mannitol injection, USP Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use MANNITOL INJECTION safely and effectively. See full prescribing information for MANNITOL INJECTION.

MANNITOL injection, for intravenous use
Initial U.S. Approval: 1964

RECENT MAJOR CHANGES

Indications and Usage (removed, revised) (1)03/2020
Contraindications (4)03/2020
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7)03/2020

INDICATIONS AND USAGE

Mannitol Injection is an osmotic diuretic, indicated for the reduction of:

  • intracranial pressure and treatment of cerebral edema. (1)
  • elevated intraocular pressure. (1)

DOSAGE AND ADMINISTRATION

Administration Instructions (2.1):

  • For intravenous infusion, preferably through a central venous catheter.
  • Prior to administration, evaluate renal, cardiac and pulmonary status and correct fluid and electrolyte imbalances.

Recommended Dosage (2.2):

  • The dosage, concentration and rate of administration depend on the age, weight and condition of the patient, including fluid requirement, urinary output and concomitant therapy.
  • Reduction of Intracranial Pressure and Treatment of Cerebral Edema: 0.25 g/kg administered every 6 to 8 hours as an intravenous infusion over at least 30 minutes.
  • Reduction of Intraocular Pressure: 1.5 to 2 g/kg administered as a single dose intravenously over at least 30 minutes. Administer 60 to 90 minutes before surgery to achieve maximal effect.

DOSAGE FORMS AND STRENGTHS

Mannitol Injection 25%, USP: 12.5 g/50 mL (0.25 g/mL) in a single-dose vial (3)

CONTRAINDICATIONS

  • Known hypersensitivity to mannitol. (4, 5.1)
  • Anuria. (4, 5.2)
  • Severe hypovolemia. (4, 5.4)
  • Pre-existing severe pulmonary vascular congestion or pulmonary edema. (4, 5.5)
  • Active intracranial bleeding except during craniotomy. (4)

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions, Including Anaphylaxis: Stop infusion immediately if hypersensitivity reactions develop. (5.1)
  • Renal Complications Including Renal Failure: Risk factors include pre-existing renal disease, conditions that put patients at risk for renal failure and concomitant use of nephrotoxic drugs or other diuretics. Avoid use of nephrotoxic drugs. Discontinue Mannitol Injection if renal function worsens. (5.2, 8.6)
  • Central Nervous System (CNS) Toxicity: Confusion, lethargy, and coma may occur during or after infusion. Concomitant neurotoxic drugs may potentiate toxicity. Avoid use of neurotoxic drugs. Discontinue Mannitol Injection if CNS toxicity develops. (5.3)
  • Fluid and Electrolyte Imbalances, Hyperosmolarity: Hypervolemia may exacerbate congestive heart failure; hyponatremia can lead to encephalopathy; hypo/hyperkalemia can result in cardiac adverse reactions in sensitive patients. Discontinue Mannitol Injection if fluid and/or electrolyte imbalances occur. (5.4)
  • Monitoring/Laboratory Tests: Monitor fluid and electrolytes, serum osmolarity and renal, cardiac, and pulmonary function. Discontinue if toxicity develops. (5.5)
  • Infusion Site Reactions: May cause irritation and inflammation, as well as severe reactions (compartment syndrome) when associated with extravasation. (5.6)
  • Interference with Laboratory Tests: High concentrations of mannitol may cause false low results of inorganic phosphorus blood concentrations. Mannitol may produce false positive results for blood ethylene glycol. (5.7, 7.6)

ADVERSE REACTIONS

Most common adverse reactions are hypersensitivity reactions, renal failure, CNS toxicity, hypo/hypervolemia, hypo/hypernatremia, hypo/hyperkalemia, and infusion site reactions. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Nephrotoxic Drugs and Diuretics: May increase the risk of renal failure; avoid concomitant use. (7.1, 7.2)
  • Neurotoxic Drugs: May potentiate CNS toxicity of mannitol; avoid concomitant use. (7.3)
  • Drugs Affected by Electrolyte Imbalances: May result in cardiac adverse reactions; monitor serum electrolytes and discontinue Mannitol Injection if cardiac status worsens. (7.4)
  • Renally Eliminated Drugs: Concomitant use may decrease the effectiveness of agents that undergo significant renal elimination. However, concomitant use of mannitol and lithium may increase risk of lithium toxicity. If concomitant use is necessary, frequently monitor lithium concentrations and for signs of toxicity. (7.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2020

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use MANNITOL INJECTION safely and effectively. See full prescribing information for MANNITOL INJECTION.

MANNITOL injection, for intravenous use
Initial U.S. Approval: 1964

RECENT MAJOR CHANGES

Indications and Usage (removed, revised) (1)03/2020
Contraindications (4)03/2020
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7)03/2020

INDICATIONS AND USAGE

Mannitol Injection is an osmotic diuretic, indicated for the reduction of:

  • intracranial pressure and treatment of cerebral edema. (1)
  • elevated intraocular pressure. (1)

DOSAGE AND ADMINISTRATION

Administration Instructions (2.1):

  • For intravenous infusion, preferably through a central venous catheter.
  • Prior to administration, evaluate renal, cardiac and pulmonary status and correct fluid and electrolyte imbalances.

Recommended Dosage (2.2):

  • The dosage, concentration and rate of administration depend on the age, weight and condition of the patient, including fluid requirement, urinary output and concomitant therapy.
  • Reduction of Intracranial Pressure and Treatment of Cerebral Edema: 0.25 g/kg administered every 6 to 8 hours as an intravenous infusion over at least 30 minutes.
  • Reduction of Intraocular Pressure: 1.5 to 2 g/kg administered as a single dose intravenously over at least 30 minutes. Administer 60 to 90 minutes before surgery to achieve maximal effect.

DOSAGE FORMS AND STRENGTHS

Mannitol Injection 25%, USP: 12.5 g/50 mL (0.25 g/mL) in a single-dose vial (3)

CONTRAINDICATIONS

  • Known hypersensitivity to mannitol. (4, 5.1)
  • Anuria. (4, 5.2)
  • Severe hypovolemia. (4, 5.4)
  • Pre-existing severe pulmonary vascular congestion or pulmonary edema. (4, 5.5)
  • Active intracranial bleeding except during craniotomy. (4)

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions, Including Anaphylaxis: Stop infusion immediately if hypersensitivity reactions develop. (5.1)
  • Renal Complications Including Renal Failure: Risk factors include pre-existing renal disease, conditions that put patients at risk for renal failure and concomitant use of nephrotoxic drugs or other diuretics. Avoid use of nephrotoxic drugs. Discontinue Mannitol Injection if renal function worsens. (5.2, 8.6)
  • Central Nervous System (CNS) Toxicity: Confusion, lethargy, and coma may occur during or after infusion. Concomitant neurotoxic drugs may potentiate toxicity. Avoid use of neurotoxic drugs. Discontinue Mannitol Injection if CNS toxicity develops. (5.3)
  • Fluid and Electrolyte Imbalances, Hyperosmolarity: Hypervolemia may exacerbate congestive heart failure; hyponatremia can lead to encephalopathy; hypo/hyperkalemia can result in cardiac adverse reactions in sensitive patients. Discontinue Mannitol Injection if fluid and/or electrolyte imbalances occur. (5.4)
  • Monitoring/Laboratory Tests: Monitor fluid and electrolytes, serum osmolarity and renal, cardiac, and pulmonary function. Discontinue if toxicity develops. (5.5)
  • Infusion Site Reactions: May cause irritation and inflammation, as well as severe reactions (compartment syndrome) when associated with extravasation. (5.6)
  • Interference with Laboratory Tests: High concentrations of mannitol may cause false low results of inorganic phosphorus blood concentrations. Mannitol may produce false positive results for blood ethylene glycol. (5.7, 7.6)

ADVERSE REACTIONS

Most common adverse reactions are hypersensitivity reactions, renal failure, CNS toxicity, hypo/hypervolemia, hypo/hypernatremia, hypo/hyperkalemia, and infusion site reactions. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Nephrotoxic Drugs and Diuretics: May increase the risk of renal failure; avoid concomitant use. (7.1, 7.2)
  • Neurotoxic Drugs: May potentiate CNS toxicity of mannitol; avoid concomitant use. (7.3)
  • Drugs Affected by Electrolyte Imbalances: May result in cardiac adverse reactions; monitor serum electrolytes and discontinue Mannitol Injection if cardiac status worsens. (7.4)
  • Renally Eliminated Drugs: Concomitant use may decrease the effectiveness of agents that undergo significant renal elimination. However, concomitant use of mannitol and lithium may increase risk of lithium toxicity. If concomitant use is necessary, frequently monitor lithium concentrations and for signs of toxicity. (7.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2020

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