PIMAFUKORT

Active material: Gidrokortizon, Natamycin, Neomycin
When ATH: D07CA01
CCF: With antibacterial drug, anti-fungal and anti-inflammatory for outdoor use
ICD-10 codes (testimony): L30.3
When CSF: 04.05
Manufacturer: ASTELLAS PHARMA EUROPE B.V. (Netherlands)

Pharmaceutical form, composition and packaging

Cream for external application from white to white with a yellowish tint.

Excipients: sodium citrate, emulsifier F, sorbitan stearate, Wax tsetilefirny, In цетиол, macrogol stearate 100, metilparagidroksiʙenzoat, propilparagidroksibenzoat, Purified water.

15 g – aluminum tuba (1) – packs cardboard.
15 g – Plastic tubes (1) – packs cardboard.

Ointment for external application white to yellow.

Excipients: polyethylene ointment base (95% Liquid paraffin, 5% polyethylene).

15 g – aluminum tuba (1) – packs cardboard.
15 g – Plastic tubes (1) – packs cardboard.

Pharmacological action

Combined preparation, providing anti-fungal, antimicrobial and local anti-inflammatory effect due to components, its constituent.

Natamycin belongs to the polyene macrolide antibiotics, It has fungicidal action. It is active against yeast and yeast-like fungi (especially Candida spp.). Dermatomitsetami less susceptible to natamycin.

Neomycin is a broad-spectrum antibiotic of the aminoglycoside, active against gram-positive bacteria: Staphylococcus spp., Enterococcus spp.; Gram negative bacteria: Klebsiella spp., Proteus spp., Escherichia coli.

Hydrocortisone Micronized – glucocorticoid hormone, prdutsiruemy human adrenal cortex, It has anti-inflammatory and vasoconstrictor activity. Eliminates the inflammation and itching, accompanying the various types of dermatoses.

Pharmacokinetics

Natamycin and neomycin substantially not absorbed through the intact skin and mucous membranes. Possible absorption of neomycin through broken skin, when applied to extensive wound and burn surface.

Through intact skin is absorbed by 1 to 3% hydrocortisone; when the amount of absorbable dermatitis hydrocortisone increases 2 times, infectious skin lesions may increase 5 time.

Children hydrocortisone absorption through intact skin above, than in adults. The degree of absorption of the drug into the systemic circulation decreases with age.

Testimony

- Dermatosis, amenable to SCS therapy, complicated by secondary bacterial and / or fungal infection (especially caused by Candida spp.).

Dosage regimen

Adults and children the drug is applied to the affected skin 2-4 times / day. Babies the drug should be applied to limited areas of the skin and not to apply occlusive dressings.

Duration of treatment is determined individually taking into account the nature of the disease, treatment generally does not exceed 14 days.

A preparation in the form of a cream suitable for therapy acute and subacute dermatoses.

A preparation in the form of an ointment intended for the treatment subacute and chronic dermatoses, especially in the presence of severe dry skin, lihenifikatsii or where, when necessary occlusive properties of the ointment.

Side effect

Side effects when applied externally Pimafukorta are rare and are reversible.

Allergic reactions: rarely – itch, burning, redness or dryness of the skin.

Dermatological reactions: rarely – atrophy and thinning of the skin, teleangiэktazii, striae, purpura, rozatseapodobny and perioral dermatitis, slow wound healing, depigmentation, hypertryhoz, withdrawal symptoms after stopping treatment; kontaktnыy dermatitis to neomycin.

Systemic reactions: with topical corticosteroids for a long time on large areas of skin, or by using occlusive dressings, especially in children, may develop side effects, due to systemic effects of GCS – Symptoms suppression of adrenocortical function.

Contraindications

- Lupus;

- Cutaneous manifestations of syphilis;

- Viral infections of the skin;

- Skin reactions after vaccination;

- Open wounds;

- Ulcerative skin lesions;

- Acne;

- Rosacea;

- Ixtioz;

- Itchy anogenital;

- Skin tumors;

- Hypersensitivity to the drug.

FROM caution use in patients with systemic tuberculosis, children under the age of 1 year, in patients with a history of instructions to defeat IX pair FSK during treatment with aminoglycosides. If there is perforation of the tympanic membrane and the direct impact of neomycin to the middle ear there is a risk Valium actions.

Pregnancy and lactation

When using Pimafukorta^® Pregnancy must be considered a theoretical risk Valium actions neomycin, therefore the drug should not be applied to the vast areas of the skin surface, use it under an occlusive dressing.

Cautions

When applying Pimafukorta^® in the region of the eyelids and periorbital area there is a risk of increasing intraocular pressure, developing cataracts.

In the case of long-term treatment, in the presence of wounds and ulcers there is a theoretical risk of nephrotoxicity and ototoxicity of neomycin.

When superinfection or excessive development of fungal microflora should stop using the product and take appropriate action.

Use in Pediatrics

In children, the drug should be used under medical supervision. In applying the drug over a large surface or under occlusive dressings should be borne in mind the possibility of the suppression of the hypothalamic-pituitary-adrenal axis.

Overdose

Information about overdose no. There is a theoretical possibility Valium actions of neomycin in the case of application of the drug in the region of the auditory canal if the eardrum perforation and neomycin direct impact on the middle ear.

Drug Interactions

Drug Interactions drug Pimafukort^® not disclosed.

Possible cross-hypersensitivity between neomycin and similar preparations of the chemical structure, such as kanamycin, paromomycin, gentamicin and cross-resistance between neomycin and other aminoglycoside antibiotics.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life cream – 3 year. Shelf life ointment – 5 years.