miconazole oral (Rx)

Brand and Other Names:Oravig
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

buccal tablet

  • 50mg
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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
more...

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 Category: C

Lactation: Unknown whether distributed in breast milk, caution advised

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

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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.