Drug Guide

Generic Name

Butoconazole Nitrate

Brand Names Femstat, Femstat 3, Gynazole-1

Classification

Therapeutic: Antifungal (Antimycotic)

Pharmacological: Imidazole antifungal

FDA Approved Indications

  • Vaginal candidiasis (vaginal yeast infection)

Mechanism of Action

Butoconazole inhibits lanosterol 14α-demethylase, an enzyme in the fungal cytochrome P450 system, leading to decreased ergosterol synthesis, an essential component of fungal cell membranes. This results in increased fungal cell membrane permeability and cell death.

Dosage and Administration

Adult: One 2 g vaginal cream or suppository once daily for 3 days.

Pediatric: Use is not established in pediatric patients.

Geriatric: No specific dosage adjustments; however, monitor for any topical irritation.

Renal Impairment: No specific adjustments; systemic absorption is minimal.

Hepatic Impairment: No specific adjustments; topical application results in minimal systemic absorption.

Pharmacokinetics

Absorption: Minimal absorption when used vaginally.

Distribution: Primarily localized to the vaginal tissues; systemic distribution is negligible.

Metabolism: Metabolized in the liver when systemically absorbed, but minimal systemic absorption occurs.

Excretion: Primarily fecal and urinary excretion of metabolites.

Half Life: Not applicable for topical use due to minimal systemic absorption.

Contraindications

  • Hypersensitivity to butoconazole or other imidazole antifungals.

Precautions

  • Use with caution in patients with a history of hypersensitivity reactions to azole antifungals.

Adverse Reactions - Common

  • Vaginal irritation (Common)
  • Vulvar burning or itching (Common)
  • Headache (Uncommon)

Adverse Reactions - Serious

  • Allergic reactions including rash, edema, or anaphylaxis (Rare)

Drug-Drug Interactions

  • None significant due to minimal systemic absorption.

Drug-Food Interactions

  • None established.

Drug-Herb Interactions

  • None established.

Nursing Implications

Assessment: Assess for signs of vaginal infection prior to treatment.

Diagnoses:

  • Risk for infection related to imbalance in normal flora.

Implementation: Apply vaginal cream or suppository as directed, typically at bedtime. Emphasize Correct administration technique.

Evaluation: Monitor symptom resolution and assess for adverse reactions.

Patient/Family Teaching

  • Use medication exactly as prescribed.
  • Complete full course of therapy.
  • Report any adverse reactions or worsening symptoms.
  • Avoid douching or using tampons during treatment.

Special Considerations

Black Box Warnings: N/A

Genetic Factors: N/A

Lab Test Interference: No known significant interference with lab tests.

Overdose Management

Signs/Symptoms: No specific overdose symptoms due to topical use.

Treatment: Supportive care as needed; none specific.

Storage and Handling

Storage: Store at room temperature, away from moisture and heat.

Stability: Stable until expiration date printed on packaging.

This guide is for educational purposes only and is not intended for clinical use.