LOKOID

Active material: Hydrocortisone butyrate
When ATH: D07AB02
CCF: SCS for external use
ICD-10 codes (testimony): L20.8, L23, L24, L28.0, L30.0, L40
When CSF: 04.05
Manufacturer: ASTELLAS PHARMA EUROPE B.V. (Netherlands)

Pharmaceutical form, composition and packaging

Ointment for external application 0.1% translucent, Soft, oily, from light gray to nearly white.

1 g
hydrocortisone 17-butyrate1 mg

Excipients: polyethylene ointment base (Oil vaseline 95%, polyethylene 5%).

30 g – aluminum tuba (1) – packs cardboard.
30 g – Plastic tubes (1) – packs cardboard.

 

Pharmacological action

Non-halogenated synthetic glucocorticoid drugs for external use. Renders quickly coming antiinflammatory, decongestant, antipruritic effect. Its efficiency is comparable with halogenated steroids.

Application Lokoid® at recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal axis. Although the use of the drug at high doses for a long time, especially when using occlusive dressings, may lead to increased levels of plasma cortisol, it is never accompanied by a decrease in reactivity of the pituitary-adrenal axis, and removal of the drug leads to rapid normalization of cortisol production.

 

Pharmacokinetics

Absorption and distribution

After application of the active substance accumulation in the epidermis, mainly in the granular layer.

Metabolism

Hydrocortisone 17-butyrate, absorbed through the skin, metabolized to hydrocortisone and other metabolites directly in the epidermis, and then the liver.

Deduction

Metabolites and a small portion of unchanged hydrocortisone 17-butyrate is excreted in the urine or feces.

 

Testimony

Surface, uninfected, sensitive to local glucocorticoids skin diseases:

- Eczema;

- Dermatitis;

- Psoriasis.

 

Dosage regimen

A small amount of the drug is applied to the affected skin 1-3 times / day. When the positive dynamics of drug use 1 to 3 once a week.

To improve the penetration of ointment applied massage.

In marked hyperkeratosis, eg, the localization of dense psoriatic plaques on ulnar areas, lap, it is desirable to use the drug under occlusive dressings.

Dose, used within a week, should normally not exceed 30-60 g.

 

Side effect

Local reactions: rarely – skin irritation.

With long-term use of the drug and / or by applying the extensive surface of the skin may develop systemic side effects, characteristic of the GCS.

The risk of side effects with Lokoid® below, than when using halogenated steroids.

 

Contraindications

- Rosacea, lokalizuyushtiesya person;

— acne vulgaris;

- Dermatitis, localized in the mouth;

- Perianal, genital itching;

- Dermatitis, complicated by bacterial (eg, impetigo), viral (eg, caused by Herpes simplex), fungal (eg, caused by Candida or dermatophytes) infections;

- Hypersensitivity to the drug.

 

Pregnancy and lactation

GCS cross the placental barrier. The impact on the fetus can be especially pronounced when applied Lokoid® on the vast surface of the skin.

No data on the number of hydrocortisone, excreted in breast milk; It recommended to be particularly careful when applying Lokoid® lactation.

 

Cautions

The risk of local and systemic side effects increases with prolonged use of the drug over a large surface of damaged skin or by using occlusive dressings.

In the case of the drug on the face area or under an occlusive dressing duration of treatment should be reduced.

Use in Pediatrics

The drug is approved for use in children 6 months and older.

In applying the drug in children duration of treatment should be reduced.

In children, the suppression of adrenocortical function may develop faster. Besides, there may be a reduction in the excretion of growth hormone. In applying the drug for a long time is required to observe the body weight, growth, plasma cortisol level.

In controlled trials in children, that received weekly by 30-60 Mr. Lokoid® or 1% hydrocortisone ointment, There were no violations of the function of the adrenal cortex.

 

Overdose

Data on overdose Lokoid® no. With long-term use of the drug in high doses may cause symptoms of Cushing.

 

Drug Interactions

Data on drug interactions Lokoid® no.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

Ointment should be stored out of reach of children at or above 25 ° C. Shelf life – 5 years.

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