Pimafucort, ointment, 15g

Composition

Active ingredients:  

Natamycin 10 mg,

neomycin (in the form of neomycin sulfate) 3500 units,

micronized hydrocortisone 10 mg;

Auxiliary substances:

polyethylene ointment base (95% liquid paraffin,5% polyethylene) 976.5 mg

Pharmacological action

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 (Staphylococcusspp., Enterococcusspp. ) and Gram-negative (Klebsiellaspp., Proteusspp., Escherichiacoli, etc. ) bacteria. Natamycin is a polyene-type antifungal drug that has a fungicidal effect against yeast and yeast-like fungi, especially Candidaspp. Dermatomycetes are less sensitive to natamycin.

Hydrocortisone has an anti-inflammatory effect. and vasoconstrictor effect. Eliminates the inflammatory phenomena and itching accompanying various types of dermatoses.

Pharmacokinetics

Natamycin and neomycin are practically not absorbed through intact skin and mucous membranes. It is possible to absorb neomycin through damaged skin, if the drug gets on wounds, ulcers.

From 1 to 3% of hydrocortisone is absorbed through intact skin; in dermatitis, the amount of absorbed hydrocortisone increases by 2 times, in 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

Dermatoses that respond to glucocorticoid therapy and are complicated by a secondary bacterial and / or fungal infection (especially caused by Candida fungi).

Use during pregnancy and lactation

When prescribing the drug during pregnancy, it is necessary to take into account the theoretical 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.

Contraindications

• Hypersensitivity to the components of the drug Pimafucort;
• skin tuberculosis, skin manifestations of syphilis, viral skin infections, skin post-vaccination reactions, open wounds, ulcers;
• acne, rosacea, ichthyosis; 
• anogenital pruritus, skin tumors.

With caution:

• in children under the age of 1 year;
• in patients with a history of indications for the defeat of the IX pair of TBI against the background of the use of aminoglycosides.

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

Side effects

Side effects with external use of Pimafucort, as with the use of other glucocorticosteroids, rarely develop and are reversible. Rarely, a hypersensitivity reaction (itching, burning, redness, or dry skin) may occur.

Extremely rare – atrophy and thinning of the skin, telangiectasia, striae, purpura, rosacea-like and perioral dermatitis, delayed wound healing, depigmentation, hypertrichosis, withdrawal syndrome after discontinuation of treatment.

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

Contact dermatitis on neomycin.

Interaction

No drug interactions have been described.

There may be cross-hypersensitivity between neomycin and drugs of similar chemical structure, such as kanamycin, paromomycin, gentamicin, and cross-resistance between neomycin and other aminoglycoside antibiotics.

How to take, course of use and dosage

For adults and children, Pimafucort 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, do not use occlusive dressings. If there is no improvement in the condition of children and adults after 14 days, you should consult a doctor.

In the form of a cream, the drug is recommended for the treatment of acute and subacute dermatoses, including those accompanied by wetness. The ointment is intended for the treatment 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.

Overdose

There is no information about an overdose of Pimafucort.

There is a theoretical possibility of the ototoxic effect of neomycin in the case of applying the drug to the external auditory canal in the presence of perforation of the tympanic membrane and direct exposure of neomycin to the middle ear.

Special instructions

When applying Pimafucort to the eyelid area 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 effects of neomycin. If a superinfection or excessive growth of fungi occurs, the drug should be discontinued and appropriate measures taken.

Form of production

Ointment for external use.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Hydrocortisone, Neomycin, Natamycin

Dosage form

ointment

Description

Children as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Skin Infections, Dermatosis, Seborrhea, Fungus