0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal] Injection/Solution for

What is 0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal]

0.45% w/v Sodium Chloride Injection, USP [Medisal] is a sterile, nonpyrogenic solution of sodium chloride (common salt) in water for injection. It is commonly used for intravenous administration to restore or maintain fluid and electrolyte balance in the body. This solution is often referred to as "half-normal saline" due to its sodium chloride concentration being half of the physiological saline (0.9%).

• Form: Infusion/Solution for intravenous use.
• Volume: 500ml Polypropylene Bottle, minimizing contamination risk.
• Generic Name: Sodium Chloride.
• Concentration: 0.45% weight/volume (w/v), which equals 4.5g of sodium chloride per liter.

This formulation is particularly beneficial for patients requiring a hypotonic solution, such as those with hypernatremia, mild dehydration, or needing a maintenance fluid therapy. It may be used as a vehicle for drug delivery or as part of parenteral nutrition plans. It’s also utilized in pediatric fluid management or as a diluent for intravenous medications.

Medisal's version ensures pharmaceutical-grade quality, manufactured under strict USP standards. The solution is free from antimicrobial agents and should not be used for multiple dose injections. It is especially suitable in clinical settings such as surgery, emergency care, and post-operative management.

Due to its hypotonic nature, caution is necessary when administering to avoid cellular overhydration or dilutional hyponatremia. Therefore, its use should be guided by a healthcare provider’s assessment based on individual patient needs and ongoing monitoring of electrolyte levels.

How to use 0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal]

0.45% Sodium Chloride Injection, USP [Medisal] is intended for intravenous administration under the supervision of qualified medical professionals. This solution is typically infused directly into the bloodstream through a sterile IV line, either alone or in combination with medications or other nutrients.

• Administration Route: Intravenous infusion (IV drip).
• Preparation: Ensure the solution is clear and the container is undamaged before use.
• Compatibility: Can be used as a diluent for IV drugs; consult compatibility data before mixing.

Before administration:

• Inspect the bottle for particulate matter or discoloration. Do not use if solution appears cloudy or if the seal is broken.
• Connect to IV tubing using aseptic technique.
• Adjust the flow rate as prescribed by the healthcare provider.

Use Cases:

• Maintenance hydration in patients who are unable to drink fluids.
• Treatment of mild dehydration or hypernatremia (high sodium levels).
• Post-operative fluid therapy.
• As a carrier fluid for other IV medications.

Always monitor the patient during administration for any signs of fluid overload, electrolyte imbalances, or adverse reactions. Dosing and infusion rate depend on the patient’s age, weight, renal function, and clinical condition. It is not suitable for intramuscular or subcutaneous injection.

Discard any unused portion. This product is for single-use only and should not be reused or stored once opened to prevent contamination or microbial growth.

Mode of Action 0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal]

0.45% Sodium Chloride Injection, USP [Medisal] functions primarily as an electrolyte replenisher and fluid replacement agent. Its mechanism of action is centered around restoring extracellular fluid balance and correcting sodium and chloride deficiencies in the body. Being a hypotonic solution, it distributes differently in the body's fluid compartments compared to normal saline.

• Sodium (Na+): Essential for maintaining fluid balance, nerve impulse transmission, and muscle contraction.
• Chloride (Cl-): Helps maintain acid-base balance and osmotic pressure in extracellular fluids.

Upon infusion, sodium chloride dissociates into free sodium and chloride ions:

• Sodium ions enter extracellular fluid spaces, promoting osmotic balance and supporting cardiovascular and neuromuscular function.
• Chloride ions help maintain electrical neutrality and participate in gastric acid formation.

As a hypotonic solution (154 mOsm/L), it allows some water to enter cells, which is useful in certain clinical scenarios such as:

• Correcting hypertonic dehydration.
• Gradual rehydration of cells after osmotic fluid loss.
• Providing basal fluid requirements in children and adults.

Unlike isotonic saline, 0.45% Sodium Chloride penetrates intracellular compartments more readily, making it less suitable for rapid plasma volume expansion. Therefore, its use should be tailored to patients with intact kidney function and under electrolyte monitoring.

0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal] Interactions 0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal]

While 0.45% Sodium Chloride Injection [Medisal] is generally considered inert, certain interactions can occur, especially when used with other intravenous medications or in patients with specific clinical conditions. Interactions may influence fluid-electrolyte balance, drug compatibility, or increase the risk of adverse effects.

• Drug Compatibility:
  • Before mixing with IV medications, consult compatibility charts. Incompatible drugs may cause precipitation or degradation.
  • Do not mix with amphotericin B, ciprofloxacin, or some cephalosporins without confirmation of compatibility.
• Renal-Affecting Agents:
  • Drugs like NSAIDs, ACE inhibitors, or diuretics can affect renal sodium excretion, increasing the risk of hypernatremia or fluid retention.
• Corticosteroids:
  • Concurrent use may enhance sodium retention and potassium loss, potentially aggravating electrolyte imbalance.
• In patients with heart failure:
  • Co-administration with sodium-retaining drugs may lead to fluid overload and pulmonary edema.

Always inform the healthcare provider about all medications being taken before administering this solution. Clinical monitoring of serum electrolytes and fluid status is essential when used concurrently with medications that affect kidney function or fluid balance.

Dosage of 0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal]

The dosage of 0.45% Sodium Chloride Injection, USP [Medisal] must be individualized based on the patient's clinical condition, age, weight, electrolyte levels, and fluid needs. It should only be administered under the supervision of healthcare professionals.

• Adults:
  • Typical infusion rate: 50–100 mL/hour, adjusted based on hydration status and electrolyte requirements.
  • Daily volume: 1,000–2,500 mL depending on fluid losses and maintenance needs.
• Children:
  • Dosing based on body weight and age: typically 20–100 mL/kg/day.
  • Close monitoring is required to avoid overhydration.
• Elderly:
  • Use with caution due to potential for decreased renal function.

Key Considerations:

• Adjust infusion rates in cases of renal impairment or heart failure.
• Monitor serum electrolytes during prolonged use.
• Do not exceed 2–3 liters/day unless indicated by a physician.
• Use infusion pumps when accurate dosing is critical (e.g., pediatrics or ICU).

This solution is not intended for bolus administration. The rate of administration should avoid fluid overload and electrolyte shifts, especially in patients with compromised regulatory mechanisms.

Possible side effects of 0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal]

Although 0.45% Sodium Chloride Injection [Medisal] is generally well tolerated when used appropriately, it can occasionally cause adverse reactions, particularly if infused in large volumes, used in susceptible individuals, or administered too rapidly.

• Common Side Effects:
  • Injection site irritation or inflammation (phlebitis).
  • Mild swelling or redness at the IV site.
  • Chills or mild fever during infusion.
• Fluid and Electrolyte Imbalances:
  • Hyponatremia: Due to its hypotonic nature, excessive use may dilute sodium levels in the blood, leading to confusion, headache, nausea, seizures, or even coma in severe cases.
  • Hypervolemia (fluid overload): Signs include shortness of breath, peripheral edema, increased blood pressure, and pulmonary congestion.
• Severe Reactions (Rare):
  • Electrolyte disturbances such as hypokalemia or hyperchloremic acidosis.
  • Heart rhythm disturbances in patients with underlying cardiac disease.
  • Seizures or cerebral edema if large volumes are infused too quickly in children.

Monitoring Parameters:

• Serum sodium and chloride levels.
• Fluid input/output, weight changes.
• Signs of pulmonary or peripheral edema.

Prompt recognition and management of these side effects are essential. Healthcare providers may adjust the infusion rate or switch to another IV fluid based on clinical response and laboratory findings. Patients with renal, cardiac, or hepatic impairments are at greater risk for complications and should be monitored closely during treatment.

0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal] Contraindications 0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal]

0.45% Sodium Chloride Injection, USP [Medisal] should not be used in certain medical conditions where the administration of free water or sodium could exacerbate the patient’s condition. Recognizing these contraindications is vital to avoid complications.

• Absolute Contraindications:
  • Water intoxication or hyponatremia: Hypotonic fluids may further lower sodium levels, causing severe neurological symptoms.
  • Cellular edema or intracranial pressure: May worsen cerebral edema, particularly in head trauma or post-operative neurosurgical patients.
  • Known hypersensitivity: Though rare, any documented allergy to sodium chloride or formulation excipients would preclude use.
• Relative Contraindications (Use with Caution):
  • Heart failure or pulmonary edema: May aggravate fluid overload and respiratory compromise.
  • Severe renal impairment or anuria: Inability to excrete sodium and water could lead to volume overload or electrolyte imbalance.
  • Liver cirrhosis with ascites: Risk of further sodium and fluid retention.

Special Populations:

• Pediatric patients: Risk of overhydration and seizures due to immature renal function.
• Geriatric patients: Monitor closely for signs of sodium imbalance and volume overload.

Before administering 0.45% Sodium Chloride Injection, a thorough medical history and assessment of fluid/electrolyte status are essential. When contraindicated, alternative fluids such as isotonic saline or electrolyte-balanced solutions may be recommended based on patient-specific needs.

Storage of 0.45% w/v SODIUM CHLORIDE INJECTION, USP [Medisal]

Proper storage of 0.45% Sodium Chloride Injection, USP [Medisal] is essential to maintain its sterility, stability, and safety for intravenous use. As a sterile, single-use solution, it must be handled and stored according to pharmaceutical standards to prevent contamination or degradation.

• Storage Temperature: Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C.
• Light Sensitivity: Protect from prolonged exposure to direct light. While the polypropylene bottle offers some protection, storing in a shaded area is preferred.
• Do Not Freeze: Freezing may compromise the integrity of the plastic container and the solution's sterility.

Handling and Inspection:

• Inspect visually for particulate matter and discoloration before use.
• Do not use if the container is leaking, discolored, or shows visible particles.
• Do not reconnect partially used containers to avoid contamination.

Post-Opening Use:

• This solution is for single-use only. Discard any unused portion immediately after use.
• Do not store partially used containers or reuse for future doses.

Ensure that storage areas are clean, dry, and compliant with hospital or pharmacy regulations. Medical staff should regularly check inventory for expiration dates and packaging integrity. Expired or compromised units should be discarded according to medical waste protocols.

By adhering to these storage guidelines, the efficacy and safety of Medisal’s 0.45% Sodium Chloride Injection can be reliably maintained until the point of use.