General

**Off Market Drug**
This medication is no longer available in the United States. Information provided here is for reference purposes only.

Pronunciation:
mi-kon-a-zole

Trade Name(s)

• Oravig

Ther. Class.

antifungals

(oral, nonabsorbed)

Indications

Treatment of oropharyngeal candidiasis.

Action

Affects the permeability of the fungal cell wall, allowing leakage of cellular contents.

Therapeutic Effect(s):

Decrease in symptoms of oropharyngeal candidiasis.

Pharmacokinetics

Absorption: Minimal systemic absorption.

Distribution: Inhibitory concentrations remain in saliva for up to 7 hr after buccal application of tablet.

Metabolism and Excretion: .

Half-life: .

TIME/ACTION PROFILE

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity to miconazole or other components of formulation
• Systemic candidiasis.
• OB:  Pregnancy (may cause fetal harm)

Use Cautiously in:

• Hepatic impairment
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi:  Safety and effectiveness in children not established.

Adverse Reactions/Side Effects

CNS: headache

GI: abnormal mouth sensations, diarrhea, dry mouth, dysgeusia, ↑ liver function tests, nausea, vomiting

Derm: pruritis

Misc: ANAPHYLAXIS

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

May ↓ metabolism and ↑ risk of toxicity from  CYP3A4 substrates, including cyclosporine,  HMG-CoA reductase inhibitors, some  benzodiazepines  ( alprazolam,  midazolam,  triazolam ),  calcium channel blockers,  colchicine,  fentanyl,  sulfonylureas  ( glipizide,  glyburide ),  phenytoin,  tacrolimus, and  warfarin.

Route/Dosage

PO (Adults): One buccal tablet once daily for 14 days.

Availability

Buccal tablet: 50 mg

Assessment

• Assess oropharnyngeal mucosa prior to and periodically during therapy.

Lab Test Considerations:

Monitor hepatic function prior to and periodically during therapy. May cause ↑AST.

Potential Diagnoses

• Impairedoral mucous membrane (Indications) 

Implementation

• Buccal:  With dry hands apply rounded side of tablet to upper gum region, just above the incisor tooth. Hold tablet in place (with light pressure) over upper lip for 30 seconds to ensure adhesion. If tablet does not adhere or falls off within 6 hr, reposition immediately or replace with a new tablet if adhesion fails on repositioning. If tablet is swallowed within 6 hr of placement, drink a full glass of water and apply a new tablet; if tablet falls off or is swallowed after 6 hr from initial placement, wait to apply a new tablet until the next regularly scheduled dose. Alternate side of mouth with each tablet placement; clear away remains of old tablet before placing another tablet. Do not crush, chew, or swallow tablets. May take food or drink normally; avoid chewing gum.

Patient/Family Teaching

Instruct patient to take miconazole as directed. Describe application and what to do if tablet falls off or is swallowed.

Evaluation/Desired Outcomes

Decrease in symptoms of oropharyngeal candidiasis.