Pimafukort® (Pimafucort®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceHydrocortisone + Natamycin + NeomycinHydrocortisone + Natamycin + Neomycin
Similar drugsTo uncover
  • Pimafukort®
    creamointment externally 
    Astellas Farma Europe BV     Netherlands
  • Pimafukort®
    creamointment externally 
    Astellas Farma Europe BV     Netherlands
    • Dosage form: & nbsp

    Cream for external use.

    Ointment for external use.

    Composition:

    Cream:

    1 g of cream contains:

    Active substances:

    natamycin 10 mg

    neomycin (as neomycin sulfate) 3500 units

    hydrocortisone micronized 10 mg

    Excipients:

    Sodium citrate 14.0 mg, emulsifier F 115.0 mg, sorbitan stearate 30.0 mg, cetyl ester wax 60.0 mg, cetyl V 150.0, macrogol stearate 100 20.0 mg, methylparahydroxybenzoate 2.0 mg, propyl parahydroxybenzoate 0.50 mg, water purified to 1000.0 mg.

    Ointment:

    1 g of ointment contains:

    Active substances:

    Natamycin 10 mg

    neomycin (as neomycin sulfate) 3500 units

    hydrocortisone micronized 10 mg

    Excipients:

    Polyethylene ointment base (95% liquid paraffin, 5% polyethylene) 976.5 mg.
    Description:

    Cream: cream from white to white with a yellowish hue of color.

    Ointment: ointment from white to yellow.

    Pharmacotherapeutic group:Glucocorticoids + antibiotic-aminoglycoside + antifungal agent
    ATX: & nbsp

    D.07.C.A.01   Hydrocortisone in combination with antibiotics

    Pharmacodynamics:

    Combined drug, which has antibacterial, antifungal, local anti-inflammatory effect.

    Neomycin is a broad-spectrum antibiotic from the aminoglycoside group, is active against a number of gram-positive (Staphylococcus spp., Enterococcus spp.) and gram-negative (Klebsiella spp., Proteus spp., Escherichia coli and others) of bacteria.

    Natamycin belongs to the antifungal preparations of the polyene series, it has a fungicidal action against yeast and yeast-like fungi, especially Candida spp. Dermatomycetes to natamycin are less sensitive.

    Hydrocortisone has an anti-inflammatory and vasoconstrictive effect. Eliminates inflammation and itching, accompanying various types of dermatoses.

    Pharmacokinetics:

    Natamycin and neomycin practically not absorbed through intact skin and mucous membranes. It is possible to absorb neomycin through damaged skin, if the product gets into wounds, ulcers. Through intact skin, 1 to 3% hydrocortisone is absorbed; with dermatitis the amount of absorbed hydrocortisone is increased by 2 times, with infectious lesions of the skin can increase up to 5 times. In children, absorption of hydrocortisone through intact skin is higher than in adults, the degree of absorption of the drug into the systemic blood stream decreases with age.

    Indications:

    Dermatoses, amenable to glucocorticosteroid therapy, complicated by a secondary bacterial and / or fungal infection (especially caused by fungi of the genus Candida).

    Contraindications:

    - hypersensitivity to the components of the drug.

    - tuberculosis of the skin, cutaneous manifestations of syphilis, viral skin infections, skin post-vaccination reactions, open wounds, ulcers.

    - acne, rosacea, ichthyosis.

    - anogenital itching, skin tumors.

    Carefully:

    With caution apply for tuberculosis (systemic lesion)

    In children under the age of 1 year

    Patients with a history of indications for the defeat of IX pairs of CMN against the background of aminoglycosides.

    If there is a perforation of the tympanic membrane and direct exposure of neomycin to the middle ear, there is a risk of ototoxic action.
    Pregnancy and lactation:When prescribing the drug during pregnancy, it is necessary to take into account the theoretical risk of ototoxic effect of neomycin, in connection with which it is impossible to apply the drug for a long time and apply it under occlusive dressings.
    Dosing and Administration:

    For adults and children, the drug is applied to affected areas of the skin 2-4 times a day.The duration of treatment is determined individually, taking into account the nature of the disease, the course of treatment usually does not exceed 14 days.

    In children, the drug should be applied to limited skin, do not apply occlusive dressings. In the absence of improvement in children and adults after 14 days should consult a doctor.
    In the form of a cream, the drug is recommended for the treatment of acute and subacute dermatoses, incl. accompanied by wetting. Ointment is intended for therapy of subacute and chronic dermatoses, especially in the presence of severe dry skin, lichenification, seborrhea, or in cases where occlusive properties of the ointment are necessary.
    Side effects:

    Side effects with external application of Pimafukorta, as well as with the use of other glucocorticosteroids, develop rarely and are reversible.

    Rarely, a hypersensitivity reaction may occur (itching, burning, redness, or dry skin)

    It is rarely rare - atrophy and thinning of the skin, telangiectasia, stria, purpura, rosace-like and perioral dermatitis, delayed wound healing, depigmentation, hypertrichosis, withdrawal syndrome after cessation of treatment.

    - When applying external glucocorticosteroids for a long time, on large areas of the skin, or with the use of occlusive dressings, especially in children, side effects, characteristic of systemic glucocorticosteroids, such as suppression of the function of the adrenal cortex, may develop.

    - Contact dermatitis at neomycin.

    Overdose:

    There is no information about an overdose of the drug. There is a theoretical possibility of the ototoxic effect of neomycin in the case of application of the drug to the region of the external auditory canal in the presence of a perforation of the tympanic membrane and the direct action of neomycin on the middle ear.

    Interaction:

    Drug interactions are not described.

    Cross-sectional hypersensitivity may be noted between neomycin and preparations of a similar chemical structure, for example, kanamycin, paromomycin, gentamycin, and cross-resistance between neomycin and other antibiotics of the aminoglycoside group.

    Special instructions:

    When Pimafucort is applied to the eyelid and periorbital area, there is a risk of increased intraocular pressure, cataract development

    When using the drug on large surfaces in children or under bandages, it is necessary to keep in mind the possibility of suppressing the function of the hypothalamic-pituitary-adrenal system.

    In the case of prolonged treatment, in the presence of wounds and ulcers, there is a theoretical risk of ototoxic and nephrotoxic action of neomycin.

    When superinfection occurs or excessive growth of fungi should stop using the drug and take appropriate measures.

    Effect on the ability to drive transp. cf. and fur:not described
    Form release / dosage:

    Ointment and cream for external use:

    For 15 grams in aluminum or plastic tubes treated with epoxy varnish, closed with an aluminum membrane and a screwed polyethylene cap having a device for puncturing the membrane.
    1 tube with instructions for use in cardboard pack.
    Packaging:
    Storage conditions:

    At a temperature of no higher than 25 ° C,

    Keep out of the reach of children.

    Shelf life:

    cream - 3 years, ointments - 5 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012689 / 02
    Date of registration:13.10.2008
    The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands
    Manufacturer: & nbsp
    Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands
    Information update date: & nbsp09.04.2014
    Illustrated instructions
      Instructions
      Up