Travocort Cream for Fungal infections
with a corticoid additive
Isoconazole nitrate 10 mg Diflucortolone valerate 1 mg
1 g Travocort contains isoconazole nitrate (1-[2,4-dichloro-b-(2,6-dichlorobenzyloxy)-phenethyl]-imidazole, nitrate) 10 mg and diflucortolone valerate (6alpha,9-difluoro-11beta-hydroxy-21-valeryloxy-16alpha-methyl-1,4-pregna- diene-3,20-dione) 1 mg in an easy-to-remove low fat base o/w emulsion.
A. 13.4.1 Corticosteroids with anti-infective agents.
What Travocort is and what it is used for
This medicine contains two active substances, isoconazole nitrate, and di ucortolone valerate. Isoconazole nitrate treats fungal diseases of the skin and di ucortolone valerate suppresses in ammation of the skin and soothes complaints such as itching, burning, and pain.
What you need to know before you use Travocort
Do not use Travocort if you:
- are allergic (hypersensitive) to isoconazole nitrate or di ucortolone-valerate or any of the other ingredients of this medicine,
- have skin lesions in the area to be treated which are associated with a tuberculosis or syphilis infection,
- have a viral infection e.g. herpes, shingles or chicken-pox (varicella, herpes zoster),
- have a chronic skin in ammation of the face (rosacea), skin in ammation around the mouth (perioral dermatitis) or a skin reaction following vaccination in the area to be treated.
Antifungal cream for perioral dermatitis
- Metronidazole cream or gel.
- Clindamycin lotion or gel.
- Erythromycin gel.
- Topical sulfur preparations.
- Azelaic acid gel.
- Tacrolimus ointment.
- Pimecrolimus cream.
Isoconazole nitrate is for use in the treatment of superficial fungal diseases of the skin. It is effective against dermatophytes and yeasts, yeast-like fungi and moulds, as well as against the causative organism of tinea versicolor and that of erythrasma.
Diflucortolone valerate suppresses inflammation in inflammatory and allergic skin conditions and alleviates the subjective complaints such as itching, burning and pain.
Fungal infections of hairless and hairy skin, eg in the region of the hands, the interdigital spaces of the feet, and in the inguinal and genital regions.
Because of the addition of diflucortolone valerate, Travocort is indicated for the initial or intermediate treatment of those fungal diseases which are accompanied by highly inflammatory or eczematous skin conditions.
Tuberculous and syphilitic processes in the area to be treated, virus diseases (herpes simplex, vaccinia, varicella and smallpox).
Potent topical corticosteroid preparations (Travocort) should not be applied to any skin crease areas.
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore Travocort should not be used during pregnancy.
DOSAGE AND DIRECTIONS FOR USE
Unless otherwise instructed, Travocort should be applied twice daily to the diseased areas of skin. In infections of the interdigital spaces it is often advisable to place a strip of gauze smeared with Travocort between the toes or fingers.
The treatment with Travocort must be terminated after regression of the inflammatory or eczematous skin condition and the therapy continued or followed up with the isoconazole nitrate preparation without corticoid additive. This applies in particular for use in inguinal and genital regions.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Long-term continuous treatment with topical corticosteroids should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasia and ecchymoses. These changes are particularly likely to occur on the face and when occlusive dressings are used.
Systemic absorption of topically applied corticosteroids may occur, particularly under the following conditions: when large quantities are used, or when the application is made to wide areas of the body, or to damaged skin; when potent topical corticosteroids are used; and when the occlusive dressing technique is applied. Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur. These effects are most likely to be severe in children. Growth may be retarded and a Cushingoid state may be produced. Benign intracranial hypertension has been rarely reported.
If a secondary microbial skin infection is present suitable concomitant anti-microbial therapy should be instituted.
Topical corticosteroids should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacea-like facies may be produced.
Topical corticosteroid preparations should be used with caution near the eyes.
Potent topical corticosteroids should be used for short courses only.
Regular review should be made of the necessity for continuing therapy.
These corticosteroid preparations should not be used in the nappy areas of infants, for flexural eruptions and ideally they should not be used for infants and young children at all.
The treatment of psoriasis with potent topical corticosteroids may provoke the pustular form of the disease.
Travocort Side effects
Like all medicines, Travocort can cause side effects, although not everybody gets them. The following side effects occurred in clinical studies, they are listed according to their frequency:
Common: may affect up to 1 in 10 people
- skin irritation or burning feeling at the application site
Uncommon: may affect up to 1 in 100 people
- redness (erythema) or dryness at the application site R stretch marks (skin striae)
Not known: frequency cannot be estimated from the available data
- itching (pruritus) or blisters (vesicles) at the application site
As with other glucocorticoids that are applied to the skin, such as Travocort, the following local side effects may also occur (their frequency cannot be estimated from the available data):
Thinning of the skin (skin atrophy), in ammation of hair follicles (folliculitis), increased body hair growth (hypertrichosis), expansion of small super cial blood vessels in the skin (telangiectasia), skin in ammation around the mouth (perioral dermatitis), changes in skin color, acne, and/or allergic skin reactions to any of the ingredients of Travocort. Since the ingredients of Travocort are absorbed by the body through the skin, further side effects to other parts of the body (systemic effects) may occur.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Travocort. When using Travocort it is important to know the following:
If you also have a bacterial infection of the skin, your doctor will prescribe you another medicine to use in addition to Travocort, to treat this infection.
- Do not allow Travocort to come into contact with the eyes when applying it to your face. Extensive application of glucocorticoid-containing topical medicines to large areas of the body or for prolonged periods of time, in particular under occlusion (e.g. diapers, dressings) increases the risk of side effects.
- There is a risk of developing an eye condition called glaucoma if you apply Travocort covered by a dressing, in large amounts, over a long period of time or if Travocort is applied to the area around the eyes.
- If Travocort is applied to the genital areas, some of its ingredients may cause damage to latex products such as condoms or diaphragms. Therefore, these may no lo longer be effective as contraception or as protection against sexually transmitted diseases such as HIV infection. Talk to your doctor or pharmacist, if you require more information.
- Regular hygienic measures are essential for successful Travocort treatment: To avoid renewed infection, you should change your personal linen (face cloths, underwear etc. preferably of cotton) daily and boil them, dry the area between the toes thoroughly after washing, change your socks and stockings daily.
If symptoms do not improve, consult the doctor again.
Other medicines and Travocort
- Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Interactions of Travocort with other medicines are not known so far.
Pregnancy, breast-feeding and fertility
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Your doctor will carefully weigh the bene ts against the risks connected with the use of Travocort. Glucocorticoids should not be applied during the rst three months of pregnancy to avoid any risk to the development of the unborn baby.
- If you are pregnant, you should in particular avoid applying Travocort covered by a dressing, to large areas of the body or using the cream for a longer time period.
- It is not known whether the active ingredients of Travocort pass into breast milk. A risk to the suckling child cannot be excluded.
If you are breast-feeding you should
- not apply Travocort to the breasts;
- avoid applying Travocort covered by a dressing or to large areas of the body;
- avoid using Travocort for a longer time period. There are no data showing that fertility is affected by the use of Travocort.
Driving and using machines:
- No effects on ability to drive and use machines have been observed in patients treated with Travocort. Travocort contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
How to use Travocort
- Always use Travocort exactly as your doctor or pharmacist has told you. You should check with them if you are not sure. Do not use Travocort for more than 2 weeks.
- Always wash your hands before and after applying Travocort.
- Travocort should be applied twice daily to the diseased areas of skin. Stop using Travocort when the skin conditions have improved. In general, the duration of treatment must not exceed 2 weeks. If necessary, your doctor may then prescribe a follow-up treatment with a glucocorticoid-free anti-fungal preparation. This applies in particular if Travocort is applied to the groin or the genital area.
- Regular hygienic measures are essential for successful Travocort treatment.
Use in children and adolescents
- There is no need to adjust the dose when children aged 2 years or older and adolescents are treated with Travocort.
- Only limited data on the safety of Travocort in children aged below 2 years are available.
If you use more Travocort than you should
- If you apply too much Travocort once, or accidentally swallow Travocort this is unlikely to be dangerous but contact your doctor or pharmacist if you are worried.
If you forget to use Travocort
- Do not use a double dose to make up for a forgotten dose. When you remember, use the next dose and continue with the treatment as prescribed. See your doctor or pharmacist, if you are worried.
- If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
How to store Travocort
- Store Travocort out of the sight and reach of children.
- Do not store above 30°C.
- Do not use this medicine after the expiry date which is stated on the tube and carton after ‘EXP’.
- The expiry date refers to the last day of that month. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
- KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
With overdosage, the symptoms described under “Side effects and special precautions” may occur. Treatment should be discontinued.SCHEDULING STATUS:
White to slightly yellowish cream.PRESENTATION
Tubes of 20 g.STORAGE INSTRUCTIONS
Store below 25°C. Keep out of reach of children.