Drug Guide
Sertaconazole Nitrate
Classification
Therapeutic: Antifungal
Pharmacological: Azole antifungal
FDA Approved Indications
- Vaginal fungal infections (vaginal candidiasis)
Mechanism of Action
Inhibits fungal cytochrome P450-dependent enzymes, leading to increased fungal cell membrane permeability and cell death.
Dosage and Administration
Adult: Vaginal cream, 100 mg once daily for 7 days.
Pediatric: Not FDA approved for pediatric use.
Geriatric: No specific dosage adjustments, use with caution.
Renal Impairment: Use cautiously; no specific dosage adjustment recommended.
Hepatic Impairment: Use with caution; no specific dosage adjustment recommended.
Pharmacokinetics
Absorption: Poor systemic absorption when applied topically.
Distribution: Primarily local in the vaginal mucosa.
Metabolism: Minimal systemic metabolism due to limited absorption.
Excretion: Negligible systemic excretion; mostly local.
Half Life: Not applicable due to minimal systemic absorption.
Contraindications
- Hypersensitivity to sertaconazole or other azoles.
Precautions
- Use with caution in women with known hypersensitivity to azole antifungals.
- Monitor for allergic reactions.
Adverse Reactions - Common
- Vaginal burning, itching, or irritation (Common)
- Vaginal discharge or itching (Common)
Adverse Reactions - Serious
- Hypersensitivity reactions like rash, angioedema (Rare)
- Contact dermatitis (Rare)
Drug-Drug Interactions
- None well-documented due to topical use
Drug-Food Interactions
- None
Drug-Herb Interactions
- Caution with herbal products that could cause hypersensitivity.
Nursing Implications
Assessment: Assess for symptoms of fungal infection before and during treatment.
Diagnoses:
- Risk for infection related to impaired tissue integrity.
- Knowledge deficit regarding new medication.
Implementation: Instruct on proper application of vaginal cream; ensure correct dosage and duration.
Evaluation: Monitor for improvement of infection symptoms and adverse reactions.
Patient/Family Teaching
- Complete full course of therapy, even if symptoms improve.
- Report any signs of allergic reactions or worsening symptoms.
- Maintain vaginal hygiene, avoid harsh soaps or irritants.
Special Considerations
Black Box Warnings:
- None specific for sertaconazole.
Genetic Factors: None established.
Lab Test Interference: None known.
Overdose Management
Signs/Symptoms: Local irritation or allergic reactions if accidentally ingested or absorbed systemically.
Treatment: Supportive care; unlikely to require specific intervention due to limited systemic absorption.
Storage and Handling
Storage: Store at room temperature, away from moisture and heat.
Stability: Stable under recommended conditions for the shelf life specified.