0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA] Infusion/Solution for

What is 0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA]

0.45% Sodium Chloride Injection, USP [WELLPHARMA] is a sterile, non-pyrogenic intravenous solution containing sodium chloride at a concentration of 0.45% (4.5 mg/mL). This hypotonic solution is typically used for fluid and electrolyte replenishment in patients who are unable to consume adequate amounts orally. It is supplied in a 500 ml flexible infusion bag and is intended for intravenous administration under the supervision of healthcare professionals.

• Composition: Each 100 mL contains 0.45 grams of sodium chloride, providing sodium (Na⁺) 77 mEq/L and chloride (Cl⁻) 77 mEq/L.
• Form: Clear, colorless solution for infusion.
• Uses: Treatment of mild sodium depletion, maintenance of hydration, and vehicle for drug delivery.
• Category: Electrolyte replenisher and parenteral hydration solution.

This preparation is free from antimicrobial agents, making it suitable for single-use only. It is important for healthcare professionals to select the appropriate fluid therapy based on the patient's clinical condition, electrolyte status, and fluid balance requirements.

How to use 0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA]

0.45% Sodium Chloride Injection, USP is administered intravenously under the guidance of a qualified healthcare provider. The method of administration, infusion rate, and volume are tailored to the individual patient's medical needs and clinical status.

• Administration route: Intravenous infusion (IV) via a sterile IV set.
• Preparation: Check the bag for particulate matter, leaks, or discoloration prior to use. Do not administer if compromised.
• Dosage volume: Determined based on patient weight, electrolyte status, fluid deficit, and medical condition.
• Monitoring: Regular monitoring of serum electrolytes, fluid balance, and vital signs is necessary during infusion.
• Adjunct use: May be used as a diluent or carrier fluid for compatible medications; compatibility must be confirmed before mixing.

It is critical not to exceed the recommended infusion rate to avoid complications such as hyponatremia or fluid overload, especially in patients with renal impairment or heart failure.

Mode of Action 0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA]

0.45% Sodium Chloride Injection exerts its clinical effect by restoring extracellular fluid and sodium balance. As a hypotonic solution, it contains fewer solutes than plasma, allowing water to move from the extracellular space into cells, hydrating intracellular compartments.

• Sodium (Na⁺): Helps regulate extracellular fluid volume, nerve conduction, and muscle function.
• Chloride (Cl⁻): Maintains acid-base balance and osmotic pressure in the body.
• Osmotic balance: The hypotonicity of this solution promotes intracellular rehydration, useful in treating dehydration without causing hypernatremia.
• Supportive role: Used as a vehicle for IV drug administration, facilitating the delivery of medications or nutrients.

Once administered, the sodium and chloride ions disperse throughout the extracellular space, correcting electrolyte imbalances and supporting cellular functions. This solution does not supply calories or other electrolytes like potassium or magnesium.

0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA] Interactions 0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA]

Although 0.45% Sodium Chloride Injection is not pharmacologically active in the conventional sense, it may interact with certain drugs, especially when used as a diluent or in patients with underlying electrolyte disturbances.

• Drug compatibility: Some medications may precipitate or degrade in saline. Always check compatibility data before combining drugs with 0.45% NaCl.
• Diuretics: Concurrent use with diuretics may potentiate electrolyte imbalances, especially sodium loss or retention.
• Corticosteroids: These can cause sodium retention and potassium loss, requiring close monitoring when co-administered.
• Antihypertensives: Electrolyte changes induced by saline infusion can affect the efficacy of antihypertensive drugs.
• Renally-excreted medications: In patients with renal impairment, fluid overload from saline infusions may alter the pharmacokinetics of drugs eliminated via the kidneys.

Always consult the prescribing information or a pharmacist before combining this solution with any IV drug. Avoid simultaneous use with potassium-sparing diuretics unless closely monitored.

Dosage of 0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA]

The dosage of 0.45% Sodium Chloride Injection is individualized and based on age, body weight, fluid and electrolyte needs, and clinical status. It should only be administered under medical supervision.

• Adults: Typically 500 mL to 1000 mL per day or as needed to restore hydration and correct sodium deficit.
• Children: Dosage adjusted according to body weight and electrolyte needs. Pediatric usage must be guided by a pediatrician.
• Elderly: Require cautious dosing to avoid fluid overload, especially with impaired cardiac or renal function.
• Infusion rate: Usually not to exceed 100–150 mL/hour unless otherwise indicated. In emergencies, faster rates may be used.
• Maximum volume: Depends on clinical condition, but prolonged use requires monitoring for electrolyte disturbances.

Frequent laboratory testing of electrolytes, renal function, and acid-base status is essential during treatment. Dosage adjustments are made according to clinical response.

Possible side effects of 0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA]

0.45% Sodium Chloride Injection is generally well-tolerated when used appropriately, but adverse effects can occur, particularly with improper administration or prolonged use.

• Common side effects:
  • Injection site reactions (redness, pain, swelling)
  • Fluid overload, especially in patients with heart or kidney disease
• Electrolyte imbalances:
  • Hyponatremia (low sodium levels)
  • Hypochloremia or metabolic alkalosis
• Rare but serious effects:
  • Pulmonary edema
  • Peripheral edema
  • Congestive heart failure exacerbation

Report any unusual symptoms such as confusion, breathing difficulty, or swelling to a healthcare provider immediately. Adverse effects are more likely with rapid or high-volume infusions.

0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA] Contraindications 0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA]

This product should not be used in patients for whom hypotonic fluid or sodium administration is contraindicated.

• Absolute contraindications:
  • Hypernatremia (elevated sodium levels)
  • Fluid retention states (e.g., pulmonary edema, congestive heart failure)
• Relative contraindications:
  • Severe renal impairment or oliguria/anuria
  • Uncontrolled hypertension
  • Conditions causing fluid overload (e.g., preeclampsia)
• Drug interactions: Avoid in patients taking medications that predispose to fluid retention unless closely monitored.

Always assess the patient’s fluid and electrolyte balance before initiating therapy. Alternative fluids may be more appropriate for patients with these contraindications.

Storage of 0.45% SODIUM CHLORIDE INJECTION, USP [WELLPHARMA]

Proper storage ensures the safety, sterility, and efficacy of 0.45% Sodium Chloride Injection. Adherence to storage guidelines is essential in hospital and clinical settings.

• Temperature: Store between 15°C and 25°C (59°F to 77°F).
• Protection: Keep away from direct sunlight, freezing, and excessive heat.
• Bag integrity: Do not use if the container is damaged, leaking, or if the solution is discolored or contains visible particulates.
• Single-use only: Discard any unused portion after opening. Do not reuse or resterilize.
• Handling: Use aseptic technique when connecting to IV administration sets.

Store in original packaging until time of use. Ensure that hospital staff and pharmacy personnel are trained in proper IV fluid handling and storage protocols.