Pot Chloride 8meq CR Capsules

Manufacturer ACTAVIS PHARMA Active Ingredient Potassium Chloride Extended- Release Capsules(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 medicine used to replace potassium in your body. Potassium is a very important mineral that helps your heart, muscles, and nerves work properly. This extended-release capsule is designed to release the medicine slowly over time to reduce stomach upset.
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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 medication whole; do not chew, break, or crush it.
Do not suck on the medication.
If you have difficulty swallowing, consult your doctor for guidance.

If you have trouble swallowing capsules, you can sprinkle the contents on a small amount of soft food, such as applesauce. Be sure to:
Not chew the food and medication mixture.
Swallow the mixture immediately.
Follow with a glass of water or juice.
Not mix the medication with hot food.
Take your dose right away after mixing; do not store the mixture for later use.

Storing and Disposing of Your Medication

To keep your medication effective and safe:

Store it at room temperature, away from light.
Keep it in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom.
Keep all medications in a secure 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 pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

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 is 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 medicine with food or immediately after a meal to reduce stomach upset.
  • Swallow the capsule whole; do not crush, chew, or suck on it, as this can cause irritation or a sudden release of potassium.
  • Do not use salt substitutes unless directed by your doctor, as many contain potassium and can lead to too much potassium in your body.
  • Report any signs of stomach pain, black/tarry stools, or vomiting blood immediately.
  • Avoid excessive intake of potassium-rich foods (e.g., bananas, oranges, potatoes, leafy greens) unless advised by your doctor, especially if you have kidney problems.

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 hypokalemia.
Dose Range: 20 - 100 mg

Condition-Specific Dosing:

hypokalemia_prevention: 20 mEq/day
mild_hypokalemia: 40-80 mEq/day
moderate_to_severe_hypokalemia: 80-100 mEq/day (or higher, up to 150 mEq/day in severe cases, with careful monitoring)
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Pediatric Dosing

Neonatal: Not established for extended-release capsules; use oral solution or IV.
Infant: Not established for extended-release capsules; use oral solution or IV.
Child: 0.5-1 mEq/kg/day in 1-2 divided doses for prevention; 2-4 mEq/kg/day in 2-4 divided doses for treatment (max 100 mEq/day). Extended-release capsules may not be suitable for young children due to choking risk.
Adolescent: Similar to adult dosing, individualized based on potassium levels and clinical condition.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution, monitor potassium levels closely.
Moderate: Reduce dose significantly or avoid; monitor potassium levels frequently. Risk of hyperkalemia is increased.
Severe: Contraindicated due to high risk of life-threatening hyperkalemia.
Dialysis: Generally contraindicated unless specific need and close monitoring in a controlled setting (e.g., during dialysis to prevent hypokalemia, but typically managed by dialysis fluid).

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor potassium levels.
Moderate: No specific dose adjustment required, but monitor potassium levels.
Severe: No specific dose adjustment required, but monitor potassium levels.

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, and skeletal and smooth muscle contraction. It is also a cofactor in many enzymatic reactions and plays a role in the maintenance of normal renal function, acid-base balance, and carbohydrate metabolism. Potassium chloride extended-release capsules provide a slow, sustained release of potassium ions to minimize high localized concentrations of potassium within the gastrointestinal tract, thereby reducing the risk of gastrointestinal irritation and ulceration.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90% (for potassium ions)
Tmax: Variable, typically 4-8 hours for extended-release formulations
FoodEffect: Food generally enhances absorption and reduces gastrointestinal irritation; recommended to take with meals or immediately after.

Distribution:

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

Elimination:

HalfLife: Not applicable (homeostatically regulated); plasma half-life is very short (minutes) but total body potassium turnover is slow.
Clearance: Primarily renal excretion, with minor amounts in feces and sweat.
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Gradual (hours to days for full repletion)
PeakEffect: Variable, depends on the extent of potassium deficit and ongoing losses.
DurationOfAction: Sustained release over 8-12 hours for extended-release formulations.
Confidence: Medium

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 symptoms that bother you or persist, contact your doctor:

Stomach pain or diarrhea
Upset stomach or vomiting
* Gas

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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, weakness, numbness or tingling in hands/feet, slow or irregular heartbeat, muscle cramps, confusion.
  • Signs of stomach problems: severe stomach pain, nausea, vomiting, diarrhea, black or tarry stools (may indicate 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 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
+ 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 are anticholinergics, 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. Taking more than the prescribed dose can increase the likelihood of adverse reactions.

If you follow a low-sodium diet or use a salt substitute, consult with your doctor to discuss any potential interactions. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to weigh the benefits and risks of this medication for both you and your baby.
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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, arrhythmias, cardiac arrest)
  • Confusion
  • Low blood pressure (hypotension)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. In the US, you can also call a poison control center at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Severe renal impairment (e.g., anuria, oliguria, acute renal failure)
  • Untreated Addison's disease
  • Acute dehydration
  • Extensive tissue breakdown (e.g., severe burns, rhabdomyolysis)
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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)
  • Cyclosporine
  • Tacrolimus
  • Heparin
  • Beta-blockers (non-selective)
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Moderate Interactions

  • Digoxin (potassium depletion can increase digoxin toxicity; hyperkalemia can reduce digoxin effects)
  • Insulin (can cause transient hypokalemia, requiring careful monitoring)
  • Certain laxatives (chronic use can lead to potassium loss)
  • Corticosteroids (can cause potassium loss, potentially increasing need for supplementation)
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Minor Interactions

  • Licorice (can cause hypokalemia)

Monitoring

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Baseline Monitoring

Serum Potassium (K+)

Rationale: To establish baseline potassium status and guide initial dosing.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine)

Rationale: To assess kidney function, as potassium is primarily renally excreted and impaired function increases hyperkalemia risk.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: To assess for cardiac abnormalities related to hypokalemia or baseline cardiac status, especially in patients with pre-existing heart conditions or severe hypokalemia.

Timing: Prior to initiation, especially if severe hypokalemia.

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Routine Monitoring

Serum Potassium (K+)

Frequency: Initially daily or every few days until stable, then weekly to monthly depending on clinical stability and concomitant medications.

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L (increase dose/evaluate cause), >5.0 mEq/L (decrease dose/hold/evaluate cause), >5.5 mEq/L (urgent intervention for hyperkalemia)

Renal Function (BUN, Serum Creatinine)

Frequency: Periodically, especially with dose changes, changes in clinical status, or initiation of interacting medications.

Target: 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 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) or hypokalemia (flattened T waves, U waves, ST depression).

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

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Symptom Monitoring

  • Symptoms of hyperkalemia: muscle weakness, fatigue, paresthesia (tingling/numbness), bradycardia, irregular heartbeat, confusion, flaccid paralysis.
  • Symptoms of hypokalemia: muscle weakness, cramps, fatigue, constipation, palpitations, irregular heartbeat, polyuria, polydipsia.
  • Gastrointestinal symptoms: nausea, vomiting, abdominal pain, diarrhea, black/tarry stools (sign of GI bleeding/ulceration).

Special Patient Groups

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Pregnancy

Potassium chloride is a Category C drug. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Potassium is an essential electrolyte, and severe maternal hypokalemia can be detrimental to both mother and fetus.

Trimester-Specific Risks:

First Trimester: No specific data indicating increased risk of congenital anomalies. Use only if clearly needed.
Second Trimester: No specific data indicating increased risk. Monitor maternal potassium levels.
Third Trimester: No specific data indicating increased risk. Monitor maternal potassium levels, especially if diuretics are also used.
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Lactation

Potassium is naturally present in breast milk. Supplemental potassium chloride is generally considered compatible with breastfeeding when used at therapeutic doses, as it is an essential electrolyte. Monitor the infant for any signs of electrolyte imbalance, though unlikely.

Infant Risk: Low risk for healthy, full-term infants. Monitor for signs of hyperkalemia in the infant if maternal doses are very high or infant has renal impairment.
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Pediatric Use

Dosing must be carefully individualized based on weight, serum potassium levels, and clinical condition. Extended-release capsules may pose a choking hazard or be difficult to swallow for young children; liquid formulations are often preferred. Close monitoring of potassium levels and renal function is essential.

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Geriatric Use

Elderly patients are 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). Lower initial doses and more frequent monitoring of serum potassium and renal function are recommended.

Clinical Information

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Clinical Pearls

  • Always take potassium chloride extended-release capsules with a full glass of water and with or immediately after meals to minimize gastrointestinal irritation and the risk of ulceration.
  • Do not crush, chew, or suck on extended-release capsules, as this can lead to a rapid release of potassium and increase the risk of hyperkalemia and GI side effects.
  • Regular monitoring of serum potassium levels and renal function (BUN, creatinine) is crucial, especially at the start of therapy, with dose adjustments, or in patients with renal impairment or those on interacting medications.
  • Educate patients on the symptoms of hyperkalemia (e.g., muscle weakness, fatigue, irregular heartbeat) and to seek immediate medical attention if they occur.
  • Consider alternative formulations (e.g., liquid, effervescent tablets) for patients who have difficulty swallowing capsules or are at high risk for GI irritation.
  • Avoid concomitant use of potassium-sparing diuretics, ACE inhibitors, or ARBs unless absolutely necessary and with extremely close monitoring due to the high risk of severe hyperkalemia.
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Alternative Therapies

  • Potassium chloride oral solution
  • Potassium chloride effervescent tablets
  • Potassium gluconate (less potassium per dose, often used for milder deficiencies)
  • Potassium citrate (often used for hypokalemia with metabolic acidosis or to prevent kidney stones)
  • Dietary potassium intake (for mild deficiencies or prevention)
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Cost & Coverage

Average Cost: Price range varies widely per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred 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. If you have any questions or concerns about this medication, don't 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.