Adult Dosing

Oropharyngeal candidiasis

• Apply 50 mg tab to gum region qday x 14 consecutive days
• Do not to crush, chew, or swallow the tablet

Pediatric Dosing

• Safety and efficacy have not been established in patients <16 years of age

[Outline]

• Adult Dosing
• Pediatric Dosing

• Oropharyngeal candidiasis

• Hypersensitivity to any of the ingredients in the product
• Hypersensitivity to milk protein concentrate

• N/A

Renal dose adjustment

• Use with caution; dose adjustments not defined

Hepatic dose adjustment

• Use with caution; dose adjustments not defined

• Hypersensitivity reactions such as anaphylactic reactions have been associated with e administration of miconazole products. Discontinue immediately at the first sign of hypersensitivity
• Coadministration of miconazole with warfarin has resulted in enhancement of anticoagulant effect; closely monitor for evidence of bleeding, prothrombin time, and INR
• Overall local adverse reactions, including oral discomfort, oral burning, oral pain, gingi­val pain, gingival swelling, gingival pruritis, tongue ulceration, mouth ulceration, glosso­dynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and altered taste have been reported with miconazole buccal tablets

Caution: Use cautiously in

• Hepatic impairment
• Renal impairment
• Breastfeeding

Oravig interacts with :

	Acenocoumarol
	Amaryl
	Avandia
	Chlorpropamide
	Coumadin
	DiaBeta
	Diabinese
	Glimepiride
	Glipizide
	Glucotrol
	Glucotrol XL
	Glyburide
	Glynase
	Jantoven
	Nateglinide
	Orinase
	Rosiglitazone
	Starlix
	Tolbutamide
	Warfarin

Pregnancy Category:C

Breastfeeding: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when s administered to a nursing woman.

• CNS: Headache, ageusia, fatigue
• GI: Diarrhea, nausea, vomiting, dry mouth, abdominal upper pain, gastroenteritis
• RESP: Upper respiratory infection, cough, pharyngeal pain
• HEMA: Anemia, lymphopenia, neutropenia
• MUSC: Pain
• LAB TESTS: Increased gamma-glutamyl transferase (GGT)

• Azole antifungal agent; inhibits enzyme cytochrome P450 14-alpha-demethylase resulting in ergosterol synthesis inhibition which is an essential component of the fungal cell membrane
• Metabolism: Absorbed miconazole metabolized by liver (<1%); no active metabolites
• Excretion: Excreted unchanged in urine
• Half-life: 24 hours

US Trade Name(s)

• Oravig

US Availability

Oravig

• TABS: 50 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Loramyc

UK Availability

Loramyc

• TABS: 50 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Miscellaneous

Uncategorized Agents

Drug Name: Oravig 50 MG Buccal Tablet

Ingredient(s): Miconazole

Imprint: L

Color(s): White

Shape: Round

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): hypromellose / starch, corn / lactose monohydrate / sodium lauryl sulfate / magnesium stearate / talc / casein

Drug Label Author:
Par Pharmaceuticals Companies, Inc.

DEA Schedule:
Non-Scheduled