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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)

Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. [2012]
osmotic agent, improves lung function and morbidity... CONCLUSIONS: Inhaled mannitol, 400 mg twice a day, resulted in improved lung

Mannitol and other osmotic diuretics as adjuncts for treating cerebral malaria. [2011.04.13]
CONCLUSIONS: There are insufficient data to know what the effects of osmotic diuretics are in children with cerebral malaria. Larger, multicentre trials are needed.

Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial. [2011.04]
BACKGROUND AND OBJECTIVE: There is no consensus concerning small bowel preparation before capsule endoscopy (CE). This study evaluated the effects of 4 regimens on small bowel cleansing and diagnostic yield... CONCLUSIONS: Small bowel preparation that involves split-dose oral mannitol plus single-dose simethicone for CE can improve mucosal visualization and subsequent diagnostic yield when compared with 10-hours overnight fasting.

Hypertonic saline versus mannitol for the treatment of elevated intracranial pressure: a meta-analysis of randomized clinical trials. [2011.03]
CONCLUSIONS: We found that hypertonic saline is more effective than mannitol for the treatment of elevated intracranial pressure. Our meta-analysis is limited by the small number and size of eligible trials, but our findings suggest that hypertonic saline may be superior to the current standard of care and argue for a large, multicenter, randomized trial to definitively establish the first-line medical therapy for intracranial hypertension.

Effect of intravenous mannitol in mobilization of resistant cirrhotic ascites. [2011.02]
INTRODUCTION: Cirrhotic ascites is conventionally treated with bed rest, salt restriction, and diuretics. In 20-30% of patients it eventually became resistant to diuretic therapy partly because of reduced sodium excretion owing to the development of resistance against atrial natriuretic peptide. Diuretics resistance can be overcome partially by increasing distal tubular sodium delivery by atrial natriuretic peptide and mannitol administration. OBJECTIVES: To determine the short-term response of intravenous mannitol administration on mobilization of resistant cirrhotic ascites in addition to conventional diuretic treatment... CONCLUSION: This study shows that resistant ascites can be initially mobilized by infusion of mannitol. The long-term benefits of such therapy are unknown.

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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.

Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis [Recruiting]
No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of CF, it failed to improve FEV1 in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis.

The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.

We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health.

Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily against control.

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%.

Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations [Recruiting]
The primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®), beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test.

The primary endpoint is to identify asthma patients responding positive or negative to the mannitol challenge test and/or the reversibility test.

The hypothesis is that not all patients are well treated.

Mannitol Versus Hypertonic Saline to Treat Intracranial Hypertension (ICHT) After Severe Traumatic Brain Injury (TBI) : Comparative Effects on PtiO2 and Microdialysis Values [Recruiting]
The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.

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Page last updated: 2013-02-10

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