Mannitol Solution 20% is a sterile, hypertonic intravenous fluid that acts as a powerful osmotic diuretic. Its primary function is to draw water from body tissues into the bloodstream, effectively reducing elevated intracranial pressure (cerebral edema) and intraocular pressure (glaucoma). It is also used to promote urine production in cases of acute renal failure (oliguria) and to enhance the excretion of certain toxic substances from the body. Administered via slow intravenous infusion, its use requires careful monitoring due to its potent effects on fluid and electrolyte balance.
Product Information
Description: A clear, sterile, and apyrogenic injectable solution.
Pharmacological Characteristics: 20% Mannitol solution exerts a significant osmotic effect and induces marked diuresis. Mannitol is an osmotic diuretic that is freely filtered by the glomeruli and poorly reabsorbed by the renal tubules. It prevents tubular water reabsorption and improves sodium and chloride excretion by increasing the osmolarity of the glomerular filtrate. This action leads to a reduction in intracranial and intraocular pressure by drawing water from tissues into the bloodstream.
Indications: Indicated for:
- Promotion of diuresis, particularly in the prevention of acute renal failure during cardiovascular surgeries and/or after trauma.
- Reduction of intracranial pressure and treatment of cerebral edema.
- Reduction of elevated intraocular pressure when it cannot be reduced by other means; treatment of glaucoma attack.
- Promotion of urinary excretion of toxic substances.
- Treatment of cerebral edema of cardiac and renal origin.
Contraindications: Mannitol solution is contraindicated in patients with:
- Total anuria (absence of urine production).
- Severe cardiac decompensation (severe heart failure).
- Active intracranial hemorrhage (except during craniotomy).
- Severe dehydration.
- Pulmonary edema.
- Known hypersensitivity to mannitol.
Important Note on Administration: Mannitol solution should never be added to whole blood for transfusion or administered in the same blood infusion set, as this can cause pseudoagglutination or hemolysis.
Dosage and Directions for Use:
- Dosage should be determined by a physician and depends on the patient’s age, weight, clinical condition, and duration of treatment, as determined by the physician.
- The solution should only be administered intravenously.
- Before administration, parenteral solutions should be visually inspected for particulate matter, cloudiness, cracks, and/or any breaches in the primary packaging. DO NOT USE if the vial seal is broken or the medication is cloudy.
- Crystallization: If crystals are observed, warm the container to redissolve them (e.g., in a water bath at 60°C), shake periodically, and then cool to body temperature before administration. Discard if crystals do not completely redissolve. An in-line filter is recommended during administration to prevent infusion of any crystals.
Important Warnings:
- PARENTERAL SOLUTIONS MUST BE ADMINISTERED BY QUALIFIED HEALTHCARE PROFESSIONALS. Self-medication or administration by untrained individuals can result in serious complications.
- ADMINISTRATION OF PARENTERAL SOLUTIONS REQUIRES CAREFUL ATTENTION TO PRESCRIBED DOSAGES. Errors in dilution or quantity administered can lead to serious or fatal adverse effects.
- PRODUCTS MUST BE STORED CORRECTLY IN ACCORDANCE WITH THE MANUFACTURER’S INSTRUCTIONS. Improper storage may lead to product contamination and loss of effectiveness.
- PARENTERAL SOLUTIONS MUST BE MONITORED AND ADMINISTRATION PROCESSED. Changes in parameters such as blood pressure, heart rate, and oxygen levels may indicate complications that require immediate intervention.
- DO NOT USE medication that has PASSED ITS VALIDITY PERIOD, as this may result in loss of therapeutic efficacy and risk of adverse effects.
- Vials should be used immediately after opening and SHOULD NOT BE STORED for future use.
- Fluid and Electrolyte Imbalances: Close monitoring of fluid balance, serum electrolytes (especially sodium and potassium), and renal function is crucial during and after administration.
- Cardiovascular Monitoring: Evaluate cardiovascular status carefully before rapid administration, as it can expand extracellular fluid volume and exacerbate heart failure or pulmonary edema.
- CNS Toxicity: Monitor for signs of central nervous system toxicity (e.g., confusion, lethargy, coma).
Presentation:
- Sol. Inj. IV of Mannitol 20% – Box. 40 FR Plas. Trans. with 250mL – Closed Syst.
- Sol. Inj. IV of Mannitol 20% – Box. 24 FR Plas. Trans. with 500mL – Closed Syst.
Composition (per mL):
- Mannitol…………………………………………………………….200 mg
- Water for injection qsp ……………………………………….1 mL
Physical Properties:
- Caloric content……………………………………….0.8 Kcal/L
- Osmolarity …………………………………………….1098 mOsm/L (Hypertonic)
- pH………………………………………………………………….4.5 – 7.0
Validity Period:
24 months after the date of manufacture.
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