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miconazole oral (Rx)Brand and Other Names:Oravig

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

buccal tablet

  • 50mg
more...

Oropharyngeal Candidiasis

Indicated for local treatment of oropharyngeal candidiasis

Apply 50 mg buccal tab to gum region qDay for 14 consecutive days

Buccal tablet designed to adhere to the gum; do not to crush, chew, or swallow the tablet

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 or older: As adults; Apply 50 mg buccal tab to gum region qDay for 14 consecutive days

Buccal tablet designed to adhere to the gum; do not to crush, chew, or swallow the tablet

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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

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

Mechanism of Action

Azole antifungal agent; inhibits enzyme cytochrome P450 14-alpha-demethylase resulting in ergosterol synthesis inhibition

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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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