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ORAVIG

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Overview

What is ORAVIG?

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 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 HClNO and a molecular weight of 416.13. The structural formula is shown in Figure 1.

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.



What does ORAVIG look like?



What are the available doses of ORAVIG?

50 mg buccal tablets ( ).

What should I talk to my health care provider before I take ORAVIG?

How should I use ORAVIG?

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

The 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.


What interacts with ORAVIG?

Sorry No Records found


What are the warnings of ORAVIG?

Sorry No Records found


What are the precautions of ORAVIG?

Sorry No Records found


What are the side effects of ORAVIG?

Sorry No records found


What should I look out for while using ORAVIG?

ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product.


What might happen if I take too much ORAVIG?

Overdose with miconazole in humans has not been reported in the literature.

Miconazole absorption and systemic exposure following application of ORAVIG are minimal [ ()].

Symptomatic and supportive care is the basis for management.


How should I store and handle ORAVIG?

Protect from light. Store in a safe place out of the reach of children.Protect from light. Store in a safe place out of the reach of children.Protect from light. Store in a safe place out of the reach of children.Protect from light. Store in a safe place out of the reach of children.Protect from light. Store in a safe place out of the reach of children.Protect from light. Store in a safe place out of the reach of children.Protect from light. Store in a safe place out of the reach of children.ORAVIG 50 mg buccal tablets are supplied as off-white tablets containing 50 mg of miconazole. ORAVIG tablets have a rounded side and a flat side. ORAVIG tablets are packaged in bottles of 14 tablets (NDC 89141-250-14).ORAVIG should be stored at 20 to 25°C (68 to 77 °F) [see USP controlled room temperature]; excursions between 15 and 30°C permitted at room temperature. Protect from moisture, and keep out of reach of children.ORAVIG 50 mg buccal tablets are supplied as off-white tablets containing 50 mg of miconazole. ORAVIG tablets have a rounded side and a flat side. ORAVIG tablets are packaged in bottles of 14 tablets (NDC 89141-250-14).ORAVIG should be stored at 20 to 25°C (68 to 77 °F) [see USP controlled room temperature]; excursions between 15 and 30°C permitted at room temperature. Protect from moisture, and keep out of reach of children.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Miconazole is an antifungal drug [ ()].

Non-Clinical Toxicology
ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product.

Aminoglutethimide:

Amphotericin B injection and potassium-depleting agents:

Antibiotics:

Anticholinesterases:

Anticoagulants, oral:

Antidiabetics:

Antitubercular drugs:

Cholestyramine:

Cyclosporine:

Digitalis glycosides:

Estrogens, including oral contraceptives:

Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin):

Ketoconazole:

Nonsteroidal anti-inflammatory drugs (NSAIDs):

Skin tests:





Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole products, including ORAVIG. Discontinue ORAVIG immediately at the first sign of hypersensitivity.

There is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.

The following serious adverse drug reactions are discussed in detail in other sections of labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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