Pimafucort, ointment 15 g

Neomycin is a broad spectrum antibiotic of aminoglycoside group, active against a number of Gram-positive (Staphylococcusspp, Enterococcusspp.) and gram-negative (Klebsiellaspp., Proteusspp., Escherichiаcoli, etc.) bacteria.

Natamycin refers to antifungal drugs of polyene series, has fungicidal effect against yeast and yeast-like fungi, especially Candidaspp. Dermatomycetes are less sensitive to natamycin.

Hydrocortisone has anti-inflammatory.and vasoconstrictor action.
It relieves inflammation and itching accompanying various types of dermatosis.

Pharmacokinetics

Natamycin and neomycin are practically not absorbed through intact skin and mucous membranes. Neomycin may be absorbed through damaged skin if the drug comes into contact with wounds and ulcers.

Within intact skin 1 to 3% of hydrocortisone is absorbed; with dermatitis the amount of absorbed hydrocortisone increases by 2 times, with infectious skin lesions it may 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 bloodstream decreases with age.

Indications

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

Pharmacological effect

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 (Klebsiellas pp., Proteus spp., Escherichia coli, etc.) bacteria.

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

Hydrocortisone has anti-inflammatory and vasoconstrictor effects.
Eliminates inflammation 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 comes into contact with wounds or 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; the degree of absorption of the drug into the systemic circulation decreases with age.

Special instructions

When applying Pimafucort to the eyelids and periorbital area, there is a risk of increased intraocular pressure and the development of cataracts.
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 superinfection or excessive fungal growth occurs, discontinue use of the drug and take appropriate measures.

Active ingredient

Hydrocortisone, Neomycin, Natamycin

Composition

Active ingredients:

Natamycin 10 mg,

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

micronized hydrocortisone 10 mg;

Excipients:

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

Pregnancy

When prescribing the drug during pregnancy, it is necessary to take into account the theoretical risk of the ototoxic effect of neomycin, and therefore the drug should not be used for a long time and should not be applied 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 itching, skin tumors.

With caution:

in children under 1 year of age;
in patients with a history of damage to the IX pair of cranial nerves due to the use of aminoglycosides.

In the presence of perforation of the tympanic membrane and direct exposure of the middle ear to neomycin, there is a risk of ototoxicity.

Side Effects

Side effects with external use of Pimafucort, as with the use of other glucocorticosteroids, develop rarely 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 cessation of treatment.

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

Contact dermatitis to neomycin.

Interaction

No drug interactions have been described.

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

Overdose

There is no information about an overdose of Pimafucort.

There is a theoretical possibility of an ototoxic effect of neomycin if the drug is applied to the area of ​​the external auditory canal in the presence of perforation of the eardrum and direct effect of neomycin on the middle ear.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Manufacturer

Temmler Italia S.r.L., Italy