0.9% SODIUM CHLORIDE INJECTION USP Infusion/Solution for

What is 0.9% SODIUM CHLORIDE INJECTION USP

0.9% Sodium Chloride Injection USP in a 500ml plastic bag is a sterile, non-pyrogenic solution intended for intravenous administration. Commonly referred to as normal saline, this solution contains 9 grams of sodium chloride (NaCl) per liter of water. In this formulation, it is combined with the antihypertensive agent Captopril, an ACE (angiotensin-converting enzyme) inhibitor used for managing high blood pressure and heart failure.

The product serves a dual purpose:

• Fluid and Electrolyte Replacement: Helps restore fluid balance and correct electrolyte deficiencies, especially sodium losses due to dehydration, vomiting, diarrhea, or surgery.
• Therapeutic Agent Delivery: Acts as a carrier for Captopril, facilitating controlled delivery for patients requiring antihypertensive therapy.

Captopril, when administered intravenously, offers rapid onset of action, particularly in acute hypertensive crises or when oral administration is not feasible. The combination ensures that patients receive both volume resuscitation and blood pressure control in critical care and hospital settings.

This medication is typically used in:

• Hypertensive emergencies
• Congestive heart failure (acute episodes)
• Post-myocardial infarction therapy
• Renal protection in diabetic nephropathy (off-label in emergency care)

How to use 0.9% SODIUM CHLORIDE INJECTION USP

Using this infusion requires strict adherence to healthcare provider instructions. Administration should be performed by trained medical personnel in a clinical setting.

• Route: Administered intravenously (IV), directly into a vein using sterile technique.
• Preparation: Ensure the plastic bag is intact. Do not use if the solution is discolored, cloudy, or contains particulates.
• Infusion Rate: Controlled via an IV infusion pump or gravity drip. Rate is based on patient’s age, weight, cardiac and renal function, and severity of dehydration or hypertension.
• Monitoring: Vital signs, renal function, and electrolyte levels must be continuously monitored. Blood pressure should be closely tracked, especially due to the effect of Captopril.
• Adjunct Therapy: May be combined with other medications, depending on the clinical scenario (e.g., diuretics, vasodilators).

Patients receiving this medication should remain under observation during the infusion to monitor for signs of hypotension, allergic reaction, or fluid overload.

Mode of Action 0.9% SODIUM CHLORIDE INJECTION USP

The mechanism of action involves two synergistic components: the sodium chloride solution and Captopril.

• Sodium Chloride (NaCl):
  • Maintains isotonic balance in body fluids
  • Provides essential sodium and chloride ions to correct hyponatremia or extracellular fluid loss
  • Restores blood volume and maintains blood pressure in hypovolemic conditions
• Captopril:
  • Inhibits angiotensin-converting enzyme (ACE), reducing the conversion of angiotensin I to angiotensin II
  • Leads to vasodilation, reduced aldosterone production, and decreased blood volume
  • Decreases systemic vascular resistance and arterial blood pressure
  • Improves cardiac output in patients with congestive heart failure

Together, the solution provides volume resuscitation while managing blood pressure and cardiac workload in critically ill patients.

0.9% SODIUM CHLORIDE INJECTION USP Interactions 0.9% SODIUM CHLORIDE INJECTION USP

While 0.9% sodium chloride has minimal direct drug interactions, the presence of Captopril introduces significant pharmacologic considerations.

• Potassium-Sparing Drugs: Concurrent use with potassium supplements or potassium-sparing diuretics (e.g., spironolactone) increases the risk of hyperkalemia.
• NSAIDs: Non-steroidal anti-inflammatory drugs may reduce the antihypertensive effect of Captopril and impair renal function, especially in volume-depleted patients.
• Diuretics: May potentiate the hypotensive effects of Captopril, especially in patients recently started on therapy or after fluid loss.
• Lithium: Captopril can increase serum lithium levels, heightening the risk of lithium toxicity.
• Other Antihypertensives: Concurrent use with beta-blockers or calcium channel blockers may cause an additive effect leading to excessive hypotension.

Caution is advised when combining with any agent affecting renal function or blood pressure regulation. Frequent monitoring of renal parameters and serum potassium is recommended.

Dosage of 0.9% SODIUM CHLORIDE INJECTION USP

Dosage varies based on the clinical indication, patient’s weight, renal function, and the severity of hypertension or fluid imbalance.

• Standard Dose (Captopril component): IV dose typically ranges from 0.25 to 0.5 mg/kg, infused slowly to avoid rapid blood pressure drop.
• Infusion Volume: Usually 500ml over 30 to 60 minutes, unless fluid restriction is necessary.
• Titration: May require adjustment based on patient’s blood pressure response and serum creatinine levels.
• Renal Impairment: Lower initial doses and longer intervals between dosing to avoid accumulation of Captopril and fluid overload.

Always follow prescriber instructions and clinical protocols. Do not self-administer or alter dose without medical supervision.

Possible side effects of 0.9% SODIUM CHLORIDE INJECTION USP

Side effects can arise from either component of the infusion. Close monitoring is essential to prevent complications.

• From Captopril:
  • Hypotension, especially after first dose
  • Hyperkalemia (elevated potassium levels)
  • Renal impairment or increased serum creatinine
  • Dry cough (common ACE inhibitor-related side effect)
  • Angioedema (rare but serious allergic reaction)
• From Sodium Chloride:
  • Fluid overload in patients with heart or kidney failure
  • Electrolyte imbalance (e.g., hypernatremia, acidosis)
  • Injection site reactions: redness, swelling, or irritation

Report any signs of dizziness, facial swelling, breathing difficulty, or unusual fatigue to healthcare providers immediately.

0.9% SODIUM CHLORIDE INJECTION USP Contraindications 0.9% SODIUM CHLORIDE INJECTION USP

This formulation is contraindicated in specific clinical conditions due to the risks associated with both sodium chloride and Captopril.

• Hypersensitivity: Known allergy to Captopril or other ACE inhibitors.
• History of Angioedema: Related to previous ACE inhibitor therapy.
• Hyperkalemia: Baseline serum potassium levels above normal limits.
• Severe Renal Impairment: Especially bilateral renal artery stenosis.
• Pregnancy: Use is contraindicated in the second and third trimesters due to the risk of fetal toxicity.

Additional caution is warranted in patients with a history of autoimmune diseases, liver dysfunction, or concurrent use of immunosuppressants.

Storage of 0.9% SODIUM CHLORIDE INJECTION USP

Proper storage ensures the efficacy and safety of the infusion solution.

• Temperature: Store at 15°C to 25°C (59°F to 77°F). Avoid excessive heat or freezing.
• Light Protection: Keep in original outer packaging to protect from light, especially due to Captopril sensitivity.
• Handling: Do not use if the container is leaking, damaged, or the solution is cloudy or discolored.
• Shelf Life: Follow expiration date on the package. Do not use expired product.
• Post-Opening: Use immediately after opening the plastic bag. Discard any unused portion to avoid contamination.

Keep out of reach of children and dispose of unused medicine in accordance with local regulations or hospital protocols.