Ertaczo

Ertaczo is part of the drug class:

• Imidazole and triazole derivatives

Sertaconazole topical is an antifungal medication that fights infections caused by fungus.

Sertaconazole topical (for the skin) is used to treat tinea pedis (athlete's foot) in adults and children who are at least 12 years old.

Sertaconazole topical may also be used for purposes not listed in this medication guide.

You should not use sertaconazole topical if you are allergic to it.

It is not known whether sertaconazole topical will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether sertaconazole topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use this medicine on anyone under 12 years old without medical advice.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Dermatophytoses

Treatment of interdigital tinea pedis (athlete’s foot) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum in immunocompetent adults and children ≥12 years of age.1 2 16

Topical antifungals usually effective for treatment of uncomplicated tinea pedis;13 25 an oral antifungal usually necessary for treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for treatment of tinea unguium (onychomycosis).13 23 25

Treatment of tinea corporis† (ringworm of the body),16 tinea cruris† (jock itch),16 or tinea manuum† (hand ringworm)16 caused by E. floccosum, Microsporum (including M. canis), or Trichophyton (including T. mentagrophytes, T. rubrum, and T. schonleinii).16 19

Topical antifungals usually effective for uncomplicated tinea corporis, tinea cruris, and tinea manuum; an oral antifungal usually necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.13 20 23 25

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor† caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).17 19

Topical treatment usually effective; an oral antifungal (alone or in conjunction with a topical agent) may be necessary in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.21 22 23

Cutaneous Candidiasis

Treatment of superficial cutaneous candidiasis caused by Candida albicans†.18 19

• Importance of applying to affected areas as directed and avoiding contact with eyes, nose, mouth, or other mucous membranes.1 Importance of not using occlusive dressings, unless otherwise directed by clinician.1

• Importance of washing hands after applying the cream.1

• Advise patients to dry affected areas thoroughly before applying cream if it is used after bathing.1

• Use only for condition prescribed.1

• Importance of completing full course of therapy, even if symptoms improve; importance of contacting clinician if skin condition worsens during therapy or if improvement does not occur after completing full course of therapy.1

• Importance of discontinuing drug and consulting clinician if treated area becomes irritated (e.g., redness, itching, burning, blistering, swelling, or oozing).1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

• It is used to treat fungal infections of the skin.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• To gain the most benefit, do not miss doses.
• Do not take Ertaczo by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• If the fungal infection keeps coming back.
• Change in color of skin.
• Burning.
• Very bad skin irritation.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Ertaczo® cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.

In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Ertaczo® cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Ertaczo cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In post-marketing surveillance for Ertaczo cream, 2%, the following were reported:

Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.

You should not use Ertaczo if you are allergic to sertaconazole.

It is not known whether Ertaczo will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether sertaconazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use Ertaczo on anyone under 12 years old without medical advice.

Applies to sertaconazole topical: topical cream

Some side effects of sertaconazole topical (the active ingredient contained in Ertaczo) may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blistering, burning, crusting, dryness or flaking of skin
• itching, redness, skin rash, swelling, or soreness at application site
• darkening of skin
• dry skin
• flushing and redness of skin
• scaling, severe redness, soreness or swelling of skin
• peeling or loosening of skin
• skin tenderness
• unusually warm skin