OSMITROL Injection (Mannitol Injection, USP) is indicated for:
The promotion of diuresis, in the prevention and/or treatment of the oliguric
phase of acute renal failure before irreversible renal failure becomes established;
The reduction of intracranial pressure and treatment of cerebral edema by reducing
The reduction of elevated intraocular pressure when the pressure cannot be lowered
by other means, and
Promoting the urinary excretion of toxic substances.
DOSAGE AND ADMINISTRATION
OSMITROL Injection (Mannitol Injection, USP) should be administered only by intravenous infusion. The total dosage, concentration, and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement, and urinary output. The usual adult dosage ranges from 20 to 100 g in a 24 hour period, but in most instances an adequate response will be achieved at a dosage of approximately 50 to 100 g in a 24 hour period. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 mL/hour. This outline of administration and dosage is only a general guide to therapy.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
Test Dose: A test dose of mannitol should be given prior to instituting
OSMITROL Injection (Mannitol Injection, USP) therapy for patients with marked
oliguria, or those believed to have inadequate renal function. Such a test dose
may be approximately 0.2 g/kg body weight (about 75 mL of a 20% solution or
100 mL of a 15% solution) infused in a period of three to five minutes to produce
a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase,
a second test dose may be given; if there is an inadequate response, the patient
should be reevaluated.
Prevention of Acute Renal Failure (Oliguria): When used during cardiovascular
and other types of surgery,, 50 to 100 g of mannitol as a 5, 10, or 15% solution
may be given. The concentration will depend upon the fluid requirements of the
Treatment of Oliguria: The usual dose for treatment of oliguria is 100
g administered as a 15 or 20% solution.
Reduction of Intraocular Pressure: A dose of 1.5 to 2.0 g/kg as a 20%
solution (7.5 to 10 mL/kg) or as a 15% solution (10 to 13 mL/kg) may be given
over a period as short as 30 minutes in order to obtain a prompt and maximal
effect. When used preoperatively the dose should be given one to one and one-half
hours before surgery to achieve maximal reduction of intraocular pressure before
Reduction of Intracranial Pressure: Usually a maximum reduction in intracranial
pressure in adults can be achieved with a dose of 0.25 g/kg given not more frequently
than every six to eight hours. An osmotic gradient between the blood and cerebrospinal
fluid of approximately 10 mOsmol will yield a satisfactory reduction in intracranial
Adjunctive Therapy for Intoxications: As an agent to promote diuresis
in intoxications, 5%, 10%, 15% or 20% mannitol is indicated. The concentration
will depend upon the fluid requirement and urinary output of the patient.
Measurement of glomerular filtration rate by creatinine clearance may be useful for determination of dosage.
All injections in VIAFLEX containers are intended for intravenous administration using sterile equipment.
The use of supplemental additive medication is not recommended.
OSMITROL Injection (Mannitol Injection, USP) in VIAFLEX plastic containers is available as follows:
|| Size (mL)
|| Product Name
|| 5% OSMITROL Injection (5% Mannitol Injection, USP)
|| 10% OSMITROL Injection
|| (10% Mannitol Injection, USP)
|| 15% OSMITROL Injection (15% Mannitol Injection, USP)
|| 20% OSMITROL Injection
|| (20% Mannitol Injection, USP)
Exposure of pharmaceutical products to heat should be minimized.o Avoid excessive heat. It is roecommended the product be stored at room temperature (25oC); brief exposure up to 40oC does not adversely affect the product.
Directions for Use of VIAFLEX Plastic Container
Warning: Do not use plastic container in series connections. Such use
could result in air embolism due to residual air being drawn from the primary
container before administration of the fluid from the secondary container is
Tear overwrap down side at slit and remove solution container. 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.
Preparation for Administration
- Suspend container from eyelet support.
- Remove plastic protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
Rev. March 2005. Baxter Healthcare Corporation, Deerfield, IL 60015 USA. FDA
rev date: 8/26/2005