Mannitol
Generic: MANNITOL
Basic Information
Manufacturer
ICU Medical Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
ba7bf864-8a4d-4262-8fd1-00174fa2f9d1
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 )
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 from voluntary reports or clinical studies have been reported with Mannitol Injection.
Because many 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 :, anaphylaxis, hypotension, dyspnea, hypertension, pyrexia, chills, sweating, urticaria/rash, pruritus [see Warnings and Precautions (5.1) ] Renal Failure : acute kidney injury, osmotic nephrosis, azotemia, anuria, hematuria, oliguria, polyuria, urinary retention [see Warnings and Precautions (5.2) ] CNS Toxicity : coma, seizures, confusion, lethargy; rebound increase in intracranial pressure; dizziness, headache [see Warnings and Precautions (5.3) ] Fluid and Electrolyte Imbalances : hypovolemia (dehydration), hypervolemia, peripheral edema, , hyponatremia, hypernatremia, hyperkalemia, hypokalemia; metabolic acidosis [see Warning and Precautions (5.4) ] Infusion Site Reactions : venous thrombosis, phlebitis, inflammation, pain, rash, erythema, pruritus; compartment syndrome and swelling associated with extravasation [see Warnings and Precautions (5.6) ] Cardiac and Respiratory Disorders : cardiac arrest, congestive cardiac failure, pulmonary edema, palpitations, tachycardia, angina-like chest pain Musculoskeletal Disorders: musculoskeletal stiffness, myalgia Gastrointestinal Disorders : thirst, dry mouth, nausea, vomiting General Disorders : asthenia, malaise The 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 name ICU Medical, Inc.
at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because many 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 :, anaphylaxis, hypotension, dyspnea, hypertension, pyrexia, chills, sweating, urticaria/rash, pruritus [see Warnings and Precautions (5.1) ] Renal Failure : acute kidney injury, osmotic nephrosis, azotemia, anuria, hematuria, oliguria, polyuria, urinary retention [see Warnings and Precautions (5.2) ] CNS Toxicity : coma, seizures, confusion, lethargy; rebound increase in intracranial pressure; dizziness, headache [see Warnings and Precautions (5.3) ] Fluid and Electrolyte Imbalances : hypovolemia (dehydration), hypervolemia, peripheral edema, , hyponatremia, hypernatremia, hyperkalemia, hypokalemia; metabolic acidosis [see Warning and Precautions (5.4) ] Infusion Site Reactions : venous thrombosis, phlebitis, inflammation, pain, rash, erythema, pruritus; compartment syndrome and swelling associated with extravasation [see Warnings and Precautions (5.6) ] Cardiac and Respiratory Disorders : cardiac arrest, congestive cardiac failure, pulmonary edema, palpitations, tachycardia, angina-like chest pain Musculoskeletal Disorders: musculoskeletal stiffness, myalgia Gastrointestinal Disorders : thirst, dry mouth, nausea, vomiting General Disorders : asthenia, malaise The 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 name ICU Medical, Inc.
at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.