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mannitol injection, USP
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
mannitol injection, USP Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
Mannitol Injection is indicated for the reduction of:
- intracranial...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Preparation and Administration Instructions
- Mannitol Injection is for intravenous infusion preferably through a central venous...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Mannitol Injection 25%, USP: 12.5 g/50 mL (0.25 g/mL) of mannitol as a clear and colorless solution in a single-dose vial.
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Contraindications
4 CONTRAINDICATIONS
Mannitol Injection is contraindicated in patients with:
- Known hypersensitivity...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Serious hypersensitivity reactions, including...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions associated with the use mannitol were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Nephrotoxic Drugs
Concomitant administration of nephrotoxic drugs (e.g., cyclosporine, aminoglycosides) increases the risk of renal...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
The available case...
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Overdosage
10 OVERDOSAGE
Signs and symptoms of overdose with Mannitol Injection include renal failure and acute kidney injury, hypo/hypervolemia, hyperosmolarity and electrolyte imbalances, CNS toxicity (e.g., coma, seizures), some of...
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Description
11 DESCRIPTION
Mannitol Injection, USP is a sterile, nonpyrogenic solution of mannitol in water for injection available in a fliptop vial for intravenous administration as an osmotic diuretic.
The content and...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Mannitol, when administered intravenously, exerts its osmotic diuretic effect as a solute of relatively small...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Mannitol Injection 25%, USP is available as 12.5 g/50 mL (0.25 g/mL) of mannitol in a single-dose vial. Supplied as a tray of 25 vials (NDC 0409-4031-01).
...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Inform patients or caregivers of the following risks of Mannitol Injection:
- Hypersensitivity Reactions [see Warnings and Precautions (5.1)...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.