0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P. Infusion/Solution for

What is 0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P.

0.45% w/v Sodium Chloride Intravenous Infusion B.P. is a sterile, non-pyrogenic solution of sodium chloride in water, specifically designed for intravenous (IV) administration. Commonly referred to as “half-normal saline,” this infusion contains 4.5 grams of sodium chloride per liter, equating to 0.45% concentration. It is supplied in a 2000ml plastic bag and is part of the standard care protocols in hospitals for managing fluid and electrolyte imbalances.

This hypotonic solution is typically used in clinical settings to provide:

• Hydration to patients who cannot drink fluids orally
• Treatment of hypernatremia (high sodium levels in blood)
• Temporary replacement of fluid losses from conditions like vomiting, diarrhea, or excessive sweating
• As a vehicle for the administration of other intravenous medications

Unlike the isotonic 0.9% sodium chloride solution, the 0.45% concentration offers a lower sodium load, making it more suitable for maintenance therapy when minimal sodium replacement is needed. It helps maintain proper hydration and assists in restoring the balance of bodily fluids, especially in individuals with compromised fluid homeostasis. Because of its hypotonic nature, it enters the body's cells more readily than isotonic solutions, promoting intracellular hydration.

This product is manufactured under strict BP (British Pharmacopoeia) standards, ensuring it is free of contaminants and suitable for IV administration under professional supervision.

How to use 0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P.

0.45% Sodium Chloride Intravenous Infusion B.P. should only be administered by qualified healthcare professionals in a clinical setting. It is typically infused into a vein using sterile IV equipment, and the procedure should follow standard aseptic techniques to prevent infections or complications.

• Route of Administration: Intravenous (IV) infusion only.
• Preparation: Ensure the solution is clear, colorless, and free of particles. Inspect the plastic bag for leaks before use.
• Connection: Use a sterile IV set and connect the solution to the patient’s venous line, adjusting the drip rate based on medical advice.
• Dosage Rate: Determined by the patient’s clinical condition, age, weight, and ongoing losses. For adults, it typically ranges from 500ml to 2000ml per 24 hours, depending on hydration needs.
• Monitoring: Continuous assessment of fluid balance, electrolyte levels, and vital signs is essential to avoid complications such as hyponatremia or fluid overload.

This infusion may also serve as a vehicle for diluting or administering other IV medications. When used for drug dilution, compatibility should be checked, and the solution must be administered immediately after mixing under medical supervision.

Patients with heart failure, renal impairment, or hepatic dysfunction must be monitored closely, as their fluid handling capability may be reduced. Infusion should be stopped or modified in case of any signs of intolerance, such as pulmonary edema, dyspnea, or swelling.

Mode of Action 0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P.

The therapeutic effect of 0.45% Sodium Chloride Intravenous Infusion lies in its ability to rehydrate cells and restore electrolyte balance. It acts by replenishing water and sodium in the body, thereby correcting fluid and electrolyte disturbances.

• Hypotonicity: As a hypotonic solution, it contains fewer solutes (sodium and chloride) compared to blood plasma, which allows water to move from the extracellular space into the intracellular space via osmosis, hydrating dehydrated cells.
• Sodium Replacement: Sodium ions play a crucial role in neuromuscular function, acid-base balance, and maintaining osmotic pressure. This solution gently increases extracellular sodium levels without causing sodium overload.
• Chloride Balance: Chloride ions help maintain electrolyte neutrality and contribute to the body’s acid-base regulation through their role in buffering systems and gastric secretion.
• Plasma Volume Expansion: Although less effective than isotonic fluids for expanding extracellular volume, 0.45% saline still contributes to plasma volume increase in hypovolemic states.

By correcting mild hypernatremia or cellular dehydration, this solution helps maintain hemodynamic stability, kidney perfusion, and overall metabolic function. When used appropriately, it supports the body's hydration status while minimizing the risk of volume overload or sodium excess.

Its mode of action makes it particularly suitable for patients requiring long-term fluid replacement or those with conditions sensitive to high sodium loads, such as heart failure or renal insufficiency.

0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P. Interactions 0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P.

Though sodium chloride infusion is relatively straightforward in composition, it can still interact with other drugs, fluids, or physiological conditions. The risk of interactions increases when combined with medications affecting fluid balance, electrolyte levels, or renal function.

• Diuretics: Concurrent use with loop or thiazide diuretics may increase the risk of electrolyte imbalances, including hyponatremia or hypokalemia.
• Corticosteroids and Mineralocorticoids: These drugs promote sodium and water retention, which may compound fluid overload when combined with sodium chloride infusions.
• Potassium-Sparing Diuretics: These may lead to hyperkalemia, particularly if other electrolyte-containing solutions are used alongside sodium chloride infusion.
• Renin-Angiotensin-Aldosterone System (RAAS) Inhibitors: ACE inhibitors, ARBs, or renin inhibitors can impair renal sodium excretion, potentially worsening fluid overload.
• Antihypertensives: Rapid fluid volume shifts may alter blood pressure control in patients on antihypertensive medications.

When 0.45% sodium chloride is used as a diluent for intravenous drugs, always ensure compatibility. Incompatible drug combinations may result in precipitation, reduced efficacy, or toxic by-products. A healthcare professional should consult compatibility charts or manufacturer guidelines before mixing medications with this solution.

Finally, avoid combining this solution with hypertonic infusions or blood products unless under direct medical instruction, as it may cause red cell hemolysis or interfere with therapeutic goals.

Dosage of 0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P.

Dosage of 0.45% Sodium Chloride Intravenous Infusion varies significantly depending on patient-specific factors such as age, body weight, underlying medical conditions, and the degree of fluid or electrolyte imbalance.

• Adult Dosage: Typically 500ml to 2000ml over 24 hours. In cases of mild dehydration or maintenance fluid therapy, infusion rates are adjusted based on daily fluid requirements and ongoing losses.
• Paediatric Dosage: Individualized by weight and fluid requirement, commonly calculated at 100 ml/kg/day for the first 10 kg, 50 ml/kg/day for the next 10 kg, and 20 ml/kg/day thereafter.
• Geriatric Consideration: Lower infusion volumes are advised due to the higher risk of fluid overload in older patients. Monitoring of cardiac and renal function is critical.
• Renal or Hepatic Impairment: Use with caution and typically at reduced volumes or slower rates to avoid complications like edema or electrolyte imbalance.

Infusion should be administered slowly to avoid circulatory overload. In emergency settings, more rapid administration may be warranted, but only with careful monitoring. Regular laboratory assessments including serum sodium, chloride, and fluid balance should guide therapy adjustments.

When used as a drug vehicle, the final volume and concentration depend on the medication’s dilution requirements. Always follow manufacturer and institutional guidelines.

Possible side effects of 0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P.

Although 0.45% Sodium Chloride IV infusion is generally well tolerated, especially under medical supervision, it may cause adverse effects in certain situations. Reactions typically occur with excessive use, rapid infusion, or in patients with comorbidities.

• Common Side Effects:
  • Local reactions at the injection site, including redness, pain, or phlebitis
  • Mild swelling or irritation at the infusion site
• Serious Adverse Effects:
  • Fluid overload, especially in patients with heart or kidney failure
  • Hyponatremia leading to confusion, seizures, or coma
  • Pulmonary edema, particularly if administered too quickly
  • Electrolyte imbalances such as hyperchloremia or acidosis
• Allergic Reactions (rare):
  • Rash, itching, or anaphylactic-like symptoms

Any signs of discomfort, abnormal fluid retention, shortness of breath, or neurological symptoms should prompt immediate cessation of the infusion and medical review.

0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P. Contraindications 0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P.

This product is contraindicated in certain clinical scenarios where hypotonic fluids may worsen the condition or lead to complications.

• Hyponatremia: Administering 0.45% saline in individuals with low sodium levels can exacerbate electrolyte disturbances and neurological symptoms.
• Fluid Overload States: Patients with congestive heart failure, pulmonary edema, or renal failure should avoid this infusion unless absolutely necessary and under close monitoring.
• Uncontrolled Diabetes Mellitus: May alter fluid balance and contribute to electrolyte shifts, especially if glucose levels are poorly managed.
• Severe Liver Disease: May impair electrolyte handling and increase the risk of fluid retention and ascites.
• Postoperative Patients with SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion): Risk of water intoxication and worsening hyponatremia is higher.

Careful consideration is necessary before use in these populations. Alternative isotonic solutions like 0.9% sodium chloride may be more appropriate depending on the clinical context.

Storage of 0.45% w/v SODIUM CHLORIDE INTRAVENOUS INFUSION B.P.

Proper storage of 0.45% Sodium Chloride IV Infusion ensures its safety, potency, and sterility until administration.

• Temperature: Store between 15°C and 25°C. Avoid freezing.
• Light Sensitivity: Protect from direct sunlight and prolonged exposure to fluorescent lighting.
• Packaging: Keep the product in its original plastic infusion bag until use. Do not use if the bag is damaged or if the solution is discolored or contains visible particulates.
• Shelf Life: Check the manufacturer's expiry date. Do not use beyond the printed expiry date.
• Post-Opening: Use immediately after opening. Do not store partially used bags or attempt to reseal.

For institutional storage, maintain aseptic conditions and ensure stock rotation to use the oldest batch first (FIFO: First In, First Out). Discard any unused solution after administration to avoid microbial contamination risks.