MANNITOL injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)

Tilgjengelig fra:

ICU Medical Inc.

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Mannitol Injection is indicated for the reduction of: - intracranial pressure and treatment of cerebral edema; - elevated intraocular pressure. 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 pulmonary vascular congestion or pulmonary edema [see Warnings and Precautions (5.5)] - Active intracranial bleeding except during craniotomy. Risk Summary The available case report data with mannitol over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see Data) . No adverse developmental effects from mannitol were reported in published animal studies; however, fluid shifts occurred in fetal ewes in response to mat

Produkt oppsummering:

Mannitol Injection is a clear and colorless solution supplied in single-dose containers as follows: Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Autorisasjon status:

New Drug Application

Preparatomtale

MANNITOL- MANNITOL INJECTION, SOLUTION
ICU MEDICAL INC.
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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)
05/2020
Contraindications (4)
05/2020
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7)
05/2020
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 into a large central vein.
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_: 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 as a single dose
administered intravenously over at least 30 minutes.
Administer 60 to 90 minutes before surgery to achieve maximal effect.
DOSAGE FORMS AND STRENGTHS
Injection: 20% (0.2 grams/mL); 20 grams of mannitol, USP per 100 mL in
single-dose 250 mL and 500 mL flexible
containers (3)
CONTRAINDICATIONS
Known hypersensitivity to mannitol. (4, 5.1)
Anuria. (4, 5.2)
Severe hypovolemia. (4, 5.4)
Pre-existing 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 Fa