Oravig

What is Oravig?

• Oravig (miconazole) is an azole antifungal used for the treatment of oropharyngeal candidiasis.

Miconazole

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Miconazole ball-and-stick

What are the uses of this medicine?

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

Limitations of use:

• 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.

How does this medicine work?

• Miconazole is an antifungal drug.
• Miconazole inhibits the enzyme cytochrome P450 14α-demethylase which leads to inhibition of ergosterol synthesis, an essential component of the fungal cell membrane.

Miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes, increasing the amount of reactive oxygen species within the cell.

Who Should Not Use this medicine ?

This medicine cannot be used in patients are allergic to:

• miconazole (M-Zole, Monistat, Vusion).
• milk protein concentrate.
• any of the ingredients in ORAVIG.

What drug interactions can this medicine cause?

• Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if ORAVIG is administered concomitantly with warfarin. Also monitor for evidence of bleeding.

Is this medicine FDA approved?

• Initial U.S. Approval: January 1974

How should this medicine be used?

Recommended dosage:

• Application of one ORAVIG 50 mg buccal tablet to the gum region once daily for 14 consecutive days.
• Instruct patients not to crush, chew, or swallow tablets.

Administration:

• Always use ORAVIG exactly as your doctor tells you.
• You should apply ORAVIG in the morning after you brush your teeth.
• ORAVIG is placed 1 time each day to your upper gum for 14 days.
• You should use ORAVIG right away after you remove it from the bottle.
• You may eat and drink normally while ORAVIG is in place.
• 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, re-apply it to the other side of your upper gum.
• If ORAVIG does not stick or falls off of your gum within the first 6 hours, re-apply the same tablet to the other side of your upper gum right away. If it still does not stick, replace it with a new tablet.
• If you swallow ORAVIG within the first 6 hours of placing it, drink a glass of water and place a new ORAVIG to your upper gum only 1 time.
• If ORAVIG falls off your gum 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 regularly scheduled time.
• Check to see if ORAVIG is still in place after you brush your teeth, rinse your mouth, eat, or drink.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 50 mg buccal tablets

This medicine is available in fallowing brand namesː

• ORAVIG

What side effects can this medication cause?

The most common side effects of this medicine include:

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

ORAVIG may cause serious side effects, including: Allergic reactions:

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

What special precautions should I follow?

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

• touching or pressing ORAVIG after placement
• wearing an upper denture that interferes with placement of the tablet
• chewing gum
• hitting tablet when brushing your teeth
• rinsing your mouth too vigorously
• Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole products, including ORAVIG. Discontinue ORAVIG immediately at the first sign of hypersensitivity.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Overdose with miconazole in humans has not been reported in the literature.

Treatment of overdosage:

• Symptomatic and supportive care is the basis for management.

Can this medicine be used in pregnancy?

• Based on findings from animal data, ORAVIG may cause fetal harm when administered to pregnant women.
• There are no available data on ORAVIG use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness of ORAVIG in pediatric patients below the age of 16 years have not been established.
• Use in younger children is not recommended due to potential risk of choking.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

• Manufactured By: Catalent Germany Schorndorf GmbH
• Steinbeisstraße 1-2 73614 Schorndorf Germany

• Distributed by: Fortovia Therapeutics Inc.

Colonnade Center Drive, Suite 101 Raleigh, NC

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Oravig
• FDA Oravig

Oravig Resources
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