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Osmitrol in Viaflex

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Osmitrol Injection in Viaflex

Osmitrol Injection in Viaflex

INDICATIONS

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 brain mass;
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 patient.

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 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 mOsmol 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 VIAFLEX containers are intended for intravenous administration using sterile equipment.

The use of supplemental additive medication is not recommended.

HOW SUPPLIED

OSMITROL Injection (Mannitol Injection, USP) in VIAFLEX plastic containers is available as follows:

Code Size (mL) NDC Product Name
2D5604 1000 0338-0351-04 5% OSMITROL Injection (5% Mannitol Injection, USP)
2D5613 500 0338-0353-03 10% OSMITROL Injection
2D5614 1000 0338-0353-04 (10% Mannitol Injection, USP)
2D5623 500 0338-0355-03 15% OSMITROL Injection (15% Mannitol Injection, USP)
2D5632 250 0338-0357-02 20% OSMITROL Injection
2D5633 500 0338-0357-03 (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 completed.

To Open

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

  1. Suspend container from eyelet support.
  2. Remove plastic protector from outlet port at bottom of container.
  3. 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

Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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