KCL

 150 mg/ml Injection
Opsonin Pharma Ltd.
10 ml ampoule: ৳ 12.00 (1 x 5: ৳ 60.00)
Indications

A. Approved Medical Uses:

  • Treatment of Hypokalemia:
    • Corrects potassium deficiency due to diuretics, gastrointestinal losses (vomiting, diarrhea), diabetic ketoacidosis, or poor dietary intake.
  • Prevention of Hypokalemia:
    • In patients receiving medications known to deplete potassium (e.g., loop or thiazide diuretics).
    • In conditions such as hyperaldosteronism, prolonged corticosteroid therapy, or chronic laxative abuse.
  • Adjunct in Digitalis Toxicity:
    • Helps manage arrhythmias caused or worsened by hypokalemia in patients on digoxin.
  • Metabolic Alkalosis (associated with chloride loss):
    • Restores potassium and chloride balance, especially in patients with persistent vomiting or nasogastric suction.

B. Clinically Accepted Off-Label Uses:

  • Hypokalemic Periodic Paralysis:
    • Acute management and prophylaxis of episodes in patients with familial hypokalemic periodic paralysis.
  • Chronic Potassium Loss in Renal Tubular Disorders:
    • Used to correct chronic hypokalemia in certain kidney disorders, with close monitoring.
Dosage & Administration

Dosage must be individualized based on serum potassium levels, patient weight, and clinical condition.

A. Adults:

  • Oral Prophylaxis of Hypokalemia:
    • 20 mEq/day in 1–2 divided doses.
  • Oral Treatment of Hypokalemia:
    • 40–100 mEq/day in 2–5 divided doses.
    • Maximum single oral dose: 20 mEq to avoid gastrointestinal irritation.
  • Intravenous (for severe or symptomatic hypokalemia):
    • 10–40 mEq diluted in 0.9% sodium chloride or other compatible fluids.
    • Infusion rate:
      • Peripheral line: Max 10 mEq/hour.
      • Central line (with ECG monitoring): Max 20 mEq/hour.

B. Pediatrics:

  • Oral:
    1–2 mEq/kg/day in divided doses (max: 100 mEq/day).
  • IV:
    0.5–1 mEq/kg/dose every 4–6 hours;
    Infusion rate: Do not exceed 0.5 mEq/kg/hour. ECG and potassium monitoring are mandatory.

C. Geriatrics:

  • Start at the lower end of dosing.
  • Regularly monitor renal function and serum potassium.

D. Renal or Hepatic Impairment:

  • Renal impairment: Use with extreme caution or avoid. Increased risk of hyperkalemia.
  • Hepatic impairment: No direct adjustment, but fluid-electrolyte monitoring is necessary.

Administration Notes:

  • Oral: Administer with meals and a full glass of water. Do not chew or crush extended-release tablets.
  • IV: Must be diluted before administration. Never give undiluted or via IV push.
Mechanism of Action (MOA)

Potassium chloride restores potassium ions in the body, which are vital for maintaining normal intracellular function. It helps re-establish the resting membrane potential of neurons and muscle cells, enabling proper nerve impulse transmission, skeletal and smooth muscle contraction, and myocardial electrical activity. By correcting potassium deficits, it stabilizes cardiac rhythms and supports renal tubular function, acid-base balance, and overall cellular metabolism.

Pharmacokinetics
  • Absorption:
    Rapidly absorbed from the gastrointestinal tract when given orally.
  • Distribution:
    Over 98% of total body potassium is intracellular. Potassium is actively transported across cell membranes.
  • Metabolism:
    Not metabolized.
  • Excretion:
    Primarily excreted by the kidneys. Excretion rate is influenced by serum potassium concentration, acid-base status, and aldosterone activity.
  • Bioavailability:
    Nearly 100% for oral formulations, assuming no significant vomiting or diarrhea.
  • Onset of Action:
    Oral: Within 1–2 hours.
    IV: Immediate.
  • Half-life:
    Not applicable; physiological ion regulated by homeostatic mechanisms.
Pregnancy Category & Lactation
  • Pregnancy:
    • Former FDA Category: C
    • No known teratogenic effects. May be used when necessary, with careful monitoring of maternal serum potassium levels.
  • Lactation:
    • Potassium is a natural component of breast milk.
    • Therapeutic supplementation is considered safe for nursing infants when serum levels are monitored.
  • Caution:
    • In pregnancy-associated conditions like preeclampsia or hyperemesis, monitoring is critical.
Therapeutic Class
  • Class: Electrolyte Supplement
  • Subclass: Potassium Salt / Electrolyte Replenisher
Contraindications
  • Known hypersensitivity to potassium chloride or any component of the formulation
  • Hyperkalemia
  • Severe renal impairment (e.g., anuria, significant oliguria)
  • Untreated Addison’s disease
  • Use of potassium-sparing agents without monitoring (e.g., spironolactone, eplerenone)
  • Gastrointestinal motility disorders (for oral tablets)
Warnings & Precautions
  • Hyperkalemia:
    Risk of life-threatening arrhythmias. Monitor ECG and serum potassium frequently.
  • Renal Dysfunction:
    High risk of potassium accumulation. Use cautiously or avoid.
  • GI Irritation:
    Oral tablets can cause ulcers or strictures. Never crush extended-release formulations.
  • IV Administration Risks:
    Must be diluted properly. Rapid or undiluted infusion can cause fatal cardiac events.
  • Monitoring Required:
    Renal function, serum electrolytes, and cardiac rhythm.
  • High-Risk Groups:
    Elderly, patients with heart failure, diabetes mellitus, or on nephrotoxic/RAAS-interfering medications.
Side Effects

Common Adverse Effects:

  • Gastrointestinal:
    Nausea, vomiting, abdominal discomfort, flatulence, diarrhea
  • Local (IV use):
    Pain at injection site, phlebitis

Serious/Rare Effects:

  • Hyperkalemia:
    Symptoms include paresthesia, muscle weakness, paralysis, bradycardia, arrhythmia
  • Cardiac:
    ECG changes (e.g., peaked T waves, widened QRS, asystole)
  • Gastrointestinal:
    Ulceration, bleeding, intestinal perforation (especially with extended-release tablets)
Drug Interactions

Major Interactions:

  • ACE Inhibitors / ARBs (e.g., enalapril, losartan):
    Increased risk of hyperkalemia
  • Potassium-Sparing Diuretics (e.g., spironolactone, amiloride):
    Additive potassium retention
  • NSAIDs:
    May impair renal potassium excretion
  • Heparin:
    May cause aldosterone suppression and hyperkalemia
  • Cyclosporine / Tacrolimus:
    Increase potassium retention via nephrotoxicity or aldosterone suppression
  • Salt Substitutes (Potassium-based):
    May contribute to dangerous potassium levels

Metabolic Pathway:

  • Not metabolized by CYP450 system but affected by renal function and aldosterone regulation.
Recent Updates or Guidelines
  • FDA/ISMP Recommendations:
    • Emphasize safe IV use: always dilute, avoid IV push.
    • Highlight fatal risk of undiluted IV potassium chloride.
  • Guidelines (KDIGO, AHA):
    • Recommend tailored potassium supplementation in patients with CKD and heart failure.
  • Labeling Updates:
    • Strengthened warnings about GI complications from oral tablets and black box warnings for IV use.
Storage Conditions
  • Oral Tablets/Capsules:
    Store at 20°C to 25°C (68°F to 77°F)
    Protect from moisture and excessive heat. Keep container tightly closed.
  • Oral Liquid:
    Store at 20°C to 25°C
    Shake well before use. Avoid contamination.
  • IV Solution:
    Store at 20°C to 25°C
    Protect from light. Do not freeze. Use aseptic technique during preparation.
  • Handling Precautions:
    Do not administer undiluted IV potassium. Use infusion pump for accurate delivery.
Available Brand Names