Travocort

Travocort

isoconazole + diflucortolone

Manufacturer:

LEO Pharma

Distributor:

DKSH
Full Prescribing Info
Contents
Isoconazole nitrate, diflucortolone valerate.
Description
1 g cream contains 10 mg (1%) isoconazole nitrate and 1 mg (0.1%) diflucortolone valerate.
Excipients/Inactive Ingredients: The other excipients are: White soft paraffin, Liquid paraffin, Cetostearyl alcohol, Polysorbate 60, Sorbitan stearate, Disodium edetate, Purified water.
Action
This medicine contains two active substances, isoconazole nitrate and diflucortolone valerate. Isoconazole nitrate treats fungal diseases of the skin and diflucortolone valerate suppresses inflammation of the skin and soothes complaints such as itching, burning and pain.
Indications/Uses
Travocort is used for the initial or interim treatment of those superficial fungal infections of the skin which are accompanied by highly inflammatory or eczematous skin conditions, e.g., in the region of the hands, the interdigital spaces of the feet, and in the groin and genital regions.
Dosage/Direction for Use
Always use this medicine exactly as the doctor or pharmacist has told to. Check with them if unsure.
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, the doctor may then prescribe a follow-up treatment with the glucocorticoid-free antifungal preparation Travogen Cream.
This applies in particular if Travocort is applied to the groin or the genital area.
Regular hygienic measures are essential for successful Travocort treatment (see Precautions).
Children and adolescents: Dose adjustments are not required when Travocort is administered to children aged 2 years or older and adolescents.
Only limited data on the safety of Travocort in children aged below 2 years are available.
If forgotten to use Travocort Cream: Do not use a double dose to make up for a forgotten dose. When remembered, simply use the next dose when due and then carry on with the treatment as prescribed.
Talk to the doctor or pharmacist if more information is required.
Overdosage
If too much Travocort is applied once or Travocort is incidentally swallowed, this is unlikely to be dangerous. Contact the doctor or pharmacist if worried. Talk to the doctor or pharmacist if more information is required.
Contraindications
Travocort Cream must not be used if: allergic to isoconazole nitrate or diflucortolone valerate or any of the other ingredients of this medicine listed in Description; skin lesions, which are associated with a tuberculosis or syphilis infection, are present in the area to be treated; a viral infection (e.g. herpes, shingles or chicken-pox (varicella, herpes zoster)) is present; a chronic skin inflammation of the face (rosacea) is present in the area to be treated; a skin inflammation is present around the mouth (perioral dermatitis); a skin reaction is present following vaccination in the area to be treated.
Special Precautions
Please talk to the doctor or pharmacist before using Travocort.
If a bacterial infection of the skin is also present, the doctor will prescribe another medicine in addition to Travocort to treat this infection.
Do not allow Travocort to come into contact with the eyes when applying it to the face.
Extensive application of glucocorticoid-containing topical medicines to large areas of the body or for prolonged periods of time, in particular under occlusion, increases the risk of side effects.
Please tell the doctor if there is history of an eye condition called glaucoma. There is a risk of developing an eye condition called glaucoma if applying 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.
Fungal infections are very persistent and long lasting. To ensure a successful treatment, strictly adhere to doctor's instructions.
Regular hygienic measures are essential: Washing the affected area twice daily - in the morning and evening - with alkali free soap helps the healing process.
In fungal infections of the toes, dry the affected area, in particular the area between the toes, thoroughly after washing.
Change personal linen, cloths, underwear, stockings or socks daily and boil them to avoid renewed infections.
In fungal infections of the toes, shoes should be changed daily.
Do not walk barefoot at home or in hotel rooms, as fungal spores can spread the disease.
If Travocort is applied to the genital areas, some of its ingredients may cause damage to latex products such as condoms or diaphragms. Talk to the doctor or pharmacist if more information is required.
In infections of the interdigital spaces, it is advisable to place a strip of gauze smeared with Travocort between the toes or finger.
Travocort Cream contains cetostearyl alcohol: Travocort contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Driving and using machines: No effects on the ability to drive and use machines have been observed in patients treated with Travocort.
Use in Pregnancy & Lactation: If pregnant or lactating, please inform the doctor.
Use in Children: Data on a limited number of children and adolescents >2 year reveal no evidence of negative effects of Travocort Cream.
Use In Pregnancy & Lactation
If pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before using this medicine. The doctor will carefully weigh the benefits against the risks connected with the use of Travocort.
Glucocorticoids should not be applied during the first three months of pregnancy to avoid any risk to the development of the unborn baby.
If pregnant, 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 breast-feeding: do 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.
Side Effects
Like all medicines, Travocort can cause side effects, although not everybody gets them.
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, 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: Frequency cannot be estimated from the available data: Thinning of the skin (skin atrophy), inflammation of hair follicles (folliculitis), increased body hair growth (hypertrichosis), expansion of small superficial blood vessels in the skin (telangiectasia), skin inflammation 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.
Side effects cannot be excluded in newborns whose mothers have been treated extensively or for a prolonged period of time during pregnancy or while breast-feeding. For example, the activity of the baby's adrenal glands may be reduced (reduced adrenocortical function) and so the baby's resistance to disease may be lowered.
Reporting of side effects: If any side effects are experienced, talk to the doctor or pharmacist. This includes any possible side effects not previously listed. By reporting side effects, more information can be provided on the safety of this medicine.
Drug Interactions
Please tell the doctor or pharmacist if 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.
Caution For Usage
Do not dispose of medicinal products with wastewater or household waste. Ask the doctor or pharmacist how to dispose of the medicinal product if it is not being used anymore. This will help to protect the environment.
MIMS Class
Topical Anti-Infectives with Corticosteroids
ATC Classification
D01AC20 - imidazoles/triazoles in combination with corticosteroids ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Presentation/Packing
Form
Travocort cream
Packing/Price
10 g x 1's
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