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 CLINICALPHARMACOLOGY].

Miconazole is an imidazole antifungal agent and is described chemically as l-[(2RS)-2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-lH-imidazole with an empirical formula of C18H14Cl4N2O 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 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


Oravig Consumer (continued)

SIDE EFFECTS: Discomfort, sores, taste changes, or irritation/pain in the mouth may occur. Nausea, vomiting, diarrhea, abdominal pain, or headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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. Consult your doctor before breast-feeding.



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