Mannitol

Mannitol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Overview

Mannitol is a osmotic diuretic that is FDA approved for the {{{indicationType}}} of oliguric phase of acute renal failure, cerebral edema, and elevated intraocular pressure. Mannitol is also indicated for promoting the urinary excretion of toxic substances. Common adverse reactions include nausea, vomiting, rhinitis, skin necrosis, thrombophlebitis, chills, dizziness, urticaria, hypotension, hypertension, tachycardia, fever, and angina-like chest pains.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Mannitol 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 Mannitol 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.
• Measurement of glomerular filtration rate by creatinine clearance may be useful for determination of dosage.

Prevention of Acute Renal Failure (Oliguria)

• Dosing Information

• 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

• Dosing Information

• The usual dose for treatment of oliguria is 100 g administered as a 15 or 20% solution.

Reduction of Intraocular Pressure

• Dosing Information

• 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

• Dosing Information

• 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

• Dosing Information

• 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mannitol in adult patients.

Non–Guideline-Supported Use

Dysequilibrium Syndrome

• Dosing Information

• 9 mosm/kg

Intracranial Tumor

• Dosing Information

• 10 mL (2.5 g) in 25% injection solution over 30 to 60 seconds

Subdural Hematoma

• Dosing Information

• 0.6 to 0.7 g/kg

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Safety and effectiveness in children below the age of 12 have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mannitol in pediatric patients.

Non–Guideline-Supported Use

Dysequilibrium Syndrome

• Dosing Information

• 40 g/m² administered over 1 hour orally as a 5.5% or a 20% solution

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Mannitol in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Mannitol in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mannitol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mannitol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Mannitol with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Mannitol with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Mannitol with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Mannitol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mannitol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mannitol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mannitol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mannitol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mannitol in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Mannitol in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Mannitol in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Mannitol in the drug label.

Pharmacology

There is limited information regarding Mannitol Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Mannitol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Mannitol in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Mannitol in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Mannitol in the drug label.

Condition1

• Description

How Supplied

Storage

There is limited information regarding Mannitol Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Mannitol in the drug label.

Precautions with Alcohol

• Alcohol-Mannitol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Osmitrol®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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