Instructions for Derilife cream 0.5mg/g tube 50g
Composition
active ingredient: clobetasol;
1 g of cream contains clobetasol propionate 0.5 mg;
excipients: white wax; propylene glycol; chlorocresol; polyethylene glycol (macrogol) cetostearyl ether; polyethoxylated hydrogenated castor oil; polyethylene glycol (macrogol) hydroxystearate; cetostearyl alcohol; purified water.
Dosage form
Cream.
Main physicochemical properties: homogeneous cream of white or almost white color.
Pharmacotherapeutic group
Topical corticosteroids. Highly active corticosteroids.
ATX code D07A D01.
Pharmacological properties
Pharmacodynamics
The main effect of clobetasol on the skin is a nonspecific anti-inflammatory effect due to vasoconstriction and reduced collagen synthesis.
Pharmacokinetics
The penetration of clobetasol through the skin varies between individuals and may be increased by the use of occlusive dressings or by inflammation or skin damage. In subjects with healthy skin, the mean maximum plasma concentration (Cmax) of 0.63 ng/mL was observed in one study 8 hours after the second application (13 hours after the first application) of 30 g of 0.05% clobetasol ointment. After a second dose of 30 g of 0.05% clobetasol cream, the mean Cmax was slightly higher than that after the ointment application and was observed after 10 hours. In another study, mean Cmax (approximately 2.3 ng/mL and 4.6 ng/mL) were observed in patients with psoriasis and eczema, respectively, 3 hours after a single application of 25 g of 0.05% clobetasol ointment. After absorption through the skin, clobetasol most likely undergoes the same metabolic pathway as corticosteroids after systemic administration. However, the systemic metabolism of clobetasol has not been fully established.
Indication
The drug is a highly active topical corticosteroid that is used in adults, the elderly, and children over 1 year of age only for short-term treatment of relatively more persistent inflammatory and pruritic manifestations of steroid-sensitive dermatoses that are insensitive to less active corticosteroids.
Such diseases are:
Psoriasis (except widespread plaque psoriasis).
Dermatoses that are difficult to treat.
Red lichen planus.
Discoid lupus erythematosus.
Other skin diseases that are not treatable with less active corticosteroids.
Contraindication
Hypersensitivity to the active substance and/or to the excipients of the medicinal product.
Untreated skin infections.
Rosacea.
Common acne.
Itching without inflammation.
Perianal and genital itching.
Perioral dermatitis.
Dermatoses in children under 1 year of age, including dermatitis and diaper rash.
Interaction with other medicinal products and other types of interactions
Concomitant use with drugs that may inhibit CYP3A4 (e.g. ritonavir, itraconazole) has been shown to inhibit the metabolism of corticosteroids, which may result in increased systemic exposure. The extent to which this interaction is clinically significant depends on the dose, route of administration of the corticosteroid, and the potency of the CYP3A4 inhibitor.
Application features
The drug should be used with caution in patients with a history of local hypersensitivity reactions to corticosteroids or any of the excipients. Local hypersensitivity reactions (see section 4.8) may resemble the symptoms of the disease being treated.
Manifestations of hypercorticism (Cushing's syndrome) and hypothalamic-pituitary-adrenal (HPA)-reverse suppression with adrenal suppression in some individuals may result from increased systemic absorption of topical steroids. If any of the above symptoms occur, the drug should be gradually discontinued by reducing the frequency of application or by changing to a less potent corticosteroid. Abrupt discontinuation of treatment may result in glucocorticosteroid insufficiency (see section "Adverse Reactions").
The medicine contains:
propylene glycol, which may cause skin irritation;
cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis);
chlorocresol, which may cause allergic reactions.
Risk factors for systemic effects include:
the potency and composition of the topical steroid;
duration of use;
application to a large area of skin;
application on skin surfaces that touch, for example, in diaper areas or where an occlusive dressing is applied (in infants, diapers can play the role of an occlusive dressing);
increased hydration of the stratum corneum;
use on areas with thin skin, such as the face;
use on areas of damaged skin or under other conditions where the skin barrier is disrupted;
Cases of serious osteonecrosis (including necrotizing fasciitis) and systemic immunosuppression (sometimes leading to relapse of Kaposi's sarcoma) have been reported with prolonged use of clobetasol propionate in excess of the recommended doses (see section 4.2). In some cases, patients were receiving concomitant treatment with other potent oral/topical corticosteroids or immunosuppressants (e.g., methotrexate, mycophenolate mofetil). If treatment with topical corticosteroids is clinically warranted for more than 4 weeks, consideration should be given to using a less potent corticosteroid.
Application to children.
Long-term use of topical corticosteroids should be avoided, where possible, in infants and children under 12 years of age, as they are more likely to develop adrenal suppression.
Children are more susceptible to developing atrophic changes when using topical corticosteroids.
The use of the drug in children should, if possible, last no more than 5 days. The feasibility of continuing treatment should be reviewed weekly. The drug should not be used in children under occlusive dressings.
Risk of infection when applying an occlusive dressing.
The risk of bacterial infections increases in warm and moist conditions in skin folds or under occlusive dressings, so the skin should be thoroughly cleaned before applying a new occlusive dressing each time.
Use in psoriasis.
Topical corticosteroids should be used with caution in the treatment of psoriasis, as in some cases relapses, development of tolerance, risk of generalization of pustular psoriasis and development of symptoms of local or systemic toxicity due to impaired skin barrier function have been reported. In the case of use of a medicinal product for the treatment of psoriasis, the patient should be under close medical supervision.
Use in concomitant infections.
Whenever treating inflammatory infected lesions, appropriate antibacterial drugs should be prescribed. In case of spread of infection, the use of the drug should be discontinued and appropriate antibacterial therapy should be prescribed.
Use for chronic leg ulcers.
Topical corticosteroids are sometimes used to treat dermatitis around chronic leg ulcers. However, this use is associated with an increased incidence of local hypersensitivity reactions and an increased risk of local infections.
Applying to the face.
Applying the cream to the skin of the face is undesirable, as this area is more vulnerable to atrophic changes. If necessary, use should be limited to 5 days.
Application to the eyelids.
When applying the cream to the eyelids, avoid getting the medicine in the eyes, as repeated use may cause cataracts and glaucoma.
Risk of vision impairment.
Visual disturbances may occur with systemic and topical corticosteroids. If blurred vision or other visual disturbances develop, the patient should be referred to an ophthalmologist for evaluation of possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported with systemic and topical corticosteroids.
Excipients precautions.
The medicinal product contains: propylene glycol, which may cause skin irritation; chlorocresol, which may cause allergic reactions; polyethoxylated hydrogenated castor oil, which may cause skin reactions; and cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
Pregnancy.
Data on the use of topical clobetasol in pregnant women are limited.
Topical administration of corticosteroids to pregnant animals may cause fetal harm. The relevance of these data to humans has not been established. The drug should be used during pregnancy only if the expected benefit to the woman outweighs the risk to the fetus. The minimum amount of the drug should be used for the shortest duration of treatment.
Breastfeeding period.
The safety of clobetasol during breastfeeding has not been established. It is not known whether topical corticosteroids can result in systemic absorption that would result in measurable amounts in breast milk. The drug should be used during breastfeeding only if the expected benefit to the woman outweighs the risk to the infant. If used during breastfeeding, the cream should not be applied to the mammary glands to avoid accidental ingestion of the cream through the infant's mouth.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted to study this effect. Given the adverse reaction profile of clobetasol, no effect on the reaction speed when driving or using other mechanisms is expected.
Method of administration and doses
Clobetasol propionate belongs to the class of the most potent topical corticosteroids (Group IV) and prolonged use may lead to serious undesirable effects (see section 4.4). If treatment with a topical corticosteroid is clinically justified after 4 weeks, a less potent corticosteroid should be considered. Repeated but short courses of clobetasol propionate may be used to control flares (see details below).
The medicine is intended for topical (cutaneous) use.
Especially suitable for treating moist and weeping areas of skin.
The cream should be applied gently in a thin layer, covering all affected areas of the skin, 1 or 2 times a day until clinical improvement occurs (if there is a good response to treatment, improvement is achieved in a few days), then reduce the frequency of application or change to a less potent preparation. After each application of the cream, wait a certain time until it is completely absorbed before applying an emollient. In case of worsening or no improvement in clinical manifestations within 2-4 weeks, the diagnosis and treatment should be reviewed.
Repeated short courses of treatment may be used to control flare-ups. Treatment should not last longer than 4 weeks. If continued long-term treatment is necessary, less potent drugs should be used.
The maximum weekly dose should not exceed 50 g.
In cases of more persistent lesions, especially with hyperkeratosis, the effect of the cream can be enhanced if necessary by covering the affected area of skin with an occlusive polyethylene dressing. Usually, applying the occlusive film only overnight will be sufficient to achieve a satisfactory result. The improvement achieved is usually maintained by applying the cream without the use of an occlusive dressing.
When disease control is achieved, the drug should be gradually discontinued, and the use of a softener should be continued as maintenance therapy.
Recurrence of symptoms of previous dermatoses is possible with sudden withdrawal of clobetasol.
Dermatoses that are difficult to treat. Patients with frequent exacerbations of the disease.
Once a continuous course of topical corticosteroid has been achieved during the acute phase of the disease, intermittent use (once daily, twice weekly, without occlusive dressing) should be considered. This treatment has been shown to be effective in reducing the frequency of exacerbations.
The cream should be continued to be applied to all previously affected areas of skin or to known areas of potential exacerbation. This regimen should be combined with continued daily use of emollients. The clinical status and the benefits and risks of continued treatment should be reassessed regularly.
Children
The drug is contraindicated for the treatment of dermatoses, including dermatitis, in children under 1 year of age.
Overdose
Symptoms.
With normal use, the cream can be absorbed in quantities sufficient to cause systemic effects. The likelihood of an acute overdose is very small, however, in case of chronic overdose or improper use, signs of hypercortisolism may occur.
Treatment.
In case of overdose, it should be gradually discontinued by reducing the frequency of cream application or replacing it with a less potent corticosteroid due to the risk of glucocorticosteroid insufficiency.
Further treatment should be based on the patient's clinical condition or national guidelines for the treatment of poisoning, if available.
Side effects
Adverse reactions, information about which is given below, are classified by organ and system and by frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10000 and < 1/1000), very rare (< 1/10,000, including isolated cases), frequency unknown (cannot be estimated from the available data).
Infections and infestations:
very rarely - opportunistic infections.
On the part of the immune system:
very rarely - local hypersensitivity.
From the endocrine system:
very rarely - suppression of the hypothalamic-pituitary-adrenal system: Cushingoid features (e.g., moon face, central obesity), delayed weight gain/growth in children, osteoporosis, glaucoma, hyperglycemia/glucosuria, cataracts, arterial hypertension, weight gain/obesity, decreased endogenous cortisol levels, alopecia, hair fragility.
On the part of the organs of vision:
frequency unknown – visual impairment.
Skin and subcutaneous tissue disorders:
common - itching, local burning sensation/pain in the skin; uncommon - local skin atrophy*, atrophic skin streaks*, telangiectasias*; very rare - skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*, hypertrichosis, exacerbation of the main symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne.
*Skin lesions secondary to local and/or systemic hypothalamic-pituitary-adrenal suppression.
On the part of the body as a whole and reactions at the site of application:
very rarely - irritation/pain at the site of application.
Reporting suspected adverse reactions that occur after the registration of a medicinal product is very important. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national pharmacovigilance system.
Expiration date
3 years.
After opening the tube, the medicine should be used within 3 months.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Packaging
50 g in a tube; 1 tube in a cardboard box.
Vacation category
According to the recipe.
Producer
WORLD MEDICINE ILACH SAN. VE TIJ. A.Sh./WORLD MEDICINE ILAC SAN. VE TIC. AS
Location of the manufacturer and address of its place of business.
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey/15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey. Applicant.
WORLD MEDICINE LLC, Ukraine/WORLD MEDICINE, LLC, Ukraine.
