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 dug 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. Do not administer unless solution is clear and seal
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 patient.
Treatment of Oliguria
The usual dose for treatment of oliguria is 100 g administered as a 15 or 20%
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 operation.
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 m0smols will yield a satisfactory reduction in intracranial pressure.
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 AVIVA containers are intended for intravenous administration
using sterile equipment.
The use of supplemental additive medication is not recommended.
Osmitrol Injection (Mannitol Injection, USP) in AVIVA plastic containers is
available as follows:
||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% Osmitrol Injection)
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature (25°C);
brief exposure up to 40°C does not adversely affect the product.
Directions for Use of AVIVA Plastic Container
Tear overwrap down side at slit and remove solution container. Moisture and
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
Caution: Do not use plastic containers in series connections.
Caution: Use only with a non-vented set or a vented set with the vent
- Suspend container from eyelet support.
- Remove protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Rev.