Instructions for use: Lokoid cream 1 mg/g, tube 30 g
Composition
active ingredient: hydrocortisone 17-butyrate;
1 g of cream contains 1 mg of hydrocortisone 17-butyrate;
excipients: cetostearyl alcohol, macrogol cetostearyl ether, light mineral oil, white soft paraffin, propyl parahydroxybenzoate (E 216), butyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, purified water.
Dosage form
Cream.
Main physicochemical properties: white cream that is easy to apply.
Pharmacotherapeutic group
Corticosteroids for use in dermatology.
ATX code D07A B02.
Pharmacological properties
Pharmacodynamics.
Hydrocortisone 17-butyrate is an active synthetic non-halogenated corticosteroid for topical use. It exhibits anti-inflammatory, anti-edematous, antipruritic effects. Its efficacy is the same as that of halogenated steroids. Use in recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system. Although prolonged use of large doses of the drug, especially when using occlusive dressings, may lead to an increase in the content of cortisol in the blood plasma, the reactivity of the pituitary-adrenal system does not decrease, and after discontinuation of the drug, cortisol production normalizes.
Pharmacokinetics.
Absorption. After application, the active substance accumulates in the epidermis, mainly in the granular layer.
Metabolism: Hydrocortisone 17-butyrate, absorbed through the skin, is metabolized to hydrocortisone and other metabolites directly in the epidermis and then in the liver.
Excretion: Metabolites and a small portion of unchanged hydrocortisone 17-butyrate are excreted in the urine and feces.
Indication
Conditions that respond to topical corticosteroids (eczema, dermatitis, psoriasis). Topical corticosteroids are generally not indicated for the treatment of psoriasis but may be acceptable, except in widespread plaque psoriasis, with precautions (see section 4.4).
Contraindication
Except in cases of treatment in combination with appropriate chemotherapeutic agents:
Skin lesions (wounds) caused by bacterial infections (e.g. pyoderma, syphilitic or tuberculous lesions), viral infections (e.g. chickenpox, herpes simplex, herpes zoster, common warts, flat warts, condyloma acuminatum, molluscum contagiosum); infections caused by fungi and yeasts; parasitic infections (e.g. scabies);
ulcerative skin lesions;
adverse reactions caused by corticosteroids (e.g. perioral dermatitis, striae);
ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, skin vascular fragility, skin atrophy;
allergic hypersensitivity reactions to the components of the drug or corticosteroids (the latter occur rarely);
skin neoplasm.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Application features
Systemic adverse reactions to topical corticosteroids in adults are extremely rare but can be serious, especially adrenocortical suppression with prolonged use.
The risk of systemic effects increases in the following cases:
application to large areas of skin, especially with the use of occlusive dressings or application to areas of skin folds;
long-term treatment;
use in children (due to thin skin and relatively large surface area);
the presence of components or excipients that enhance penetration through the stratum corneum and/or enhance the effect of the active ingredient (for example, propylene glycol).
The risk of local adverse reactions increases with increasing drug potency and duration of treatment. Application under occlusive dressings or application to skin folds increases this risk. The skin of the face, scalp and genitals are particularly susceptible to adverse reactions. In case of inappropriate use, as well as in the presence of bacterial, parasitic, fungal or viral infections, the manifestations of these diseases may be masked and/or exacerbated.
The ointment should not be applied to the eyelids due to the possibility of contact with the conjunctiva and an increased risk of developing ordinary glaucoma or subcapsular cataracts.
Topical corticosteroids can be dangerous for patients with psoriasis for a number of reasons, including rebound syndrome due to tolerance, the risk of generalized pustular psoriasis, or local and systemic toxicities due to impaired skin barrier function. Steroids may be used in scalp psoriasis or chronic plaque psoriasis of the hands and feet. Close monitoring is important.
There is a possibility of side effects in infants with excessive use. Particular caution should be exercised in dermatoses in infants, in particular diaper dermatitis. In such patients, the course of treatment should generally not last more than 7 days.
Adrenal suppression (Cushing's syndrome) may develop rapidly in children. Growth hormone production may also be suppressed and intracranial hypertension may occur. Manifestations of intracranial hypertension have included fontanelle swelling, headache, and bilateral optic disc edema. If long-term treatment is necessary, it is advisable to regularly monitor the child's height and weight, as well as determine plasma cortisol levels.
In comparative studies, no significant differences in adrenocortical function were observed in children who were treated with Locoid® cream or 1% hydrocortisone in an amount of 30–60 grams per week for 4 weeks.
Excipients included in the preparation.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Propyl and butyl parahydroxybenzoate may cause delayed allergic reactions.
Use during pregnancy or breastfeeding
Pregnancy. There are no or limited amount of data from the use of hydrocortisone butyrate in pregnant women. Animal studies have shown reproductive toxicity. Corticosteroids cross the placenta. Effects on the fetus or newborn (fetal growth retardation, adrenocortical suppression) have been reported with systemic use of high doses of corticosteroids.
Although there is little information on the use of corticosteroids on the skin in pregnant women, due to the limited systemic absorption of this class of drugs, it is possible to use weak and moderate-potency corticosteroids (class 1 and class 2), such as hydrocortisone, for short periods of time and on limited areas of the skin. The above-mentioned effects cannot be excluded with long-term use or when applied to large areas of the skin. This should only be done if there are special indications.
Breastfeeding. Hydrocortisone butyrate/metabolites pass into breast milk, but when using the drug Lokoid® in therapeutic doses, no effects on newborns/infants who are breastfed are expected. Lokoid® can be used by women during breastfeeding only for short-term treatment and application to small areas of skin. For long-term treatment or application to large areas of affected skin, breastfeeding should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of the drug Lokoid® cream on the ability to drive or operate other mechanisms; no effect is expected.
Method of administration and doses
For cutaneous use.
Apply the drug in a small amount in a thin, even layer to the affected areas no more than 2 times a day.
It can be applied under an occlusive dressing in the presence of more persistent lesions, such as thickened psoriatic plaques on the elbows and knees (excluding weeping lesions).
Dosage
The total course dose should not exceed 30–60 g of cream per week.
Adults and elderly patients
Adults and elderly patients are given the same doses as there is no clinical evidence to suggest that elderly patients require a special dosing regimen.
Children
If possible, long-term treatment should be avoided.
Aged 6 months to 1 year
If possible, the treatment period should last a maximum of 7 days.
Overdose
Excessive use under occlusive dressing may cause adrenal suppression. There is no specific treatment or antidote. If any adverse effects occur, treatment should be discontinued and symptomatic treatment should be administered.
Side effects
Rare (>1/10,000, <1/1,000)
Skin and subcutaneous tissue disorders:
dermatitis, eczema, stretch marks, contact dermatitis;
contact allergy, pustular acne;
skin atrophy, often irreversible, accompanied by thinning of the epidermis, telangiectasias, purpura, and striae;
depigmentation, hypertrichosis;
Rosacea-like and perioral dermatitis, with or without skin atrophy;
rebound effect, which can lead to steroid dependence;
delayed wound healing;
skin infection, redness, irritation, burning, rashes, itching, dry skin, folliculitis, impetigo, acne, maceration.
Endocrine disorders: adrenocortical suppression, Cushing's syndrome, hyperglycemia, glycosuria, growth retardation, and intracranial hypertension.
Very rare (<1/10,000, including isolated reports)
Visual disturbances: increased intraocular pressure and risk of cataracts (with systematic contact of the drug with the conjunctiva).
Immune system disorders: hypersensitivity reactions.
It is important to report possible adverse reactions after a medicine has been authorised. This allows for continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Do not store in the refrigerator.
Keep out of reach of children.
Packaging
30 g in a tube; 1 tube in a cardboard pack.
Vacation category
According to the recipe.
Producer
Temmler Italia S.r.l.
Temmler Italia Srl
Address
Via delle Industri, 2, 20061, Carugate (MI), Italy.
Via delle Industrie, 2, 20061, Carugate (MI), Italy.
