Dosing & Uses
Dosage Forms & Strengths
buccal tablet
- 50mg
Oropharyngeal Candidiasis
Indicated for local treatment of oropharyngeal candidiasis
Apply 50 mg buccal tab to gum region qDay for 14 consecutive days
See Administration
Dosage Forms & Strengths
buccal tablet
- 50mg
Oropharyngeal Candidiasis
Indicated for local treatment of oropharyngeal candidiasis
<16 years: Safety and efficacy not established
≥16 years: Apply 50 mg buccal tab to gum region qDay for 14 consecutive days
See Administration
Adverse Effects
1-10%
Diarrhea (6%)
Nausea (4.6%)
Headache (5%)
Dysgeusia (2.9%)
Upper abdominal pain (2.5%)
Vomiting (2.5%)
Warnings
Contraindications
Hypersensitivity to drug, milk protein concentrate, or other excipients
Cautions
Allergic reactions, including anaphylactic reactions and hypersensitivity, reported with administration of miconazole products; discontinue immediately at first sign of hypersensitivity; there is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents; monitor patients with history of hypersensitivity to azoles
Drug interaction overview
- Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect; cases of bleeding and bruising following concomitant use of warfarin and topical, intravaginal, or oral miconazole reported; closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if this drug is administered concomitantly with warfarin; also monitor for evidence of bleeding
- No formal drug interaction studies have been performed; miconazole is a known inhibitor of CYP2C9 and CYP3A4; although the systemic absorption of miconazole following administration of this drug is minimal and plasma concentrations of miconazole are substantially lower than when given intravenously, the potential for interaction with drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics, phenytoin, or ergot alkaloids cannot be ruled out
Pregnancy & Lactation
Pregnancy
There are no available data on therapy use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; based on findings from animal data, therapy may cause fetal harm when administered to pregnant women
Animal data
- In animal reproduction studies, prolonged gestation, dystocia and/or increased number of resorptions were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits; advise pregnant women of potential risk to a fetus
Lactation
There is no available information on presence of drug in human milk, effects on breastfed child, or on milk production
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Azole antifungal agent; inhibits enzyme cytochrome P450 14-alpha-demethylase resulting in ergosterol synthesis inhibition
Pharmacokinetics
Mean maximum salivary concentration: (7 hr after application) 15 mcg/mL
Average saliva exposure: AUC 55.23 mcg-hr/mL
Plasma concentration: Below lower limit of quantification (even after 7 days)
Metabolism: Absorbed miconazole metabolized by liver (<1%); no active metabolites
Half-life: (following systemic administration) 24 hr
Administration
Buccal Administration
Do not crush, chew, or swallow tablet
Food and drink can be taken normally when buccal tablet is in place, but avoid chewing gum
Applying buccal tablet
- Apply buccal tablet in AM, after brushing the teeth
- The tablet should be applied with dry hands
- The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion
- Tablet is round on one side for comfort, but either side of the tablet can be applied to the gum
- Once applied, the tablet stays in position and gradually dissolves
- Subsequent applications should be made to alternate sides of the mouth
- Before applying the next tablet, the patient should clear away any remaining tablet material
Buccal tablet falls off or is swallowed
- Buccal tablet does not adhere or falls off within the first 6 hr: The same tablet should be repositioned immediately; if the tablet still does not adhere, a new tablet should be placed
- Buccal tablet is swallowed within the first 6 hr: The patient should drink a glass of water and a new tablet should be applied only once
- Buccal tablet falls off or is swallowed after it was in place for ≥6 hr: Apply a new tablet until the next regularly scheduled dose
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Oravig buccal - | 50 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
miconazole buccal
MICONAZOLE TABLET - BUCCAL
(mye-KON-a-zole)
COMMON BRAND NAME(S): Oravig
USES: This medication is used to treat fungal infection in the mouth or throat. Miconazole is known as an azole antifungal drug. It works by stopping the growth of fungus.
HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using miconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Use this medication by mouth as directed by your doctor, usually once daily in the morning, after brushing your teeth. Before applying the tablet, locate the area in your mouth at which to place the tablet. It should be placed at the upper gum, just above the left or right incisor tooth. The incisors are the teeth just to the left and right of your two front teeth. With dry hands, place one tablet in your mouth with the round side facing against your gum and gently push it into place. Remove your hand from inside your mouth and apply 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. Leave the tablet in place until it is dissolved (usually 6 hours or longer). You may eat and drink while using this medication. Do not crush, chew or swallow the tablet. Check if the tablet is still in place after you brush your teeth, rinse your mouth, eat, or drink. Before applying the next dose, clear away any remaining tablet pieces. Change sides of the mouth with each dose.It is okay if the tablet sticks to your gum, or to the inside of your lip or cheek. If it does not stick or if it falls off your gum within the first 6 hours, apply it again as directed. If it still does not stick, replace it with a new tablet. If you accidentally swallow the tablet within the first 6 hours after placement, drink a glass of water and apply a new dose to your gum.If it is 6 hours or longer after placement and the tablet falls off or is accidentally swallowed, do not apply a new dose. Just use your next dose at your usual time.Avoid activities that may prevent the buccal tablet from sticking to your gum, including touching or pressing the tablet after placement, wearing an upper denture that interferes with tablet placement, chewing gum, hitting the tablet when brushing your teeth, or rinsing your mouth too forcefully.Antifungals work best when the amount of medicine in your body is kept at a constant level. Use this drug at evenly spaced intervals.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Discomfort, sores, taste changes, or irritation/pain in the mouth may occur. Nausea, vomiting, diarrhea, abdominal pain, or headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using miconazole buccal tablets, tell your doctor or pharmacist if you are allergic to miconazole; or if you have any other allergies. This product may contain inactive ingredients (such as milk protein concentrate), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: warfarin.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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