mannitol injection, USP Contraindications | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

Mannitol Injection is contraindicated in patients with:

Known hypersensitivity to mannitol [see Warnings and Precautions (5.1)].
Anuria [see Warnings and Precautions (5.2)].
Severe hypovolemia [see Warnings and Precautions (5.4)].
Pre-existing severe pulmonary vascular congestion or pulmonary edema [see Warnings and Precautions (5.5)].
Active intracranial bleeding except during craniotomy.

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mannitol injection, USP Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

Mannitol Injection is indicated for the reduction of:

intracranial...

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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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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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4 CONTRAINDICATIONS

Mannitol Injection is contraindicated in patients with:

Known hypersensitivity...

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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Serious hypersensitivity reactions, including...

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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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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The available case...

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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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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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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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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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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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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

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.