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ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.
There is currently no drug history available for this drug.
ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [ see Clinical Pharmacology (12.3)].
Miconazole is an imidazole antifungal agent and is described chemically as 1-[(2RS)-2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole with an empirical formula of C 18H14Cl4N2O and a molecular weight of 416.13. The structural formula is shown in Figure 1.
Figure 1: Structural Formula of Miconazole
Miconazole drug substance is a white to almost white powder.
ORAVIG contains 50 mg of miconazole base, USP and the following inactive ingredients: hypromellose, USP; milk protein concentrate; corn starch, NF; lactose monohydrate, NF; sodium lauryl sulfate, NF; magnesium stearate, NF; and talc, USP.