The instruction for medical use
of FLUTSINAR® medicine
the Trade name
the International unlicensed
name Fluotsinolona acetonide
the Dosage form
Gel of 0.025%
of 1 g of gel contains
active agent – a fluotsinolon acetonide of 0.25 mg
excipients: propylene glycol, ethanol, citric acid, dinatrium edetat, methylparahydroxybenzoate, propilparagidroksibenzoat, carbomer 980 (high-molecular carboxypolymethylene), trolamin, the water purified up to 1.0 g
Colourless transparent gel with easy opalescence and a smell of alcohol.
Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids active (group III). Fluotsinolona acetonide
ATH D07AC 04 Code
Fluotsinolon’s Pharmacokinetics properties acetonide at local drawing on skin easily gets into a corneal layer of skin where it kumulirutsya, its existence can be confirmed even in 15 days after external use. It does not biotransformirutsya in skin. After absorption in an organism it biotransformirutsya generally in a liver. It is removed with urine and, in smaller quantities, with bile, generally in the form of connections with glucuronic acid and in a small amount in not changed look.
Absorption fluotsinolon acetonide through skin increases after use by gentle skin in the field of folds or by face skin, by skin with the injured epidermis or damaged by inflammatory process. Use of the occlusive bandage causing increase in temperature and humidity of skin also increases absorption fluotsinolon acetonide. Besides, absorption increases at frequent putting drug or use on the extensive surface of skin, dermal absorption at young faces is more significant, than at elderly.
of Flutsinar® gel – is a highly active synthetic glucocorticosteroid for external use on skin. Applied in the form of gel of 0.025%, drug shows anti-inflammatory, antipruritic, antiallergic and vasopressor action. Has lipophilic properties and gets through skin into an organism. After use of 2 g of gel there can be a decrease in secretion of adrenocorticotropic hormone (AKTG) a hypophysis by means of inhibition of a hypophysial and adrenal system.
The mechanism of anti-inflammatory action of a fluotsinolon of acetonide is studied not up to the end, and is considered to be that this medicine reduces inflammatory processes by oppression of products of prostaglandins and leukotrienes as a result of oppression of activity of a phospholipase of A2 and reduction of release of arachidonic acid from phospholipids of cellular covers. Shows also antiallergic action by oppression of development of local allergic reactions. As a result of local vasoconstrictive action reduces exudative reactions. Reduces protein synthesis, collagen adjournment. Accelerates disintegration of proteins in skin and weakens proliferative processes.
of Flutsinar® apply gel outwardly, in the first phase of treatment (before ointment) the acute and heavy, not infected, dry dermatitis which reacts to treatment by glucocorticosteroids and proceed with a persistent itching or with a hyperkeratosis.
– allergic contact dermatitis
– atopic dermatitis
– urtikarny deprive
– allergic contact eczema
– a polymorphic erythema
– a lupus erythematosus
– the started psoriasis form, psoriasis of a hairy part of skin
– red flat deprive
the Route of administration and doses
In an initiation of treatment gel apply 2-3 times a day, and then after permission of acute inflammatory condition, is not more often than 1 – 2 time a day. Treatment it is not necessary to spend without interruption more than 2 weeks. Gel should be applied with a thin layer on the struck surface of skin. It is not necessary to apply gel under an occlusive bandage. If imposing of a bandage is necessary, it is necessary to use the bandage which is passing air. In a face not to use more than 1 week. Not to use more than one tube a week.
At children 2 years are more senior to apply with extra care only in case of need, once a day, on the small surface of skin. Not to apply on face skin.
– atrophic dermatitis and emergence of striya
– a post-steroid purpura
– a depigmentation or xanthopathy
– perioral dermatitis
– a folliculitis
– a hypertrichosis or baldness
It is rare:
– urticaria or makulo-papular rash, or aggravation of the existing changes.
Topical administration on skin in the field of a century can give to
– to formation of glaucoma or cataract
Medicine under an occlusive bandage, in view of the increased absorption, can cause the systemic action which is shown approach of hypostases, arterial hypertension, decrease in immunity.
– hypersensitivity to drug components
viral, bacterial and fungal infections of skin
– chicken pox
– vulgar and pink eels
– perioral dermatitis
– states after vaccination
– the first trimester of pregnancy
– children up to 2 years
are not known cases of interactions at topical administration of glucocorticosteroids. During drug treatment it is not necessary to carry out smallpox inoculations and other types of immunization, in connection with danger of emergence of immunological deficit. Флуцинар® gel can increase influence of immunosuppressive medicines and reduce effect of immunoexcitants.
more prolonged use and on big sites of skin as the frequency of side effects increases is not recommended.
Under the influence of topical administration of a fluotsinolon of acetonide, decrease in secretion of adrenocorticotropic hormone (AKTG) of a hypophysis by means of inhibition of a hypophysial and adrenal system is possible that leads to decrease in concentration of cortisol in blood and to emergence of an iatrogenic syndrome of a giperadrenokortitsizm which intensity decreases at the treatment termination.
It is necessary to avoid use on eyelids or on skin in the field of a century at persons with a closed-angle and open angle glaucoma and also at persons with a cataract, considering a possibility of strengthening of symptoms of a disease.
On face skin and in inguinal area to apply only in cases of special need, in view of the increased absorption and high risk of development of side effects, even after short-term use (a teleangiectasia, dermatitis perioralis).
It is careful to apply at already available conditions of an atrophy of hypodermic cellulose, especially at elderly people. In case of development of an infection in the place of use of gel, it is necessary to carry out additional antibacterial or antifungal therapy. If symptoms of an infection remain, it is necessary to suspend use of gel until treatment of an infection.
Pregnancy and a lactation
of Flutsinar® gel can be applied at pregnant women in II and III trimesters only quickly, on the small surface of skin if the expected advantage can exceed potential risk for a fruit.
Drug categorically cannot be used in the first trimester of pregnancy.
It is recommended to observe extra care at use of Flutsinar® gel at the feeding women.
Influence on ability of control of vehicles and service of potentially dangerous devices
Medicine does not limit psychomotor activity and does not affect ability to control of vehicles and service of moving mechanisms.
At prolonged use on the extensive surface of skin there can come the overdose symptoms which are shown the high pressure, hypostases, a hyperglycemia and immunosuppressive effect, and in hard cases development of a syndrome of Cushing. Symptoms of overdose disappear after drug withdrawal and use of therapy with the smaller maintenance of glucocorticosteroids.
The form of release and packing
On 15 g of drug place in tubas aluminum with the varnished internal surface, with the plastic wound covers.
On one tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not above 25 °C. Not to freeze.
To store out of children’s reach!
A period of storage
not to apply after an expiration date
According to the prescription
the Jelfa Pharmaceutical Plant A Producer. Lake
of ul. W.Pola 21, 58-500 Jelenia Góra, Poland
the Owner of the registration certificate
of OOO “Valeant”, Russia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Representative office of OOO “Valeant” to RKKazahstan, 050059, Almaty, Al-Farabi Avenue, 17, Business center “Nurly-Tau” Block 4B, office 1104 Phone number + 7 727 3 111 516, fax +7 727 3 111 517 E-mail:
To Develop Office.KZ@valeant.com