Active ingredients: Sertaconsazole
SERTACREAM 2% Cream
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
SERTACREAM 2% CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 grams of cream contain:
active principle: sertaconazole nitrate 2 g
Excipients: methyl parahydroxybenzoate
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Topical treatment of cutaneous mycoses such as dermatophytosis, Tinea pedis, Tinea capitis, Tinea cruris, Tinea corporis, Tinea barbae and Tinea manus; Candidiasis (Moniliasis) and Pytiriasis versicolor (Malassezia furfur, Pityrosporum orbiculare).
04.2 Posology and method of administration
The use of the product is reserved for adult patients
Average recommended dose: the cream should be applied lightly and evenly once or twice a day on the affected areas, also covering about 1 cm of surrounding healthy skin. The quantity to be applied is variable and in relation to the extension of the diseased area. The duration of the treatment to obtain healing varies from one patient to another, depending on the etiological agent and the localization of the infection. In general, 4 weeks of treatment are recommended to ensure complete healing, although in many cases clinical-microbiological healing occurs between the second and fourth week.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Do not use for ophthalmic treatments. There are currently no studies on the use of the drug in pediatrics.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena.
The product contains methyl p-hydroxybenzoate: slightly irritating to the skin, eyes and mucous membranes.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions with other substances have been reported.
04.6 Pregnancy and breastfeeding
After topical application of large quantities of the drug, no trace of it was ever found in the plasma; despite this, the perfect harmlessness in pregnant women has not yet been demonstrated, therefore the risk / benefit ratio must be evaluated before applying the product during pregnancy and lactation.
04.7 Effects on ability to drive and use machines
Sertacream does not affect the ability to drive or use machines.
04.8 Undesirable effects
To date, no toxic or photosensitizing effects have been reported. During the first days of treatment, no cases of local and transient erythematous reaction, such as to have to interrupt the treatment, have been reported.
As with all imidazoles, particularly after prolonged use, episodes of local irritation (such as burning and itching) may occur.
04.9 Overdose
The concentration of the active principle and the method of administration are such as to make intoxication impossible, however in case of accidental ingestion the appropriate symptomatic treatment will be carried out.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Therapeutic drug category: antifungals for topical use - imidazole and triazole derivatives
ATC code: D01AC14
Sertaconazole is a new imidazole derivative for topical use with a broad spectrum of action that includes pathogenic yeasts (Candida albicans, Candida tropicalis, C. spp., Pityrosporum orbiculare), dermatophytes (Tricophyton, Epidermophyton and Microsporum) and other agents that cause or accompany skin or mucosal infections (Gram positive germs such as Staphylococci and Streptococci) . The mechanism of action of sertaconazole is typical of imidazole agents and consists in damaging the biosynthesis of ergosterol, an important constituent of yeast and fungal membranes.
05.2 Pharmacokinetic properties
From a pharmacokinetic point of view, the absorption of C14-labeled sertaconazole administered via the skin to rats is very low. After treatment of healthy volunteers for 14 days, no presence of the drug was found in the blood and urine. The sensitivity of the analytical method was of 25 ng / ml.
05.3 Preclinical safety data
Toxicological studies showed that the highest oral dose (8g / kg) to rats and mice did not cause any death, therefore it was not possible to determine the LD50 in these animals. In long-term oral and cutaneous administration, no appreciable side effects were found, while toxicity in chronic high-dose studies was limited to low weight gain, increase in some biochemical parameters of hepatic origin, mild hepatomegaly associated with hepatic enzyme induction and with a luteinizing effect in the ferret; however, these effects are commonly caused by all antifungal imidazole derivatives. In rats, the non-toxic dose is 50 mg / kg orally. Embryotoxicity and foetotoxicity studies in mice and rabbits have shown minimal toxic effects. The maximum dose without toxic effects is 100 mg / kg, therefore, unlike other imidazole agents, the use of sertaconazole offers greater guarantees of safety. Mutagenicity tests (AMES, micronuclear erythrocytes, etc.) have shown the inability of the product of inducing point mutations or interactions with the normal development of the mitotic process. No promoted activity was reported.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Polyethylene glycols and ethylene glycol-palmito stearates (Tefose 63), polyoxyethylenated lauropalmitostearic glycerides (Labrafil M-2130-CS), glycerol mono-diisostearate, vaseline oil, methyl parahydroxybenzoate, sorbic acid, purified water.
06.2 Incompatibility
No physical or physicochemical incompatibilities are highlighted.
06.3 Period of validity
3 years
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C, in a dry place, in the original package to protect the medicine from light.
06.5 Nature of the immediate packaging and contents of the package
Case with internally lacquered aluminum tube containing 30g of cream.
06.6 Instructions for use and handling
No particular instruction.
07.0 MARKETING AUTHORIZATION HOLDER
AIC holder : FERRER INTERNACIONAL SA
Gran Via Carlos III, 94 - BARCELONA (Spain)
Dealer for sale :
GEYMONAT S.p.A.
Via S. Anna, 2 - ANAGNI (FR)
08.0 MARKETING AUTHORIZATION NUMBER
Sertacream 2% cream - tube 30 g AIC n ° 029083021
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 20 July 2001
Renewal date: July 2011
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of May 16, 2012
