Potassium Chloride ER 8meq Tablets

Manufacturer UPSHER-SMITH 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; Mineral supplement
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Pharmacologic Class
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 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 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 difficulty swallowing, consult your doctor for guidance.
Some formulations may 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, follow these steps:
+ Mix the 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; 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 them 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. You may also have access to local drug take-back programs.

Missing a Dose

If you miss a dose, follow these steps:

Take the missed dose as soon as you remember.
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 a missed dose.
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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.
  • Do not use salt substitutes or low-sodium foods that contain potassium unless directed by your doctor, as this can lead to dangerously high potassium levels.
  • Report any signs of high potassium (e.g., muscle weakness, slow heart rate, tingling) or severe stomach upset immediately to your doctor.
  • Regular blood tests will be needed to check your potassium levels.

Dosing & Administration

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Adult Dosing

Standard Dose: 20-40 mEq/day in 1-2 divided doses for prevention; 40-100 mEq/day in 2-5 divided doses for treatment of mild-moderate hypokalemia.
Dose Range: 20 - 100 mg

Condition-Specific Dosing:

prevention_hypokalemia: 20-40 mEq/day in 1-2 divided doses
mild_moderate_hypokalemia: 40-100 mEq/day in 2-5 divided doses
severe_hypokalemia: Higher doses may be required, but typically managed with IV potassium initially. Oral therapy is for maintenance or less severe cases.
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Pediatric Dosing

Neonatal: Not established for oral ER tablets; typically managed with IV or liquid formulations if needed.
Infant: Not established for oral ER tablets; typically managed with IV or liquid formulations if needed. Dosing is weight-based (e.g., 2-4 mEq/kg/day in divided doses).
Child: Not established for oral ER tablets; typically managed with IV or liquid formulations if needed. Dosing is weight-based (e.g., 2-4 mEq/kg/day in divided doses, max 100 mEq/day).
Adolescent: Similar to adult dosing, but individualize based on weight and potassium levels. Max 100 mEq/day.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum potassium and renal function closely.
Moderate: Reduce dose significantly or avoid; monitor serum potassium and renal function very closely. Risk of hyperkalemia is increased.
Severe: Contraindicated due to high risk of life-threatening hyperkalemia.
Dialysis: Generally contraindicated unless specifically indicated by nephrologist for documented hypokalemia, with very close monitoring.

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor renal function as hepatic impairment can indirectly affect renal clearance.
Moderate: No specific adjustment needed, but monitor renal function as hepatic impairment can indirectly affect renal clearance.
Severe: No specific adjustment needed, but monitor renal function as hepatic impairment can indirectly affect renal clearance.

Pharmacology

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Mechanism of Action

Potassium is the major intracellular cation and is essential for the maintenance of acid-base balance, isotonicity, and electrodynamic characteristics of the cell. It is involved in many enzymatic reactions and plays a vital role in the physiological processes of nerve impulse transmission, contraction of cardiac, skeletal, and smooth muscle, and maintenance of normal renal function. Potassium chloride supplements replace potassium deficits in the body.
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Pharmacokinetics

Absorption:

Bioavailability: Nearly 100% (for potassium ion)
Tmax: Approximately 1-2 hours for immediate release; extended-release formulations have a prolonged Tmax, typically 4-6 hours.
FoodEffect: Food may slow absorption but generally does not significantly reduce the extent of absorption. Taking with food or after meals is recommended to minimize GI irritation.

Distribution:

Vd: Approximately 0.5 L/kg (reflects total body water)
ProteinBinding: Not protein bound
CnssPenetration: Limited (primarily extracellular, but essential for neuronal function)

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, regulated by aldosterone.
ExcretionRoute: Renal (approximately 90%), fecal (approximately 10%), sweat (small amounts).
Unchanged: 100% (as potassium ion)
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Pharmacodynamics

OnsetOfAction: Hours to days (for correction of deficiency)
PeakEffect: Days (for stable potassium levels)
DurationOfAction: Dependent on continued intake and renal function; effects are sustained with regular dosing.

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, indicating that 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:

  • Unusual tiredness or weakness
  • Numbness or tingling in hands or feet
  • Slow, fast, or irregular heartbeat
  • Muscle cramps or pain
  • Severe nausea or vomiting
  • Black, tarry, or bloody stools (sign of GI bleeding)
  • Severe abdominal pain or bloating
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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 block 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 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 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, it is crucial to adhere to the prescribed dosage and not exceed the amount recommended by your doctor. 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 taking this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Hyperkalemia (high potassium levels)
  • Paresthesias (tingling or numbness) of the extremities
  • Muscle weakness or paralysis
  • Lethargy
  • Confusion
  • Hypotension (low blood pressure)
  • Cardiac arrhythmias (e.g., bradycardia, heart block, ventricular fibrillation, asystole)
  • ECG changes (peaked T waves, widened QRS complex, prolonged PR interval, absent P waves)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment involves discontinuing potassium, administering calcium gluconate (for cardiac stability), insulin and glucose (to shift potassium intracellularly), sodium bicarbonate, and/or diuretics. Hemodialysis may be necessary in severe cases, especially with renal failure.

Drug Interactions

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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride): Increased risk of severe hyperkalemia.
  • ACE inhibitors (e.g., lisinopril, enalapril): Increased risk of hyperkalemia.
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan): Increased risk of hyperkalemia.
  • Aldosterone antagonists (e.g., eplerenone): Increased risk of hyperkalemia.
  • Non-steroidal anti-inflammatory drugs (NSAIDs): May impair renal potassium excretion, increasing hyperkalemia risk, especially in patients with renal impairment.
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Moderate Interactions

  • Cyclosporine, tacrolimus: May increase potassium levels.
  • Heparin: May cause hyperkalemia by inhibiting aldosterone secretion.
  • Digoxin: Hyperkalemia can worsen digoxin toxicity; hypokalemia can precipitate digoxin toxicity. Careful monitoring is required.
  • Salt substitutes (containing potassium chloride): Additive potassium intake, increasing hyperkalemia risk.

Monitoring

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Baseline Monitoring

Serum Potassium (K+)

Rationale: To establish baseline level and determine the severity of hypokalemia.

Timing: Prior to initiation of therapy.

Renal Function (BUN, 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 hypokalemia (e.g., U waves, flattened T waves) or hyperkalemia (e.g., peaked T waves, widened QRS) if potassium levels are significantly abnormal.

Timing: Prior to initiation, especially if severe hypokalemia or underlying cardiac disease.

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Routine Monitoring

Serum Potassium (K+)

Frequency: Daily initially for severe hypokalemia, then weekly to monthly depending on stability and underlying condition. More frequently if dose 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/discontinuation); Above 5.5 mEq/L (urgent intervention for hyperkalemia).

Renal Function (BUN, Creatinine)

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

Target: Within normal limits for age/sex

Action Threshold: Significant decline in GFR or increase in creatinine (re-evaluate potassium dosing).

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 hyper/hypokalemia

Action Threshold: Peaked T waves, widened QRS, PR prolongation (hyperkalemia); U waves, flattened T waves, ST depression (hypokalemia).

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Symptom Monitoring

  • Muscle weakness
  • Fatigue
  • Paresthesias (tingling or numbness)
  • Bradycardia (slow heart rate)
  • Arrhythmias (irregular heart beat)
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal discomfort
  • Confusion
  • Lethargy

Special Patient Groups

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Pregnancy

Potassium chloride is generally considered safe for use during pregnancy when indicated to treat or prevent hypokalemia. Potassium is an essential electrolyte, and maintaining normal levels is important for maternal and fetal health. However, use should be carefully monitored to avoid hyperkalemia.

Trimester-Specific Risks:

First Trimester: No known specific risks beyond general electrolyte balance.
Second Trimester: No known specific risks beyond general electrolyte balance.
Third Trimester: No known specific risks beyond general electrolyte balance.
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Lactation

Potassium is a normal component of breast milk and is essential for infant growth and development. Supplemental potassium chloride is generally considered safe for use during breastfeeding when indicated, as it is unlikely to cause adverse effects in the breastfed infant at therapeutic doses. Monitor infant for any unusual symptoms.

Infant Risk: Low risk (L1)
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Pediatric Use

Dosing must be carefully calculated based on weight and serum potassium levels. Extended-release tablets may pose a choking hazard for young children and are generally not recommended for infants or very young children; liquid formulations are preferred. Close monitoring of potassium levels is crucial due to smaller body mass and potential for rapid changes.

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Geriatric Use

Elderly patients are at increased risk for renal impairment, which can significantly reduce potassium excretion and increase the risk of hyperkalemia. Close monitoring of serum potassium and renal function is essential. Start with lower doses and titrate carefully.

Clinical Information

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Clinical Pearls

  • Always take potassium chloride ER tablets with a full glass of water and with or immediately after meals to minimize gastrointestinal irritation and ulceration.
  • Do not crush, chew, or suck on extended-release tablets, as this can lead to a sudden release of potassium, causing esophageal or gastric irritation/ulceration and potentially hyperkalemia.
  • Patients should be advised to avoid salt substitutes containing potassium while on potassium chloride therapy, unless specifically instructed by a healthcare provider.
  • Regular monitoring of serum potassium and renal function is critical, especially in patients with renal impairment, those on interacting medications (e.g., ACEIs, ARBs, potassium-sparing diuretics), or the elderly.
  • Symptoms of hyperkalemia (e.g., muscle weakness, tingling, slow heart rate) should be immediately reported to a healthcare provider.
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Alternative Therapies

  • Potassium chloride liquid solution
  • Potassium gluconate (oral solution or tablet)
  • Potassium bicarbonate (effervescent tablets)
  • Dietary potassium intake (e.g., bananas, oranges, potatoes, leafy greens)
  • Intravenous potassium chloride (for severe or acute hypokalemia)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (8 mEq)
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 is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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.