Instructions for Lokoid ointment 1 mg/g tube 30 g
Composition
active ingredient: hydrocortisone 17-butyrate;
1 g of ointment contains 1 mg of hydrocortisone 17-butyrate;
excipient: polyethylene oleogel.
Dosage form
Ointment.
Main physicochemical properties: transparent, light gray to whitish soft fatty ointment.
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 quickly has anti-inflammatory, anti-edematous, antipruritic effects. Its effectiveness is the same as that of halogenated steroids. Use in 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 when using occlusive dressings, can lead to an increase in the content of cortisol in the blood plasma, this is not accompanied by a decrease in the reactivity of the pituitary-adrenal system, and withdrawal of the drug leads to a rapid normalization of cortisol production.
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
Superficial non-infected dermatoses treated with topical corticosteroids (eczema, allergic and contact dermatitis, neurodermatitis, psoriasis), the occurrence of which is not associated with microorganisms and which are expected to give an incomplete response to treatment with active drugs of weak action.
Continuation of treatment or maintenance therapy for dermatoses that have been treated with stronger corticosteroids in the past.
Contraindication
Skin lesions 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, molluscum contagiosum); infections caused by fungi and yeasts; parasitic infections (e.g. scabies);
ulcerative skin lesions, wounds;
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).
Interaction with other medicinal products and other types of interactions
There are no data on drug interactions of Lokoid® ointment.
Application features
Do not apply the ointment to the eyelids due to the possibility of contact with the conjunctiva and an increased risk of developing ordinary glaucoma or subcapsular cataracts.
The skin of the face, genitals, and scalp is most sensitive to corticosteroids, so only low-potency corticosteroids should be used to treat lesions in these areas.
Sometimes it may be advisable to apply an air-permeable or non-air-permeable dressing to the affected area or to apply an occlusive dressing.
The effect of corticosteroids can be enhanced by the application of an occlusive dressing due to increased penetration (by a factor of approximately 10) of the drug through the stratum corneum of the epidermis. However, this increases the risk of side effects.
It should be noted that when corticosteroids are applied to large areas of skin, especially with the use of a (cellophane) bandage or in the area of folds, there is a possibility of increased absorption of the drug, which may lead to suppression of adrenocortical function.
Adrenal suppression can develop rapidly in children. Growth hormone production may also be suppressed. 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 noted in children who were treated with Locoid® ointment or 1% hydrocortisone at 30–60 grams per week for 4 weeks.
Application of the drug to the face, flexors, and other areas of thin skin may lead to skin atrophy and increased absorption of the drug.
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 systemic toxicity due to compromised skin barrier function. Steroids may be used for scalp psoriasis or chronic scaly psoriasis of the hands and feet. Close monitoring is important.
Visual disturbances may occur with systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, an ophthalmologist should be consulted to evaluate possible causes, including cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSR), which have been reported following systemic or topical corticosteroid use.
Use during pregnancy or breastfeeding
Pregnancy.
Corticosteroids cross the placenta. There is no clear evidence to date of teratogenic effects in humans similar to those observed in animal studies. Topical administration of corticosteroids to pregnant animals at high doses may cause fetal malformations such as cleft palate and intrauterine growth retardation. Furthermore, preclinical data do not add to the existing clinical experience.
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 of pregnant women, due to their limited systemic absorption, it is possible to use corticosteroids of weak and moderate potency (class 1 and class 2), such as hydrocortisone, for short periods of time and on limited areas of skin. The above-mentioned effects cannot be excluded with long-term use or application to large areas of skin. This should only be done if there are special indications.
Breast-feeding.
Locoid® ointment can be used in breastfeeding women only for short-term treatment and application to small areas of skin. Breastfeeding should be discontinued for long-term treatment or application to large areas or affected skin.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no data on the effect of Lokoid® ointment on the ability to drive or use machines. No effects are expected.
Method of administration and doses
Apply a small amount of the drug to the skin 1–3 times a day. When the condition improves, it is usually sufficient to apply the drug once a day or 2–3 times a week.
The total course dose should not exceed 30–60 g per week.
Lokoid® should be applied in a thin, even layer to the affected areas of the skin. The product can be gently rubbed into the skin to accelerate its penetration.
To ensure a better therapeutic effect, an occlusive dressing can be applied.
Children
Use for children aged 3 months and over.
Overdose
In case of chronic overdose or inappropriate use, side effects described in the "Adverse Reactions" section may occur.
If symptoms of hypercorticism are observed, treatment should be discontinued.
Side effects
| Organ system class | Rare (>1/10,000, <1/1,000) | Very rare (<1/10,000, including isolated reports) |
| On the part of the immune system | | Hypersensitivity |
| From the endocrine system | Adrenocortical suppression | |
| From the organs of vision | | Increased intraocular pressure, increased risk of cataracts (with topical use). Frequency unknown: blurred vision (see also section "Special instructions"). |
| Skin and subcutaneous tissue disorders | Contact allergy; pustular acne; skin atrophy, often irreversible, accompanied by thinning of the epidermis, telangiectasias, purpura and striae; depigmentation; rosacea-like and perioral dermatitis, accompanied or not accompanied by skin atrophy; "ricochet effect", which can lead to steroid dependence; dermatitis and eczema, including contact dermatitis, delayed wound healing; hypertrichosis. | |
Systemic adverse reactions to topical corticosteroids in adults are rare but can be serious, especially adrenocortical suppression with prolonged use.
The risk of systemic effects increases in the following cases: application with a bandage (cellophane bandage or in skin folds); application to large areas of skin; long-term treatment; application to children (children are extremely sensitive due to their 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 substance (propylene glycol).
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions during the post-marketing period of a medicinal product is important. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
30 g of ointment in an aluminum tube; 1 tube in a cardboard box.
Vacation category
According to the recipe.
Producer
Temmler Italia Srl / Temmler Italia Srl
Address
Via delle Industrie, 2, 20061, Carugate (MI), Italy / Via delle Industrie, 2, 20061 Carugate (MI), Italy.
