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Oravig (Miconazole) - Summary

 
 



ORAVIG SUMMARY

ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves. Miconazole is an imidazole antifungal agent.

ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.


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NEWS HIGHLIGHTS

Published Studies Related to Oravig (Miconazole)

Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp. [2014]
the treatment of scalp seborrheic dermatitis... CONCLUSIONS: Miconazole shampoo is at least as effective and safe as ketoconazole

Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp. [2014]
the treatment of scalp seborrheic dermatitis... CONCLUSIONS: Miconazole shampoo is at least as effective and safe as ketoconazole

Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis. [2011.05]
Sertaconazole is a new antifungal agent. To compare the efficacy and tolerability of sertaconazole and miconazole cream in cutaneous dermatophytosis, this prospective, randomized, multicentric comparative, phase 4 study was undertaken in 260 patients with cutaneous dermatophytosis after approvals from Institutional Ethics Committees...

Miconazole oral gel increases exposure to oral oxycodone by inhibition of CYP2D6 and CYP3A4. [2011.03]
Our aim was to assess the effect of miconazole oral gel on the pharmacokinetics of oral oxycodone. In an open crossover study with two phases, 12 healthy volunteers took a single oral dose of 10 mg of immediate-release oxycodone with or without thrice-daily 85-mg miconazole oral gel treatment... Miconazole oral gel produces a rather strong inhibitory effect on CYP2D6, which deserves further study.

Randomized, comparative, double-blind, double-dummy, multicenter trial of miconazole buccal tablet and clotrimazole troches for the treatment of oropharyngeal candidiasis: study of miconazole Lauriad(R) efficacy and safety (SMiLES). [2010.07]
BACKGROUND: Oropharyngeal candidiasis (OPC) is the most common opportunistic infection among persons infected with human immunodeficiency virus (HIV). Once-daily miconazole 50 mg buccal tablet (MBT) is a novel delivery system using an extended-spectrum azole with potent in vitro activity against many Candida species, including some that may be resistant to other azoles... CONCLUSIONS: In this large trial, once-daily MBT was shown to be noninferior to CT 5 times daily in the treatment of OPC in HIV-positive patients. MBT offers an effective, safe, and well-tolerated topical treatment option for OPC administered as a convenient once-daily dose.

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Clinical Trials Related to Oravig (Miconazole)

Clinical Trial of Hydroquinone Versus Miconazol in Melasma [Recruiting]
Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%), and the other group topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 30. The purpose of this study is determine if there is a difference in the effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.

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).

Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans [Completed]
The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole when used as a vaginal suppository in young women. The investigators want to know if the uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).

Antifungal Use in Oncohematological Neutropenic Patients [Completed]

Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin UltraŽ & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis [Completed]
The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin UltraŽ (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).

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Page last updated: 2015-08-10

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