Pimafucort, 15 g, ointment. Product

Description

A homogeneous ointment from white to light yellow in color.

Pharmacotherapeutic group: Glucocorticoids + antibiotic-aminoglycoside + antifungal agent

Pharmacological properties

Pharmacodynamics

A combined drug that has antibacterial, antifungal, and local anti-inflammatory effects.

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

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

Hydrocortisone has an anti-inflammatory effect.and vasoconstrictive effect. Eliminates inflammatory phenomena and itching that accompany various types of dermatoses.

Pharmacokinetics

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

Indications for use

Dermatoses amenable to glucocorticosteroid therapy, complicated by 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 infections of the skin, skin post-vaccination reactions, open wounds, ulcers.

acne, rosacea, ichthyosis.

anogenital itching, skin tumors.

With caution

It is used with caution in tuberculosis (systemic lesion)

In children under the age of 1 year

In patients with a history of indications of a lesion of the IX pair of PMN against the background of the use of aminoglycosides.

In the presence of a perforation of the eardrum and direct exposure of neomycin to the middle ear, there is a risk of ototoxic effects.

Use during pregnancy and breastfeeding

Before using Pimafucort®, if you are pregnant, or assume that you could be pregnant, or are planning a pregnancy, you should consult your doctor.

When prescribing the drug during pregnancy, it is necessary to take into account the potential risk of ototoxic effects of neomycin, and therefore it is impossible to use the drug for a long time and apply it under occlusive dressings.

Method of administration and dosage

Externally.

For adults and children, the drug is applied to the 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 areas of the skin, not used under occlusive dressings. If there is no improvement in the condition of children and adults, consult a doctor after 14 days.

The ointment is intended for the treatment of subacute and chronic dermatoses, especially in the presence of severe dry skin, lichenification or in cases where the occlusive properties of the ointment are necessary.

If there is no improvement after treatment, or the symptoms worsen, or new symptoms appear, it is necessary to consult a doctor. Use the drug only according to the indications, the method of application and in the doses specified in the instructions.

Side effect

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

Rarely

Endocrine disorders: Suppression of adrenal cortex function.

Disorders of the skin and subcutaneous tissue: Atrophy with thinning of the skin, telangiectasia, purpura and striae; rosacea-like and perioral dermatitis with or without skin atrophy; withdrawal syndrome, which can lead to dependence on corticosteroids; delayed healing process; depigmentation; hypertrichosis.

(Note: The above are side effects of topical corticosteroids in general. In the case of hydrocortisone use, the probability of their occurrence is significantly lower than when using more powerful corticosteroids).

Contact allergy to neomycin

Very rarely

Visual impairment: increased intraocular pressure; increased likelihood of developing cataracts

If you experience side effects listed in the instructions or they worsen, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

There is no information about an overdose of the drug. There is a theoretical possibility of an ototoxic effect of neomycin in the case of application of the drug to the area of the external auditory canal in the presence of a perforation of the eardrum and direct exposure of neomycin to the middle ear.

Interaction with other medicinal products

No drug interactions have been described.

There may be cross-hypersensitivity between neomycin and drugs of similar chemical structure, for example, kanamycin, paromomycin, gentamicin, and cross-resistance between neomycin and other antibiotics of the aminoglycoside group.

Special instructions

When applying Pimafucort® to the eyelid area and periorbital area, there is a risk of increased intraocular pressure, the development of cataracts

When using the drug on extensive 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 effects of neomycin.

If a superinfection or excessive growth of fungi occurs, stop using the drug and take appropriate measures.

Influence on the ability to drive vehicles and mechanisms

There are no data available, but no effect is expected when using the drug Pimafucort®.

Release form

Ointment for external use.

15 g of ointment in an aluminum tube with an aluminum membrane and a screw-on cap made of high-density polyethylene. 1 tube together with the instructions for use is placed in a cardboard pack.

Storage conditions:

At a temperature not exceeding 25C.

Keep out of reach of children.