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Пимафуцин®

Препарат Пимафуцин®. Astellas Pharma Europe B.V.(Астеллас Фарма Юроп Б.В.) Нидерланды


Producer: Astellas Pharma Europe B.V. (Astellas of Pharm Yurop B. V.) Netherlands

Code of automatic telephone exchange: A07AA03

Release form: Firm dosage forms. Suppositories vaginal.

Indications to use: Balanoposthitis. Skin candidiasis. Candidiasis of mucous membranes. Dermatomycosis. Vulvovaginitis. Vulvitis. Vaginitis. Skin candidiasis. Outside otitis. Otomycosis. Acute atrophic candidiasis (Candidosis glossitis). Oral cavity candidiasis. Generalized (system, disseminated) candidiasis.


General characteristics. Structure:

Suppositories vaginal:
1 suppository contains:
Active agents: Natamitsin of 100 mg
Other ingredients: cetyl alcohol of 690 mg, solid fat of 700 mg, sorbitic triolet of 460 mg, polysorbate of 80 - 460 mg, carbonate of hydrogen of sodium of 69 mg, adipic acid 64 of mg.

The tablets covered with an enterosoluble cover:
1 tablet contains:
Active ingredients: натамицин 100 mg;
Other ingredients: potato starch of 79,2 mg, polyvinylpirrolidone of 5 mg, magnesium stearate of 2,5 mg, lactose of 66 mg, gelatin of 3,3 mg, acacia (arabic gum) of 7,3 mg, methyl-r-oxybenzoate of 0,07 mg, calcium carbonate of 30 mg, kaolin of 14,2 mg, talc of 21,7 mg, cellulose acetate phthalate of 18 mg, triacetin of 2,7 mg, wax of white bee 0,13 mg, titanium oxide of 3 mg, sucrose of 122 mg.

Cream:
1 g of cream contains:
Active agents: натамицин 20 mg
Other ingredients: цетиол V 100 mg, wax on the basis of cetyl ethers of 50 mg, cetostearyl alcohol of 135 mg, sodium lauryl sulfate of 15 mg, methyl-r-oxybenzoate of 1 mg, propylene glycol of 150 mg, the water purified to 10 mg.

Description

Suppositories vaginal: a torpednoobrazny form, color from white to pale yellow.

The tablets covered with an enterosoluble cover: white round tablets, coated.

Cream: homogeneous cream of a light shade.




Pharmacological properties:

Pharmacodynamics. The antifungal half-yen antibiotic from group of macroleads having a broad spectrum of activity. Has fungicidal effect. Natamitsin connects sterola of cellular membranes, breaking their integrity and functions that leads to death of microorganisms. The majority of a pathogenic barmy fungi, especially Candida albicans are sensitive to a natamitsin. Dermatophytes are less sensitive to a natamitsin. Resistance to a natamitsin in clinical practice does not meet. Natamitsin in tablets, thanks to a kishechnorastvorimy cover, acts only in intestines.

Pharmacokinetics. Natamitsin is not soaked up from a GIT, through the unimpaired skin and mucous membranes.


Indications to use:

- The fungus diseases of skin and mucous membranes caused by activators, sensitive to drug, including:
- acute pseudomembranous and acute atrophic candidiasis at patients with a cachexia, immune insufficiency, and also after therapy by antibiotics, corticosteroids, cytostatics;
- the otomycoses, outside otitises or which are initially caused by mushrooms, or complicated by candidiasis;
- candidiasis of skin and nails;
- intestines candidiasis;
- vaginita, vulvita, a vulvovaginitis, balanoposthites caused mainly by Candida mushrooms;
- dermatomycoses.

Drug can be used as an additional tool at treatment of a dermatomycosis by griseofulvin.


Route of administration and doses:

At intestines candidiasis the adult appoint on 1 таб. 4 times/days, on average within 1 week.

To children appoint on 1 таб. 2 times/days.
At dermatomycoses (including candidiases of skin and nails, an intertrigo at children) cream is applied on the struck surface of skin and nails 1 or several times in days.
At an otomycosis the struck surface is greased with cream 1 or several times in days. Before drug use the ear is cleared. After use of drug place a turunda from natural material in acoustical pass (cotton, wool).
At vaginita, vulvita, a vulvovaginitis appoint on 1 suppository vaginal within 3-6 days. Suppository is entered into a vagina in a prone position as it is possible more deeply, 1 time/days for the night. At a persistent current of the vaginit caused by Candida albicans in addition appoint tablets inside (on 1 таб. 4 times/days, within 10-20 days) for sanitation of the center of a candidosis infection in intestines.

For treatment of candidosis defeat of generative organs of the partner use Pimafutsin in the form of cream.
At a balanoposthitis cream apply on affected areas of skin one or several times in days.
Duration of a course of treatment is established individually. After disappearance of symptoms of a disease some more days are recommended to continue treatment.


Features of use:

Suppositories vaginal under the influence of body temperature are quickly dissolved, forming foamy weight that promotes hypodispersion of active substance.
In case of a persistent or recurrent infection topical treatment can be added with purpose of tablets and cream.
Ethanol which is a part of suppositories vaginal can cause hypersensitivity reactions. In the period of periods therapy with suppositories is interrupted, during treatment by suppositories there is no need for an exception of sexual contacts. However it is recommended to conduct examination of sexual partners and, in case of identification of candidosis defeat, to treat with Pimafutsin. Also it is necessary to provide use during treatment of barrier contraceptives. Pimafutsin it is possible to appoint the newborn.

Pregnancy and lactation
Pimafutsin's use during the periods of pregnancy and a lactation is possible.


Side effects:

From a GIT: the nausea and diarrhea (which are arising in the first days of reception of tablets and passing independently during treatment are possible).
Local reactions: perhaps slight irritation, a burning sensation (at use of cream, suppositories vaginal).


Interaction with other medicines:

Medicinal interaction of drug Pimafutsin is not described.


Contraindications:

Hypersensitivity to drug components.


Overdose:

Now about drug overdose cases Pimafutsin it was not reported.


Storage conditions:

Drug should be stored at a temperature from 15 to 25 °C in the place, unavailable to children. A period of validity of tablets and cream - 4 years. A period of validity of suppositories vaginal - 2 years. Not to use after a period of validity.


Issue conditions:

According to the recipe


Packaging:

The tablets covered with an enterosoluble cover on 100 mg in a bottle 20 таб.
Suppositories vaginal 100 mg in the blister of 3 pieces.
Cream of 2% in a tuba of 30 g.



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