MANNITOL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

B. Braun Medical Inc.

INN (International Name):

MANNITOL

Composition:

MANNITOL 20 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mannitol Injection is indicated for: - Reduction of intracranial pressure and treatment of cerebral edema. - Reduction of elevated intraocular pressure. Mannitol Injection is contraindicated in patients with: - 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 severe pulmonary vascular congestion or pulmonary edema [see Warnings and Precautions (5.5)] -   Active intracranial bleeding except during craniotomy. 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

Product summary:

Mannitol Injection USP, 20% (0.2 grams/mL) as a clear and colorless solution is supplied in sterile and nonpyrogenic 250 mL and 500 mL single-dose EXCEL® Containers. Not made with natural rubber latex, PVC or DEHP. NDC REF Size 0264-7578-10 L5781 500 mL 0264-7578-20 L5782 250 mL The 500 mL and 250 mL containers are packaged 24 per case. Store at room temperature (25°C). Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing.

Authorization status:

New Drug Application

Summary of Product characteristics

MANNITOL- MANNITOL INJECTION, SOLUTION
B. BRAUN 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) 09/2019
Contraindications (4) 09/2019
Warnings and Precautions (5.1, 5.3, 5.7) 09/2019
INDICATIONS AND USAGE
Mannitol Injection is an osmotic diuretic, indicated for the reduction
of: (1)
• 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 gram/kg administered every
6 to 8 hours as an intravenous
infusion over 30 minutes.
_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.
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 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
preexisti