Pimafucort® [Hydrocortisone, Natamycin, Neomycin]

Pharmacological properties

pimafucort® is a combined preparation containing hydrocortisone, neomycin and natamycin.

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

Neomycin is a broad-spectrum antibiotic that is active against a number of gram-positive (staphylococci, enterococci) and gram-negative (Klebsiella, Proteus spp., E. coli) bacteria. Pseudomonas aeruginosa is resistant to in vitro neomycin.

Natamycin belongs to the polyene antibiotics of the macrolide group, has a fungicidal effect against infections caused by fungi, in particular Candida spp. It is not known whether other types of fungi are resistant to natamycin.

Cross-resistance between neomycin and other antibiotics of the aminoglycoside group can occur for the following reasons: the development of plasmids, the enzymes of which deactivate aminoglycosides and reduce the permeability of the cell membrane, as a result of which the effect of aminoglycosides decreases due to impaired energy metabolism or a ribosomal mutation, although the latter mechanism rarely occurs.

Pharmacokinetics

Absorption. Natamycin and neomycin are practically not absorbed through intact skin and mucous membranes. Possible slight absorption of neomycin through damaged skin, wounds and ulcers. Approximately 1-3% of hydrocortisone is absorbed through intact skin; with eczema, the amount of hydrocortisone that is absorbed doubles, with infectious skin lesions - 5 times. In children, the degree of absorption decreases with age.

Indications

Short-term treatment of superficial dermatoses that respond to corticosteroid therapy, complicated by a secondary bacterial and / or fungal infection (especially caused by candida fungi), sensitive to neomycin and natamycin.

Application

Pimafucort® is applied a thin layer on the affected skin 2-4 times a day. the duration of the course of treatment is determined individually depending on the nature of the disease. the course of treatment should not exceed 14 days.

Pimafukort^® in the form of an ointment, it is most suitable for the treatment of chronic skin diseases in which lesions occur, accompanied by dry skin, the formation of freckles and cracks.

Pimafukort^® in the form of a cream is most suitable for the treatment of acute and subacute skin diseases, as well as for the treatment of skin areas covered with hair and areas with folds.

Contraindications

Since pimafucort® contains hydrocortisone (a weak-acting corticosteroid), the following contraindications exist:

• skin disease caused by primary bacterial infections; primary infections caused by fungi and yeast; parasitic infections (including significant and severe skin damage)
• viral infections;
• skin wounds and ulcers, trophic ulcers, burns;
• adverse reactions caused by corticosteroids (perioral dermatitis, striae);
• ichthyosis, juvenile plantar dermatosis, acne vulgaris (acne vulgaris), rosacea, fragility of the blood vessels of the skin, skin atrophy.

Pimafukort^® should not be used in the external auditory canal during perforation of the eardrum.

In addition, Pimafukort^® should not be used in case of hypersensitivity to any of the components of the drug: neomycin, natamycin, to aminoglycosides or corticosteroids (which happens very rarely), or to any of the excipients.

Side effects

Rarely (0.01, 0.1%)

From the endocrine system. Adrenocortical suppression due to topical administration of drugs that contain corticosteroids is rarely observed in adults, and it is not expected that it may occur due to the use of Pimafucort^®. The possibility of developing systemic effects increases with the use of an occlusive dressing, applied to large areas of the skin, when applied over a long period, as well as in children.

On the part of the skin and subcutaneous tissue

When using Pimafucort^® at first, a slight exacerbation at the site of the lesion may occur. Stop treatment is not worth it.

Hypersensitivity reactions, burning and skin irritation, dermatitis, eczema, contact dermatitis. The following side effects of corticosteroids may occur, but their reliability with hydrocortisone is minimal compared with the use of stronger corticosteroids: skin atrophy, often irreversible, accompanied by thinning of the skin, telangiectasias, purpura and striae; rosacea-like and perioral dermatitis, which is accompanied or not accompanied by skin atrophy; ricochet effect, which can be addictive to corticosteroids; delayed wound healing; depigmentation, hypertrichosis.

The risk of local adverse reactions increases with increasing duration of treatment. The use of an occlusive dressing (cellophane) or the presence of skin folds on the site increases this risk. The skin of the face, scalp and genitals is especially sensitive to local reactions.

When used improperly, bacterial, parasitic, fungal and viral infections can mask and / or worsen.

Very rare (0.01%)

Violations of the organ of vision: increased intraocular pressure, increased risk of cataracts.

Frequency unknown

On the part of the skin and subcutaneous tissue: skin rash, itching of pustular acne.

The risk of systemic effects is increased in the following cases: use with a dressing (cellophane dressing or in areas of skin folds) use in large areas of the skin; long-term treatment; when used by children (children are extremely sensitive due to the presence of thin skin and a relatively large surface area); the presence of components or auxiliary substances enhance penetration through the stratum corneum of the skin and / or enhance the effect of the active substance.

The risk of developing local adverse reactions increases with increasing strength of the drug and the duration of treatment. The use of a dressing (cellophane dressing or application to areas of skin folds) increases this risk. The skin of the face and scalp, as well as the genitals, is especially sensitive to the occurrence of adverse reactions. With improper use of the drug, as well as in the presence of bacterial, parasitic, fungal or viral infections, the manifestations of these diseases can be masked and / or amplified.

Pimafukort drug^® contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which can cause allergic reactions (possibly delayed).

special instructions

The risk of local adverse reactions increases with increasing duration of treatment. the use of an occlusive dressing (cellophane) or application in the area of ​​skin folds increases this risk.

Facial skin, scalp and genitals are especially sensitive to local reactions.

The use of the drug in the face, on curving surfaces and other areas of thin skin can lead to skin atrophy and increased absorption of the drug.

Topical corticosteroids can be dangerous for patients with psoriasis for a number of reasons, including rebound syndrome due to tolerance, the risk of generalized pustular psoriasis, or local systemic toxicity due to impaired skin barrier function. Steroids can be used for scalp psoriasis or chronic scaly psoriasis of the hands and feet.Careful monitoring of patients is important.

When used improperly, bacterial, parasitic, fungal and viral infections can mask and / or worsen.

Do not apply the drug forever due to the possibility of contact with the conjunctiva of the eye and an increased risk of developing glaucoma or subcapsular cataract.

When applying the drug Pimafukort^® on large areas of the skin, when applied to children or using an occlusive dressing (experience with which is limited), it is necessary to remember the possibility of adrenocortical suppression.

There is the possibility of both cross sensitization between neomycin and chemically related antibiotics such as kanamycin, paromycin and gencitamine, and cross resistance between neomycin and other aminoglycosides. Accordingly, in order to maintain the necessary levels of aminoglycosides, recommendations regarding the use and duration of treatment must be followed.

Prolonged treatment and application to wounds or damaged skin should be avoided due to the theoretical risk of oto- and nephrotoxicity due to absorption of neomycin.

The use of a combination of corticosteroids, antifungal drugs and antibiotics is possible only in emergency cases. A correct diagnosis eliminates the possibility of resistance of microorganisms. In some cases, there is a need to use two or more active substances, however, a positive result can be achieved using a preparation containing one active substance.

In case of superinfection or excessive growth of fungal infection, treatment should be discontinued and appropriate measures taken.

Particular care should be taken in patients with renal failure when using drugs containing aminoglycosides.

Use during pregnancy and lactation. Limited data on the use of natamycin during pregnancy did not reveal an increased risk of congenital disorders. For external use in small areas, the systemic absorption of natamycin is minimal.

With systemic use of aminoglycosides during pregnancy, cases of ototoxicity were noted. For external use in small areas, systemic absorption of aminoglycosides is minimal. In animal studies, after the use of neomycin, its toxic effect on reproductive function was noted. Corticosteroids can penetrate the placenta. At present, a person has not revealed teratogenic effects observed in animal studies. With the systemic use of corticosteroids in high doses, the effect on the fetus / newborn was revealed (intrauterine growth retardation, adrenosuppression). Although there is limited data on the external use of GCS in humans during pregnancy, their minimal systemic absorption must be considered; GCS of mild to moderate activity (I and II class), such as hydrocortisone, can be used in short courses in limited areas of the skin. The effects described above cannot be excluded with prolonged use or application to large surfaces of damaged skin.

Pimafukort^® can be used during pregnancy in short courses on small areas of the skin. Long-term use or application to large areas of damaged skin is possible only in extreme cases.

Lactation. There is no information on the possible penetration of natamycin into breast milk. When used in short courses on small areas of the skin, corticosteroids and neomycin are excreted in breast milk only in small quantities.

Pimafukort^® can be used during breastfeeding short courses in small areas of the skin.With prolonged use or application to large areas of damaged skin, breastfeeding is not recommended.

Children. The drug is used in children over the age of 1 year under the supervision of a doctor.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. There is no data on the effect of Pimafucort^® on the ability to drive vehicles or work with other mechanisms, and the occurrence of such an effect is not expected.

Interactions

There are no data on the drug interaction of pimafucort®.

Overdose

There is no evidence of an overdose of the drug. 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 the direct action of neomycin in the middle ear. in some cases, if the contents of an entire package of pimafucort® are accidentally ingested, the drug may be tolerated without the development of toxic effects.

Storage conditions

Ointment and cream are stored at a temperature not exceeding 25 ° C.