Oravig

ORAVIG
(miconazole) Buccal Tablets

Oravig

DRUG DESCRIPTION

ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [see CLINICAL PHARMACOLOGY].

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 empiricalformula of C18H14CI4N2O and a molecular weight of 416.13. The structural formula is shown in Figure 1.

Figure 1: Structural Formula of Miconazole

ORAVIG (miconazole)  Structural Formula Illustration

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 are the possible side effects of miconazole buccal (ORAVIG)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe burning or pain in your mouth;
  • new sores in your mouth or on your tongue;
  • tooth problems;
  • pain or swelling in your gums; or
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Less serious side effects may include:

  • decreased sense of...

Read All Potential Side Effects and See Pictures of Oravig »

What are the precautions when taking miconazole buccal tablets (Oravig)?

Before using miconazole buccal tablets, tell your doctor or pharmacist if you are allergic to miconazole; or if you have any other allergies. This product may contain inactive ingredients (such as milk protein concentrate), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk....

Read All Potential Precautions of Oravig »

Last reviewed on RxList: 3/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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