Potassium Cl 20meq ER Tablets

Manufacturer TEVA /ACTAVIS Active Ingredient Potassium Chloride Extended- Release Tablets(poe TASS ee um KLOR ide) Pronunciation poe TASS ee um KLOR ide
It is used to treat or prevent low potassium levels.
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Drug Class
Electrolyte replacement
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Pharmacologic Class
Mineral/electrolyte
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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 chloride is a mineral supplement used to prevent or treat low potassium levels in the body. Potassium is very important for your heart, muscles, and nerves to work properly.
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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 or immediately after a meal to help your body absorb it.
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.
If you have trouble swallowing, consult your doctor for guidance.

Some medications can be broken in half or mixed with water. Check with your doctor to see if this is an option for your specific medication. If you can mix your medication with water:

Mix the entire tablet with 1/2 cup of water.
Drink the mixture immediately.
Rinse the cup with more water and drink it to ensure you get the full dose.
Repeat the rinsing process to confirm all the medication has been taken.
Do not store the mixture for later use; take it right away.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature, protected from light.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly.
Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take it as soon as you remember.
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 with food or immediately after a meal to reduce stomach upset.
  • Swallow the extended-release tablet whole. Do NOT crush, chew, or suck on the tablet, as this can cause a sudden release of potassium and lead to serious side effects.
  • Do not stop taking this medication without talking to your doctor, even if you feel better.
  • Avoid salt substitutes that contain potassium unless directed by your doctor.
  • Limit foods high in potassium (e.g., bananas, oranges, potatoes, leafy greens) if your doctor advises, especially if you have kidney problems.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mEq (1 tablet) once daily or twice daily, adjusted based on serum potassium levels and clinical response.
Dose Range: 10 - 100 mg

Condition-Specific Dosing:

hypokalemia_prevention: 10-20 mEq/day
mild_moderate_hypokalemia: 20-40 mEq/day in 1-2 divided doses
severe_hypokalemia: Up to 100 mEq/day in divided doses (requires careful monitoring, often IV initially)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 0.5-1 mEq/kg/day in 1-2 divided doses, maximum 3 mEq/kg/day or 40 mEq/day (whichever is less) for prevention; 2-3 mEq/kg/day in divided doses for treatment of hypokalemia. ER tablets may not be suitable for young children due to choking risk and inability to swallow whole.
Adolescent: Similar to adult dosing, adjusted based on weight and serum potassium levels.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution, monitor serum potassium closely.
Moderate: Reduce dose significantly or avoid, monitor serum potassium and renal function frequently. Risk of hyperkalemia increased.
Severe: Contraindicated due to high risk of life-threatening hyperkalemia.
Dialysis: Generally contraindicated. Potassium levels are managed by dialysis. If supplementation is needed, it must be done with extreme caution and frequent monitoring.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for associated renal dysfunction.
Severe: No specific adjustment needed, but monitor for associated renal dysfunction.

Pharmacology

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Mechanism of Action

Potassium is the principal intracellular cation, essential for maintaining intracellular tonicity, nerve impulse transmission, cardiac contraction, and maintenance of normal renal function. It plays a critical role in a number of physiological processes including acid-base balance, carbohydrate metabolism, and protein synthesis. Potassium chloride supplements replace potassium deficits.
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Pharmacokinetics

Absorption:

Bioavailability: Nearly 100% (oral solutions/immediate release); Extended-release formulations slow absorption.
Tmax: Approximately 4-6 hours for extended-release formulations.
FoodEffect: Food can slow the rate of absorption but does not significantly affect the extent of absorption. Taking with food or after meals is recommended to minimize gastrointestinal irritation.

Distribution:

Vd: Approximately 0.5 L/kg (reflects total body water distribution)
ProteinBinding: Not protein bound.
CnssPenetration: Limited

Elimination:

HalfLife: Not applicable (homeostatically regulated); plasma half-life is very short (minutes) due to rapid cellular uptake and renal excretion.
Clearance: Primarily renal clearance, highly variable depending on renal function and potassium balance.
ExcretionRoute: Primarily renal (approximately 90%), small amounts via feces and sweat.
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Hours (for significant change in serum levels with oral ER formulations)
PeakEffect: 4-8 hours (for ER formulations)
DurationOfAction: Approximately 8-12 hours (due to extended release)
Confidence: Medium

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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
Slow heartbeat
Chest pain or pressure
Signs of bowel problems, such as:
+ Black, tarry, or bloody stools
+ Fever
+ Mucus in the stools
+ Vomiting blood or coffee ground-like material
+ Severe stomach pain, constipation, or diarrhea
Abdominal swelling

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Stomach pain or diarrhea
Upset stomach or vomiting
Gas
Some potassium products have a wax matrix that may appear in your stool; this is a normal occurrence, as the potassium has been absorbed by the body, but the wax has not.

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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of too much potassium (hyperkalemia): unusual tiredness, muscle weakness, numbness or tingling in hands/feet, slow or irregular heartbeat, confusion, shortness of breath.
  • Signs of stomach irritation/ulceration: severe stomach pain, black/tarry stools, vomiting blood or material that looks like coffee grounds.
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
If you have high potassium levels in your blood.
If you are currently taking any of the following medications: Amiloride, Eplerenone, Spironolactone, or Triamterene.
If you have any of the following health conditions:
+ A bowel block or obstruction
+ A slow-moving gastrointestinal (GI) tract
+ Slow stomach emptying or delayed gastric clearing
+ Heart disease accompanied by esophageal problems
+ If you are taking other medications classified as anticholinergics, such as Ipratropium or Oxybutynin. If you are unsure whether any of your medications fall into this category, consult your doctor.

Please note that this list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. This will help determine whether it is safe to take this medication in conjunction with your other treatments. 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 tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your chances of experiencing adverse reactions. If you follow a low-salt diet or use a salt substitute, consult with your doctor to discuss any potential interactions.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Extreme muscle weakness or paralysis
  • Numbness or tingling in the extremities
  • Slow, irregular, or absent heartbeat (bradycardia, asystole)
  • Confusion
  • Shortness of breath
  • Cardiac arrest

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve IV calcium (to stabilize cardiac membrane), IV insulin and glucose (to shift potassium into cells), sodium bicarbonate, diuretics, or dialysis.

Drug Interactions

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Contraindicated Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - concurrent use significantly increases risk of severe hyperkalemia.
  • Eplerenone (a selective aldosterone blocker) - concurrent use significantly increases risk of severe hyperkalemia.
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Major Interactions

  • ACE inhibitors (e.g., lisinopril, enalapril) - increased risk of hyperkalemia.
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan) - increased risk of hyperkalemia.
  • NSAIDs (e.g., ibuprofen, naproxen) - may impair renal potassium excretion, increasing hyperkalemia risk.
  • Cyclosporine - increased risk of hyperkalemia.
  • Tacrolimus - increased risk of hyperkalemia.
  • Heparin - may cause hyperkalemia by inhibiting aldosterone secretion.
  • Digoxin - hyperkalemia can reduce the therapeutic effect of digoxin; hypokalemia can potentiate digoxin toxicity.
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Moderate Interactions

  • Beta-blockers (non-selective) - may reduce potassium uptake into cells, potentially increasing serum potassium.
  • Succinylcholine - may cause a sudden increase in serum potassium, especially in patients with pre-existing hyperkalemia or conditions predisposing to hyperkalemia.

Monitoring

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Baseline Monitoring

Serum Potassium (K+)

Rationale: To establish baseline level and guide initial dosing.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine, eGFR)

Rationale: Potassium is primarily renally excreted; impaired renal function significantly increases risk of hyperkalemia.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: To assess for pre-existing cardiac abnormalities and establish baseline, especially in patients at risk for hyperkalemia or with cardiac disease.

Timing: Prior to initiation, especially if severe hypokalemia or cardiac risk factors.

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Routine Monitoring

Serum Potassium (K+)

Frequency: Initially daily or every 2-3 days until stable, then weekly to monthly depending on patient stability and concomitant medications.

Target: 3.5-5.0 mEq/L

Action Threshold: Below 3.5 mEq/L (consider dose increase); Above 5.0 mEq/L (consider dose decrease/hold); Above 5.5 mEq/L (urgent intervention for hyperkalemia).

Renal Function (BUN, Creatinine)

Frequency: Periodically (e.g., every 1-3 months) or more frequently if renal function is unstable or interacting drugs are added.

Target: Within normal limits for age/sex

Action Threshold: Significant increase in BUN/Creatinine (re-evaluate potassium dosing, consider holding).

Electrocardiogram (ECG)

Frequency: As clinically indicated, especially if serum potassium is outside target range or symptoms of hyperkalemia/hypokalemia develop.

Target: Normal sinus rhythm, no signs of hyperkalemia (peaked T waves, prolonged PR, widened QRS, absent P waves)

Action Threshold: ECG changes consistent with hyperkalemia (urgent intervention).

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Symptom Monitoring

  • Symptoms of hyperkalemia: muscle weakness, fatigue, paresthesia (tingling/numbness), bradycardia, irregular heartbeat, confusion.
  • Symptoms of hypokalemia (if treatment is insufficient): muscle weakness, cramps, fatigue, constipation, palpitations, polyuria.

Special Patient Groups

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Pregnancy

Category C. Potassium is an essential electrolyte. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hypokalemia during pregnancy should be treated.

Trimester-Specific Risks:

First Trimester: No specific increased risk identified beyond general Category C considerations.
Second Trimester: No specific increased risk identified.
Third Trimester: No specific increased risk identified.
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Lactation

L1 (Safest). Potassium is a normal component of breast milk. Supplemental potassium is generally considered compatible with breastfeeding, as the amount excreted into breast milk is not expected to cause adverse effects in a breastfed infant.

Infant Risk: Low risk; unlikely to cause adverse effects.
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Pediatric Use

Use with caution. Dosing must be carefully calculated based on weight and serum potassium levels. Extended-release tablets may pose a choking hazard or be difficult for young children to swallow whole. Liquid formulations or immediate-release tablets (which can be crushed) may be more appropriate for some pediatric patients. Close monitoring of serum potassium is essential.

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Geriatric Use

Increased risk of hyperkalemia due to age-related decline in renal function and increased likelihood of concomitant medications (e.g., ACE inhibitors, ARBs, NSAIDs) that can elevate potassium. Initiate at lower doses and monitor serum potassium and renal function more frequently.

Clinical Information

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Clinical Pearls

  • Always take potassium chloride extended-release tablets with food or immediately after a meal to minimize GI irritation and the risk of esophageal ulceration.
  • Instruct patients NOT to crush, chew, or suck on the extended-release tablets. This can lead to a rapid release of potassium, causing hyperkalemia and potential GI ulceration.
  • Regular monitoring of serum potassium levels and renal function is crucial, especially when initiating therapy, adjusting doses, or adding interacting medications.
  • Be vigilant for signs and symptoms of hyperkalemia, particularly in patients with renal impairment, diabetes, or those on ACE inhibitors, ARBs, or potassium-sparing diuretics.
  • Consider alternative potassium formulations (e.g., liquid, powder) for patients who have difficulty swallowing pills or are at high risk for GI ulceration.
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Alternative Therapies

  • Potassium chloride immediate-release tablets/capsules
  • Potassium chloride oral solution/powder
  • Potassium gluconate (less potassium per dose, often used for milder deficiencies)
  • Potassium bicarbonate (often combined with citrate, useful if metabolic acidosis is also present)
  • Dietary potassium supplementation (e.g., potassium-rich foods)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.