Pevaryl 1% Econazole Nitrate Dermal Powder 30g

NAME
PEVARYL 1%

PHARMACOTHERAPEUTIC CATEGORY
Topical antifungals, imidazole and triazole derivatives.

ACTIVE PRINCIPLES
100 g contain: econazole nitrate 1.0 g.

EXCIPIENTS
Cream: mixture of stearic acid esters with glycols; mixture of fatty acids with polyethylene glycol; Vaseline oil; butylated hydroxyanisole; perfume 4074; benzoic acid; purified water. Skin spray alcohol solution: ethyl alcohol; propylene glycol; perfume 4074; tris (hydroxymethyl) amino methane. Skin dust: precipitated silica; perfume 4074; zinc oxide; talc. Skin emulsion: precipitated silica; mixture of stearic acid esters with glycols; mixing fatty acids with polyethylene glycol; Vaseline oil; butylated hydroxyanisole; benzoic acid; perfume 4074; purified water. Non-alcoholic skin solution: polysorbate 20; benzyl alcohol; sorbitan monolaurate; N- [2-hydroxyethyl] -N- [2- (laurylamino) -ethyl] amino acetic acid sodium salt of 3,6,9-trioxadocosyl sulfate; polyoxyethylene glycol 6000 distearate; purified water.

INDICATIONS
The product is indicated in the therapy of cutaneous mycosis caused by dermatophytes, yeasts and molds; skin infections caused by Gram-positive bacteria: streptococci and staphylococci; mycotic otitis externa, mycosis of the ear canal (limited to the cutaneous emulsion form); onychomycosis; Pityriasis Versicolor.

CONTRAINDICATIONS / SECONDARY EFFECT
Patients with known hypersensitivity to the active substance or to any of the excipients.

DOSAGE
Apply morning and evening, on the infected skin areas, with a light massage, until the mycosis has completely disappeared (1-3 weeks). It is advisable to continue the application for a few days after the disappearance of the mycosis. Intertriginous spaces (e.g. interdigital spaces of the foot, folds of the buttocks) in the wet stage should be cleansed with gauze prior to application. An occlusive dressing is recommended in the treatment of onychomycosis. In the treatment of otomycosis (only if there is no lesion of the eardrum) instill 1-2 drops of skin emulsion 1-2 times a day, or insert a gauze strip soaked with it into the external auditory canal. used as a complementary therapy of the cream and alcoholic solution skin spray. In the case of intertrigo, the use of cutaneous powder may be sufficient. Non-alcoholic skin solution: sprinkle the entire moist body for three consecutive evenings by placing the product on a sponge; do not rinse. The drug works during the night and must be washed off the following morning. If after 15 days from the end of the applications the Pityriasis Versicolor is not eradicated, repeat the treatment. To avoid relapses it is recommended to carry out the treatment again after 1 and 3 months. Regular and prescribed use is of decisive importance for recovery.

STORAGE
Emulsion, skin powder, skin spray alcohol solution and cream: store at a temperature not exceeding 25 degrees C.

WARNINGS
All pharmaceutical forms are indicated for external use only. It is not for ophthalmic or oral use. In case of sensitization or irritation reaction, discontinue use of the product. Econazole nitrate powder contains talc. Avoid inhalation to prevent irritation of the airways, especially in children and infants. The application of the spray forms must be done avoiding inhaling the product and making excessive and improper use of it. Contains butylated hydroxyanisole. It can cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes. Contains benzoic acid. Slightly irritating to the skin, eyes and mucous membranes. Contains propylene glycol. It can cause skin irritation.

INTERACTIONS
Econazole is a known inhibitor of CYP3A4 and CYP2C9 cytochromes. Despite the limited systemic availability after skin application, clinically relevant interactions with other medicinal products may occur and some have been reported in patients receiving oral anticoagulants, such as warfarin and acenocoumarol. In patients receiving oral anticoagulants, caution should be exercised and the INR should be monitored more frequently. An adjustment of the dosage of the oral anticoagulant drug may be necessary during treatment with econazole and after its discontinuation.

SIDE EFFECTS
Based on safety data, the most commonly reported adverse drug reactions were: itching, burning sensation of the skin and pain. Frequencies of adverse reactions: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000), not known. Disorders of the immune system. Not known: hypersensitivity '. Skin and subcutaneous tissue disorders. Common: itching, burning sensation of the skin; uncommon: erythema; not known: angioedema, contact dermatitis, rash, urticaria, blistering, skin exfoliation. General disorders and administration site conditions. Common: pain; uncommon: malaise, swelling. The use of products for topical use, especially if prolonged, can give rise to sensitization phenomena. In case of hypersensitivity reactions it is necessary to interrupt the treatment and institute a suitable therapy. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
Animal studies have shown reproductive toxicity. The risk in man is not known. In humans, after topical application on intact skin, the systemic absorption of econazole is low (<10%). There are no adequate and controlled studies, nor epidemiological data, on the undesirable effects deriving from use in pregnancy. Due to systemic absorption, it should not be used during the first trimester of pregnancy unless the doctor considers it necessary for the patient's health. It can be used during the second and third trimester of pregnancy if the potential benefit to the mother outweighs the possible risks to the fetus. After oral administration of econazole nitrate to lactating rats, econazole and / or its metabolites were excreted in breast milk and detected in pups. It is not known whether dermal administration of the drug can cause sufficient systemic absorption of econazole to produce detectable concentrations of the same in human breast milk. Caution should be used when administered to breastfeeding women. The results deriving from reproduction studies conducted in animals have shown no effects on fertility.