Usage
Sertaconazole is prescribed for the topical treatment of interdigital tinea pedis (athlete’s foot), a fungal infection of the skin between the toes. It is effective against Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. It’s pharmacological classification is antifungal, specifically, it belongs to the azole class. Sertaconazole works by inhibiting the fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme is crucial for the synthesis of ergosterol, a vital component of the fungal cell membrane. By inhibiting ergosterol synthesis, sertaconazole disrupts the integrity of the fungal cell membrane, leading to increased permeability and leakage of cellular contents, ultimately resulting in fungal cell death.
Alternate Names
Sertaconazole nitrate is the chemical name. A common brand name is Ertaczo. Dermofix and Zalain are other brands used in some regions.
How It Works
Pharmacodynamics: Sertaconazole exerts its antifungal effect by inhibiting the synthesis of ergosterol, a crucial component of the fungal cell membrane. This leads to increased cell membrane permeability and leakage of essential cellular components, resulting in fungal cell death.
Pharmacokinetics: Sertaconazole is minimally absorbed systemically following topical application. Studies have shown plasma concentrations below the limit of quantitation (2.5 ng/mL) after repeated topical applications in patients with interdigital tinea pedis. Therefore, systemic effects are not expected.
Mode of Action: Sertaconazole binds to 14-alpha demethylase, a cytochrome P-450 enzyme essential for the conversion of lanosterol to ergosterol in fungal cells. This inhibition disrupts the fungal cell membrane structure and function, leading to cell death.
Elimination Pathways: Due to minimal systemic absorption, information on metabolism and excretion pathways following topical application is limited.
Dosage
Standard Dosage
Children: Safety and efficacy have not been established in children under 12 years of age. For children 12 years and older, the dosage is the same as for adults.
Special Cases:
- Elderly Patients: No specific dosage adjustments are recommended. Clinical trials did not include enough elderly patients to determine if their response differs from younger patients.
- Patients with Renal Impairment: No dose adjustments are necessary due to minimal systemic absorption.
- Patients with Hepatic Dysfunction: No dose adjustments are necessary due to minimal systemic absorption.
- Patients with Comorbid Conditions: No specific dosage adjustments are needed based on comorbid conditions; however, a physician should always consider any potential drug interactions for individual cases.
Clinical Use Cases
Sertaconazole is indicated solely for the topical treatment of interdigital tinea pedis. It is not recommended for use in situations like intubation, surgical procedures, mechanical ventilation, intensive care unit (ICU) use, or emergency situations.
Dosage Adjustments
No dosage adjustments are required for specific patient factors like renal or hepatic dysfunction or metabolic disorders because of limited systemic absorption following topical administration.
Side Effects
Common Side Effects:
Burning, swelling, irritation, tenderness, discoloration, or dry skin at the application site.
Rare but Serious Side Effects:
Blistering, oozing, or open sores at the application site. Allergic reactions, though rare, can occur.
Long-Term Effects:
No long-term adverse effects have been reported with topical sertaconazole use.
Adverse Drug Reactions (ADR):
Severe allergic reactions are rare but require immediate medical attention.
Contraindications
Hypersensitivity to sertaconazole or any component of the formulation. Cross-sensitivity with other azole antifungals may occur.
Drug Interactions
No clinically significant drug interactions have been reported with topical sertaconazole. However, inform patients to avoid using other topical products on the treated area unless directed by a physician.
Pregnancy and Breastfeeding
Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Animal studies have not shown teratogenic effects, but adverse effects have been observed at high doses.
Breastfeeding: It is unknown if sertaconazole is excreted in human milk. Caution should be exercised when prescribing to a nursing woman. Avoid application to the nipple area.
Drug Profile Summary
- Mechanism of Action: Inhibits fungal ergosterol synthesis, disrupting cell membrane integrity.
- Side Effects: Burning, irritation, dryness, discoloration at the application site (common); blistering, oozing, allergic reactions (rare).
- Contraindications: Hypersensitivity to sertaconazole.
- Drug Interactions: No significant drug interactions reported.
- Pregnancy & Breastfeeding: Category C; caution advised; unknown excretion in breast milk.
- Dosage: Apply topically twice daily for 4 weeks.
- Monitoring Parameters: Monitor for treatment response and local skin reactions.
Popular Combinations
Sertaconazole is typically used as a monotherapy. There are no commonly recommended combinations with other drugs.
Precautions
- General Precautions: Confirm diagnosis of tinea pedis before starting treatment. Discontinue use if irritation or sensitivity develops.
- Specific Populations: See above for pregnancy and breastfeeding precautions. Use in children under 12 is not established. No specific precautions are necessary for elderly patients.
- Lifestyle Considerations: No specific lifestyle considerations are associated with topical sertaconazole use.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Sertaconazole?
A: Apply sertaconazole cream 2% twice daily for 4 weeks to the affected area and surrounding skin.
Q2: How does Sertaconazole work?
A: It inhibits the synthesis of ergosterol, a component of the fungal cell membrane, leading to fungal cell death.
Q3: What are the common side effects?
A: Common side effects include burning, irritation, dryness, and discoloration at the application site.
Q4: Can Sertaconazole be used during pregnancy?
A: It’s a Pregnancy Category C drug. Use only if the potential benefit outweighs the risk. Consult with an obstetrician.
Q5: Is it safe to use Sertaconazole while breastfeeding?
A: Excretion in human milk is unknown. Exercise caution. Avoid applying to the nipple area.
Q6: Can children use Sertaconazole?
A: Safety and efficacy are not established for children under 12. Children 12 and over can use the adult dosage.
Q7: What if my symptoms don’t improve after using Sertaconazole?
A: If no improvement is seen after 2 weeks, re-evaluate the diagnosis.
Q8: Are there any drug interactions with Sertaconazole?
A: No significant drug interactions are known. Avoid using other topical products on the treated area concurrently unless directed by a physician.
Q9: What should I do if I experience a skin reaction?
A: Discontinue use and consult a physician if skin irritation or sensitivity develops.
