Mannitol
Generic: MANNITOL
Basic Information
Manufacturer
Hospira, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
8ad3145e-00e7-4412-b9a5-06f00f264f30
Indications & Usage
1 INDICATIONS AND USAGE Mannitol Injection is indicated for the reduction of: • intracranial pressure and treatment of cerebral edema.
• elevated intraocular pressure.
Mannitol Injection is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema.
( 1 ) • elevated intraocular pressure.
( 1 )
• elevated intraocular pressure.
Mannitol Injection is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema.
( 1 ) • elevated intraocular pressure.
( 1 )
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 of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions: Cardiac arrest, anaphylaxis, hypotension, dyspnea, hypertension, pyrexia, chills, sweating, cough, musculoskeletal stiffness, myalgia, urticaria/rash, pruritus, generalized pain, discomfort, nausea, vomiting, headache [see Warnings and Precautions (5.1) ] Renal failure: Acute kidney injury, osmotic nephrosis, anuria, oliguria, urinary retention [see Warnings and Precautions (5.2) ] CNS toxicity: Coma, seizures, confusion, lethargy, rebound increase in intracranial pressure, headache, dizziness [see Warnings and Precautions (5.3) ] Fluid and electrolyte imbalances: Metabolic acidosis, dehydration (hypovolemia), hypervolemia, hyponatremia, hypernatremia, hyperkalemia, hypokalemia [see Warnings and Precautions (5.4) ] Infusion site reactions: Venous thrombosis, thrombophlebitis extending from the site of injection, compartment syndrome and swelling associated with extravasation [see Warnings and Precautions 5.6) ] Cardiac and respiratory disorders: Tachycardia, angina-like chest pain, congestive heart failure, pulmonary congestion, hypotension, edema, rhinitis Gastrointestinal disorders: Dryness of mouth, nausea, vomiting General disorders: Thirst 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.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions: Cardiac arrest, anaphylaxis, hypotension, dyspnea, hypertension, pyrexia, chills, sweating, cough, musculoskeletal stiffness, myalgia, urticaria/rash, pruritus, generalized pain, discomfort, nausea, vomiting, headache [see Warnings and Precautions (5.1) ] Renal failure: Acute kidney injury, osmotic nephrosis, anuria, oliguria, urinary retention [see Warnings and Precautions (5.2) ] CNS toxicity: Coma, seizures, confusion, lethargy, rebound increase in intracranial pressure, headache, dizziness [see Warnings and Precautions (5.3) ] Fluid and electrolyte imbalances: Metabolic acidosis, dehydration (hypovolemia), hypervolemia, hyponatremia, hypernatremia, hyperkalemia, hypokalemia [see Warnings and Precautions (5.4) ] Infusion site reactions: Venous thrombosis, thrombophlebitis extending from the site of injection, compartment syndrome and swelling associated with extravasation [see Warnings and Precautions 5.6) ] Cardiac and respiratory disorders: Tachycardia, angina-like chest pain, congestive heart failure, pulmonary congestion, hypotension, edema, rhinitis Gastrointestinal disorders: Dryness of mouth, nausea, vomiting General disorders: Thirst 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.