(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
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
- 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,
Know the medicines you take.
Keep a list of them to show your doctor and pharmacist when you get a new
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
- 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
- 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)
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.
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
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
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
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
- 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
- change in taste
- upper stomach (abdominal) pain
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
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
Active ingredient: miconazole
Inactive ingredients: hypromellose, milk protein concentrate, corn starch,
lactose monohydrate, sodium lauryl sulfate, magnesium stearate, and talc.