OSMITROL Solution for injection Ref.[10896] Active ingredients: Mannitol

2.1 Important Preparation and Administration Instructions

• OSMITROL is for intravenous infusion preferably into a large central vein [see Warnings and Precautions (5.5), Description (11)].
• Prior to administration of OSMITROL, evaluate renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances [see Dosage and Administration (2.2)].
• Do not administer OSMITROL simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.

Preparation:

• Tear overwrap down side at slit and remove solution container.
• Visually inspect the container. Do not administer unless solution is clear and seal is intact.
  • If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.
  • Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
• Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
• Admixing OSMITROL with other medications is not recommended.
• Inspect OSMITROL visually for particulate matter and discoloration prior to administration. If particulates or discoloration are present, discard the bag.
• OSMITROL solutions may crystallize when exposed to low temperature. At higher concentrations, the solutions have a greater tendency to crystallize. Inspect OSMITROL for crystals prior to administration. If crystals are visible, re-dissolve by warming the solution up to 70°C, with agitation. Solutions should not be heated in water or in a microwave oven due to potential for product contamination or damage. Allow the solution to cool to room or body temperature before re-inspection for crystals and use.

Administration:

• Suspend container from eyelet support.
• Remove protector from outlet port at bottom of container.
• Attach administration set. Refer to complete directions accompanying set.
• Use administration sets with a final in-line filter because of the potential for OSMITROL crystals to form.
• To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.
• For single use only; discard unused portion.

2.2 Recommended Dosage

Prior to administration of OSMITROL, evaluate renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances.

The total dosage, concentration, and rate of administration depend on the age, weight, and condition of the patient being treated, including fluid requirement, electrolyte balance, serum osmolality, urinary output, and concomitant therapy.

The following outline of administration and dosage is only a general guide to therapy.

Reduction of Intracranial Pressure

Usually a maximum reduction in intracranial pressure can be achieved with a dose of 0.25 gram/kg given intravenously as an intravenous infusion over 30 minutes which may be repeated every six to eight hours.

During and following OSMITROL infusion, monitor fluid and electrolytes, serum osmolarity, and renal, cardiac and pulmonary function. Discontinue OSMITROL if renal, cardiac, or pulmonary status worsens or CNS toxicity develops [see Warnings and Precautions (5.2, 5.3, 5.4, 5.5)].

Reduction of Intraocular Pressure

The recommended dosage is 1.5 to 2 grams/kg of a 20% w/v solution (7.5 to 10 mL/kg) or as a 15% w/v solution (10 to 13 mL/kg) as a single dose administered intravenously over at least 30 minutes. When used preoperatively, administer OSMITROL sixty to ninety minutes before surgery to achieve maximal reduction of intraocular pressure before operation.

Signs and symptoms of overdose with OSMITROL include renal failure and AKI, hypo/hypervolemia, hyperosmolarity and electrolyte imbalances, CNS toxicity (e.g., coma, seizures), some of which can be fatal [see Warnings and Precautions (5.2, 5.3, 5.4)].

Management of overdosage with OSMITROL is symptomatic and supportive. Discontinue the infusion and institute appropriate corrective measures with particular attention to renal, cardiac and pulmonary systems. Correct fluid and electrolyte imbalances.

OSMITROL is dialyzable (hemodialysis and peritoneal dialysis), hemodialysis may increase OSMITROL elimination.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.