Travogen^® (Cream) Instructions for Use

Marketing Authorization Holder

Leo Pharma, A/S (Denmark)

Manufactured By

LEO Pharma Manufacturing Italy, S.r.l. (Italy)

ATC Code

D01AC05 (Isoconazole)

Active Substance

Isoconazole (Rec.INN registered by WHO)

Dosage Form

Travogen®

Cream for external use 1%: tube 20 g

Dosage Form, Packaging, and Composition

Cream for external use homogeneous, opaque, from white to slightly yellowish in color.

Excipients: polysorbate 60 – 3.5 g, sorbitan stearate – 1 g, cetearyl alcohol – 5 g, liquid paraffin – 10 g, white soft paraffin – 10 g, purified water – 69.5 g.

20 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

A drug for external use, a synthetic derivative of imidazole. It has local antifungal and antibacterial action. It acts fungistatically, and fungicidally at increased concentrations. It suppresses the synthesis of ergosterol and alters the composition of the microbial cell membrane.

Active against dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton spp.), molds, yeasts and yeast-like fungi (Candida spp., Pityrosporum orbiculare), Corynebacterium minutissium (the causative agent of erythrasma) and gram-positive bacteria (Streptococcus spp., Staphylococcus spp.).

Pharmacokinetics

When applied to the skin, systemic absorption is negligible.

Indications

Fungal skin lesions, including secondarily infected:

• Mycoses of the feet and smooth skin (including with localization in skin folds and in the area of the external genitalia);
• Microsporia, trichophytosis, rubrophytosis;
• Epidermophytosis;
• Candidamycoses;
• Pityriasis (tinea) versicolor;
• Erythrasma.

ICD codes

Dosage Regimen

Adults and children from the age of 1 month Travogen^® is applied once a day in a thin layer to the affected areas of the skin and gently rubbed in. The course of treatment usually lasts 2-3 weeks, with localization of mycoses in folds – up to 4 weeks. A longer course of treatment is possible. To prevent relapse, treatment should be continued for 2 weeks after the resolution of clinical manifestations.

Adverse Reactions

Dermatological reactions rarely – skin irritation (sensation of burning and itching, erythema); extremely rarely – skin allergic reactions.

As a rule, Travogen^® is well tolerated, even when applied to sensitive skin.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Use of the drug during pregnancy is possible in cases where the potential benefit to the mother outweighs the risk to the fetus.

It has not been established whether Isoconazole passes into breast milk, so the drug should not be applied to the mammary glands before feeding. If it is necessary to use the drug, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Treatment of children from 1 month to 2 years of age with Travogen^® is carried out under medical supervision.

Children from the age of 1 month Travogen^® is applied once a day in a thin layer to the affected areas of the skin and gently rubbed in. The course of treatment usually lasts 2-3 weeks, with localization of mycoses in folds – up to 4 weeks. A longer course of treatment is possible. To prevent relapse, treatment should be continued for 2 weeks after the resolution of clinical manifestations.

Special Precautions

The drug is for external use only.

If symptoms indicating hypersensitivity or irritation appear, the drug should be discontinued.

Avoid getting the drug into the eyes. If the drug accidentally gets into the eyes, they should be thoroughly rinsed with warm water.

The patient should inform the doctor about the occurrence of any adverse effects during treatment with Travogen^®.

If there is no effect, the patient should consult a doctor.

Use in pediatrics

Treatment of children from 1 month to 2 years of age with Travogen^® is carried out under medical supervision.

Overdose

To date, there have been no reports of drug overdose.

Drug Interactions

Not identified.

Storage Conditions

The drug should be stored out of the reach of children, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.