Medicinal Products

EFUDIX 5%

Generic drug of the therapeutic class: Dermatology
active ingredients: Fluorouracil
laboratory: Meda Pharma

Cream
40 g tube
All forms

Indication

- Preepitheliomatous keratoses.

- Bowen's disease - erythroplasia of Queyrat: when surgery is impossible, this treatment can be used but the control of healing must be performed.

- Genital condylomas.

Dosage EFUDIX 5% Cream Tube 40 g

Before any application, it is necessary to ensure the exact nature of the lesion to be treated: it may be necessary to perform a biopsy.

In principle, one to two applications per day in a thin layer and in small amounts, exclusively on the lesions.

The application on healthy skin should be avoided.

The treatment should be continued for several weeks (3 to 4 on average), under medical supervision.

In view of the persistence of a lesion beyond the normal healing times, it will be necessary to perform a new biopsy.

In some cases, when it is desired a better penetration of the active substance, the dermal cream will be applied with a renewed occlusive dressing every day.

The application of this drug may be a useful preparation or a complement necessary for surgical curettage or cryotherapy, chemotherapy, laser.

After application to a lesion, the therapeutic response can be manifested in four stages:

1. simple or no inflammatory

2. more severe inflammatory: erythema, burning, edema, vesicle

3. destruction of the lesion with erosion, ulceration, necrosis

4. re-epithelization then healing with possible hyperpigmentation.

This normal therapeutic response is not an adverse effect. Its particular importance in some subjects, in stage 2 and 3, may lead to a temporary suspension of treatment or its adaptation: decrease the rate of applications, remove an occlusive dressing, help local treatments emollient or corticoids local.

Against indications

This drug is contraindicated in case of hypersensitivity to any of the constituents.

The use of locally administered fluorouracil is contraindicated during pregnancy and lactation (see section Pregnancy and breastfeeding ).

Deficiency known as dihydropyrimidine dehydrogenase (DPD) (see Warnings and Precautions for Use section ).

Combination with sorivudine and other DPD-inhibiting analogues such as brivudine is contraindicated (see Warnings and Precautions for Use section ).

In combination with yellow fever vaccine (see section Interactions with other medicinal products and other forms of interaction ).

Efudix side effects

The most commonly observed reactions were local reactions such as pain, pruritus, hyperpigmentation, burning at the point of application.

If an application is made beyond lesions erythematous reactions can be observed on healthy skin. They are moderate, transient, but may require a temporary interruption of treatment.

In the event of a significant systemic passage of 5FU (see section Warnings and Precautions for Use ):

· Blood and lymphatic system disorders:

Pancytopenia, neutropenia, thrombocytopenia.

· Gastrointestinal disorders:

Diarrhea, haemorrhagic diarrhea, vomiting, abdominal pain

· Immune system disorders:

Hypersensitivity reaction

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