sertaconazole (Rx)

Brand and Other Names:Ertaczo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream

  • 2%

Tinea Pedis

Apply BID x 4 weeks; apply enough to cover affected area, & immediately surrounding healthy skin

If no improvement 2 weeks after treatment period, review diagnosis

Other Indications & Uses

Interdigital tinea pedis in immunocompetent patients >12 years old:, caused by Tricophyton rubrum, Tricophyton mentagrophytes, & Epidermophyton floccosum

<12 years old: Safety & efficacy not established

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Adverse Effects

Frequency Not Defined

Contact dermatitis

Dry skin

Burning

Erythema

Vesiculation

Desquamation

Hyperpigmentation

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Warnings

Contraindications

Hypersensitivity

Not indicated for ophthalmic, oral or intravaginal use

Cautions

Sensitivity to imidazole antifungals (cross-reactivity may occur)

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Pregnancy & Lactation

Pregnancy

There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Animal data

  • In animal reproduction studies, there were no adverse developmental effects observed with oral administration of sertaconazole nitrate to pregnant rats and rabbits during organogenesis at doses 40 and 80 times, respectively, the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison
  • In rats, when maternal dosing was continued until weaning, a reduction in live birth indices and an increase in the number of still-born pups was observed at doses 20 and 40 times the MRHD based on BSA comparison

Lactation

There are no data available on presence of drug in human or animal milk, its effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Absorption: minimal

Mechanism of Action

Imidazole class of antifungals; believed to inhibit cytochrome P450-dependent synthesis of ergosterol, leading to fungal cell membrane injury through leakage of key constituents

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Ertaczo topical
-
2 % cream

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
sertaconazole topical

SERTACONAZOLE - TOPICAL

(ser-ta-CAW-nah-zole)

COMMON BRAND NAME(S): Ertaczo

USES: This medication is used to treat athlete's foot. It is an azole antifungal that works by preventing the growth of fungus.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using sertaconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin twice daily or as directed by your doctor. Apply enough medication to cover the affected skin and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased.Do not apply this medication in the eyes, nose, mouth, or vagina.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting sertaconazole. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection.Tell your doctor if your condition does not improve after 2 weeks of treatment or if it worsens at any time.

SIDE EFFECTS: Burning, swelling, irritation, tenderness, discoloration, or dry skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: blistering, oozing, open sores.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using sertaconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, ketoconazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.