Active ingredients: Fenticonazole (Fenticonazole nitrate)
LORENIL 2% gel
LORENIL 2% lotion
LORENIL 1% and 2% cutaneous powder
LORENIL 2% cutaneous spray, solution
Lorenil package inserts are available for pack sizes: - LORENIL 2% gel, LORENIL 2% lotion, LORENIL 1% and 2% skin powder, LORENIL 2% skin spray, solution
- LORENIL 200 mg soft vaginal capsules, LORENIL 600 mg soft vaginal capsules
Why is Lorenil used? What is it for?
Pharmacotherapeutic group
Topical antifungal
Therapeutic indications
- Dermatomycosis caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton) with different localization: tinea capitis, tinea corporis, tinea cruris, tinea pedis (athlete's foot), tinea manuum, tinea faciei, tinea barbae, tinea unguium.
- Skin candidiasis (intertrigo, perleche, facial candidiasis, "diaper", perineal and scrotal candidiasis); balanitis, balanoposthitis, onychia and paronychia.
- Pityriasis versicolor (from Pityrosporum orbiculare and P. ovale).
- Otomycosis (from Candida or molds); only if no eardrum lesions are present.
- Erythrasma.
- Mycosis with bacterial superinfections (from Gram positive bacteria)
Contraindications When Lorenil should not be used
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Lorenil
Although the percutaneous absorption of fenticonazole is rather poor, it is recommended not to use the preparation during pregnancy and breastfeeding.
Interactions Which drugs or foods can modify the effect of Lorenil
Not known. Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
Although the absorption of the drug is poor, the use of Lorenil during pregnancy and lactation is not recommended except in special cases and after a careful evaluation of the benefit / risk ratio by the doctor. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena.
At the time of application on the lesion, a modest burning sensation may be found which disappears rapidly.
Dose, Method and Time of Administration How to use Lorenil: Posology
Lorenil should be applied 1-2 times a day, according to the doctor's opinion, after washing and drying the injured part, using the formulation suitable for the location of the lesion.
Gel - has a drying action and is more suitable for intertrigo, athlete's foot, inguinal skin and in general for wet lesions.
Lotion and skin spray, solution - are indicated for localizations on the scalp and for skin areas covered with hair. Furthermore, the skin spray is easy and convenient to use for extensive mycosis and for areas that are difficult to reach.
Skin powder 1% and 2% - it is used for the athlete's foot and in general for the intertriginous areas and for wet lesions, both as a single treatment and as a complement to the cream. In foot infections it is recommended to sprinkle with Lorenil skin powder also the inside of the socks and shoes.
In athlete's foot and in onychomycosis, in order to avoid reinfection, it is advisable to continue the above treatment for one or two weeks after the symptoms have disappeared.
Lorenil treatments should be performed regularly until the lesions have completely disappeared.
Lorenil is not greasy, does not stain and can be easily removed with water
Side Effects What are the side effects of Lorenil
Mild and transient erythematous reactions have been reported.
At the time of application on the lesion, a modest burning sensation may be found which usually disappears quickly.
In the event of the appearance of more persistent irritative phenomena or the development of resistant microorganisms, the treatment must be interrupted and consult a doctor.
Lorenil is only poorly absorbed, therefore, under the recommended conditions of use, systemic repercussions can be excluded. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
Other Information
Composition
Lorenil 2% gel
100 g of gel contain: fenticonazole nitrate 2g - Excipients: carbomer; purified water; propylene glycol.
Lorenil 2% lotion
100 g of lotion contain: fenticonazole nitrate 2g - Excipients: ethyl alcohol; hydroxypropylcellulose; purified water; propylene glycol.
Lorenil 1% cutaneous powder
100 g of powder contain: fenticonazole nitrate 1g - Excipients: silica precipitated; zinc oxide talc.
Lorenil 2% cutaneous powder
100 g of powder contain: fenticonazole nitrate 2g - Excipients: silica precipitated; zinc oxide; talc.
Lorenil 2% cutaneous spray, solution
100 g of solution contain: fenticonazole nitrate 2g - Excipients: ethyl alcohol; propylene glycol; purified water.
Pharmaceutical forms and content
Gel- tube of 30 g.
Skin spray, solution - bottle of 30 ml.
Lotion - bottle of 30 ml.
Skin powder 1% and 2% - 50 g jar.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
LORENIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lorenil 2% cream:
100 g contain: active ingredient fenticonazole nitrate 2 g.
Lorenil 2% gel:
100 g contain: active ingredient fenticonazole nitrate 2 g.
Lorenil 2% lotion:
100 g contain: active ingredient fenticonazole nitrate 2 g.
Lorenil 1% cutaneous powder:
100 g contain: active ingredient fenticonazole nitrate 1 g.
Lorenil 2% cutaneous powder:
100 g contain: active ingredient fenticonazole nitrate 2 g.
Lorenil 2% cutaneous spray, solution:
100 g contain: active ingredient fenticonazole nitrate 2 g.
Lorenil 2% skin foam:
100 ml contain: active ingredient fenticonazole nitrate 2 g.
03.0 PHARMACEUTICAL FORM
Cream; gel; skin foam; lotion; skin powder; skin spray, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Dermatomycosis caused by dermatophytes (Trichophyton, Microsporum, Epidermiphyton) with different localization: tinea capitis, tinea corporis, tinea cruris, tinea pedis (athlete's foot), tinea manuum, tinea faciei, tinea barbae, tinea unguium.
Skin candidiasis (intertrigo, perleche, facial candidiasis, "diaper", perineal and scrotal candidiasis); balanitis, balanoposthitis, onychia and paronychia.
Pityriasis versicolor (from Pityrosporum orbiculare and P. ovale).
Otomycosis (from Candida or molds); only if no eardrum lesions are present.
Erythrasma.
Mycosis with bacterial superinfections (from Gram positive bacteria).
04.2 Posology and method of administration
Lorenil should be applied 1-2 times a day, according to the doctor's opinion, after washing and drying the injured part, using the formulation suitable for the location of the lesion. The cream is indicated for the treatment of hairless skin, skin folds and mucous membranes; it is applied by rubbing lightly.
Cream: it is preferably used for dry mycoses: Pityriasis versicolor, erythrasma, onychomycosis (in onychomycosis the cream should be applied with an occlusive bandage); the cream is suitable for use in male genital mycosis.
Gel: it has a drying action and is more suitable for intertrigo, athlete's foot, inguinal skin and in general for wet lesions.
Skin foam: the use of foam is particularly advantageous for the treatment of Pityriasis versicolor and in the case of extensive dermatomycosis of the hairless skin; in Pityriasis versicolor it is applied in the evening on damp skin or directly or with a sponge, allowing it to dry and rinse the following morning. In the course of infections Lorenil foam can be advantageously used in cleansing, avoiding, by virtue of its physiological pH, further irritation of the already compromised skin.
Lotion and skin spray, solution: it is indicated for locations on the scalp and for skin areas covered with hair. Furthermore, the spray is easy and convenient to use for extensive mycoses and areas that are difficult to reach.
Skin powder: it is used for athlete's foot and in general for intertriginous areas and for wet lesions, both as a single treatment and as a complement to the cream. In foot infections it is advisable to sprinkle the inside of the socks with Lorenil powder. shoes.
Lorenil cutaneous powder 1% is indicated for the prophylaxis of reinfections.
In athlete's foot and in onychomycosis, in order to avoid reinfection, it is advisable to continue the above treatment for one or two weeks after the symptoms have disappeared.
Lorenil treatments should be performed regularly until the lesions have completely disappeared.
Lorenil is not greasy, does not stain and can be easily removed with water.
04.3 Contraindications
Hypersensitivity to product components or other closely related substances from a chemical point of view. Generally contraindicated in pregnancy and during lactation.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena.
After applying Lorenil foam, do not expose yourself to sunlight or UVA rays.
At the time of application on the lesion, a modest burning sensation may be found which disappears rapidly.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and breastfeeding
Although the percutaneous absorption of fenticonazole is rather poor, it is recommended not to use the preparation during pregnancy and breastfeeding.
04.7 Effects on ability to drive and use machines
Nothing to report.
04.8 Undesirable effects
Lorenil is generally well tolerated, both on the skin and on the mucous membranes; only exceptionally mild and transient erythematous reactions have been reported.
In the event of hypersensitivity reactions or the development of resistant microorganisms, treatment must be discontinued. Lorenil in the recommended conditions of use is only poorly absorbed, therefore systemic repercussions can be excluded.
04.9 Overdose
Nothing to report.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Lorenil is a broad spectrum antifungal.
In vitro: high fungistatic and fungicidal activity on dermatophytes (all species of Trichophyton, Microsporum, Epidermophyton), on Candida albicans and on other agents of fungal infections of the skin and mucous membranes.
In vivo: healing in 7 days of cutaneous mycoses caused by dermatophytes and Candida in the guinea pig.
Lorenil also has antibacterial action on Gram-positive microorganisms.
05.2 Pharmacokinetic properties
Presumed mechanism of action: block of oxidizing enzymes with accumulation of peroxides and necrosis of the fungal cell; direct action on the membrane.
05.3 Preclinical safety data
LD50 mouse: os> 3000 mg / kg; i.p. 1276 mg / kg (M), 1265 mg / kg (F)
LD50 rat: os> 3000 mg / kg; s.c.> 750 mg / kg; i.p. 440 mg / kg (M) - 309 mg / kg (F)
Chronic toxicity: 40-80-160 mg / kg / day os for 6 months in the rat and dog were well tolerated, except for mild or moderate general toxicity manifestations (in the rat an increase in liver weight at a dose of 160 mg / kg, however, without histopathological changes and in the dog a transient increase in SGPT at doses of 80 and 160 mg / kg associated with an increase in liver weight).
Lorenil does not interfere with the functions of the female and male sexual organs nor does it have effects on the early stages of reproduction. Reproductive toxicity studies showed, as with other imidazoles, an embryolethal effect which occurs only at high oral doses (> 20 mg / kg), 20-60 times higher than the vaginally absorbed dose in women.
Lorenil did not show teratogenic properties in rats and rabbits.
Lorenil was not mutagenic in 6 mutagenicity tests.
Tolerability of Lorenil was satisfactory in guinea pigs and rabbits. The results obtained in the dwarf pig, whose skin is morphologically and functionally similar to that of humans and generally shows a marked sensitivity to various irritants, were excellent.
Lorenil showed no evidence of sensitization, phototoxicity and photoallergy.
Pharmacokinetic tests showed a completely negligible transcutaneous absorption, both in animals and in humans.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lorenil 2% cream:
5 g propylene glycol; hydrogenated lanolin 1 g; sweet almond oil 10 g; polyglycol ester of fatty acids 15 g; cetyl alcohol 3 g; glyceryl monostearate 3 g; sodium edetate 0.5 g; purified water 60.5 g.
Lorenil 2% gel:
Carbomer 3 g; purified water 10 g; propylene glycol
Lorenil 1% cutaneous powder:
Precipitated silica 3 g; zinc oxide 5 g; talc 91 g.
Lorenil 2% cutaneous powder:
Precipitated silica 3 g; zinc oxide 5 g; talc 90 g.
Lorenil 2% cutaneous spray, solution:
Ethyl alcohol 32 g; propylene glycol 31 g; purified water 35 g.
Lorenil 2% skin foam:
10 g propylene glycol; ethyl alcohol 20 g; sodium laureth sulfate solution 4 g; alkylamidobetaine solution 24 g; purified water q.s. to 100 ml.
06.2 Incompatibility
None.
06.3 Period of validity
36 months.
24 months (foam).
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
Cream: aluminum tubes internally coated with paint
Gel: aluminum tubes internally coated with varnish
Skin spray, solution: glass bottle
Lotion: polyethylene bottles
Skin powder: polypropylene jar
Skin foam: plastic bottles sealed with a foaming device (dispenser)
06.6 Instructions for use and handling
Lorenil should be applied 1-2 times a day, according to the doctor's opinion, after washing and drying the injured part, using the formulation suitable for the location of the lesion. The cream is indicated for the treatment of hairless skin, skin folds and mucous membranes; they are applied by rubbing lightly.
07.0 MARKETING AUTHORIZATION HOLDER
Effik Italia S.p.A. - Via Lincoln 7 / A - 20092 Cinisello Balsamo (MI)
08.0 MARKETING AUTHORIZATION NUMBER
Cream 2% - tube 15 g AIC n. 028228106
Gel tube of 30 g AIC n. 028228029
Skin spray, solution 2% - bottle 30 ml AIC n. 028228031
Lotion bottle 30 ml AIC n. 028228043
Skin powder 1% - 50 g jar AIC n. 028228056
Skin powder 2% - 50 g jar AIC n. 028228068
Skin foam 2% - 100 ml bottle AIC n. 028228082
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: June 1991
Renewal: May 2000
10.0 DATE OF REVISION OF THE TEXT
01/12/2002
