active substance: fluticazone propionate;
1 g contains 0.5 mg of fluticasone propionate
excipients : mineral oil, propylene glycol, cetostearyl alcohol, methyl ethyl ketone, imagemachine, sodium phosphate anhydrous, citric acid, polyethylene glycol cetostearyl ether, purified water.The
Basic physical and chemical properties: homogeneous soft cream white or almost white.The
Corticosteroids for use in dermatology. Active corticosteroids (group iii). ATC code D07A C17.The
Fluticasone propionate is a glucocorticoid preparation with high anti-inflammatory activity and a very low level of depression of the hypothalamic-pituitary-adrenal system with local application, so its therapeutic index is one of the widest of all currently available GCS.
Fluticasone propionate has a high systemic activity after subcutaneous application, but a very low activity when administered orally, probably due to metabolic inactivation. In vitro studies have shown its high affinity with human GCS receptors.
fluticasone propionate does not exhibit an unpredictable hormonal effect and a noticeable effect on the Central and peripheral nervous systems, gastrointestinal, cardiovascular or respiratory systems.
local and oral bioavailability is very low due to limited absorption of the drug through the skin or from the gastrointestinal tract and due to intensive first-pass metabolism. Oral bioavailability is close to zero, so the systemic effect of fluticasone propionate in any internal application of the cream will be low.
Studies have shown that systemic circulation reaches a very small amount of orally administered fluticasone propionate, sho is rapidly excreted in the bile and excreted in the feces. Fluticasone propionate does not linger in any tissues and does not bind to melanin.
according to pharmacokinetic animal studies, fluticazone propionate is rapidly excreted and is subject to extensive metabolic clearance. In humans, the metabolic clearance is wide and, accordingly, the conclusion is fast. Getting the drug through the skin in the systemic circulation is quickly inactivated. The main mechanism of metabolism is hydrolysis to carboxylic acid, which has a very low glucocorticoid and anti-inflammatory activity.
According to animal studies, no way out does not depend on the method of application of fluticasone propionate. The output is mainly with feces, and the process is fully completed within 48 hours.
dermatoses sensitive to treatment with corticosteroids, such as:The
psoriasis (excluding widespread plaque psoriasis)
Treatment of atopic dermatitis in children aged 3 months, in the absence of the effect of treatment with less potent corticosteroids.
Hypersensitivity to the active substance or to any component of the drug.
Untreated skin infections.
Perianal and genital itching.
itching without inflammation.
Dermatoses in children under 3 months of age, including dermatitis and diaper rash.The
it has been shown that co-administration with drugs that may inhibit CYP3A4 (such as ritonavir, Itraconazole), inhibits corticosteroid metabolism, can cause 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.
the Drug should be used with caution in patients with a history of which were local reactions of hypersensitivity to corticosteroids or any excipients. Local hypersensitivity reactions (see "Adverse reactions") may resemble symptoms of the disease being treated.
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 patients 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 may result in glucocorticoid insufficiency (see Section "Adverse reactions").
the risk Factors for systemic effects are:The
compared with older children and adolescents may absorb proportionally larger number of GCS, and therefore they are more susceptible 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 daily use of GCS in children under 12 years of age Should be avoided, where possible, as they are more likely to experience adrenal supression.
Treatment of psoriasis.
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. If used to treat psoriasis, the patient should be under close medical supervision.
Applying the cream on your face.
Long-term application of the cream on the skin is undesirable, because this area is vulnerable to atrophic changes.
Drawing on the centuries.
when applying the cream for eyelids should avoid contact with the eyes, because it can cause repeated use of cataracts and glaucoma.
Every time in the treatment of infected inflammatory lesions, it is necessary to assign appropriate antibacterial drugs. In the case of infection, topical corticosteroids should be abolished and appropriate antibacterial therapy should be prescribed.
the Risk of infection when applying an occlusive bandage.
the risk of bacterial infections increases in warm and humid conditions, which can occur occlusive dressings, so before applying a new bandage, the skin should be carefully processed every time.
Chronic leg ulcers.
sometimes topical corticosteroids are used to treat 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.
a Clear inhibition of the function of the adrenal cortex (the morning levels of cortisol in the blood plasma less than 5 µg/DL) is unlikely to occur if the use of Flooders in therapeutic doses, if not treated, more than 50% of the body surface in adults and does not apply more than 20 g per day.
the cream of Fluoderm as an auxiliary substance includes imagemachine, a metabolite of which is formaldehyde in trace amounts. Formaldehyde may cause allergic sensitization or irritation upon contact with skin.
the cream of Fluoderm as excipients include cetostearyl alcohol and propylene glycol which may cause local skin reactions.
data on the use of fluticasone propionate in pregnant women are limited.
topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. The appropriate effect on pregnant women is not established, however, assign fluticasone propionate pregnant should only when the expected benefit of the drug for women will be greater than the possible risk to the fetus and child. Should apply a minimum effective dose of the drug for the shortest possible period of time.
the Safety of using corticosteroids during the period of lactation has not been established. It is not known whether the use of GCS can lead to such systemic absorption, as a result of which the amount of the drug is detected in breast milk, is measurable. During the study in laboratory rats at a certain level in blood plasma after subcutaneous injection, signs of the presence of fluticasone propionate in breast milk were found.
to Assign the cream of Flooders in the period of breast-feeding should only be done when the expected benefit from the use of the drug to the mother exceeds potential risk for the baby. When appointed during breastfeeding cream should not be applied to the chest to avoid accidental contact with cream through the mouth of the child.
Data to assess the impact of corticosteroids on fertility in humans is not.The
studies of this effect have not been conducted. Taking into account the profile of adverse reactions, the influence on the reaction rate when driving or working with other mechanisms is not expected.
Adults and children aged 3 months and above.
Cream is especially suitable for the treatment of wet or wet skin surfaces.
the Drug is applied in a thin layer to the affected areas of the skin 1 or 2 times a day. The duration of treatment with daily use is up to 4 weeks before improving, then reduce the frequency of applying the cream or change to a less powerful treatment. After applying the cream should provide sufficient time for absorption before a subsequent application to emolient.
after achieving disease control, the frequency of use of GCS should be gradually reduced to complete elimination and as maintenance therapy to use emolients.
the Renewal of the existing symptoms of the disease is possible in case of sudden discontinuation of corticosteroids, especially potent.
duration of treatment for adults, including elderly patients.
if the condition deteriorates or there is no improvement within 2-4 weeks, the diagnosis and treatment should be reviewed.
Children under the age of 3 months.
children are more likely to experience local or systemic adverse reactions when using GCS, so in General they are prescribed short courses of treatment and less powerful drugs than adults.
Cream Fluoderm should be used with caution to ensure the application of minimum effective amounts of the drug.
the Duration of treatment children.
If the application of the cream children within 7-14 days there is no improvement, treatment should be discontinued and the child of doublegate. If control of the disease is achieved within 7-14 days of treatment, then the minimum effective doses should be applied as soon as possible. The duration of treatment with daily use should not exceed 4 weeks.
according to clinical studies, there was no difference in response to treatment in elderly patients and young patients. Since elderly patients are likely to have impaired renal or liver function, it may cause a delay in the release of the drug with systemic absorption, it is necessary to apply minimum effective doses of the drug for a short period of treatment to achieve the desired result.
in the case of systemic absorption (for use on large surfaces and for a long time), the metabolism and elimination of the drug may slow down, which may increase the risk of systemic toxicity. Therefore, to achieve the desired result, minimal effective doses should be used as soon as possible.The
is Used to treat children under the age of 3 months.
Fluticasone propionate in the local application may be absorbed in quantities sufficient to cause systemic effect. Acute overdose is very unlikely. In the case of chronic overdose or abuse, signs of hypercorticism may occur (see "Adverse reactions").
in case of overdose cream should be gradually stopped by reducing the frequency of application or replacement of less powerful GCS, taking into account the risk of GCS insufficiency. Further treatment is carried out in accordance with the clinical condition of the patient.
Side effects are classified by organs and systems and frequency of occurrence. The incidence of side effects is determined by the following criteria: very common (>1/10), often ( > 1/100, <1/10), uncommon ( > 1/1000, <1/100), rare (>1/10000,<1/1000), very rare (<1/10000), including isolated cases.
Infections and infestations.
opportunistic infections are Very rare.
the part of the immune system.
hypersensitivity is Very rare.
by the endocrine system.
Very rare: depression of the hypothalamic-pituitary-adrenal system:The
on the part of the skin and subcutaneous tissue.
Infrequently: the sensation of local burning in the skin.
very rarely thinning of the skin, skin atrophy, telangiectasia, hypertrichosis, pigmentation changes, allergic contact dermatitis, exacerbation of the main symptoms, pustular form of psoriasis, erythema, rash, urticaria.The
2 years old.
Store in its original packaging at a temperature not exceeding 25 ° C.
do not freeze. Keep out of reach of children.The
15 g in a tube in a box.The
According to the recipe.The
limited liability Company "Pharmaceutical company" Health ".
Ukraine, 61013, Kharkiv region, city Kharkiv, street Shevchenko, building 22.
Fluzinar ointment for external use has anti-allergic, anti-inflammatory, anti-exudative effect, soothes itching.
the Ointment is assigned to short-term rates for chronic and acute dermatitis non-infectious nature side effects which are flaking and itching, and also used in inflammatory skin lesions without exudation,
Flucinar Ointment should be applied on the damaged skin area with a thin layer not more than 2 times per day. Application of ointment under the bandage shown only in psoriasis, but in this case, it is necessary to regularly change the bandage. The time of use of the Fluzinar for treatment should not be more than 14 days, and the dose of ointment used should be no more than two tubes (30 g). Obligatory consultation of the expert!
With care, you can apply the ointment Flucinar for children under 2 years of age, if there are certain medical indications. The gel is applied in this case no more than 1 time a day, and is applied only to a limited area of the skin. Do not use ointment on face skin in children.