Sodib

 7.5% IV Infusion
Jayson Pharmaceutical Ltd.

25 ml vial: ৳ 25.08 (24's pack: ৳ 601.92)

Indications

Approved Indications:

  • Metabolic Acidosis:
    • Treatment of metabolic acidosis in conditions such as renal tubular acidosis, diabetic ketoacidosis, and severe dehydration.
  • Cardiac Arrest:
    • Management of severe acidosis during cardiopulmonary resuscitation (CPR).
  • Hyperkalemia:
    • As part of the treatment of hyperkalemia to promote intracellular shift of potassium.
  • Urinary Alkalinization:
    • To alkalinize urine in cases of drug overdose (e.g., salicylate, phenobarbital) or cystitis.
  • Peptic Ulcer Disease and Dyspepsia:
    • Occasional use as an antacid for quick symptomatic relief.
  • Hemodialysis:
    • Used in dialysate solutions to maintain appropriate acid-base balance.

Clinically Accepted Off-Label Uses:

  • Tricyclic Antidepressant (TCA) Toxicity:
    • For cardiac membrane stabilization and correction of acidosis.
  • Contrast-Induced Nephropathy:
    • In prophylactic protocols (in combination with saline and N-acetylcysteine) to reduce risk of kidney injury.
Dosage & Administration

Route of Administration:

  • Intravenous (IV) injection or infusion
  • Oral tablets or powder

Adult Dosage:

  • Metabolic Acidosis (IV):
    • Initial dose: 1 mEq/kg as IV bolus.
    • Maintenance: Adjust based on blood gas analysis and bicarbonate deficit.
  • Hyperkalemia (IV):
    • 50–100 mEq of Sodium Bicarbonate diluted in D5W over 5–10 minutes.
  • Cardiac Arrest (IV):
    • 1 mEq/kg IV bolus, repeat every 10 minutes if acidosis persists.
  • Oral Antacid:
    • 325–2000 mg orally every 4–6 hours as needed.
  • Urinary Alkalinization:
    • 48–250 mEq/day IV infusion or divided oral doses to maintain urine pH >7.

Pediatric Dosage:

  • IV Metabolic Acidosis:
    • 1 mEq/kg IV bolus; adjust based on arterial blood gas and bicarbonate deficit.

Renal Impairment:

  • Dose adjustments required; use cautiously due to risk of volume overload or alkalosis.

Hepatic Impairment:

  • No specific dosing, but monitor acid-base balance closely.

Geriatric Use:

  • Use with caution; monitor for sodium load and fluid retention.
Mechanism of Action (MOA)

Sodium Bicarbonate dissociates into sodium (Na⁺) and bicarbonate (HCO₃⁻) ions in solution. The bicarbonate ion acts as a systemic buffer, neutralizing excess hydrogen ions (H⁺) and raising blood pH in acidotic conditions. This buffering action helps restore physiological acid-base balance. In hyperkalemia, sodium bicarbonate induces a shift of potassium from extracellular to intracellular space by alkalinizing the serum, thereby temporarily lowering serum potassium levels. Additionally, alkalinization of urine assists in enhancing the elimination of weak acid drugs such as salicylates or barbiturates.

Pharmacokinetics
  • Absorption: Well absorbed orally; IV administration provides immediate systemic availability.
  • Distribution: Widely distributed in extracellular fluid; sodium and bicarbonate freely diffuse.
  • Metabolism: Not metabolized; bicarbonate reacts with hydrogen ions to form carbonic acid, which dissociates to water and carbon dioxide.
  • Elimination:
    • CO₂ is excreted via lungs.
    • Excess bicarbonate excreted renally.
  • Half-life: Short; determined by respiratory elimination of CO₂.
  • Onset of Action:
    • IV: Immediate
    • Oral: 15–60 minutes
  • Duration of Action: Up to 1–2 hours orally; variable IV depending on renal/respiratory function.
  • Bioavailability: 100% (IV); high (oral)
Pregnancy Category & Lactation
  • Pregnancy:
    • FDA Category C (old system). Use only if clearly needed; excess sodium load and alkalosis may be harmful during pregnancy.
  • Lactation:
    • Excreted in breast milk in small amounts. No known adverse effects on nursing infants. Use with caution.
Therapeutic Class
  • Primary Class: Systemic Alkalinizer
  • Subcategory: Electrolyte Replacement / Acid-Base Agent
Contraindications
  • Known hypersensitivity to sodium bicarbonate or any component of the formulation
  • Metabolic or respiratory alkalosis
  • Hypocalcemia
  • Hypochloremia
  • Excessive sodium retention or edema (e.g., congestive heart failure, cirrhosis, renal failure)
Warnings & Precautions
  • High-Risk Populations:
    • Patients with CHF, renal impairment, or hypertension—risk of fluid overload.
  • Alkalosis Risk:
    • Overcorrection can lead to metabolic alkalosis, which may cause hypokalemia, tetany, or seizures.
  • Electrolyte Imbalance:
    • Monitor serum potassium, sodium, and pH.
  • Injection Site Reactions:
    • IV administration may cause local irritation or extravasation.
  • Clinical Monitoring Required:
    • Regular blood gas analysis, serum electrolytes, and fluid status.
Side Effects

Common (Systemic):

  • Gastric distension (oral)
  • Belching (oral)
  • Hypokalemia
  • Hypernatremia
  • Volume overload

Serious:

  • Metabolic alkalosis
  • Tetany (due to hypocalcemia)
  • Seizures (in severe alkalosis)
  • Pulmonary edema (especially in CHF patients)

Local (IV use):

  • Phlebitis
  • Pain at injection site
  • Tissue necrosis with extravasation
Drug Interactions
  • Tetracyclines & Quinolones (oral):
    • Reduced absorption due to increased gastric pH.
  • Calcium or Magnesium Salts:
    • May increase risk of alkalosis or calcium/magnesium precipitation.
  • Aspirin & Salicylates:
    • Enhanced renal clearance during urinary alkalinization.
  • Potassium Supplements/Diuretics:
    • Monitor for hypokalemia due to intracellular shift.
  • CYP Enzymes:
    • No major CYP-mediated interactions reported.
Recent Updates or Guidelines
  • Guidelines for TCA Overdose Management (Toxbase, Poison Control):
    • Emphasize IV sodium bicarbonate as first-line therapy for cardiac toxicity.
  • Nephrology Guidelines (KDIGO):
    • Recommend cautious use in CKD patients with metabolic acidosis to slow progression.
Storage Conditions
  • Injection Solution:
    • Store below 25°C. Do not freeze. Protect from light. Use immediately after opening.
  • Oral Tablets or Powder:
    • Store at 20°C to 25°C (68°F to 77°F); protect from moisture and excessive heat.
  • Handling:
    • Use aseptic technique when administering IV.
    • Shake oral powder well before use if reconstituted.
Available Brand Names