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)
Effect of mannitol on postreperfusion cardiac output and central venous oxygen
saturation during orthotopic liver transplant: a double-blind randomized clinical
trial. [2014]
central venous oxygen saturation... CONCLUSION: Infusion of mannitol 1 g/kg during the anhepatic phase was effective
Effect of mannitol on postreperfusion cardiac output and central venous oxygen
saturation during orthotopic liver transplant: a double-blind randomized clinical
trial. [2014]
central venous oxygen saturation... CONCLUSION: Infusion of mannitol 1 g/kg during the anhepatic phase was effective
Pooled analysis of two large randomised phase III inhaled mannitol studies in
cystic fibrosis. [2013]
subgroups of a large global CF population... CONCLUSIONS: Sustained six-month improvements in lung function and decreased
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.
Clinical Trials Related to Osmitrol (Mannitol)
A Comparative Bronchial Provocation Study With Mannitol and Methacolinie in a Korean Population [Completed]
Asthmatic patients and non-asthmatic controls were recruited prospectively from four
referral hospitals in Korea. Participants were challenged with each of methacholine and
mannitol inhalation on different days. Their diagnostic utility was evaluated by calculating
their sensitivity and specificity for asthma diagnosis. Response-dose-ratio was also
compared.
Mannitol Brain Relaxation Effect [Recruiting]
Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical
field, especially in large size or with brain edema, it is necessary to decrease brain
volume to facilitate surgical approach. In general, 0. 25 - 1. 5g of mannitol per kilogram has
been known to decrease ICP effectively. But there are some debates in regard to appropriate
dose of mannitol.
Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough [Completed]
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 Cream for Post Herpetic Neuralgia [Not yet recruiting]
30% mannitol cream has shown its ability to reduce the activation of the Capsaicin (TRPV1)
(Transient Receptor Potential Vanilloid 1) receptor, a likely cause of the pain of
post-herpetic neuralgia (PHN). This randomized placebo-controlled crossover study compares
PHN pain one week before, for one week on the randomly assigned mannitol versus placebo
cream and, after a three day washout, for one week on the other cream. Following this
crossover study, participants receive mannitol cream for three months, and ,on request, for
a further 9 months. Pain levels and pain area will be checked to assess whether continued
use of this cream significantly reduces the pain levels and the area of pain associated with
PHN.
Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 Years [Active, not recruiting]
It is hypothesised that inhaled mannitol 400 mg b. d. will lead to a significant improvement
in the absolute change in percentage of predicted FEV1 from baseline following eight-weeks
of trial treatment compared to treatment with inhaled placebo b. d.
Any improvement in FEV1 is considered clinically meaningful; however, this trial has set a
threshold of 3% for the purposes of determining an appropriate sample size for statistical
power whilst retaining trial feasibility in an orphan disease population.
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