Fungal infection is a serious medical and social problem. According to statistics, more than a billion people on the planet are infected today. Fungus wins this battle: more than 10 million cases of the disease are reported each year. According to an all-Russian population survey, one in five people in Russia find themselves with symptoms of nail or skin fungus.
Fungal infection affects a person’s daily life. According to a UA (usage attitude) study, almost half of those surveyed do not wear open-toed shoes and do not visit public places. In the fight against infection, local and general antifungal agents are used. The right drug destroys fungus, eliminates unpleasant symptoms and improves quality of life.
Far from medicine it is difficult for a person to understand all the variety of antifungal drugs. We will help – we will show you how the medications differ.
Today we are focusing on two antimycotic agents – Exoderil and Mycoderil. At first glance they are similar – the composition, dosage, product form and indications are the same. But Exoderil is an original drug that has undergone randomized trials and proven to be effective. Mycoderil is a generic, and it has not been involved in serious studies. In this article we will tell you what else characterizes the drugs.
Naftifin against fungus: let’s compare the composition of drugs
The active substance of both antimycotics is naphthifine (10 mg). It belongs to the group of drugs for external use. Available in different forms:
A solution for external use of 1%;
The cost of drugs differs. The original Exoderil is made in Switzerland. Cream (15 mg) will cost 500-800 rubles, the solution (10 ml) – 600-900 rubles. Generic Mycoderil is made in Russia and costs 20% less. Both products are available in the pharmacy without a prescription.
How do antifungal agents work?
Naftifin is active against certain fungi:
ichophyton, Epidermophyton, Microsporum;
Mold fungi Aspergillus spp;
yeast fungi Candida spp; – yeast fungi Candida spp; – yeast fungi Candida spp., Pityrosporum;
Other fungi Sporotrix schenckii.
The drug acts differently on certain groups of microorganisms. It has a fungicidal effect against mold fungi and dermatophytes. By penetrating the fungus, it destroys its wall and inhibits key metabolic processes. Microorganisms are killed by the drug. Against yeast fungi, it exhibits fungistatic activity – suppresses cell reproduction, but does not lead to cell death. Only against some yeast fungi does naphthifine work as a complex agent – both interfering with reproduction and causing death.
Naphtifine has a nonspecific antibacterial action. It is effective against bacteria that cause secondary infection. The drug also reduces inflammatory response and accelerates nail healing.
Naphtifine quickly penetrates the skin and nail plate, creating sustained concentrations in the tissue thickness. This allows the antimycotic to be used once a day.
For dermatophytosis (fungal skin infection), naftifin removes swelling, redness, peeling, and restores the skin’s protective properties;
For onychomycosis (fungal nail lesions), restores the integrity of the nail plate and prevents the spread of infection.
What the experts say: evaluation of the effectiveness of the medication
The activity of naphthifin against fungal infection has been confirmed by clinical studies:
The Cochrane Library database provides a review from 2014. It analyzed 129 studies of. Throughout, naphthifine was compared to a placebo, a pacifier gel. The authors concluded that the drug copes with fungal infection, but the quality of such evidence was evaluated as low. There is insufficient data on whether the disease has relapsed and whether patients are satisfied with the result. The authors emphasize: it is not yet possible to say whether treatment with naphthifin will be effective – new studies are needed.
The PubMed database includes several studies of naphthifin’s action in vitro. In vitro, the drug performed well, but not enough to draw serious conclusions. Not all products that work in vitro cope with infection in a real clinical setting.
A 2015 review showed the efficacy of naftifin for foot and toe interfinger lesions (moccasin tinea pedis, or “moccasin type”). The only embarrassing thing about the analysis is that more than 1,100 people took part in the study, but only half of them were evaluated for the result.
In foreign literature, naphthifine is positioned as a remedy for rapid elimination of fungal infection. The drug has been shown to penetrate deep into the tissues and stay in the skin and nail plate for a long time.
Russian-language sources present naftifine as the drug of choice for infections with dermatophytic and mold fungi.
According to many authors, to treat onychomyococcosis and dermatophytosis, a cream or solution with a pronounced antifungal, antibacterial, and anti-inflammatory effect should be used. Naphtifine meets these criteria.
Studies show that the causative agents of fungal infection retain sensitivity to naphthifene. This allows the use of the drug for long-term therapy.
All of the above applies to the original Exoderil. The drug has undergone randomized clinical trials and its efficacy against fungal infections has been proven. Mikoderil is a generic, and don’t let the same composition of the medication confuse you. Generics enter the market after the patent of the original product expires. The technology of their production differs, and other excipients may be declared in the composition.
Practice shows: even a slight change in the structure affects the quality of the drug. The rate at which the drug enters the tissues changes, and its concentration in the nail plates and skin decreases. All of this reduces the effectiveness of the generic and gives an advantage to the original drug.
The World Health Organization requires that generics be fully equivalent to the original product, biologically and therapeutically. This means that the generic must undergo randomized clinical trials and prove its efficacy. In Russia the requirements are milder: only biological equivalence is required. The pattern of distribution of the generic in the tissues should match the original – and that’s it. No other studies are necessary, which means we cannot provide more data on the drug Micoderil.
Regimen of use
The indications for Mikoderil and Exoderil are the same:
Fungal skin infection;
Onychomycosis – fungal infection of the nails.
Drugs are prescribed for candidiasis and dermatomycosis, pityriasis – lesions of the skin, skin folds, interdigital spaces and nails.
The drug is applied externally 1-2 times a day. For the treatment of fungal skin infections, a cream is prescribed: it absorbs well and reaches the deepest layers of the skin. Exoderil has a unique nozzle for more precise application.
For onychomycosis, a solution for external use is used. The effectiveness of the drug is only guaranteed when no more than one-third of the nail plate is affected.
The course of therapy lasts at least 4-6 weeks. Under indications, the doctor may prolong the treatment.
Comparative characteristics of the original drug and generic have not been conducted. Exoderil and Mycoderil are thought to be equally likely to cause these side effects:
Dry and reddened skin.
They occur at the site of application, self-administered, and do not require treatment completion.
Antifungal agents are prohibited during pregnancy and lactation, in children’s age. Not used if hypersensitivity to the components of the drug is detected.
Exoderil and Mycoderil are antifungal drugs for topical use. They are similar in composition, form of release, indications and contraindications.
Exoderil is the original drug. Its effectiveness has been confirmed by clinical trials. It has proven itself in the treatment of fungal skin and nail infections.
Mycoderil is a generic. It differs from the original by the manufacturing technology. Its effectiveness has not been evaluated.
Remember that avoiding a fungal infection is easier than treating it. Follow simple rules: do not wear other people’s shoes without a sock, do not walk barefoot in public places, monitor the condition of the skin and nails on the feet. Risk of infection increases with excessive foot sweating and chronic vascular disease.