Description
Composition
Active substance:
hydrocortisone 17-butyrate – 1 mg,
Excipients:
White soft paraffin – 35.00 mg, solid paraffin – 50.00 mg, cetomacrogol 25 – 20.00 mg
cetostearyl alcohol – 20.00 mg, borage oil – 17.50 mg Propylene Glycol – 50.00 mg BHT – 0.20 mg propyl parahydroxybenzoate – 3.00 mg butyl parahydroxybenzoate – 1.50 mg, citric acid – 6.00 mg, sodium citrate – 5.00 mg purified water – 790.80 mg.
Description:
White or almost white emulsion
Product form:
30 g of the emulsion into vials of low density polyethylene with a dropper from a low density polyethylene and a polypropylene screw cap. On the bottle label paste.
1 bottle together with instructions for use in a cardboard box.
Contraindications
– hypersensitivity to hydrocortisone or auxiliary ingredients.
– bacterial infection of the skin (streptoi stafilodermii, gram negative folliculitis, etc.);
– viral skin infections (herpes simplex, chicken pox, shingles, etc.)
– fungal infection of the skin;
– tubercular and syphilitic lesions of the skin;
– parasitic skin infection;
– neoplastic skin lesions (benign and malignant tumors);
– acne, rosacea, perioral dermatitis;
– post-vaccination period;
– violation of integrity of the skin (wounds, ulcers);
Precautions: Pregnancy, lactation. During pregnancy, be used with caution in connection with identified at the pre-clinical study of the drug toxic effects on the fetus.
Indications
Superficial, non-infected, sensitive to local glucocorticosteroids skin diseases,
accompanied by itching:
– atopic dermatitis, allergic contact dermatitis, contact dermatitis (including professional..)
seborrheic dermatitis – eczema (various forms), psoriasis – photodermatosis – reaction to insect bites,
– itching of various etiologies,
– Adults and children from 6 months.
Interaction with other drugs
data on drug interactions lokoid not.
Overdose
Data on overdose lokoid not.
Prolonged use of high doses of the drug may increase the above-described side effects.
When the symptoms of Cushing’s medication should be discontinued.
pharmachologic effect
Pharmacological group:
glucocorticosteroid for topical application.
Pharmacological properties:
Lokoid® is a synthetic non-halogenated glucocorticosteroid preparation for external application. Esterification molecule hydrocortisone residue butyric acid (butyrate) afforded radically improve drug activity as compared to native hydrocortisone.
Lokoid® has rapidly occurring anti-inflammatory, anti, antipruritic effect. Application lokoid at recommended doses does not cause suppression of the hypothalamic gipofizarnoadrenalovoy system. Although the use of high doses for long periods, especially when using occlusive dressings.
can lead to an increase in cortisol in the blood plasma, it is not usually accompanied by a decrease in reactivity of the pituitary-adrenal system, and removal of the drug results in a rapid normalization of cortisol production.
Pharmacokinetics:
Suction
After application of the active substance accumulation 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 an unchanged form.
Metabolism
Most of hydrocortisone 17-butyrate, hydrocortisone and metabolized to other metabolites directly in the epidermis and subsequently in the liver.
breeding
Metabolites and a small portion of unchanged hydrocortisone 17-butyrate is excreted by the kidneys and through the intestines.
Pregnancy and breast-feeding
Glucocorticosteroids cross the placenta. Effects on the fetus can be especially pronounced when applying the drug to large surfaces.
In the absence of data, the use of the drug during breast feeding is possible if the expected benefit to the mother outweighs the potential risk to the child.
Conditions of supply of pharmacies
Without a prescription.
side effects
The frequency of occurrence of adverse reactions
Violations of the skin and subcutaneous tissue
Rare (> 1/10 000,
Violations by the endocrine system
Very rarely (
Violations by the immune system
Not known: hypersensitivity
If any of these instructions side effects are compounded or you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
Do not apply Lokoid® in the periorbital region due to the risk of developing glaucoma. At regular contact with the conjunctiva there is a risk of increasing intraocular pressure.
In severe lichenification, dryness, hyperkeratosis lokoid better to give preference in the form of an ointment or lipocreams.
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 large swathes of destruction, long-term use, and the use of occlusion in childhood.
If no effect within 2 weeks of continuous treatment, it is necessary to clarify the diagnosis.
As with any glucocorticosteroid drug, it is desirable to limit the duration of application and driving the minimum dose sufficient for the relief of skin process.
Pediatric use
Can be used in children from 6 months of age. In the case of the drug in children in the area of the face or under occlusive dressings, duration of the course of treatment should be reduced.
When used in children skin surface area on which drug is applied should not exceed 20% of the total.
In childhood, the suppression of adrenocortical function may develop more quickly. Furthermore, there may be a decrease of excretion of growth hormone.
In applying the drug for a long time is required to observe the body weight, height, level of plasma cortisol. In a study in children receiving 30-60 g lokoid a week for 4 weeks, compared with 1% hydrocortisone ointment, none of the children were not detected violations of adrenocortical function, the differences hydrocortisone 17-butyrate on the indicator from conventional hydrocortisone was not observed.
In children between the ages of 6 months to 1 year use of the drug may not be longer than 7 days.
Effects on ability to drive and use machines
Data on the impact of lokoid on ability to drive and work with no mechanisms.
Storage conditions
At temperatures above 25 ° C.
In the reach of children.
Dosing and Administration
Outwardly.
Lokoid Krelo® preferably used in acute inflammation, especially in moist areas, as this dosage form is the best choice at a lesion of the skin with copious hairline (e.g., the scalp).
The drug is applied to the affected skin a thin layer of 1-3 times a day. When the positive dynamics in the multiplicity of the drug can be reduced to 2-3 times a week.
The drug can be applied to light massaging movements, if necessary on a surface with weeping lesions after application lokoid Krelo® occlusive dressing is applied.
Residues lokoid Krelo® removed from the skin with water. The dose of the drug used during the week should not exceed ’60
If symptoms persist for more than 7 days, it is recommended to consult a doctor. Use drug only according to the application and in those doses which are specified in the instruction.
If necessary, please consult your physician before using the drug.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist
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