Butoconazole

FDA label, Padagis Israel Pharmaceuticals Ltd, vaginal, effective 2023-06-01. Full label on DailyMed

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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

CONTRAINDICATIONS GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for butoconazole. Check the label's hepatic warnings.

Source: LiverTox, NIDDK

Pregnancy and lactation

Pregnancy

Pregnancy:

Lactation

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

Breastfeeding (LactMed)

Vaginal butoconazole has not been studied during breastfeeding. About 5.5% of a vaginal dose is absorbed and its plasma half-life is 21 to 24 hours. Because there is no published experience with butoconazole during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.

Alternatives LactMed suggests considering:
Source: LactMed: Butoconazole (NICHD, public domain)Revised Oct 31, 2018

Supply and cost

Drug shortage status

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Source: FDA Drug Shortages Database via openFDA

Recalls (last 24 months)

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Source: FDA Enforcement Reports via openFDAFDA recalls and safety alerts

Therapeutic equivalence (Orange Book)

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Source: FDA Orange Book data filesSearch the Orange Book

Price ladder

Not the price at the counter
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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.

VA Federal Supply ScheduleCMS NADACMedicare Part D plan filesMedicaid State Drug Utilization Data

Products and NDCs

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Recruiting clinical trials

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Source: ClinicalTrials.gov API (NLM)Search on ClinicalTrials.gov