Universal reference book for medicines
Product name: LOCOID (LOCOID)

Active substance: hydrocortisone butyrate

Type: GCS for external use

Manufacturer: ASTELLAS PHARMA EUROPE (Netherlands) manufactured by TEMMLER ITALIA (Italy)
Composition, form of production and packaging
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Cream for external application of white color, homogeneous.
1 g

hydrocortisone butyrate 1 mg

Auxiliary substances: cetostearyl alcohol 72 mg, macrogol 25 cetostearyl ether 18 mg, paraffin liquid 60 mg, paraffin white soft 150 mg, propyl parahydroxybenzoate 1 mg, butyl parahydroxybenzoate 0.5 mg, citric acid anhydrous 4.2 mg, sodium citrate anhydrous 2.8 mg, purified water up to 1 in

30 g - aluminum tubes (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

The lokoid is a synthetic, non-halogenated glucocorticosteroid for external use.
The esterification of the hydrocortisone molecule with the residue of butyric acid (butyrate) made it possible to radically increase the activity of the preparation as compared to native hydrocortisone. The lokoid exerts a rapidly advancing anti-inflammatory, anti-edematous, antipruritic effect.
The use of Lokoid in the 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 with the use of occlusive dressings, can lead to an increase in the level of cortisol in the blood plasma, it is usually not accompanied by a decrease in the reactivity of the pituitary-adrenal system, and the withdrawal of the drug leads to a rapid normalization of cortisol production.
PHARMACOKINETICS

Suction

After application, the active substance accumulates in the epidermis, mainly in the granular layer, systemic absorption is negligible.
A small amount of hydrocortisone 17-butyrate is absorbed into the systemic blood stream unchanged.
Metabolism

Most hydrocortisone 17-butyrate is metabolized to hydrocortisone and other metabolites directly in the epidermis and subsequently in the liver.

Excretion

Metabolites and a small part of unchanged hydrocortisone 17-butyrate is excreted by the kidneys and through the intestine.

INDICATIONS

Superficial, uninfected, sensitive to local glucocorticosteroids skin diseases:

- dermatitis, including atopic, contact, seborrheic;

- eczema;

- psoriasis.

DOSING MODE

Outwardly.

Lokoid cream is preferably used in acute and subacute skin processes (without wetting).

The drug is applied to the affected skin with a thin layer 1-3 times / day.
To improve penetration, the drug is applied with light massaging movements. When there is a positive dynamics, the frequency of application of the drug can be reduced to 2-3 times a week.
The dose of the drug used during the week should not exceed 30-60 g.

SIDE EFFECT

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

Systemic reactions: with prolonged use, application to large surfaces and / or the use of occlusion, side effects characteristic of systemic glucocorticosteroids can be observed.
The risk of local and systemic side effects when using Lokoid is lower than using fluorinated steroids.
CONTRAINDICATIONS

- hypersensitivity to hydrocortisone or ancillary components of the drug;

- bacterial skin infections (strepto- and staphyloderma, gram-negative folliculitis, etc.);

- viral skin infections (herpes simplex, chicken pox, shingles, etc.);

- fungal skin infections;

- tuberculosis and syphilitic skin lesions;

- parasitic skin infections;

- Neoplastic skin changes (benign and malignant tumors);

- Acne, rosacea, perioral dermatitis;

- Post-vaccination period;

- violation of the integrity of the skin (wounds, ulcers).

With caution: pregnancy, lactation.

PREGNANCY AND LACTATION

Use with caution in pregnancy, during lactation.

Glucocorticosteroids penetrate the placenta.
Effects on the fetus can be particularly pronounced when applying the drug on large surfaces. There is no data on the amount of hydrocortisone excreted in breast milk; it is recommended to observe special caution when prescribing the drug during lactation.
APPLICATION FOR CHILDREN

Possible use in children from 6 months of age.
In cases of use of the drug in children, on the face area or under occlusive dressings, the duration of the course of treatment should be reduced.
When used in children, the skin surface area on which the drug is applied should not exceed 20% of the total.

In childhood, suppression of the function of the adrenal cortex can develop faster.
In addition, there may be a decrease in the excretion of growth hormone. When using the drug for a long time, it is necessary to observe the body weight, growth, plasma cortisol level. In a study in children who received 30-60 g of Lokoid per week for 4 weeks compared to 1% hydrocortisone ointment, no child showed any adrenocortical dysfunction, while the difference between hydrocortisone 17-butyrate in this indicator from the usual hydrocortisone was not observed.
SPECIAL INSTRUCTIONS

Do not apply Lokoid to the periorbital area due to the risk of developing glaucoma.
With a systematic hit on the conjunctiva, there is a risk of increased intraocular pressure.
When the process is localized on the scalp and with exudative inflammation, it is preferable to use a Lokoid in the form of a Creole.

In cases of refractory disease, for example, in the localization of dense psoriatic plaques on the ulnar areas, knees, pronounced lichenification, dryness, it is better to prefer Lokoid in the form of an ointment or lipocream, if necessary, under occlusive dressings.

The drug is not desirable to use in the presence of atrophic skin changes.
The risk of local and systemic side effects increases when applied to extensive areas of damage, prolonged use, the use of occlusion and in childhood.
If there is no effect within 2 weeks of continuous treatment, the diagnosis should be clarified.

As with any glucocorticosteroid drug, it is desirable to limit the duration of application and the course dose is minimal enough to stop the skin process.

Influence on ability to drive vehicles and work with mechanisms

Data on the influence of Lokoid on the ability to drive vehicles and work with mechanisms there.

OVERDOSE

There are no data on Lokoid overdose.
With prolonged use of the drug in high doses, it is possible to enhance the side effects described above. When symptoms of hypercortisy appear, the drug should be discarded.
DRUG INTERACTION

There are no data on drug interactions of Lokoid.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

Keep the drug out of reach of children at a temperature of no higher than 25 ° C.
Do not freeze.
Shelf life - 3 years.
Do not use after expiry date.
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