Kutivate ointment for external use 0,005% 15g
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Active ingredients
Fluticasone
Release form
Ointment
Composition
1 g of fluticasone micronized propionate 50 mcg. Excipients: propylene glycol - 50 mg, sorbitan sesquioleate - 5 mg, microcrystalline wax - 250 mg, liquid paraffin - up to 1 g.
Pharmacological effect
GKS for external use. It has anti-inflammatory, antipruritic and vasoconstrictive properties. Anti-inflammatory properties are due to numerous mechanisms that inhibit the late phase of allergic reactions, including reducing the number of mast cells, weakening chemotaxis and activating eosinophils, reducing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, as well as inhibiting arachidonic acid metabolism. Fluticasone refers to the corticosteroids with a pronounced local anti-inflammatory action. When applied to the skin, the likelihood of inhibition of the function of the hypothalamic-pituitary-adrenal system (HGNS) is negligible. In vitro studies have shown that fluticasone is characterized by high selectivity and affinity for glucocorticoid receptors. According to clinical studies, when fluticasone is released into the systemic circulation, the liver quickly transforms into an inactive metabolite (carboxylic acid), followed by rapid elimination from the body. Due to these properties, drug Kutiveyt. has a high therapeutic index. Fluticasone does not cause unforeseen hormonal disorders, does not have a significant effect on the central and peripheral nervous systems, gastrointestinal tract, cardiovascular and respiratory systems.
Indications
Adults and children aged 1 year and older for relief of inflammation and itching in acute and chronic dermatoses sensitive to glucocorticosteroid therapy, such as: - atopic dermatitis (including atopic dermatitis in children aged 6 months) - numular dermatitis (discoid eczema) - seborrheic dermatitis - psoriasis (with the exception of common plaque psoriasis) - simple chronic lichen - lichen planus - contact or allergic contact dermatitis - discoid lupus erythematosus - erythroderma (as a supplement to the systemic corticosteroids therapy) - inflammatory reactions to insect bites.The drug Kutivate. used to reduce the risk of recurrence in chronic form of atopic dermatitis, if there was a therapeutic effect in the treatment of the acute phase of the disease.
Contraindications
- hypersensitivity to the active substance or any other component of the drug - primary lesions of the skin of bacterial, viral and fungal etiology - acne rosacea - common acne - perioral dermatitis - perianal and genital itching - itching without inflammation symptoms - children up to 6 months . The drug should be used with caution in psoriasis, renal failure, liver failure, elderly patients, in children (from 6 months to 12 years).
Use during pregnancy and lactation
Fertility There are no data available to assess the effect of GCS for external use on human fertility. Pregnancy There is a limited amount of data on the use of fluticasone during pregnancy. As a result of preclinical studies, it was found that the external use of corticosteroids in pregnant animals may cause a deviation of embryonic development, but the significance of this phenomenon for humans has not been established. The drug Kutivate. it can be prescribed only if the intended benefit to the mother exceeds any possible risk to the fetus. In this case, the cream should be applied in a minimum amount for the shortest possible period of time, sufficient for the manifestation of the clinical effect. Breastfeeding Period The safety of GCS therapy for external use has not been established. There is no data available to confirm the possibility of systemic absorption of GCS for external use in an amount sufficient for their detection in breast milk. As a result of preclinical studies, it was found that during the breastfeeding period, under subcutaneous injection, in quantities sufficient for determination in plasma, fluticasone was detected in milk. The drug Kutivate. can be prescribed during the breastfeeding period only if the intended benefit to the mother exceeds any possible risk to the baby.When using the drug Kutivate. during breastfeeding, the drug should not be applied to the area of the mammary glands to prevent its accidental ingestion by the child.
Side effects
The adverse reactions listed below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (& # 8805 .1 / 10), often (& # 8805 .1 / 100 and less than 1/10), infrequently (& # 8805 .1 / 1000 and less than 1/100), rarely ( & # 8805 .1 / 10,000 and less than 1/1000), very rarely (less than 1/10 0000, including individual cases). Frequency categories were formed on the basis of post-registration observation. Infectious and parasitic diseases: very rarely - opportunistic infections. On the part of the immune system: very rarely - hypersensitivity (itching at the site of application, rash, edema). On the part of the endocrine system: very rarely - inhibition of HGNS (weight gain or obesity, slow weight gain or growth retardation in children, cushingoid features (eg, moon-shaped face, central obesity), decrease in the concentration of endogenous cortisol, hyperglycemia or glycosuria, arterial hypertension, osteoporosis, cataract, glaucoma. From the skin and subcutaneous tissues: often - itching at the site of the ointment, rarely - burning at the site of the ointment, very rarely - thinning of the skin, atrophy, striae, telangiectasia, hypopigma tation, hypertrichosis, allergic contact dermatitis, exacerbation of symptoms of the underlying disease, pustular psoriasis, erythema, rash, urticaria. You should inform your doctor about any adverse reactions mentioned above.The doctor will decide on further treatment strategies. reactions are aggravated or any other undesirable reactions that are not mentioned in the instructions are noted; the patient should be informed about this by the doctor.
special instructions
The adverse reactions listed below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (& # 8805 .1 / 10), often (& # 8805 .1 / 100 and less than 1/10), infrequently (& # 8805 .1 / 1000 and less than 1/100), rarely ( & # 8805 .1 / 10,000 and less than 1/1000), very rarely (less than 1/10 0000, including individual cases). Frequency categories were formed on the basis of post-registration observation. Infectious and parasitic diseases: very rarely - opportunistic infections. On the part of the immune system: very rarely - hypersensitivity (itching at the site of application, rash, edema).On the part of the endocrine system: very rarely - inhibition of HGNS (weight gain or obesity, slow weight gain or growth retardation in children, cushingoid features (eg, moon-shaped face, central obesity), decrease in the concentration of endogenous cortisol, hyperglycemia or glycosuria, arterial hypertension, osteoporosis, cataract, glaucoma. From the skin and subcutaneous tissues: often - itching at the site of the ointment, rarely - burning at the site of the ointment, very rarely - thinning of the skin, atrophy, striae, telangiectasia, hypopigma tation, hypertrichosis, allergic contact dermatitis, exacerbation of symptoms of the underlying disease, pustular psoriasis, erythema, rash, urticaria. You should inform your doctor about any adverse reactions mentioned above.The doctor will decide on further treatment strategies. reactions are aggravated or any other undesirable reactions that are not mentioned in the instructions are noted; the patient should be informed about this by the doctor.