DAKTARIN POLVERE CUTANEA 30G 20MG / G

  • JANSSEN CILAG SpA
  • 041411012

Skin or nail infections caused by dermatophytes or Candida possibly complicated by superinfections with Gram-positive bacteria.

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DAKTARIN POLVERE CUTANEA 30G 20MG / G

Therapeutic indications

Skin or nail infections caused by dermatophytes or Candida possibly complicated by superinfections with Gram-positive bacteria.

Dosage and method of use

Skin infections Treatment should be continued daily and continuously at least up to a week after the symptoms disappear, and can last from 2 to 6 weeks, depending on the type and extent of the infection. Wash the affected area and dry well. Treat not only the infected part, but also the area around it. Wash your hands thoroughly after each application to avoid transferring germs to other parts of the body or to other people. Generally, DAKTARIN DERMATOLOGICO powder or skin spray, powder with DAKTARIN DERMATOLOGICO cream are used in combination. Skin powder - Skin spray, powder They are indicated for the treatment of wet lesions. Apply enough powder to cover the affected area twice a day. If you are also using DAKTARIN DERMATOLOGICO cream in combination, it is sufficient to use both the powder and the cream once a day. In foot infections it is recommended to sprinkle the feet daily with DAKTARIN DERMATOLOGICO powder during and after treatment with another topical formulation (DAKTARIN DERMATOLOGICO cream), especially the spaces between the toes, and also the socks and shoes. Cream Apply 1 cm of cream on the lesion (or more depending on the extent of the lesion) 2 times a day, then spread with your fingers until completely absorbed. If you are also using DAKTARIN DERMATOLOGICO powder, it is recommended to apply both formulations once a day. Nail infections Cut the infected nails as short as possible. Continue the treatment without interruption even after the fall of the infected nail (mostly after 2-3 weeks), until its complete regrowth and the definitive healing of the lesions (rarely before 3 months). It may also be necessary to combine treatment with other drugs. Skin solution DAKTARIN DERMATOLOGICO solution is applied with the brush inserted into the bottle cap. 1-2 times a day brush the solution on the infected nail, all around it and, if possible, under it and let it dry. Once dry, the solution forms an occlusive film on the nail. Before the next application, it is necessary to clean the nail with acetone. If this procedure is not performed, the overlapping layers become too thick and DAKTARIN DERMATOLOGICO solution can no longer reach the nail. Cream Apply a little cream 1-2 times a day on the infected nail, then spread with your fingers; cover the nail with a non-perforated occlusive dressing.

Contraindications

Hypersensitivity to the active substance, to other imidazole derivatives or to any of the excipients listed in section 6.1. Babies and children (up to 12 years).

Side effects

Data collected from clinical studies The table below shows the percentage of undesirable effects considered drug related reported by 834 patients who received miconazole 20mg / g cream (426 patients) vs. placebo (basic cream) (408 patients), enrolled in 21 double-blind clinical trials.

% side effects
Organ / system Miconazole cream 20mg / g Placebo - base cream
Total 1.9 1.2
Alterations of the skin and subcutaneous tissue
• Burning sensation of the skin 0.2 0.7
• Inflammation of the skin 0.2 -
• Hypopigmentation of the skin 0.2 -
General disorders and alterations of the administration site
• Application site irritation 0.7 0.5
• Burning at the application site 0.2 0.2
• Application site itching 0.2 -
• Application site reactions 0.2 -
• Heat at the application site 0.2 -

Note: Individual patients may have reported more than one adverse event. Post-marketing data

Undesirable effects from post-marketing spontaneous reports, worldwide, organized according to the MedDRA classification, are listed below. Undesirable effects are classified according to frequency according to the following convention: very common ≥ 1/10 common ≥ 1/100 e

Disorders of the immune systemVery rare: anaphylactic reactions, hypersensitivitySkin and subcutaneous tissue disordersVery rare: angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, burning sensation of the skinGeneral disorders and administration site conditionsVery rare: irritation or other reactions at the application site

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Special warnings

If sensitization or irritation occurs, discontinue treatment and institute appropriate therapy. Avoid contact with eyes. Wash your hands carefully after each application, unless the treatment affects the hands themselves. Since the skin solution contains alcohol, avoid contact with open wounds and mucous membranes. In these cases, use DAKTARIN DERMATOLOGICO cream. DAKTARIN DERMATOLOGICO cutaneous powder contains talc: avoid inhaling the powder which could cause irritation of the respiratory tract. It is advisable to apply the following hygiene measures to avoid the sources of infections or reinfections: - keep towels and underwear for personal use in order to avoid infection of other people; - regularly change clothes that come into contact with the infected area to avoid re-infection. DAKTARIN DERMATOLOGICO does not stain the skin or clothing. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with DAKTARIN DERMATOLOGICO and other topical miconazole formulations. If a reaction due to hypersensitivity or irritation occurs, the treatment should be discontinued. DAKTARIN DERMATOLOGICO must not come into contact with the mucous membrane of the eyes. Important information about some of the ingredients DAKTARIN DERMATOLOGICO cream contains benzoic acid Benzoic acid can cause local irritation. DAKTARIN DERMATOLOGICO cream contains butylated hydroxyanisole Butylated hydroxyanisole can cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. DAKTARIN DERMATOLOGICO cutaneous solution contains propylene glycol which may cause skin irritation. The solution also contains ethyl alcohol: avoid contact with open wounds and mucous membranes.

Pregnancy and breastfeeding

Pregnancy DAKTARIN DERMATOLOGICO, applied topically, is minimally absorbed into the systemic circulation (bioavailability Feeding time Miconazole, applied topically, is minimally absorbed into the systemic circulation and it is not known whether miconazole is excreted in human milk. Caution is advised in the use of topical products containing miconazole during breastfeeding

Expiration and retention

Cream, Skin Spray, Powder, Skin Solution : store at a temperature not exceeding 25 ° C. Skin powder: no particular storage conditions

Interactions with other drugs

Systemically administered miconazole is known to inhibit CYP3A4 / 2C9. Since, following local application, the presence of the drug in the blood is limited (see section 5.2 Pharmacokinetic properties), interactions deemed clinically relevant are very rare. However, in patients treated with oral anticoagulants such as warfarin, caution and anticoagulant action should be monitored. The efficacy and undesirable effects of other drugs (e.g. oral hypoglycemic agents and phenytoin), when administered concomitantly with miconazole, may be increased and special caution is therefore required.

Overdose

Symptoms and signs In general, excessive use of DAKTARIN DERMATOLOGICO can cause skin irritation which generally disappears with discontinuation of therapy. Treatment In case of accidental ingestion: DAKTARIN DERMATOLOGICO is intended for local application and not for oral use. In case of accidental ingestion of large quantities of DAKTARIN DERMATOLOGICO, use appropriate supportive therapy. Accidental ingestion of DAKTAARIN DERMATOLOGICO cutaneous solution may cause gastric irritation. There is no specific antidote available. Treatment is symptomatic and supportive. Also, as the skin solution contains alcohol, the amount of alcohol that may be ingested should be considered, especially in children. DAKTARIN DERMATOLOGICO powder and skin spray, powder contain talc: the accidental inhalation of large quantities of the medicine can cause obstruction of the respiratory tract. Respiratory arrest can be treated with intensive supportive therapy and oxygen. If breathing is impaired, endotracheal intubation, removal of obstructive material, and assisted breathing are recommended.

Active principles

DAKTARIN DERMATOLOGICO 20mg / g skin powder 100 grams of powder contain active principle: Miconazole nitrate 2 g DAKTARIN DERMATOLOGICO 20mg / g cream 100 g of cream contain active principle: Miconazole nitrate 2 g Excipients with known effect benzoic acid (E210) and butylated hydroxyanisole (E320) This medicine contains 60mg of benzoic acid in each 30g tube of cream which is equivalent to 2mg / g of cream DAKTARIN DERMATOLOGICO 20mg / g cutaneous solution 100 ml of solution contain active principle: Miconazole 2 g excipients: propylene glycol, alcohol DAKTARIN DERMATOLOGICO 20mg / g skin spray, powder 100 grams of powder contain active principle: Miconazole nitrate 2 g For a full list of excipients, see section 6.1

Excipients

Skin powder : zinc oxide, precipitated silica, talc. Skin spray, powder : talc, sorbitan sesquioleate, anhydrous ethanol, steralkonium hectorite, propellant (mixture of propane and butane). Cream : polyethylene glycol palmito stearate, macrogol, glycerol oleate, liquid paraffin, butylated hydroxyanisole, benzoic acid, purified water. Skin solution : acrylic resin (Carboset 525), polymerized acrylic resin (Carboset 515), propylene glycol, alcohol.

041411012
24 Items