Oravig
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Oravig Manufacturers
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Dara Biosciences, Inc.
![Oravig (Miconazole) Tablet [Dara Biosciences, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Oravig | Dara Biosciences, Inc.
2.1 Basic Dosing InformationThe recommended dosing schedule for ORAVIG is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days.
2.2 Administration InstructionsORAVIG should be applied in the morning, after brushing the teeth. The tablet should be applied with dry hands. The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. The tablet is round on one side for comfort, but either side of the tablet can be applied to the gum.
Once applied, ORAVIG stays in position and gradually dissolves. [ See Clinical Pharmacology (12.3)] Subsequent applications of ORAVIG should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away any remaining tablet material. In addition,
ORAVIG should not be crushed, chewed or swallowed. Food and drink can be taken normally when ORAVIG is in place but chewing gum should be avoided. If ORAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet still does not adhere, a new tablet should be placed. If ORAVIG is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied only once. If ORAVIG falls off or is swallowed after it was in place for 6 hours or more, a new tablet should not be applied until the next regularly scheduled dose. [See Patient Counseling Information (17)]. -
Praelia Pharmaceuticals Inc
Oravig | Praelia Pharmaceuticals Inc
2.1 Basic Dosing InformationThe recommended dosing schedule for ORAVIG is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days.
2.2 Administration InstructionsORAVIG should be applied in the morning, after brushing the teeth. The tablet should be applied with dry hands. The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. The tablet is round on one side for comfort, but either side of the tablet can be applied to the gum.
Once applied, ORAVIG stays in position and gradually dissolves. [ See Clinical Pharmacology (12.3)] Subsequent applications of ORAVIG should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away any remaining tablet material. In addition,
ORAVIG should not be crushed, chewed or swallowed. Food and drink can be taken normally when ORAVIG is in place but chewing gum should be avoided. If ORAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet still does not adhere, a new tablet should be placed. If ORAVIG is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied only once. If ORAVIG falls off or is swallowed after it was in place for 6 hours or more, a new tablet should not be applied until the next regularly scheduled dose. [See Patient Counseling Information (17)].
![Oravig (Miconazole) Tablet [Praelia Pharmaceuticals Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ef3b205e-8526-48a0-afce-ddcef865d907&name=oravig-6.jpg)
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