Zalain (sertaconazole nitrate) cream 2% 20 g. tube

Description

Zalain (sertaconazole nitrate) cream 2% 20 g. tube

Composition 

active substance: sertaconazole nitrate;

1 tube (20 g) contains 0.4 g of sertaconazole nitrate;

Excipients: ethylene glycol and polyethylene glycol palmitostearate, lauryl macrogol glycerides, glycerol isostearate, light mineral oil, methyl parahydroxybenzoate (E 218), sorbic acid, purified water.

Dosage form

Cream.

Basic physical and chemical properties: semi-solid white cream of liquid consistency, odorless or with a faint odor of fat.

Pharmacotherapeutic group

Antifungal drugs for topical use.

ATX code D01A C14.

Pharmacological properties

Pharmacodynamics. Zalain / Zalain Ovuli is an antifungal drug derived from imidazole, with high fungicidal activity, intended for topical use in gynecology. the mechanism of action is to suppress the synthesis of ergosterol and increase the permeability of the cell membrane, which leads to the destruction of pathogens. It is effective against pathogenic yeasts (candida albicans, candida spp. and malassezia furfur), dermatophytes (trichophyton, epidermophyton and microsporium spp.) and pathogens that cause infectious diseases of the skin and mucous membranes, including gram-positive strains.

Indications

Zalain cream. local treatment of fungal skin infection caused by dermatophytes and yeasts: epidermophytia of the feet, inguinal epidermophytia, dermatomycosis of smooth skin, trichophytia of the beard and mustache, dermatomycosis of the hands, candidiasis, ringworm.
Zalain ovules, vaginal suppositories. Local treatment of vaginal candidiasis.

Application

Cream. the cream is applied 1 or 2 times a day (preferably at night or in the morning and evening) in a thin layer gently and evenly on the affected area of ​​skin, capturing about 1 cm of healthy skin around it.
The duration of treatment depends on the etiology of the pathogen and the location of the infection. It is generally recommended to use for about 4 weeks to achieve clinical remission with a negative microbiological control study to prevent recurrence, but in many cases clinical recovery occurs earlier – between 2 and 4 weeks.
Pessaries. Adult women: 1 pessary is inserted deep into the vagina at night before bedtime once a day. If the clinical signs of the disease do not disappear, it is possible to re-use the drug after 7 days.

Contraindications

Cream: hypersensitivity to any antifungal derivatives of the imidazole group in the anamnesis or to any other component of the drug.

Side effects

Cream. the drug showed good tolerability when applied to both intact and damaged skin.
Topically, contact dermatitis may appear (dry skin, burning, itching, hives). Possible hypersensitivity reactions, local transient erythematous reactions that do not require discontinuation of the drug.
The medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
The drug contains sorbic acid, which can cause local skin reactions (eg contact dermatitis).

Special instructions

During treatment it is not recommended to use soap with acidic ph, it is necessary to use mainly cotton linen, not to carry out douching.
It is also advisable to apply the antifungal cream Zalain in the vulva and perineum.
When using the drug should refrain from sexual intercourse. It is recommended to consider the possibility of simultaneous treatment of a sexual partner.
Therapy can be performed during menstruation.
Factors (hygienic or lifestyle) that contribute to the development and manifestations of fungal infection should be identified and eliminated. It is also recommended to treat other pathogenic microorganisms that may be associated with candidiasis.
Therapy should be discontinued if a local allergic reaction occurs.
In the absence of characteristic clinical signs of vaginal candidiasis, a positive result of microbiological examination is not in itself an indication for treatment.
Zalain cream should not be used in ophthalmology. Acid detergents should be used with caution in patients, as the reproduction of Candida spp.
Use during pregnancy or breastfeeding. There are no data on the presence of embryotoxicity and teratogenic effect of sertaconazole. Given the route of administration (single dose of treatment) and the absence of systemic absorption, the use of sertaconazole in pregnant women is possible only when the expected benefit to the mother outweighs the potential risk to the fetus.
There are also no data on the penetration of sertoconazole into breast milk. Therefore, the drug should not be used during breastfeeding, unless, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the child.
After external application of the drug in large quantities, plasma levels were not observed. As the adverse effects of the drug on newborns or pregnant women have not been studied, the benefit-risk balance for woman and fetus / child should be assessed before prescribing Zalain during pregnancy and breastfeeding.

Do not use in children
Ability to influence the speed of reaction when driving vehicles or working with other mechanisms. Does not affect.

Interactions

No interactions have been established for the drug in the form of a cream. at simultaneous use of pessaries with local contraceptives can note decrease in their spermicidal action. do not recommend concomitant use with latex condoms or pessaries due to the risk of damage.

Overdose

When applying the cream, an overdose is unlikely. after vaginal application of pessaries overdose was practically not noted.