levels. Close monitoring of electrolytes and renal function is essential due to higher susceptibility to electrolyte imbalances.

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Geriatric Use

Elderly patients may be at increased risk for hyperkalemia due to age-related decline in renal function and potential concomitant use of medications that increase potassium (e.g., ACE inhibitors, ARBs, NSAIDs). Initiate therapy with lower doses and monitor serum potassium and renal function more frequently. Contraindicated in severe renal impairment.

Clinical Information

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Clinical Pearls

  • Always dilute the solution in water or juice and take with or immediately after meals to minimize gastrointestinal irritation and saline laxative effect.
  • Instruct patients on how to monitor their urinary pH at home using pH paper, and how to adjust their dose based on results, if appropriate.
  • Emphasize the importance of regular blood tests for potassium and renal function, especially when starting therapy or changing doses.
  • Advise patients to report any symptoms of hyperkalemia immediately.
  • This medication is often a long-term therapy for stone prevention; adherence is key to efficacy.
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Alternative Therapies

  • Sodium bicarbonate (less preferred due to sodium load)
  • Thiazide diuretics (for calcium stones, by reducing urinary calcium excretion)
  • Allopurinol (for uric acid stones or hyperuricosuric calcium oxalate stones)
  • Increased fluid intake (general stone prevention)
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Cost & Coverage

Average Cost: Price varies widely by pharmacy and formulation (e.g., $30-$100+ per 473 mL bottle) 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'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.