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medicalmeds.eu Medicines Antifungal antibiotics. Пимафукорт®

Пимафукорт®

Препарат Пимафукорт®. 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: D07CA01

Release form: Soft dosage forms. Ointment. Cream.

Indications to use: Dermatosis.


General characteristics. Structure:

Cream:
1 g of cream contains:
Active agents:
Natamitsin of 10 mg
Neomycinum (in the form of sulfate Neomycinum) 3500 PIECES
the hydrocortisone micronized 10 mg
Excipients:
Sodium citrate of 14,0 mg,  F 115,0 emulsifier of mg, sorbitan stearate of 30,0 mg, wax of cetylradio 60,0 mg,   цетиол V 150,0, a macrogoal  mg stearate 100 20,0, methylparahydroxybenzoate of 2,0 mg, пропилпарагидроксибензоат 0,50 mg, the water purified to 1000,0 mg.

Ointment:
1 g of ointment contains:
 Active agents:
Natamitsin of 10 mg
Neomycinum (in the form of sulfate Neomycinum) 3500 PIECES
the hydrocortisone micronized 10 mg
Excipients:
Polyethylene ointment basis (95% liquid paraffin, 5% polyethylene) 976,5 mg.

Description:
Cream: cream from color, white to white with a yellowish shade.
Ointment: ointment from white till yellow color. 




Pharmacological properties:

The combined drug rendering antibacterial, antifungal, local antiinflammatory action.
Neomycinum is an antibiotic   of a broad spectrum of activity from group of aminoglycosides, is active concerning a row gram-positive (Staphylococcus spp., Enterococcus spp.) and gram-negative (Klebsiella spp., Proteus spp., Escherichia coli, etc.) bacteria.

Natamitsin treats antifungal drugs of a half-yen row, has fungicidal effect concerning barmy and drozhzhepodobny mushrooms, especially Candida spp. Dermatomitseta are less sensitive to a natamitsin.
The hydrocortisone possesses antiinflammatory and vasoconstrictive action.
Eliminates the inflammatory phenomena and an itch accompanying different types of a dermatosis.

Pharmacokinetics. Natamitsin and Neomycinum are practically not absorbed through the unimpaired skin and mucous membranes. Absorption of Neomycinum through the injured skin is possible, at hit of drug on wounds, ulcers. From 1 to 3% of a hydrocortisone are absorbed through the unimpaired skin; at dermatitis the quantity of the absorbed hydrocortisone increases twice, at infectious damages of skin can increase up to 5 times. At children absorption of a hydrocortisone through the unimpaired skin is higher, than at adults, extent of absorption of drug in a system blood stream decreases with age.


Indications to use:

The dermatosis which is giving in to glucocorticosteroid therapy, complicated by the consecutive bacterial and/or fungal infection (which is especially caused by sort Candida mushrooms).


Route of administration and doses:

To adults and children drug is applied on affected areas of skin by 2-4 times a day. Duration of treatment is defined individually with the nature of a disease, the course of treatment usually   does not exceed 14 days.
At children it is necessary to apply drug on limited speed up skin, not to apply occlusive bandages. In the absence of improvement of a state at children and adults 14 days later it is necessary to consult at the doctor.
In the form of cream drug is recommended for therapy of an acute and subacute dermatosis, including followed moknutiy. Ointment is intended for therapy of a subacute and chronic dermatosis, especially in the presence of the expressed xeroderma, to lichenification, seborrhea or when occlusal properties of ointment are necessary.


Features of use:

When drawing Pimafukort's on area a century and periorbital area there is a risk of increase in intraocular pressure, development of a cataract.
At use of drug on extensive surfaces at children or under bandages it must be kept in mind a possibility of suppression of function гипоталамо - pituitary and adrenal system.
In case of long treatment, in the presence of wounds and ulcers there is a theoretical risk of ototoksichesky and nephrotoxic action of Neomycinum.
At emergence of superinfection or  overgrowth of mushrooms it is necessary to stop use of drug and to take the appropriate measures.


Side effects:

Side effects at external use of Pimafukort, as well as at use of other glucocorticosteroids, develop seldom and have reversible character. Hypersensitivity reaction (an itch, burning, reddening or a xeroderma) can seldom develop.
Extremely seldom - an atrophy and thinning of skin, a teleangiectasia, a striya, purple, rozatsea-like and perioral dermatitis, delay of healing of wounds, a depigmentation, a hypertrichosis, a withdrawal after the treatment termination.
At use of outside glucocorticosteroids for a long time, on extensive sites of skin, or when using occlusive bandages, especially at children the side effects characteristic of glucocorticosteroids of systemic action, such as suppression of function of bark of adrenal glands can develop.
Contact dermatitis on Neomycinum.


Interaction with other medicines:

Medicinal interactions are not described.
Cross hypersensitivity between Neomycinum and drugs of similar chemical structure, for example Kanamycinum, paromomitsiny, gentamycin and cross stability between Neomycinum and other antibiotics of group of aminoglycosides can be noted.


Contraindications:

- hypersensitivity to drug components;
- tuberculosis cutis, skin displays of syphilis, viral infections of skin, skin postvaccinal reactions, open wounds, ulcers;
- acne disease, rozatsea, ichthyosis;
- anogenitalny itch, skin tumors.

With care
With care apply at tuberculosis (systemic lesion)
- at children aged till 1 year;
- at the patients having in the anamnesis of the instruction on defeat of the IX couple of ChMN against the background of use of aminoglycosides.

In the presence of perforation of a tympanic membrane and direct impact of Neomycinum on a middle ear there is a risk of ototoksichesky action.

Pregnancy and lactation
At purpose of drug during pregnancy it is necessary to consider theoretical risk of ototoksichesky action of Neomycinum in this connection it is impossible to use drug it is long and to put it under occlusive bandages.


Overdose:

There are no data on overdose of drug. There is a theoretical possibility of ototoksichesky action of Neomycinum in case of putting drug on the field of outside acoustical pass in the presence of perforation of a tympanic membrane and direct impact of Neomycinum on a middle ear.


Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. The term of a hraneniya:krem - 3 years, ointments - 5 years. Not to use after expiry date.


Issue conditions:

Without recipe


Packaging:

Ointment and   external use cream:
On 15 g in the aluminum or plastic tubas processed by the epoxy varnish, closed by an aluminum membrane and the screw-on polyethylene cap having the device for a membrane puncture.
On 1 tuba together with the application instruction in a cardboard pack.



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