Oravig

PATIENT INFORMATION

Oravig
(OR-a-vig)
(miconazole) Buccal Tablets

Read the Patient Information that comes with ORAVIG before you starttaking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor or about your medical condition or your treatment.

What is ORAVIG?

ORAVIG is a prescription antifungal medicine used in adults to treat fungal (yeast) infections of the mouth and the throat.

It is not known if ORAVIG is safe and effective in children under the age of 16 years. It is not known if children can follow the instructions on what to do with the buccal tablet. In younger children, there is a possible risk of choking.

Who should not use ORAVIG?

Do not use ORAVIG if you:

  • are allergic to miconazole (M-Zole, Monistat, Vusion)
  • are allergic to milk protein concentrate
  • are allergic to any of the ingredients in ORAVIG. See the end of this Patient Information leaflet for a complete list of ingredients inORAVIG

What should I tell my doctor before using ORAVIG?

Before taking ORAVIG, tell your doctor if you:

  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if ORAVIG will harm your unborn baby. Talk to your doctor if youare pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if ORAVIG passes into your breast milk. Talk to your doctor aboutthe best way to feed your baby if you use ORAVIG.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

ORAVIG may affect the way other medicines work, and other medicines may affect how ORAVIG works.

Especially tell your doctor if you take:

  • adiabetes medicine
  • phenytoin (Dilantin, Phenytek)
  • an ergot medicine. Ask your doctor or pharmacist if you are notsure if your medicine is an ergot medicine.
  • the blood thinner medicine warfarin sodium (Coumadin, Jantoven)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use ORAVIG?

  • Always use ORAVIG exactly as your doctor tells you. ORAVIG is usually applied in the morning after you brush your teeth.
  • ORAVIG is placed 1 time each day to your upper gum for 14 days.
  • You may eat and drink while using ORAVIG.
  • Do not crush, chew or swallow ORAVIG.
  • You should change where you place ORAVIG, between the left andright side of your upper gum with each use.
  • It is okay if ORAVIG sticks to your cheek, the inside of your lip or your gum. If ORAVIG does not stick or falls off of your gum within the first 6 hours, re-apply it. If it still does not stick, replace it with a new tablet.
  • If you swallow ORAVIG within the first 6 hours of placing, drink aglass of water and place a new ORAVIG to your gum.
  • If ORAVIG falls off or is swallowed after it was in place for 6 hours or more, do not apply a new ORAVIG. Just place your next dose atyour regular time.
  • Check to see if ORAVIG is still in place after you brush your teeth, rinse your mouth, eat, or drink.

How to use ORAVIG?

Before applying the tablet,

1. Locate the area on the upper gum, just above either theleft or the right incisor. The incisor tooth is the tooth just to the right or left of your two front teeth (See Figure A)

Figure A

Area where to place the tablet - Illustration

2. Take one ORAVIG tablet out of the bottle. ORAVIG is round on one side and flat on the other side (Figure B). The tablet is marked with an “L” on the flat side.

Figure B

Shape of Oravig tablets - Illustration

Applying the ORAVIG tablet,

3. Place the flat side of the ORAVIG tablet on your dry fingertip. Gently push the round side of the tablet against your upper gum in the area shown in figure C. Push theORAVIG tablet up as high as it will go on your gum. The flat side will be facing the inside of your lip.

Figure C

Applying the ORAVIG tablet - Illustration

4. Hold the ORAVIG tablet in place by applying a slight pressure with your finger on the outside of your upper lip for 30 seconds. This will make the tablet stick to your gum(See Figure D).

Figure D

Hold the ORAVIG tablet in place - Illustration

5. Leave the tablet in place until it dissolves.

6. Before applying your next dose, be sure to clear away any remaining ORAVIG tablet material.

What should I avoid while using ORAVIG?

You should avoid activities that may prevent ORAVIG from sticking to your gum, including:

  • touching or pressing ORAVIG after placement
  • wearing upper denture that interfere with placement of the tablet
  • chewing-gum.
  • hitting tablet when brushing your teeth
  • rinsing your mouth too vigorously

What are the possible side effects of ORAVIG?

ORAVIG may cause serious side effects, including:

Allergic reactions. Tell your doctor or get emergency medical help rightaway if you have any of the symptoms below:

  • skin rash or hives
  • swelling of your face, eyes, lips, tongue or throat
  • trouble swallowing or breathing

The most common side effects of ORAVIG include:

  • diarrhea
  • change in taste
  • headache
  • upper stomach (abdominal) pain
  • nausea
  • vomiting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ORAVIG. For more information, ask your doctor or pharmacist.

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

How should I store ORAVIG?

  • Store ORAVIG between 68 to 77°F (20 to 25°C)
  • Keep ORAVIG dry

Keep ORAVIG and all medicine out of the reach of children.

General information about the safe and effective use of ORAVIG

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use ORAVIG for a condition for which it was not prescribed. Do not give ORAVIG to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information Leaflet summarizes the most important information about ORAVIG. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ORAVIG that is written for health professionals. You can also visit www.oravig.com for more information.

What are the ingredients in ORAVIG?

Active ingredient: miconazole

Inactive ingredients: hypromellose, milk protein concentrate, corn starch, lactose monohydrate, sodium lauryl sulfate, magnesium stearate, and talc.

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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