Potassium Cl 10meq ER Capsules

Manufacturer AMNEAL PHARMACEUTICALS 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 supplement; 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. 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 medication whole; do not chew, break, or crush it.
Do not suck on the medication.
If you have trouble swallowing, consult your doctor for guidance.
If you need to, you can sprinkle the contents of the capsule onto applesauce or another soft food. However, do not chew the mixture. Swallow it immediately and follow with a glass of water or juice.
Avoid mixing the medication with hot food.
After preparing your dose, take it immediately. 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, avoiding storage in a bathroom.
Ensure all medications are kept in a safe 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 or healthcare provider.
Check with your pharmacist for the best method of disposal. Your area may have drug take-back programs available.

What to Do If You Miss a Dose

If you miss a dose of your medication:

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 continue with 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 medicine with food or immediately after a meal to reduce stomach upset.
  • Swallow extended-release capsules whole; do not crush, chew, or suck on them, as this can cause a sudden release of potassium and lead to irritation or ulceration of the esophagus/stomach.
  • Do not use salt substitutes or low-sodium foods that contain potassium unless directed by your doctor.
  • Report any signs of severe 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: Initial dose for hypokalemia: 20 mEq/day in divided doses. For severe hypokalemia: 40-100 mEq/day in divided doses.
Dose Range: 20 - 100 mg

Condition-Specific Dosing:

hypokalemia_prevention: 20 mEq/day
mild_moderate_hypokalemia: 40-80 mEq/day in 2-4 divided doses
severe_hypokalemia: Up to 100 mEq/day or more, with careful monitoring
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Pediatric Dosing

Neonatal: Not established (use IV for severe cases, consult specialist)
Infant: Not established (use IV for severe cases, consult specialist)
Child: 0.5-1 mEq/kg/day in 1-2 divided doses; Max 3 mEq/kg/day or 40 mEq/day (whichever is less) for prevention/mild hypokalemia. For treatment of hypokalemia: 2-5 mEq/kg/day in divided doses; Max 100 mEq/day.
Adolescent: Similar to adult dosing, based on weight and severity of hypokalemia.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution, monitor serum potassium closely.
Moderate: Reduce dose significantly or avoid if possible; monitor serum potassium and renal function frequently. Risk of hyperkalemia is 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 under strict medical supervision with frequent monitoring.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Potassium is the principal intracellular cation and is essential for the maintenance of acid-base balance, isotonicity, and the 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.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90% (oral)
Tmax: Approximately 4-6 hours for extended-release formulations
FoodEffect: Food may delay absorption but generally increases tolerability and reduces GI irritation. Recommended to take with food or immediately after meals.

Distribution:

Vd: Not applicable (distributed throughout total body water)
ProteinBinding: Minimal
CnssPenetration: Yes (maintains electrochemical gradients)

Elimination:

HalfLife: Not applicable (homeostatically regulated; excretion rate varies with intake and renal function)
Clearance: Primarily renal clearance, regulated by aldosterone and acid-base status.
ExcretionRoute: Urine (approximately 90%), feces (approximately 10%), sweat (small amounts).
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Hours to days for full correction of deficit, depending on severity and dose.
PeakEffect: Correction of hypokalemia is gradual.
DurationOfAction: Maintained as long as therapy continues and underlying cause is addressed.

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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, nausea, diarrhea.
  • Signs of gastrointestinal irritation/ulceration: severe stomach pain, bloating, black/tarry stools, vomiting blood, difficulty swallowing.
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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 are anticholinergics, consult your doctor.

Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. 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. 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 the likelihood of 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:

  • Severe hyperkalemia symptoms: profound muscle weakness, flaccid paralysis, paresthesias, bradycardia, hypotension, cardiac arrhythmias (e.g., peaked T waves, widened QRS, ventricular fibrillation, asystole).

What to Do:

Seek immediate emergency medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment may include IV calcium (for cardiac stability), IV insulin with glucose, sodium bicarbonate, diuretics, or dialysis.

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
  • Eplerenone (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.
  • Non-steroidal anti-inflammatory drugs (NSAIDs): May impair renal potassium excretion, increasing hyperkalemia risk.
  • Cyclosporine, Tacrolimus: May increase serum potassium.
  • Digoxin: Hyperkalemia can antagonize the effects of digoxin; hypokalemia can potentiate digoxin toxicity.
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Moderate Interactions

  • Beta-blockers (non-selective): May impair cellular uptake of potassium, leading to slight increases in serum potassium.
  • Heparin: May cause hypoaldosteronism, leading to hyperkalemia.
  • Certain laxatives (chronic use): May cause potassium depletion, requiring higher potassium supplementation.
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Minor Interactions

  • Salt substitutes (contain potassium chloride): Additive potassium intake, increasing hyperkalemia risk.
  • Foods high in potassium: Additive potassium intake.

Monitoring

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Baseline Monitoring

Serum Potassium (K+)

Rationale: To establish baseline potassium level and assess 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).

Timing: Prior to initiation, especially in severe hypokalemia or high-risk patients.

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Routine Monitoring

Serum Potassium (K+)

Frequency: Daily initially for severe hypokalemia, then 2-3 times per week, then weekly to monthly for maintenance, or as clinically indicated.

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/hold); Above 5.5 mEq/L (urgent intervention for hyperkalemia).

Renal Function (BUN, Creatinine)

Frequency: Weekly initially, then monthly or as clinically indicated, especially in patients with pre-existing renal impairment or on interacting medications.

Target: Within normal limits for patient's age/baseline.

Action Threshold: Significant increase in BUN/Creatinine may indicate worsening renal function and increased hyperkalemia risk.

Electrocardiogram (ECG)

Frequency: As clinically indicated, especially if potassium levels are rapidly changing or symptoms of hyper/hypokalemia develop.

Target: Normal cardiac rhythm and morphology.

Action Threshold: Presence of peaked T waves, widened QRS, or other signs of hyperkalemia; or U waves, flattened T waves, ST depression with hypokalemia.

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Symptom Monitoring

  • Symptoms of hyperkalemia: muscle weakness, fatigue, paresthesias (tingling/numbness), flaccid paralysis, bradycardia, irregular heartbeat, confusion.
  • Symptoms of gastrointestinal irritation/ulceration: severe abdominal pain, black/tarry stools, vomiting blood, severe nausea, diarrhea.

Special Patient Groups

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Pregnancy

Potassium chloride is generally considered safe for use during pregnancy when indicated for the treatment or prevention of hypokalemia. Potassium is an essential electrolyte, and maintaining normal levels is crucial for maternal and fetal health. Category C due to lack of adequate, well-controlled studies, but clinical experience suggests low risk when used appropriately.

Trimester-Specific Risks:

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

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

Infant Risk: Low risk (L1)
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Pediatric Use

Use with caution. Dosing must be carefully calculated based on weight and severity of hypokalemia. Risk of hyperkalemia is higher in infants and young children due to smaller body mass and potentially less mature renal function. Extended-release formulations may pose a choking hazard or be difficult to swallow for very young children.

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Geriatric Use

Elderly patients are at increased risk for 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 levels. 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 extended-release capsules with food or immediately after a meal to minimize gastrointestinal irritation and ulceration.
  • Do NOT crush, chew, or suck on extended-release capsules. They must be swallowed whole to ensure proper release and prevent a sudden surge of potassium.
  • Monitor serum potassium levels regularly, especially when initiating therapy, changing doses, or in patients with renal impairment or those on interacting medications.
  • Educate patients on symptoms of hyperkalemia (muscle weakness, fatigue, irregular heartbeat) and GI irritation (severe abdominal pain, black stools) and to seek immediate medical attention if they occur.
  • Avoid concomitant use of potassium-sparing diuretics, ACE inhibitors, ARBs, and NSAIDs unless absolutely necessary and with very close monitoring of potassium levels.
  • Consider dietary sources of potassium and advise patients to avoid excessive intake of high-potassium foods or salt substitutes unless specifically instructed by their physician.
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Alternative Therapies

  • Potassium chloride oral solution/liquid
  • Potassium chloride tablets (immediate-release or wax-matrix extended-release)
  • Potassium gluconate (oral solution/tablets)
  • Potassium bicarbonate (effervescent tablets)
  • Intravenous potassium chloride (for severe or symptomatic hypokalemia)
  • Dietary modification (for mild hypokalemia or prevention)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 capsules (10 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. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.