Nurses Compass
Drug Guide
Oteseconazole
Classification
Therapeutic: Antifungal
Pharmacological: Triazole antifungal
FDA Approved Indications
- Treatment of recurrent vulvovaginal candidiasis (RVVC) in women of reproductive age who are planning pregnancy or are pregnant
Mechanism of Action
Oteseconazole inhibits the fungal enzyme lanosterol 14α-demethylase, a key enzyme in ergosterol biosynthesis, leading to impaired fungal cell membrane synthesis and cell death.
Dosage and Administration
Adult: 300 mg orally once daily for 3 days; may repeat dose if necessary as per clinician guidance.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dosage adjustment required; use with caution as per general geriatric guidelines.
Renal Impairment: No specific adjustment required.
Hepatic Impairment: Use with caution; no specific dosage adjustment established.
Pharmacokinetics
Absorption: Well absorbed orally, with food not significantly affecting absorption.
Distribution: Extensively distributed; protein binding approximately 99%.
Metabolism: Metabolized primarily via hepatic pathways involving CYP3A4.
Excretion: Primarily excreted in feces, with minor renal excretion.
Half Life: Approximately 56 hours.
Contraindications
- Hypersensitivity to oteseconazole or other azole antifungals.
Precautions
- Use with caution in patients with hepatic impairment; monitor liver function tests. Risk of drug interactions due to CYP3A4 metabolism.
Adverse Reactions - Common
- Nausea (Common)
- Headache (Common)
- Vaginal itching or discomfort (Less common)
Adverse Reactions - Serious
- Hepatic adverse effects, including hepatitis (Rare)
- Allergic reactions including hypersensitivity (Rare)
Drug-Drug Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) increase oteseconazole levels.
- CYP3A4 inducers (e.g., rifampin) decrease efficacy.
Drug-Food Interactions
- None specifically reported, but high-fat meals may slightly alter absorption.
Drug-Herb Interactions
- No well-documented interactions, but caution with herbal CYP3A4 modulators.
Nursing Implications
Assessment: Monitor for signs of hepatic dysfunction (jaundice, elevated LFTs). Assess for allergic reactions.
Diagnoses:
- Risk for hepatic injury related to medication use.
- Knowledge deficit regarding drug therapy.
Implementation: Administer as prescribed, counsel patient on potential side effects and interactions, monitor liver function.
Evaluation: Assess symptom resolution and monitor for adverse effects.
Patient/Family Teaching
- Take medication as directed, with or without food.
- Report any unusual symptoms, especially signs of liver problems.
- Avoid alcohol and hepatotoxic drugs during therapy.
- Inform about possible drug interactions.
Special Considerations
Black Box Warnings:
- None specific, but caution due to potential hepatotoxicity.
Genetic Factors: Potential pharmacogenomic variations in CYP3A4 activity may influence drug levels.
Lab Test Interference: None documented.
Overdose Management
Signs/Symptoms: Nausea, vomiting, abdominal pain, elevated liver enzymes.
Treatment: Supportive care; there is no specific antidote. Monitor liver function and provide symptomatic treatment.
Storage and Handling
Storage: Store at room temperature, away from moisture, light, and heat.
Stability: Stable under recommended storage conditions for at least 24 months.