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

Composition

Active ingredients:

Natamycin 10 mg,

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

micronized hydrocortisone 10 mg;

Associated substances:

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

How to take, the dosage

Pimafucort is applied to the affected areas of the skin 2-4 times a day in adults and children.

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 skin and no occlusive dressings should be used. If there is no improvement in children and adults after 14 days, a doctor should be consulted.

In cream form the drug is recommended for the treatment of acute and subacute dermatoses, including those accompanied by mucous membranes. The ointment is indicated for treatment of sub-acute and chronic dermatoses, especially in the presence of severe dry skin, lichenification, seborrhea or in cases where occlusive properties of the ointment are required.

Interaction

No drug interactions have been described.

Cross-sensitivity between neomycin and drugs of similar chemical structure, such as kanamycin, paramomycin, gentamicin and cross-resistance between neomycin and other antibiotics of the aminoglycoside group may occur.

Special Instructions

When Pimafucort is applied to the eyelid area and periorbital area there is a risk of increased intraocular pressure, development of cataracts.
When using the drug on large surfaces in children or under bandages one should bear in mind the possibility of suppression of hypothalamic-pituitary-adrenal system function.
In case of prolonged treatment, with wounds and ulcers there is a theoretical risk of ototoxic and nephrotoxic effects of neomycin.
In case of superinfection or excessive fungal growth the drug should be stopped and appropriate measures taken.

Contraindications

With caution:

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

Side effects

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

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

When external glucocorticosteroids are used for long periods of 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 cortical function may develop.

Contact dermatitis to neomycin.

Overdose

There is no information about Pimafucort overdose.

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

Pregnancy use