Composition, form of production and packaging
? Emulsion for external use 0.1% white or almost white.
1 g
hydrocortisone 17-butyrate 1 mg
Auxiliary substances: paraffin white soft - 35 mg, paraffin hard - 50 mg, cetomacrogol 25 - 20 mg, cetostearyl alcohol - 20 mg, borage oil - 17.5 mg, propylene glycol - 50 mg, butyl hydroxytoluene - 0.2 mg, propyl parahydroxybenzoate - 3 mg, butyl parahydroxybenzoate - 1.5 mg, citric acid - 6 mg, sodium citrate - 5 mg, purified water - 790.8 mg.
30 g - polyethylene bottles with a dropper (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Lokoid Krelo В® is a synthetic, non-halogenated glucocorticosteroid drug 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. Lokoid Krelo В® has a rapidly advancing anti-inflammatory, anti-edematous, antipruritic effect.
The use of Lokoid Krelo В® at 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
Surface, uninfected, sensitive to local SCS skin diseases:
- eczema;
- dermatitis (including atopic, contact, seborrheic);
- psoriasis.
DOSING MODE
Outwardly.
Lokoid Krelo В® is preferably used for acute inflammation, especially on wet areas, and this dosage form is also an optimal choice for lesions of skin areas with abundant hair (for example, the scalp).
The drug is applied to the affected skin with a thin layer 1-3 times / day. When there is a positive dynamics, the frequency of application of the drug can be reduced to 2-3 times a week.
The drug can be applied with light massaging movements, if necessary, on the surface of the foci with wetting after applying Lokoid Krelo В® an occlusive dressing is applied. Remains of Lokoid Krelo В® from the surface of the skin are removed with water. 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 for therapy GCS.
Systemic reactions: with long-term use, application to large surfaces and / or the use of occlusive dressings, side effects characteristic of systemic SCS can be observed. The risk of local and systemic side effects when using Lokoid Krelo В® is lower than using fluorinated steroids.
CONTRAINDICATIONS
- bacterial skin infections (strepto- and staphyloderma, gram-negative folliculitis);
- viral skin infections (simple herpes, chicken pox, shingles);
- 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);
- Hypersensitivity to the drug.
Caution should be given to the drug during pregnancy and lactation.
PREGNANCY AND LACTATION
GCS penetrate the placental barrier. Effects on the fetus can be particularly pronounced when applying the drug to large areas of the skin.
There is no data on the amount of hydrocortisone excreted in breast milk; It is recommended to take special care when applying Lokoid Krelo В® 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 KreloВ® per week for 4 weeks compared to 1% hydrocortisone ointment, no child showed adrenocortical dysfunction, while the difference between hydrocortisone 17-butyrate in this indicator was not observed from conventional hydrocortisone.
SPECIAL INSTRUCTIONS
Do not apply Lokoid Krelo В® 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.
With pronounced lichenification, dryness, hyperkeratosis, it is better to use Lokoid in the form of an ointment or lipocream.
The drug is preferably not used 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 occlusive dressings and in childhood.
If there is no effect within 2 weeks of continuous treatment, the diagnosis should be clarified.
As with any SCS, it is desirable to limit the duration of the drug and prescribe a course dose that is minimal enough to stop the skin process.
Use in Pediatrics
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 KreloВ® per week for 4 weeks compared to 1% hydrocortisone ointment, no child showed adrenocortical dysfunction, while the difference between hydrocortisone 17-butyrate in this indicator was not observed from conventional hydrocortisone.
Impact on the ability to drive vehicles and manage mechanisms
Data on the influence of Lokoid Krelo on the ability to drive vehicles and work with mechanisms are not.
OVERDOSE
There are no data on the overdose of Lokoid Krelo В® . 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 the drug interaction of Lokoid Krelo В® .
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
