OSMITROL- mannitol injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Baxter Healthcare Corporation

INN (International Name):

MANNITOL

Sammensetning:

MANNITOL 5 g in 100 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

OSMITROL is indicated for: OSMITROL is contraindicated in patients with: 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 maternal infusion of mannitol. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Human Data Published literature reports the presence of mannitol in amniotic f

Produkt oppsummering:

OSMITROL injection is supplied in single-dose, flexible VIAFLEX plastic containers and is available as follows: Code Size (mL) NDC Product Name 2D5604 1000 0338-0351-04 5% (0.05 g/mL mannitol, USP) 2D5613 500 0338-0353-03 10% (0.1 g/mL mannitol, USP) 2D5623 500 0338-0355-03 15% (0.15 g/mL mannitol, USP) 2D5632 250 0338-0357-02 20% (0.2 g/mL mannitol, USP) 2D5633 500 0338-0357-03 20% (0.2 g/mL mannitol, USP) Do not remove container from overwrap until intended for use. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

Autorisasjon status:

New Drug Application

Preparatomtale

OSMITROL- MANNITOL INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OSMITROL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OSMITROL.
OSMITROL (MANNITOL INJECTION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1964
RECENT MAJOR CHANGES
Indications and Usage (removed, revised) (1) 11/2018
Contraindications (4) 11/2018
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7) 11/2018
INDICATIONS AND USAGE
OSMITROL is an osmotic diuretic, indicated for the reduction of:
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DOSAGE AND ADMINISTRATION
Administration Instructions (2.1):
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Recommended Dosage (2.2):
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DOSAGE FORMS AND STRENGTHS
Injection (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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intracranial pressure and treatment of cerebral edema. (1)
elevated intraocular pressure. (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.
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 gram/kg administered every
6 to 8 hours as an intravenous infusion over 30
minute s.
_Reduction of Intraocular Pressure_: 1.5 to 2 grams/kg of a 15% or 20%
w/v solution as a single dose administered
intravenously over at least 30 minutes.
5% (0.05 grams/mL): 5 grams of mannitol, USP per 100 mL in a
single-dose 1000 mL flexible container
10% (0.1 grams/mL): 10 grams of mannitol, USP per 100 mL in a
single-dose 500 mL flexible container
15% (0.15 grams/mL): 15 grams of mannitol, USP per 100 mL in a
single-dose 500 mL flexible container
20% (0.2 grams/mL): 20 grams of mannitol, USP per 100 mL in
single-dose 250 mL and 500 mL flexible containers
Known hypersensitivity to mannitol. (4, 5.1)
Anuria.