Potassium Chloride ER 8meq ER Tabs

Manufacturer MYLAN 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
Electrolyte
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Pregnancy 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 levels of potassium in your blood (hypokalemia). 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.
Swallow your medication whole with a full glass of water.
Do not chew, break, or crush your medication.
Avoid sucking on the medication.
If you have difficulty 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.
Repeat the rinsing process to ensure you take the entire dose.
Do not store the mixture for later use.

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.
Consult your pharmacist for guidance on the best disposal method or to learn about potential drug take-back programs in your area.

Missing a Dose

If you miss a dose:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take with food or immediately after a meal to reduce stomach upset.
  • Swallow extended-release tablets whole; do not crush, chew, or suck on them, as this can cause a sudden release of potassium and lead to irritation or high potassium levels.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double doses.
  • Avoid salt substitutes that contain potassium unless advised by your doctor.
  • Inform your doctor about all other medications you are taking, especially blood pressure medications (like ACE inhibitors or ARBs) and diuretics.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mEq (2 x 10 mEq or 2.5 x 8 mEq) orally 1-4 times daily for hypokalemia, adjusted based on serum potassium levels and clinical response.
Dose Range: 10 - 100 mg

Condition-Specific Dosing:

mild_hypokalemia: 20-40 mEq/day in divided doses
moderate_severe_hypokalemia: 40-100 mEq/day in divided doses, with close monitoring
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Pediatric Dosing

Neonatal: Not established (use IV in critical cases, consult specialist)
Infant: 2-3 mEq/kg/day in divided doses (max 1 mEq/kg/dose)
Child: 2-3 mEq/kg/day in divided doses (max 1 mEq/kg/dose or 40 mEq/day, whichever is less)
Adolescent: 2-3 mEq/kg/day in divided doses (max 1 mEq/kg/dose or 40 mEq/day, whichever is less), or adult dose if body weight allows
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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.
Severe: Contraindicated (CrCl < 30 mL/min) due to high risk of hyperkalemia.
Dialysis: Generally contraindicated. If used, only under strict supervision with frequent monitoring, as potassium is removed by dialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Potassium is the principal intracellular cation and is essential for the maintenance of intracellular tonicity, nerve impulse transmission, cardiac contraction, skeletal and smooth muscle contraction, and maintenance of normal renal function. It plays a critical role in many enzymatic reactions and physiological processes, including carbohydrate metabolism and protein synthesis. Potassium chloride supplements replace potassium deficits.
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Pharmacokinetics

Absorption:

Bioavailability: Well absorbed (approximately 90%)
Tmax: Approximately 1-2 hours for immediate release; extended-release formulations have prolonged absorption.
FoodEffect: Food may decrease the rate but not the extent of absorption; taking with food or after meals is recommended to minimize GI irritation.

Distribution:

Vd: Approximately 0.5 L/kg (distributes throughout total body water)
ProteinBinding: Not protein bound
CnssPenetration: Limited (primarily extracellular)

Elimination:

HalfLife: Variable, depends on renal function and potassium balance (normal renal function: rapid turnover, effectively no fixed half-life for exogenous potassium)
Clearance: Primarily renal excretion (80-90%), with some fecal excretion (10-20%).
ExcretionRoute: Renal (urine)
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Within hours for electrolyte correction.
PeakEffect: Within 4-6 hours for serum potassium levels.
DurationOfAction: Dependent on renal function and ongoing potassium losses; extended-release formulations provide sustained release over 8-12 hours.

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
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. 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:

Stomach pain or diarrhea
Upset stomach or vomiting
Gas
Note: 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 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, tingling or numbness in hands/feet, slow or irregular heartbeat, nausea, vomiting, diarrhea, abdominal pain.
  • Signs of gastrointestinal 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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 blockage or obstruction
+ A slow-moving gastrointestinal (GI) tract
+ Slow stomach emptying or gastric clearance
+ Heart disease accompanied by esophageal problems
+ If you are taking anticholinergic medications, such as Ipratropium or Oxybutynin. If you are unsure whether any of your medications belong to this class, consult your doctor.

Please note that this list is not exhaustive, and 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 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 breast-feeding, notify your doctor immediately. You and your doctor will need to carefully weigh the benefits and risks of this medication to you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Hyperkalemia symptoms: muscle weakness, flaccid paralysis, paresthesias, confusion, slow or irregular heartbeat, severe abdominal pain, diarrhea.
  • Severe hyperkalemia can lead to life-threatening cardiac arrhythmias (e.g., peaked T waves, widened QRS, ventricular fibrillation, asystole).

What to Do:

Seek immediate medical attention or call 911. Management includes IV calcium (for cardiac stability), IV insulin with glucose, sodium bicarbonate, loop diuretics, and potentially hemodialysis for severe cases. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) in patients with impaired renal function or severe heart failure
  • Patients with 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.
  • Aliskiren: Increased risk of hyperkalemia.
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (e.g., ibuprofen, naproxen): May impair renal potassium excretion, increasing hyperkalemia risk.
  • Cyclosporine, Tacrolimus: Increased risk of hyperkalemia.
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Moderate Interactions

  • Digoxin: Hypokalemia can potentiate digoxin toxicity; hyperkalemia can reduce digoxin effects. Close monitoring of potassium levels is crucial.
  • Beta-blockers (non-selective): May impair cellular uptake of potassium, potentially increasing serum potassium.
  • Heparin: Can cause hypoaldosteronism, leading to hyperkalemia.
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Minor Interactions

  • Laxatives (chronic use): May increase potassium loss, potentially counteracting potassium supplementation.

Monitoring

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Baseline Monitoring

Serum Potassium

Rationale: To establish baseline level and guide initial dosing.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess kidney's ability to excrete potassium, as impaired renal function significantly increases hyperkalemia risk.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: To assess for cardiac manifestations of severe hypokalemia or pre-existing cardiac conditions.

Timing: Prior to initiation, especially in patients with cardiac disease or severe hypokalemia.

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Routine Monitoring

Serum Potassium

Frequency: Daily to weekly initially, then periodically (e.g., monthly to quarterly) once stable, or more frequently if dose changes, renal function changes, or interacting drugs are added.

Target: 3.5-5.0 mEq/L

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

Renal Function (BUN, Serum Creatinine)

Frequency: Periodically (e.g., every 3-6 months) or more frequently if renal function is unstable or interacting drugs are used.

Target: Normal limits for age/sex

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

Electrocardiogram (ECG)

Frequency: As clinically indicated, especially if potassium levels are outside target range or symptoms of hyper/hypokalemia develop.

Target: Normal sinus rhythm, no signs of hyperkalemia (peaked T waves, prolonged PR, widened QRS, absent P waves) or hypokalemia (U waves, flattened T waves, prolonged QT).

Action Threshold: Any ECG changes suggestive of hyperkalemia (urgent intervention).

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Symptom Monitoring

  • Muscle weakness
  • Fatigue
  • Muscle cramps
  • Paresthesias (tingling or numbness)
  • Palpitations or irregular heartbeat
  • Nausea
  • Vomiting
  • Abdominal discomfort
  • Diarrhea
  • Confusion
  • Dizziness

Special Patient Groups

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Pregnancy

Potassium chloride is Pregnancy Category C. While potassium is an essential electrolyte, high doses or uncontrolled levels can be harmful. Use only if clearly needed and the benefit outweighs the potential risk to the fetus. Close monitoring of maternal potassium levels is essential.

Trimester-Specific Risks:

First Trimester: No specific data suggesting increased risk of congenital anomalies, but caution advised.
Second Trimester: Generally considered safe if maternal potassium levels are monitored and maintained within normal range.
Third Trimester: Generally considered safe if maternal potassium levels are monitored and maintained within normal range. Risk of hyperkalemia in mother could affect fetus.
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Lactation

Potassium is a normal component of breast milk. Oral potassium chloride supplementation is generally considered compatible with breastfeeding when used at therapeutic doses, as it is unlikely to cause adverse effects in a breastfed infant. Monitor infant for any unusual symptoms.

Infant Risk: Low risk at therapeutic doses.
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Pediatric Use

Dosing is weight-based and requires careful calculation. Children, especially infants, are more susceptible to hyperkalemia due to immature renal function. Close monitoring of serum potassium and renal function is crucial.

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Geriatric Use

Elderly patients are at increased risk of hyperkalemia due to age-related decline in renal function and potential concomitant use of medications that increase potassium (e.g., ACE inhibitors, ARBs, potassium-sparing diuretics). Lower starting doses and more frequent monitoring of serum potassium and renal function are recommended.

Clinical Information

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Clinical Pearls

  • Always take oral potassium chloride with food or immediately after a meal to minimize gastrointestinal irritation and potential ulceration.
  • Extended-release tablets must be swallowed whole; crushing or chewing can lead to a rapid release of potassium, causing hyperkalemia and/or severe GI irritation.
  • Regular monitoring of serum potassium levels and renal function (BUN, creatinine) is critical, especially when initiating therapy, adjusting dose, or in patients with renal impairment or those on interacting medications.
  • Educate patients on symptoms of both hypokalemia (if not fully corrected) and hyperkalemia, and when to seek medical attention.
  • Avoid concomitant use with potassium-sparing diuretics, ACE inhibitors, or ARBs unless absolutely necessary and with extremely close monitoring due to high risk of hyperkalemia.
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Alternative Therapies

  • Dietary potassium intake (e.g., bananas, oranges, potatoes, leafy greens)
  • Potassium gluconate (less potassium per dose, often used for milder deficiencies)
  • Potassium bicarbonate (if metabolic acidosis is also present)
  • Intravenous potassium chloride (for severe or symptomatic hypokalemia, or when oral intake is not possible)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (8mEq)
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'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.