VUSION SUMMARY
VUSIONTM
(0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) Ointment
Rx only.
FOR TOPICAL USE ONLY.
NOT FOR OPTHALMIC, ORAL, OR INTRAVAGINAL USE.
VUSION Ointment contains the synthetic antifungal agent, miconazole nitrate (0.25%), zinc oxide (15%) and white petrolatum (81.35%) for topical use.
VUSION Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.
VUSION Ointment should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.
VUSION Ointment should not be used as a substitute for frequent diaper changes. VUSION Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.
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NEWS HIGHLIGHTSMedia Articles Related to Vusion (Miconazole Nitrate / Zinc Oxide / White Petrolatum Topical)
Contact Dermatitis
Source: MedicineNet Allergy Specialty [2013.03.28]
Title: Contact Dermatitis
Category: Diseases and Conditions
Created: 3/28/2013 5:49:00 PM
Last Editorial Review: 3/28/2013 5:49:47 PM
Atopic Dermatitis
Source: MedicineNet betamethasone dipropionate Specialty [2012.08.03]
Title: Atopic Dermatitis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/3/2012 12:00:00 AM
Eczema (Atopic Dermatitis) Pictures Slideshow: Causes, Symptoms and Treatment
Source: MedicineNet Skin Test For Allergy Specialty [2012.03.26]
Title: Eczema (Atopic Dermatitis) Pictures Slideshow: Causes, Symptoms and Treatment
Category: Slideshows
Created: 3/26/2012 12:00:00 AM
Last Editorial Review: 3/26/2012 12:00:00 AM
Seborrheic Dermatitis
Source: MedicineNet ciclopirox Specialty [2012.03.16]
Title: Seborrheic Dermatitis
Category: Diseases and Conditions
Created: 3/16/2012 5:47:00 PM
Last Editorial Review: 3/16/2012 5:47:54 PM
Picture of Atopic Dermatitis
Source: MedicineNet pimecrolimus Specialty [2010.12.15]
Title: Picture of Atopic Dermatitis
Category: Images
Created: 12/15/2010 6:54:00 PM
Last Editorial Review: 12/15/2010 6:54:33 PM
Published Studies Related to Vusion (Miconazole Nitrate / Zinc Oxide / White Petrolatum Topical)
Topical miconazole nitrate ointment in the treatment of diaper dermatitis complicated by candidiasis. [2006.02]
Diaper dermatitis (DD) complicated by candidiasis is a common problem in diaper-wearing infants and children. We report a double-blind, vehicle-controlled, parallel-group study evaluating the efficacy and safety of a low concentration of miconazole nitrate in a zinc oxide/petrolatum ointment for the treatment of DD complicated by candidiasis...
Clinical Trials Related to Vusion (Miconazole Nitrate / Zinc Oxide / White Petrolatum Topical)
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo [Recruiting]
The purpose of this study is to determine if people with moist, red, patches on their skin
in body folds would benefit treatment of those areas with an FDA-approved drug called
Vusion.
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients [Completed]
The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg
(1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days
of treatment (at the test of cure visit, at Day 17-19).
Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) [Completed]
To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches
(lozenges) as prophylaxis (preventive treatment) against fungal infections in patients
enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and
serious bacterial infection). Primarily, to compare the rates of invasive infections by C.
neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal
infections between two antifungal prophylactic treatments. Secondarily, to assess the effect
of prophylaxis on the incidence of severe fungal infections, defined as invasive infections
and esophageal candidiasis and less severe mucocutaneous infection.
Serious fungal infections are significant complicating and life-threatening occurrences in
patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such
patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly,
esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and
coccidioidomycosis also cause significant illness and death in AIDS patients. Once
established, fungal infections in AIDS patients generally require continuous suppressive
therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has
a number of characteristics that would make it a logical candidate to examine as a
prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to
be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and
coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis
appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans [Recruiting]
The purpose with this study, is to study the uptake of the pharmaceutical antifungal
miconazole when used as a vaginal suppository in young women. We want to know if the uptake
is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches [Not yet recruiting]
Background: Oral candidiasis is most frequently found among the elderly .It is accompanied
with oral pain, irritation, burning sensation. In addition, the altered taste sensation may
cause nutrition compromise, which may affect ones diet. Management of superficial oral
Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is
given five times per day with instruction to slowly suck on it with out the dentures.
Working hypothesis and aims: Management of oral candidiasis is feasible. The major
disadvantage of the mode of action now days is the substantively of the drug in the oral
cavity and patient compliance. A sustained release varnish which is easily applied on the
dentures, which also release the anti fungal drug for at least a day, may overcome some of
the pit falls of the treatment applied today.
Based on our past experience, in developing local sustained release varnishes for dental
use, we anticipate that we can also formulate a special anti fungal sustained release
varnish which will fit the special and unique needs of the elderly population.
Methods: Sustained release varnish will be developed in our laboratory. The kinetics of
release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The
formulation showing the optimal results will be tested on human subjects with oral
candidiasis. The efficacy of the varnish will be examined clinically (reduction in
symptoms), microbiology (reduction of oral fungal), pharmaceutically (release kinetics in
vivo).
Expected results: The clinical out come of one time varnish application will be improved
compared to the five times application of lozenges (used today). The severity of the
disease should decrease and the healing period should be shorten drastically.
Importance: This is a novel pharmaceutical development of a local application of a dental
varnish designed specially to the elderly population
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