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.
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)
Research Report
An Expert Monograph on Mannitol: Chemistry, Pharmacology, and Clinical Applications
1. Drug Identification and Overview
1.1. Introduction to Mannitol
Mannitol is a small molecule drug, classified chemically as a six-carbon sugar alcohol, or polyol.[1] It is a versatile and critically important agent in modern medicine, primarily functioning as a potent osmotic diuretic.[3] Chemically, it is a hexahydric alcohol related to the sugar mannose and is a stereoisomer of sorbitol.[2] Its multifaceted utility spans a wide range of clinical scenarios. Therapeutically, it holds a vital role in emergency and critical care settings for the reduction of acutely elevated intracranial pressure (ICP) associated with cerebral edema and for lowering high intraocular pressure (IOP) in conditions like glaucoma.[1] It is also employed to promote diuresis in certain renal conditions, to facilitate the elimination of toxins, and as a diagnostic agent to measure kidney function.[1] In a distinct application, an inhaled formulation of Mannitol serves as an adjunctive therapy for managing the pulmonary symptoms of cystic fibrosis.[1]
Beyond its direct therapeutic roles, Mannitol is extensively utilized in the pharmaceutical and food industries. Its unique physicochemical properties, including chemical stability, non-hygroscopicity, and safety profile, make it a valuable pharmaceutical excipient in various dosage forms.[6] In the food sector, it functions as a low-calorie sweetener and texturizing agent.[4] The compound is identified by the DrugBank Accession Number DB00742 and the Chemical Abstracts Service (CAS) Registry Number 69-65-8.[1]
1.2. Chemical and Physical Profile
A thorough understanding of Mannitol's clinical and industrial applications begins with its fundamental chemical and physical characteristics.
Chemical Identity
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/23 | Not Applicable | Recruiting | Emmanuel Carrera | ||
2025/07/15 | Not Applicable | Recruiting | |||
2025/05/25 | Phase 2 | Not yet recruiting | |||
2025/04/06 | Phase 2 | Not yet recruiting | |||
2025/03/19 | Phase 4 | Not yet recruiting | |||
2025/02/26 | Phase 3 | Completed | |||
2025/02/24 | Phase 4 | Recruiting | |||
2025/01/10 | Phase 1 | ENROLLING_BY_INVITATION | |||
2024/08/06 | Phase 2 | Recruiting | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | ||
2024/05/06 | Not Applicable | Active, not recruiting | National Cancer Institute, Egypt |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
ICU Medical Inc. | 0990-7715 | INTRAVENOUS | 20 g in 100 mL | 5/7/2020 | |
ICU Medical Inc. | 0990-7981 | URETHRAL | 0.54 g in 100 mL | 4/7/2021 | |
Baxter Healthcare Corporation | 0338-0357 | INTRAVENOUS | 20 g in 100 mL | 11/15/2018 | |
Chiesi USA, Inc. | 10122-212 | RESPIRATORY (INHALATION) | 40 mg in 1 1 | 1/12/2024 | |
HF Acquisition Co LLC, DBA HealthFirst | 51662-1468 | INTRAVENOUS | 12.5 g in 50 mL | 1/27/2024 | |
B. Braun Medical Inc. | 0264-7578 | INTRAVENOUS | 20 g in 100 mL | 8/15/2023 | |
Henry Schein, Inc. | 0404-9905 | INTRAVENOUS | 12.5 g in 50 mL | 11/9/2023 | |
Hospira, Inc. | 0409-4031 | INTRAVENOUS | 12.5 g in 50 mL | 3/30/2020 | |
Fresenius Kabi USA, LLC | 63323-024 | INTRAVENOUS | 250 mg in 1 mL | 3/16/2023 | |
Baxter Healthcare Corporation | 0338-0353 | INTRAVENOUS | 10 g in 100 mL | 11/15/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 4/13/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
OSMOFUNDIN INJECTION 20% | SIN05957P | INJECTION | 17.5 g/100 ml | 5/27/1991 | |
MANNITOL INTRAVENOUS INJECTION 20% | SIN10315P | INJECTION | 20 g/100 ml | 10/29/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
BRONCHITOL mannitol 40 mg powder for inhalation hard capsule | 437010 | Medicine | A | 1/23/2024 | |
OSMITROL Mannitol 100g/500mL injection AHB3025 | 19496 | Medicine | A | 9/30/1991 | |
OSMITROL Mannitol 100g/L injection AHB3026 | 19479 | Medicine | A | 9/30/1991 | |
BRONCHITOL mannitol 40mg powder for inhalation hard capsule | 168002 | Medicine | A | 3/11/2011 | |
Aridol mannitol inhalation powder, hard capsules 0 mg, 5 mg, 10 mg, 20 mg, 40 mg | 445506 | Medicine | A | 4/8/2024 | |
ARIDOL mannitol powder for inhalation composite pack | 116832 | Medicine | A | 4/11/2006 | |
Bronchitol mannitol 40 mg inhalation powder, hard capsules | 444241 | Medicine | A | 3/22/2024 | |
ARIDOL mannitol powder for inhalation, hard capsules 0 mg, 5 mg, 10 mg, 20 mg, 40 mg | 439258 | Medicine | A | 2/1/2024 | |
BRONCHITOL (mannitol) inhalation powder, 40mg per capsule, for oral inhalation | 443970 | Medicine | A | 3/19/2024 | |
BRONCHITOL mannitol 40mg powder for inhalation hard capsule | 187575 | Medicine | A | 8/10/2011 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MANNITOL INJECTION, USP | fresenius kabi canada ltd | 02243176 | Solution - Intravenous | 25 % | 4/9/2002 |
OSMITROL INJECTION 20% | baxter corporation | 00060437 | Solution - Intravenous | 20 % | 12/31/1989 |
SAG-M | 02386925 | Solution - 0-Unassigned | 0.525 % / W/V | 1/20/2013 | |
MANNITOL INJ 5% ABBOVAC | ABBOTT LABORATORIES, LIMITED | 00037982 | Liquid - Intravenous | 50 MG / ML | 12/31/1963 |
MANNITOL INJ 25% | International Medication Systems Ltd. | 00243809 | Liquid - Intravenous | 250 MG / ML | 12/31/1971 |
MANNITOL INJ 25% | astra pharma inc. | 00729183 | Liquid - Intravenous | 250 MG / ML | 12/31/1987 |
MANNITOL INJ 10% ABBOVAC | ABBOTT LABORATORIES, LIMITED | 00037990 | Liquid - Intravenous | 100 MG / ML | 12/31/1963 |
ARIDOL | 02489562 | Powder
,
Kit - Inhalation | 10 MG / CAP | 6/15/2020 | |
ARIDOL | 02489562 | Powder
,
Kit - Inhalation | 40 MG / CAP | 6/15/2020 | |
ARIDOL | 02489562 | Powder
,
Kit - Inhalation | 20 MG / CAP | 6/15/2020 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CELSIOR SOLUCION PARA LA CONSERVACION DE ORGANOS | Institut Georges Lopez | 73767 | SOLUCIÓN PARA CONSERVACIÓN DE ÓRGANOS | Uso Hospitalario | Commercialized |
OSMOFUNDINA 10% SOLUCIÓN PARA PERFUSION | B Braun Medical S.A. | 43559 | SOLUCIÓN PARA PERFUSIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
CORHUM SOLUCIÓN PARA CARDIOPLEJIA | S.A.L.F. S.P.A. Laboratorio Farmacologico | 89242 | SOLUCION PARA CARDIOPLEJIA | Uso Hospitalario | Not Commercialized |
CUSTODIOL SOLUCION PARA CARDIOPLEJIA Y PARA CONSERVACION DE ORGANOS | Dr. Franz Koehler Chemie Gmbh | 84838 | SOLUCION PARA CARDIOPLEJIA/CONSERVACION DE ORGANOS | Uso Hospitalario | Commercialized |
MANITOL MEIN 10% solución para perfusión | Fresenius Kabi España, S.A.U. | 42568 | SOLUCIÓN PARA PERFUSIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
OSMOHALE POLVO PARA INHALACION (CAPSULAS DURAS) | 69945 | POLVO PARA INHALACIÓN (CÁPSULA DURA) | Uso Hospitalario | Commercialized | |
BRONCHITOL 40 MG POLVO PARA INHALACION, CAPSULAS DURAS | 112760 | POLVO PARA INHALACIÓN (CÁPSULA DURA) | Uso Hospitalario | Commercialized | |
HIDROFUNDIN GLUCOSADO SOLUCION PARA PERFUSION | B Braun Medical S.A. | 69694 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
HIDROFUNDIN FISIOLOGICO SOLUCION PARA PERFUSION | B Braun Medical S.A. | 69695 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
MANITOL MEIN 20% solución para perfusión | Fresenius Kabi España, S.A.U. | 42569 | SOLUCIÓN PARA PERFUSIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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