1 g ointment/fatty ointment/cream contains 0.5 mg of clobetasol propionate;
white soft paraffin, paraffin, stearyl alcohol, servicesecurity, Polysorbate 80, sodium edetate, purified water.
propylene glycol, white soft paraffin, glycerol monostearate, servicesecurity;
methylparahydroxybenzoate (E 218), sodium edetate, stearyl alcohol, white soft paraffin, paraffin, servicesecurity, Polysorbate 80, glycerin, purified water.The
Ointment, fatty ointment, cream.
basic physico-chemical properties:white homogeneous ointment with a specific mild odor white homogeneous oily ointment with a specific mild odor white homogeneous cream with a specific mild odor.The
Corticosteroids for topical use.
Code ATC D07A D01.The
the Major effect of clobetasol propionate on skin is a nonspecific anti-inflammatory effect due to vasoconstriction and decrease in collagen synthesis.
the Penetration of clobetasol propionate through the skin of different individuals are different and may increase if the use of occlusive dressings or in case of inflammation or damage to the skin. In individuals with healthy skin the maximum concentration of clobetasol propionate in plasma was 0.63 ng/ml in one study was observed in 8:00 after the second application (13 hours after the first application) of 30 g of 0.05% ointment and clobetasol propionate. After applying the second dose of 30 g of 0.05% cream clobetasol propionate, the maximum concentration in blood plasma was slightly higher than when applying ointment, and was observed after 10:00. In another study, maximum concentration of approximately 2.3 ng/ml and 4.6 ng/ml were observed respectively in patients with psoriasis and eczema in 3:00 after a single application of 25 g 0.05% ointment and clobetasol propionate. After absorption through the skin, the drug is likely to pass the same metabolic pathway, and corticosteroids in systemic administration. However, systemic metabolism of clobetasol to the end is not installed.
Psoriasis (excluding widespread plaque psoriasis), persistent eczema, red flat, red diskoidnaya lupus, and other diseases not amenable to treatment to less active corticosteroids.
Hypersensitivity to any components of the drug.
Untreated skin infections.
itching without inflammation.
Perianal and genital itching.
Dermatoses in children under 1 year of age, including dermatitis and diaper rash.
Initially infected skin lesions caused by fungi (e.g. candidiasis, lichen) or bacteria (e.g. impetigo). Specific processes on the skin (skin tuberculosis, syphilitic skin diseases).
Parasitic diseases of the skin, chickenpox, reactions to the vaccine.The
it Was shown that the combined use with drugs that can inhibit CYP3A4 (e.g. ritonavir, Itraconazole), inhibits the metabolism of corticosteroids can have systemic effects. How such interaction is clinically significant depends on the dose of the drug, the route of administration of GCS and the inhibitor CYP3A4.
use with caution for the treatment of patients with local hypersensitivity reaction to corticosteroids or any other substance in the drug history. Local hypersensitivity reactions (see section "Adverse reactions") can resemble the symptoms of the disease, treat.
the Manifestation of hyperadrenocorticism (Cushing's syndrome) and reverse suppression of the hypothalamic-pituitary-adrenal inhibition of the function of the adrenal glands in some individuals may be the result of increased systemic absorption of corticosteroids. In case of any of the above symptoms, the drug should be gradually stopped by reducing the frequency of application or replacement with a less powerful GCS. Sudden discontinuation of treatment can lead to steroid deficiency (see section "Adverse reactions").
the Risk factors of systemic effects are:The
compared to adults, children can absorb proportionally larger amounts of GCS, so they are more sensitive to systemic side effects. This is due to the fact that children have an underdeveloped skin barrier and a large surface of the skin relative to body weight compared to adults.
long-term use of GCS in infants and children under 12 years of age Should be avoided, if possible, as they are more likely to experience adrenal suppression.
Children are more sensitive to the development of atrophic changes in the application of GCS. If use is necessary for children, it is recommended that it be continued for a few days and reviewed weekly.
the Risk of infection when applying an occlusive bandage
the Risk of bacterial infection grows in warm and moist conditions that can occur during occlusive dressings, so when changing the bandage the skin should be each time carefully processing.
use topical corticosteroids for the treatment of psoriasis should be used with caution, as in some cases it was reported the occurrence of recurrence, the development of tolerance, the risk of generalization of pustular psoriasis and the development of symptoms of local or systemic toxicity caused by a violation of the barrier function of the skin. In the case of the drug for the treatment of psoriasis, the patient should be under medical supervision.
Every time in the treatment of infected inflammatory lesions it is necessary to assign appropriate antibacterial drugs. In the case of infection, topical steroids should be abolished and appropriate antibacterial therapy should be prescribed.
Chronic leg ulcers
Sometimes topical corticosteroids can be used for the treatment of dermatitis that occurs around chronic leg ulcers. However, such use is associated with an increase in the frequency of local hypersensitivity reactions and an increase in the risk of local infections.
application of the cream on the face
applying the cream on the skin is undesirable, because in this area more often there are atrophic changes. If necessary, use should be limited to a few days.
do Not apply on the eyelids and periorbital area, to avoid drug in the eye.
simultaneous use in the anogenital zone may damage the structure of latex condoms and reduce their safety.
Stearyl alcohol may cause locally limited skin reactions (e.g. contact dermatitis).
In the first trimester of pregnancy the drug is contraindicated.
topical administration of corticosteroids to pregnant animals can lead to disruption of fetal development. The consistency of these data relative to humans has not been established, therefore, use of Clobetasol for pregnant women should only be in cases when the expected benefit to the mother outweighs risk to the fetus. Apply a minimum amount of the drug for a minimum period of treatment.
the safe use of clobetasol propionate during lactation has not been established. Use the drug during breastfeeding should only be in cases where the expected benefit to the mother exceeds the risk to the child. When administered during breastfeeding, do not apply the drug to the chest to avoid accidental contact with the child through the mouth.
Ability to influence the reaction rate when driving motor transport or operating other mechanisms.
no Studies have been carried out to study this effect. Taking into account the profile of adverse reactions effects on reaction rate when driving motor transport or operating other mechanisms are expected.
Cream/oily ointment/ointment should be applied once a day with a thin layer.
the Cream is more suitable for the treatment of wet or wet areas of the skin. The ointment should be appointed for treating dry skin, oily ointment for skin lysinami or lusakowski lesions.
As with other highly active corticosteroids, treatment should be discontinued once disease control is achieved. It is recommended to continue treatment for no more than 4 weeks the total area of application should not exceed 20% of the body surface. If the condition does not improve, it is necessary to clarify or revise the diagnosis.
repeated short courses of treatment can be carried out to prevent exacerbation of the disease. If long-term continuous treatment with steroids is necessary, it is necessary to apply other, not such strong preparations.The
the Drug is contraindicated for the treatment of dermatoses, including dermatitis, in children under 1 year.
in normal use, the drug may be absorbed in quantities sufficient to produce a systemic effect. The probability of acute overdose is very small, but in the case of chronic overdose or improper use, there may be signs of hypercorticism.
in case of overdose, the drug should be gradually eliminated by reducing the frequency of application or replacing it with a less potent steroid taking into account the risk of GCS insufficiency.
Further treatment should be carried out according to the clinical condition of the patient or according to national recommendations for the treatment of poisoning, if any.
Side effects, details of which are given below, classified by organs and systems and the frequency of their occurrence. The frequency of occurrence of adverse reactions divided into the following categories: very common (? 1/10), often (? 1/100 and<1/10), infrequently (? 1/1000 and<1/100), rare (?1/10000 and<1/1 000), very rare (<1/10000), including isolated cases.
Infections and infestations
opportunistic infections are Very rare.
very rarely local hypersensitivity, allergic reactions (possibly delayed action).
the endocrine system
Very recompression hypothalamic-pituitary-adrenal system: cushingoid characteristics (for example, Crescent-shaped face, Central obesity), delayed weight-gain/growth in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased body mass/adiposity, a decrease in the level of endogenous cortisol levels, alopecia, brittle hair.
Leather and subcutaneous tissue
itching Often, sensation of local burning/pain in the skin.
Rarely local skin atrophy * atrophic streaks on the skin * telangiectasia *.
Very rare skin thinning *, skin wrinkling *, skin dryness *, pigmentation changes *, hypertrichosis, exacerbation of core symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria.
General violations and breaches at the place of application
Very rarelytease/pain at the site of application.
disorders of the skin are secondary relative to the local and/or system of the hypothalamic-pituitary-adrenal inhibition.The
After the opening of the tube is 3 months.
Keep out of reach of children at temperatures not exceeding 25 ° C.The
Tube of 15 g, 30 g or 50 g in a carton with instructions for use.The
According to the recipe.The
mibe GmbH Arzneimittel.
M?nchenerstra?e 15 06796 Brenna, Germany.The
Dermapharm AG, Germany.
mibe Ukraine Ltd. 01024, g. . Kiev, Chekistov lane 2A, Ukraine.
carizon cream 0.5 mg/1G 15g has antiproliferative, vasoconstrictor, as well as immunomodulatory and anti-inflammatory effects. Main the active ingredient of the drug is clobetasol propionate.
the product is used for treatment:
the Drug penetrates through the skin, relieves redness and inflammation, reducing collagen synthesis. As a result of applying the cream to the patient area of the body slows the release of prostaglandins, arachidonic acid and thromboxanes.
the Medicine is intended for external use only. Apply a thin layer of Carison on the affected area of the body and RUB the cream with light circular movements. For maximum efficiency, apply a dry bandage to the sore spot.
to Apply the product no more than once a day. To avoid preparation hit in eyes. Treatment should be continued for a month. If during this time the condition does not change – consult your doctor for clarification or revision of the diagnosis.