Osmitrol (Mannitol) - Summary

OSMITROL SUMMARY

OSMITROL Injection (Mannitol Injection, USP)
in VIAFLEX Plastic Container
For Therapeutic Use Only

OSMITROL Injection (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of Mannitol, USP in a single dose container for intravenous administration. It contains no antimicrobial agents. Mannitol** is a six carbon sugar alcohol prepared commercially by the reduction of dextrose. Although virtually inert metabolically in humans, it occurs naturally in fruits and vegetables. Mannitol is an obligatory osmotic diuretic. The pH is adjusted with sodium hydroxide or hydrochloric acid.

OSMITROL Injection (Mannitol Injection, USP) is indicated for:

The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established;

The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass;

The reduction of elevated intraocular pressure when the pressure cannot be lowered by other means, and

Promoting the urinary excretion of toxic substances.

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NEWS HIGHLIGHTS

Published Studies Related to Osmitrol (Mannitol)

Forced euvolemic diuresis with mannitol and furosemide for prevention of contrast-induced nephropathy in patients with CKD undergoing coronary angiography: a randomized controlled trial. [2009.10]
BACKGROUND: Contrast-induced nephropathy is common in patients with coronary angiography. Mechanistically, forced euvolemic diuresis with mannitol and furosemide ought to prevent contrast-induced nephropathy. Our objectives are to: (1) undertake a randomized trial testing this hypothesis, and (2) conduct a meta-analysis of our findings with 2 earlier studies... CONCLUSIONS: Forced euvolemic diuresis led to a significantly increased risk of contrast-induced nephropathy. This strategy should be abandoned, and our results suggest that oral furosemide therapy perhaps should be held before angiography.

Effects of haemofiltration and mannitol treatment on cardiopulmonary-bypass induced immunosuppression. [2009.03]
Cardiac surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response... In the light of data showing that this depression of the immune response might affect the post-operative course of patients, these results could have a potential clinical relevance.

Sodium lactate versus mannitol in the treatment of intracranial hypertensive episodes in severe traumatic brain-injured patients. [2009.03]
OBJECTIVES: Traumatic brain injury (TBI) is still a major cause of mortality and morbidity. Recent trials have failed to demonstrate a beneficial outcome from therapeutic treatments such as corticosteroids, hypothermia and hypertonic saline. We investigated the effect of a new hyperosmolar solution based on sodium lactate in controlling raised intracranial pressure (ICP)... CONCLUSION: Acute infusion of a sodium lactate-based hyperosmolar solution is effective in treating intracranial hypertension following traumatic brain injury. This effect is significantly more pronounced than that of an equivalent osmotic load of mannitol. Additionally, in this specific group of patients, long-term outcome was better in terms of GOS in those receiving as compared to mannitol. Larger trials are warranted to confirm our findings.

Treatment of patients with complex regional pain syndrome type I with mannitol: a prospective, randomized, placebo-controlled, double-blinded study. [2008.08]
To assess the effects of intravenous administration of the free radical scavenger mannitol 10% on complaints associated with complex regional pain syndrome Type I (CRPS I), a randomized, placebo-controlled, double-blinded trial was performed. Forty-one CRPS I patients according to the Bruehl et al diagnostic criteria, were included in 2 outpatient pain clinics of 2 university medical centers and randomly assigned to receive either 10% mannitol iv in 1 L 0.9% NaCL in 4 hours for 5 consecutive days or equal volumes of 0.9% NaCL (placebo)...

The effect of mannitol on renal function after cardiopulmonary bypass in patients with established renal dysfunction. [2008.07]
The usefulness of mannitol in the priming fluid for cardiopulmonary bypass is uncertain in patients with normal renal function, and has not been studied in patients with established renal dysfunction. We studied 50 patients with serum creatinine between 130 and 250 micromol.l(-1) having cardiac surgery...

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Clinical Trials Related to Osmitrol (Mannitol)

Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis [Completed]
The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.

A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects [Completed]
The study has an open-label, randomized, crossover design, in which each subject will receive mannitol powder for inhalation using a dry powder inhaler with and without premedication with a bronchodilator, mannitol powder for inhalation in capsules administered orally, and mannitol in a commercial formulation designed for intravenous use.

Mannitol Dose Response Study in Cystic Fibrosis [Active, not recruiting]
Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.

Mannitol as Adjunct Therapy for Childhood Cerebral Malaria [Active, not recruiting]
Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection in African children and nonimmune travellers despite availability of quinine, the current drug of choice. Several reports have suggested that raised intracranial pressure (ICP) is a major cause of death among children with cerebral malaria. Mannitol, an osmotic diuretic, effectively lowers ICP and is used to treat post traumatic raised ICP. There have been some case reports of reduction in mortality and morbidity in African children with cerebral malaria following administration of mannitol, but as these were not randomized controlled trials it is difficult to evaluate their significance. This study seeks to establish whether a single dose of intravenous mannitol given to children with cerebral malaria will significantly reduce the coma recovery time.

Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough [Recruiting]
Chronic cough is defined by its persistence beyond 8 weeks. Many conditions can explain the existence of a bronchial inflammation. In the management of chronic cough, the search for bronchial hyperreactivity (HRB) is recommended. The treatment relies primarily on the prescription of inhaled corticosteroids. It has been shown recently that the existence of an HRB with Methacholine (bronchial provocation test used in routine) does predict the effectiveness of inhaled corticosteroid treatment in no more than 50% of cases.

It is now possible to assess the bronchial inflammation by rapid, non-invasive and reproducible tests such that the fraction of exhaled nitric oxide (FeNO) and bronchial provocation test with mannitol. In a retrospective study, it was shown that an increased value of FeNO (cut-off > 35 ppb) predicts a positive response to treatment with a sensitivity of 90% and a specificity of 80%.

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