miconazole (oral)

Absorption: Minimal systemic absorption.

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

Metabolism/Excretion: .

Half-Life: .

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	up to 15 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to miconazole or other components of formulation (including milk protein);
Systemic candidiasis;
OB: Pregnancy.

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.

Adv. Reactions/Side Effects ⬆ ⬇

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

Derm: pruritis

Neuro: headache

Misc: ANAPHYLAXIS

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 oropharyngeal mucosa (pain or swelling) before and periodically during therapy.
Assess for allergic reactions (rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat) and hypersensitivity reactions (e.g., anaphylactic). Discontinue immediately if reaction occurs and implement appropriate care measures.

Lab Test Considerations:

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

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. DNC: Do not crush, chew, or swallow tablets. May take food or drink normally; avoid chewing gum.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient to take as directed. Describe application and what to do if tablet falls off or is swallowed.
Advise patient of allergic and hypersensitivity reactions. If they occur, notify a health care professional immediately and seek emergent medical attention if needed.
Advise patient to notify a health care professional of milk allergies before starting treatment.
Rep: May cause fetal harm. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in symptoms of oropharyngeal candidiasis.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

17337- Olon S.p.A.
- 17337-0529-
  - 17337-0529-0- 1 BAG in 1 DRUM (17337-0529-0) / 1 BAG in 1 BAG / 25 kg in 1 BAG

49452- Spectrum Laboratory Products, Inc.
- 49452-4723-
  - 49452-4723-1- 5 g in 1 BOTTLE, GLASS (49452-4723-1)

49452- Spectrum Laboratory Products, Inc.
- 49452-4723-
  - 49452-4723-2- 25 g in 1 BOTTLE, GLASS (49452-4723-2)

49452- Spectrum Laboratory Products, Inc.
- 49452-4723-
  49452-4723-3- 100 g in 1 BOTTLE, GLASS (49452-4723-3)

49452- Spectrum Laboratory Products, Inc.
- 49452-4723-
  49452-4723-4- 1000 g in 1 BOTTLE, GLASS (49452-4723-4)

51927- Professional Compounding Centers of America dba PCCA
- 51927-0102-
  51927-0102-0- 1 kg in 1 CONTAINER (51927-0102-0)

51927- Professional Compounding Centers of America
- 51927-0311-
  51927-0311-0- 1 kg in 1 BOTTLE (51927-0311-0)

51927- Professional Compounding Centers of America dba PCCA
- 51927-2094-
  51927-2094-0- 1 kg in 1 CONTAINER (51927-2094-0)

61825- Galt Pharmaceuticals, LLC
- 61825-303- Oravig
  61825-303-14- 14 TABLET in 1 BOTTLE (61825-303-14)

67777- Dynarex Corporation
- 67777-316- Dynarex Antifungal Powder
  - 67777-316-02- 24 BOTTLE, PLASTIC in 1 CASE (67777-316-02) / 85 g in 1 BOTTLE, PLASTIC (67777-316-01)

72742- Zen Chemicals Private Limited
- 72742-2500-
  - 72742-2500-2- 10 kg in 1 DRUM (72742-2500-2)

72742- Zen Chemicals Private Limited
- 72742-2500-
  72742-2500-3- 25 kg in 1 DRUM (72742-2500-3)

84722- VIVE HEALTH LLC
- 84722-3057- ANTIFUNGAL
  84722-3057-0- 1 g in 1 JAR (84722-3057-0)

84722- VIVE HEALTH LLC
- 84722-3060- ANTIFUNGAL
  - 84722-3060-0- 1 g in 1 TUBE (84722-3060-0)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇