Oravig

Avoid chewing gum while using this medication.

There may be other drugs that can interact with miconazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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
• are breastfeeding or plan to breastfeed

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

How to use Oravig Tablet:

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.

2.  Take one Oravig tablet out of the bottle. Oravig is round on one side and flat on the other side. 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 rounded side of the tablet against your upper gum. 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.

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.

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.

Oravig Tablet:

• 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.

If you take too much Oravig, call your local Poison Control Center or seek emergency medical attention right away.

• If you have an allergy to miconazole, milk, or any other part of Oravig (miconazole (oral)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Oravig as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Use in the morning after brushing teeth.
• Wash your hands before and after use.
• Dry your hands and place the tablet in your mouth above the incisor tooth between the upper cheek and gum. Let it melt during the day.
• Switch sides of your mouth each day when you place Oravig.
• Do not swallow whole. Do not chew, break, or crush.
• Either side of tablet may be placed next to the gum, but the rounded side may feel better.
• Do not chew gum.
• If the tablet does not stick to the gum or falls out within 6 hours, put the tablet back in.
• If you swallow the tablet within 6 hours, drink a glass of water and use a new tablet.
• If the tablet falls out or is swallowed after 6 hours, do not put back in until the next dose.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with miconazole have not been conducted.

Miconazole nitrate was not genotoxic when tested in vitro in a bacterial reverse mutation (Ames) assay or in an in vivo mouse bone marrow micronucleus test. Intraperitoneal injections of miconazole to mice induced chromosomal aberrations in spermatocytes and bone marrow cells, and morphologic abnormalities in sperm at doses similar to or below clinical doses. However, no impairment of fertility was observed in intravenous studies with miconazole at 40 mg/kg/day in rats or 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an Oravig buccal tablet, based on body surface area comparisons.

Animal Toxicology and/or Pharmacology

Local tolerance studies (LLNA sensitization test and tolerance study on the jugal mucosa of hamster) did not reveal any toxicity.