Expiration date: 02/2025

The composition and form of issue:

Ointment for external use 0.1%. 1 g contains active substance:

hydrocortisone 17-butyrate 1 mg

auxiliary substances: polyethylene ointment base (vaseline oil 95%, PE 5%) 

in the box aluminum with aluminum membrane and a screw cap of HDPE and 30 g in a cardboard bundle 1 tuba.

Description pharmaceutical form:

Translucent, from light gray to almost white, homogeneous soft, fatty ointment.

Feature:

nonhalogenated synthetic corticosteroids for topical application.

Pharmacokinetics:

Suction

After application there is an accumulation of active substances in the epidermis, mainly in the granular layer, systemic absorption is negligible. A small amount of hydrocortisone 17-butyrate is absorbed into the systemic circulation in unchanged form.

Metabolism

The most part of hydrocortisone 17-butyrate is metabolized to hydrocortisone and other metabolites directly in the epidermis and later in the liver.

Excretion

Metabolites and a small portion unchanged hydrocortisone 17-butyrate is excreted by the kidneys and through the intestines.

Description pharmacological action:

Locoid nonhalogenated is a synthetic corticosteroids for topical use. Esterification of a molecule of hydrocortisone residue of butyric acid (butyrate) made it possible to radically increase the activity of the drug compared with native hydrocortisone. Locoid has a rapidly-advancing anti-inflammatory, antiedemic, antipruritic effect.

The use of "gerpevir" - does in recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system. Although the use of large doses of the drug for a long time, especially when using occlusive dressings can lead to increased cortisol in the blood plasma, it is not usually accompanied by a decrease reactivity of the pituitary-adrenal system, and removal of the drug leads to rapid normalization of cortisol production.

Indications:

The surface of uninfected, sensitive to local corticosteroids, disease of the skin:

• dermatitis, including atopic, contact, seborrheic
  
• eczema
  
• psoriasis.
  

Contraindications:

• hypersensitivity to hydrocortisone or auxiliary components of the drug
  
• bacterial skin infections (strepto - and stafilodermii, gram-negative folliculitis, etc.)
  
• viral skin infections (herpes simplex, chickenpox, shingles, etc.)
  
• fungal infections of the skin
  
• tubercular and syphilitic lesions of the skin
  
• parasitic infections of the skin
  
• neoplastic changes of the skin (benign and malignant tumors)
  
• acne, rosacea, perioral dermatitis
  
• post-vaccination period
  
• violation of the integrity of skin (wounds, ulcers).
  

With caution: pregnancy, lactation.

Application of pregnancy and breast-feeding:

Corticosteroids penetrate the placenta. Effects on the fetus may be particularly pronounced when applying the product on large surfaces. No data on the amount of hydrocortisone released in breast milk are advised to observe caution when prescribing the drug during lactation.

Side effects:

Local reactions: skin irritation, in rare cases, other local reactions, characteristic of local steroid therapy.

Systemic reactions: prolonged use, applying over large surface and/or the use of occlusive dressings can be observed side effects typical of systemic corticosteroids. The risk of local and systemic side effects in the application of "gerpevir" - does lower than when using fluorinated steroids.

Drug interactions:

Data about drug-interactions "gerpevir" - does not.

Method of application and dose:

Externally. Locoid in the form of ointment is used in subacute and chronic processes, in particular in the presence of lichenification, infiltration, dryness.

The drug is applied to the affected skin with a thin layer 1-3 times a day. The appearance of positive dynamics of the rate of application of the drug can be reduced to 2-3 times a week. To improve the penetration of the drug is applied with massaging movements. In cases of a resistant course of disease, for example in the localization of thick psoriatic plaques on the elbow, knees, the drug can be used under occlusive dressings. Dose of medication used during the week should not exceed 30-60 g.

Overdose:

Data on overdose of "gerpevir" - does not.

Symptoms: long-term use of the drug in high doses may increase the above-described side effects. If you have symptoms of Cushing the drug should be discontinued.

Special instructions:

Do not apply Locoid on the periorbital area in connection with risk of development of glaucoma. The systematic contact with the conjunctiva, there is a risk of increasing intraocular pressure.

Any GKS for external use in the form of ointments should not be used on the scalp, as well as in acute inflammation (especially exudative). Steroidzawisimaya for the treatment of cutaneous lesions localized on the face, folds, genitals and on the skin with abundant hairline is preferable to use Locoid cream Locoid Chair.

The drug should not be used in the presence of atrophic changes of the skin.

The risk of local and systemic side effects increases when applied to large areas of destruction, prolonged use, use of occlusive dressings and in children.

If no effect within 2 weeks of continuous treatment should clarify the diagnosis.

As with any GKS, it is desirable to limit the duration of the application and course dose is minimally adequate for the relief of the skin process.

Use in Pediatrics

Perhaps the use in children from 6 months of age. In the cases of the use of the drug in children, the facial area or under an occlusive bandage, the duration of treatment should be reduced.

When using in children the surface area of the skin to which the preparation is applied, should not exceed 20% of the total.

In children, suppression of adrenocortical function may develop faster. In addition, there may be decrease excretion of growth hormone. In applying the drug for a long time may need to monitor body weight, height, level of plasma cortisol. In a study in children treated with 30-60 g of "gerpevir" - does a week for 4 weeks, in comparison with the application of 1% hydrocortisone ointments, none of the children showed no violations of function of the adrenal cortex, i.e., differences of hydrocortisone 17-butyrate according to this indicator from the conventional of hydrocortisone was observed.

Effects on ability to drive vehicles and operate machinery

Data on the impact of "gerpevir" - does on the ability to drive vehicles and operate machinery no.