Ampoules - 0.9% Sodium Chloride Injection B.P 

Sodium Chloride 0.9% w/v (Normal Saline)

Therapeutic Class

Isotonic crystalloid salt solution

Description and Composition

A clear, colorless, sterile solution each 25 ml. of which contains:

• Sodium Chloride B.P. - 0.225 grams
• Water for Injections - q.s.

Indications

• Used as a diluting agent for I.V. medication
• Used for reconstitution of various I.V. injections
• Flushing of I.V. ports and cannula
• As nasal drops for relieving congestion in children and adults
• Used to dilute various bronchodilator solutions (such as procaterol, salbutamol, etc) for nebulization
• Used for cleaning of small wounds
• Used as irrigation solution for eyes
• Compresses (moistened gauze) of normal saline may also be used to reduce discomfort due to inflammation or skin irritation and to soften necrotic tissues
• (Data sheet of specific medication should be referred to, before dilution, reconstitution or nebulization)

Dosage and Administration

0.9% Sodium Chloride Injection should be used in accordance with the age and clinical condition of the patient.

Duration of Action and Excretion

When infused, passes out of the bloodstream quite rapidly, especially when normal renal function and renal blood flow are present.

Adverse Effects

• If administered in large amounts can cause fluid overload, edema, electrolyte imbalance, hypertension, and congestive heart failure.

Contraindications

• Congestive heart failure.

Precautions

• The sodium chloride content of 0.9% Sodium Chloride Injection is 0.225 grams/ampoule. Care is therefore required in those cases where salt intake is restricted, such as in hypertensive patients.
• Infusion of large volumes may cause dilutional acidosis due to the dilution of the bicarbonate concentration in the plasma (as the preparation does not contain bicarbonate).
• Care is required in conditions where hypokalemia and/or hypocalcemia exist or may arise as the infusion of the product can decrease the concentration of these electrolytes.
• Caution should be exercised in patients with renal failure and in those with reduced urinary output due to obstructive urinary tract diseases.
• Continuous infusion of 0.9% Sodium Chloride Injection may cause hypernatremia, unless free water is supplied along with it.

Tonicity and Osmolarity

Isotonic solution having a tonicity of 150.

Isosmotic solution (308 mOsm/L)

Caloric Value

Nil

Pharmaceutical Precautions

• Normal Saline is compatible with almost all drugs. Therefore, it can usually be mixed and used with other injectable medicines. However, the data sheet of the medication should be referred to before admixture.
• Store at room temperature. Protect from sunlight.
• Do not use if the ampoule is leaking, the solution is cloudy, or contains foreign matter.
• Discard unused portion.
• Keep all medicines out of the reach of children.
• Shelf life is 5 years from the date of manufacturing.

Packaging

25 mL in low-density polyethylene, twist-off, plastic ampoules.

Pharmacological Effects

• 0.9% Sodium Chloride Injection is considered to be a physiological solution as it is isotonic and isoosmotic.
• Infusion of large amounts can expand circulating volume by approximating sodium content of the blood.
• Provides the following electrolytes in each liter of fluid:
  • Sodium: 150 mEq
  • Chloride: 150 mEq
• Each ampoule of 25 mL provides 3.75 mEq of sodium and 3.75 mEq of chloride.
• The pH range is 3.5 - 7.5.