miconazole oral (Rx)

Brand and Other Names:Oravig
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Dosing & Uses

AdultPediatric

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

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Adverse Effects

1-10%

Diarrhea (6%)

Nausea (4.6%)

Headache (5%)

Dysgeusia (2.9%)

Upper abdominal pain (2.5%)

Vomiting (2.5%)

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Warnings

Contraindications

Hypersensitivity to miconazole or other components

Milk protein allergy

Cautions

Monitor closely in patients with history or allergic reaction to other azole antifungals; discontinue immediately at first sign of hypersensitivity

No formal drug interaction studies have been performed with miconazole buccal administration

Coadministration of miconazole (topical, intravaginal, oral administration) with warfarin has resulted in enhancement of anticoagulant effect; closely monitor for evidence of bleeding, prothrombin time, and INR

Known CYP2C9 and CYP3A4 inhibitor; although the systemic absorption is minimal and plasma concentrations are substantially lower than when given IV, the potential for interaction with drugs metabolized via CYP2C9 and CYP3A4 (eg, oral hypoglycemics, phenytoin, ergot alkaloids) cannot be ruled out

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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.

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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

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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
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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Oravig buccal
-
50 mg tablet

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
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 (usually 14 days), even if symptoms disappear after a few days. Stopping the medication too early may allow fungus to continue to grow, which may result in a return of the infection.Tell your doctor if your condition persists or worsens.

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 persist or worsen, 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 August 2021. Copyright(c) 2021 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.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.