Why Oravig^® Tablet?

A number of factors make Oravig^® an effective delivery system for a drug treating candidiasis in the mouth; these include:

• It is a local treatment, delivering the drug directly at the site of infection.
• It offers once-daily dosing, morning application for treatment throughout the day.
• It adheres to the gum or cheek and remains in place throughout the day.
• Because it is a local treatment, there is less risk of drug-drug interaction.
• The miconazole is released into the saliva to treat the infection. A high salivary concentration of the drug is maintained, due to the prolonged local delivery.

How Oravig^® Works

Oravig^® has special ingredients that combine with the moisture in your mouth to help stick to your gum and slowly dissolve, releasing miconazole during the day to treat oral thrush.

Using Oravig^®

Dosing

Oravig^® is applied once daily for the treatment of oral thrush:

• 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 and right 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 a glass 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 at your regular time.
• Check to see if Oravig^® is still in place after you brush your teeth, rinse your mouth, eat, or drink.

Hypersensitivity and Side effects:

• Patients who develop hives, skin rash, or other symptoms of an allergic reaction, and patients who develop swelling or pain at the tablet application site should stop Oravig^® and contact a healthcare provider.
• Patients may experience other adverse reactions including diarrhea, headache, nausea, and change in taste.

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^®.

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 you are 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 about the best way to feed your baby if you use Oravig^®.

Storage

Oravig^® should be stored at 20° to 25°C (68° to 77°F); excursions between 15° and 30°C (59° to 86°F) permitted at room temperature. Protect from moisture and keep out of reach of children.

How to Apply Oravig^®

Before applying the tablet

1. Locate the area on the upper gum, just above either the left 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

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

Figure B

To apply 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 the Oravig^® tablet up as high as it will go on your gum. The flat side will be facing the inside of your lip.

Figure C

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

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.
7. Subsequent applications of Oravig^® should be made to alternate sides of the mouth.

F.A.Q.

Q: Should I discontinue Oravig^® if my symptoms subside?

A. No. Do not discontinue Oravig^® treatment prior to 14 days even if the signs and symptoms of the yeast infection begin to subside.

Q: Do I swallow Oravig^®?

A. No. Do not crush, chew, or swallow Oravig^®.

Q: What do I do if I accidentally swallow the tablet?

A. If you swallow Oravig^® within the first 6 hours of placing it, drink a glass of water and place a new Oravig^® tablet on your gum. If Oravig^® is swallowed after it was in place for 6 hours or more, do not apply a new Oravig^® tablet. Wait until your next regularly scheduled dose. Oravig’s active ingredient, miconazole, has minimal gastrointestinal absorption.

Q: When should I apply Oravig^®?

A. Oravig^® should be applied in the morning, after brushing your teeth.

Q: What do I do if Oravig^® falls off or comes loose?

A. If Oravig^® comes loose within 6 hours, try to reapply it. If the tablet still does not stick, apply a new tablet. If Oravig^® falls off after 6 hours, do not apply a new tablet. Wait until your next regularly scheduled dose.

Q: How long will Oravig^® stay in my mouth?

A. Oravig^® was designed to slowly dissolve during the day. In clinical studies, over half of Oravig^® tablets were still in place at 12 hours. However, this time will vary from person to person.

Q: Can I eat and drink while Oravig^® is in place?

A. Yes. You can eat and drink while taking Oravig^®. Always double check to see if Oravig^® is still in place after you brush your teeth, rinse your mouth, eat, or drink.

Q: How does Oravig^® stick to my gum?

A. Oravig^® has special ingredients that combine with the moisture in your mouth to help Oravig^® stick to your gum.

Q: How will using Oravig^® impact my daily routine?

A. Oravig^® is applied once per day, so there is no need for multiple daily doses. You will still be able to eat, drink, and go about your daily routine while the Oravig^® tablet is in place.

Q: Does Oravig^® taste or smell bad?

A. Oravig^® is flavorless and odorless.

What Pharmacies Carry Oravig^®?

Oravig^® is available at many independent and retail pharmacies. If you are unable to find this product locally, Sterling Specialty Pharmacy is able to mail to patients across the US. Should your healthcare provider choose to prescribe Oravig^®, click here to download an information sheet to give to them.

E-scribe #: 2433693
Pharmacy Name: Sterling Specialty Pharmacy, Mendota Heights, MN
Phone Number: 888-618-4126
Fax Number: 866-588-0371