Miconazole (vaginal)

FDA label, Actavis Pharma, Inc., vaginal, effective 2020-10-21. Full label on DailyMed

Patient handout

Looking up MedlinePlus…

From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Contraindications

Patients known to be hypersensitive to this drug.

Safety data

Reported adverse events (FAERS)

Loading
Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for miconazole (vaginal). Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Since imidazoles are absorbed in small amounts from the human vagina, they should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient. Clinical studies, during which miconazole nitrate vaginal cream and suppositories were used for up to 14 days, were reported to include 541 pregnant patients. Follow-up reports available in 471 of these patients reveal no adverse effects or complications attributable to miconazole nitrate therapy in infants born to these women.

Lactation

Nursing Mothers It is not known whether miconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when miconazole nitrate is administered to a nursing woman.

Breastfeeding (LactMed)

Because miconazole has poor absorption from the skin and vagina and has poor oral bioavailability, it is unlikely to adversely affect the breastfed infant, including after topical application to the nipples. However, miconazole ointment appears to have no advantage over lanolin for treating sore nipples during breastfeeding and a survey of members of the Academy of Breastfeeding Medicine found topical miconazole is rarely prescribed to nursing mothers to treat thrush. Any excess cream or ointment should be removed from the nipples before nursing. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.

Alternatives LactMed suggests considering:
Source: LactMed: Miconazole (NICHD, public domain)Revised Sep 19, 2022

Supply and cost

Drug shortage status

Loading

Recalls (last 24 months)

Loading

Therapeutic equivalence (Orange Book)

Loading

Price ladder

Not the price at the counter
Loading

These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

Products and NDCs

Loading

Recruiting clinical trials

Loading