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Mannitol

Generic Name
Mannitol
Brand Names
Aridol, Bronchitol, Cystosol, Osmitrol, Sag-M
Drug Type
Small Molecule
Chemical Formula
C6H14O6
CAS Number
69-65-8
Unique Ingredient Identifier
3OWL53L36A

Overview

Mannitol is an osmotic diuretic that is metabolically inert in humans and occurs naturally, as a sugar or sugar alcohol, in fruits and vegetables. Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. As a result, cerebral edema, elevated intracranial pressure, and cerebrospinal fluid volume and pressure may be reduced. Mannitol may also be used for the promotion of diuresis before irreversible renal failure becomes established; the promotion of urinary excretion of toxic substances; as an Antiglaucoma agent; and as a renal function diagnostic aid. On October 30, 2020, mannitol was approved by the FDA as add-on maintenance therapy for the control of pulmonary symptoms associated with cystic fibrosis in adult patients and is currently marketed for this indication under the name BRONCHITOL® by Chiesi USA Inc.

Background

Mannitol is an osmotic diuretic that is metabolically inert in humans and occurs naturally, as a sugar or sugar alcohol, in fruits and vegetables. Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. As a result, cerebral edema, elevated intracranial pressure, and cerebrospinal fluid volume and pressure may be reduced. Mannitol may also be used for the promotion of diuresis before irreversible renal failure becomes established; the promotion of urinary excretion of toxic substances; as an Antiglaucoma agent; and as a renal function diagnostic aid. On October 30, 2020, mannitol was approved by the FDA as add-on maintenance therapy for the control of pulmonary symptoms associated with cystic fibrosis in adult patients and is currently marketed for this indication under the name BRONCHITOL® by Chiesi USA Inc.

Indication

Used for the promotion of diuresis before irreversible renal failure becomes established, the reduction of intracranial pressure, the treatment of cerebral edema, and the promotion of urinary excretion of toxic substances. Mannitol is also indicated as add-on maintenance therapy for improving pulmonary function in cystic fibrosis patients aged 18 and over who have passed the BRONCHITOL tolerance test (BTT). It is recommended that patients take an orally inhaled short-acting bronchodilator 5-15 minutes prior to every inhaled mannitol dose.

Associated Conditions

  • Acute Renal Failure (ARF)
  • Cystic Fibrosis (CF)
  • Edema of the cerebrum
  • Increased Intra Ocular Pressure (IOP)

FDA Approved Products

Mannitol
Manufacturer:Henry Schein, Inc.
Route:INTRAVENOUS
Strength:12.5 g in 50 mL
Approved: 2023/11/09
NDC:0404-9905
MANNITOL
Manufacturer:HF Acquisition Co LLC, DBA HealthFirst
Route:INTRAVENOUS
Strength:12.5 g in 50 mL
Approved: 2024/01/27
NDC:51662-1468
Mannitol
Manufacturer:Hospira, Inc.
Route:INTRAVENOUS
Strength:12.5 g in 50 mL
Approved: 2020/03/30
NDC:0409-4031
Mannitol
Manufacturer:Fresenius Kabi USA, LLC
Route:INTRAVENOUS
Strength:250 mg in 1 mL
Approved: 2023/03/16
NDC:63323-024
Osmitrol
Manufacturer:Baxter Healthcare Corporation
Route:INTRAVENOUS
Strength:20 g in 100 mL
Approved: 2018/11/15
NDC:0338-0357

Singapore Approved Products

OSMOFUNDIN INJECTION 20%
Manufacturer:B BRAUN MEDICAL INDUSTRIES SDN BHD
Form:INJECTION
Strength:17.5 g/100 ml
Online:Yes
Approved: 1991/05/27
Approval:SIN05957P
MANNITOL INTRAVENOUS INJECTION 20%
Manufacturer:EURO-MED LABORATORIES PHIL INC
Form:INJECTION
Strength:20 g/100 ml
Online:Yes
Approved: 1998/10/29
Approval:SIN10315P

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