Pharmacological properties

Pharmakodinamichesky parameters. active pharmaceutical ingredient of a lomeksin fentikonazol represents differentiated derivative an imidazole which unique dekhlorirovanny structure shows fungicide effect of a wide range concerning dermatophytes (all types of trichophyton, microsporum, epidermophyton), yeast, other causative agents of mycoses of mucous membranes, skin and its derivatives and also the simplest and gram-positive bacteria.

Mechanism of multimodal action of a fentikonazol against types of Candida includes

:

1. Inhibition of the cosecreted aspartateproteases that leads to prevention of growth, adhesion and a penetration of Candida spp. and, respectively, to clinically significant decrease in frequency of a recurrence.

2. Inhibition of fungal enzyme of P450 3A cytochrome — ланозин-14α-деметилазы, responsible for transformation of a lanosterol into ergosterol, the main sterol causing integrity of a cellular membrane of a mushroom and survival of its cells.

3. The inhibition of additional oksidazny and peroksidazny enzymes leading to structural and functional disturbances in a fungal cell.

Fentikonazol shows also antibacterial activity which range includes gram-positive bacteria (such as golden and epidermal staphylococcus, streptococci) — the frequent reason of skin and vaginal superinfections, and protozoa (trichomonad) by means of inhibition of enzyme of a piruvatoksidreduktaza responsible for division or replication of cells. As medicament of a class of imidazoles fentikonazol is active also against Gardnerella vaginalis.

Fentikonazol does not influence release and activity of a histamine, adrenaline, noradrenaline and acetylcholine and also indicators of the vital functions, such as ABP, ChSS and ventilation of the lungs.

Pharmacokinetic parameters. Drug is late in a corneal layer of skin for an appreciable length of time and collects in a mucous membrane as active agent up to 72 h, forming "vessel". Besides, medicament is badly soaked up in a system blood stream through a mucous membrane and integuments.

Lomeksin did not show to

mutagen properties, potential of hypersensitivity, photoallergic and phototoxic action and also negative effects concerning gonads and functions of a reproduction.

Indication

Cream vaginal, capsules of 200 mg / 600 mg: genital candidiasis, the mixed vaginal infections (capsules of 1000 mg also vaginal trichomoniasis and mikst-infections of mucous membranes of a genital tract of a mecotic and candidosis etiology).

Cream: mycoses of integuments dermatophyte (Trichophyton, Microsporum, Epidermophyton) or candidosis etiology; paronychia, onychia; balanoposthitis, balanitis; erythrasma; pityriasis versicolor; mycoses with superinfection gram-positive bacteria; dry dandruff and seboreid.

Use

Capsule of 200 mg / 600 mg enter

deeply intravaginalno in a prone position of 1 times a day before going to bed. a course of treatment — 3 days (or as directed the doctor); at use of capsules of 600 mg in 3 days of therapy in case of existence of symptoms the introduction of 1 more capsule is allowed.

At the same time sexual partner of the patient applies Lomeksin cream (on a penis and a prepuce).

Capsule of 1000 mg: enter one capsule deeply intravaginalno in horizontal position before going to bed once. In case of a mecotic infection or an infection of a mecotic and candidosis etiology if necessary enter 1 capsule of 1000 mg repeatedly in a day. In therapy of a candidosis infection at safety of manifestations of a disease the introduction of 1 capsule of 1000 mg is repeated in 3 days

Cream of vaginal 2%: before going to bed contents of one applicator are entered deeply intravaginalno in a prone position with the bent in knees and divorced legs. Perhaps additional use in morning parts in case of need. The applicator has to be clean.

Applicator is screwed on a tuba instead of a lid, fill it entirely (if the doctor did not specify other dosing) by easy compression of a tuba. After removal of the applicator immediately screw a lid on a tuba. After intravaginalny introduction of the applicator the piston is lowered and further will not see with it any manipulations to removal of the applicator.

simultaneous topical therapy at the sexual partner Is necessary for

(to apply cream on a head of a penis and a prepuce).

Cream of 2% are distributed on affected areas of skin and its folds, a mucous membrane the superficial rubbing or greasing movements by 1–2 times a day (depends on weight of pathology). The damaged area is previously washed and dried, the remains of the injured skin and its appendages delete.

In a fungal infection of nails cream is combined with an occlusive bandage.

Drug also should be used to the sexual partner of the patient. Duration of therapy is established by the doctor (is defined by the volume and the nature of damage).

Contraindication

Hypersensitivity to active ingredient of medicament or other its components.

Side effects

Vaginal forms — burning sensation in a mucous membrane of a vagina; hyperaemia, itching, rash.

Cream of 2% — hyperaemia, an itching, rashes, including erythematic, skin irritation, burning sensation.

Special instructions

When using are the probability of non-constant insignificant burning sensation in affected areas of skin or on a mucous membrane in the injection site.

At long use the development of a sensitization or emergence of insensitive microorganisms is probable

that demands completion of therapy by medicament and medical consultation.

Separate additional ingredients of medicament can become the reason of local reactions on skin (irritation, contact dermatitis and others) or on a mucous membrane, also demanding completion of therapy by drug.

needs to observe indications of the instruction for medicament use.

If serious side reactions developed or manifestations of a disease remain for 7 days of therapy by medicament (or renew), consultation of the doctor is necessary.

should be convinced by

Before use of vaginal cream of ideal purity of the applicator, after use — to wash out it in soap warm water. In need of sterilization of the applicator not to apply for this purpose solvents of organic origin or hot water (50 °C). The applicator contains in a container in a dry form.

Vaginal forms do not apply

combined with barrier methods of contraception.

simultaneous therapy of the sexual partner in case of his infection Is necessary for

.

Cream of 2% — only for external use. To protect eyes from cream hit, in case of contact accurately to wash out a large amount of water.

during pregnancy and feeding by a breast and also at children's age is not applied.

does not influence speed of response at control of vehicles and other mechanisms.

Interaction

Components of vaginal forms — oils and fat-containing substances can cause damage of products from latex.

by

Overdose

it is not revealed. at introduction of per os the vomiting and abdominal pain are possible.

Storage conditions

In the place inaccessible for children, at a temperature of ≤25 °C. cream vaginal needs to be used within 30 days from the moment of the first opening of a tuba.