Flutsinar 0.025% 15g ointment tube

The instruction for medical use


of FLUTSINAR® medicine


the Trade name
of Flutsinar®

the International unlicensed
name Fluotsinolona acetonide

the Dosage form
Ointment for external use of 0.025%, 15 g

Structure
of 1 g of ointment contains
active agent - a fluotsinolon acetonide of 0.25 mg,
excipients: propylene glycol, citric acid, lanolin anhydrous, vaseline white.

The description
White or almost white translucent fat weight with a specific light smell.

Pharmacotherapeutic group
Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids active (group III). Fluotsinolona acetonide
ATH D07AC04 Code

the Pharmacological

Fluotsinolon's Pharmacokinetics properties acetonide gets into a corneal layer of skin where kumulirut, its presence can be confirmed even in 15 days after topical administration. It is not metabolized 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 of a fluotsinolon of 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 of a fluotsinolon of acetonide. Besides, absorption increases at frequent use of medicine or after drawing by the extensive surface of skin. Dermal absorption at young faces is significant more, than at adults.
The pharmacodynamics
of Flutsinar® is a highly active synthetic glucocorticosteroid for external use. Drug shows anti-inflammatory, antipruritic, antiallergic and vasoconstrictive action. Has lipophilic properties and gets through skin into an organism. After use of 2 g of ointment the products a hypophysis of adrenocorticotropic hormone (AKTG) as a result of oppression of a system a hypophysis adrenal glands can decrease.
The mechanism of anti-inflammatory action of a fluotsinolon of acetonide consists in oppression of products of prostaglandins and leukotrienes as a result of suppression of activity of a phospholipase of A2 and reduction of release of arachidonic acid from phospholipids of cellular covers. Development of local allergic reactions oppresses. As a result of local vasoconstrictive action reduces exudative reactions. Reduces protein synthesis, collagen forming. Accelerates disintegration of proteins in skin and weakens proliferative processes.

Indications
- seborrheal dermatitis
- atopic dermatitis
- urtikarny deprive
- contact allergic eczema
- a polymorphic erythema
- a lupus erythematosus
- psoriasis
- flat deprive
of Flutsinar® in the form of ointment it is applied to short treatment of the acute and heavy, not infected, dry inflammatory
diseases of skin which are sensitive to treatment by glucocorticosteroids and proceed with a persistent itching or with a hyperkeratosis.

The route of administration and doses
apply a Small amount of ointment with a thin layer on affected areas of skin, is not more often than 1-2 times within a day. It is not necessary to apply ointment under an occlusive bandage, except for psoriasis where use of the closed bandage which should be changed every day is allowed.
It is not necessary to carry out treatment without interruption more than 2 weeks. Not to apply to face skin it is more than 1 week. Within one week it is possible to use no more than 15 g of ointment (1 tuba).
At children since 2 years 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.
Side effects
- eels, a post-steroid purpura, oppression of growth of epidermis, an atrophy of hypodermic cellulose, an atrophy of skin and a striya
- xeroderma, a hypertrichosis or baldness, a depigmentation or xanthopathy
- teleangiectasias
- perioral dermatitis
- a furunculosis, consecutive infection
Seldom
- urticaria or makulo-papular rash or aggravation of the existing changes
- under an occlusive bandage can cause resorptive action in the form of hypostases, arterial hypertension, decrease in body resistance to infections
- at use on an eyelid skin the glaucoma or a cataract

of the Contraindication
- hypersensitivity to a fluotsinolon to acetonide or other glucocorticosteroids and components of a basis
- bacterial, viral and fungal infections of skin
- ordinary and pink eels
- perioral dermatitis
- states after vaccination
- the I trimester of pregnancy and the period of a lactation can develop
- children's age up to 2 years


the Medicinal interactions
are not known cases of medicinal interaction at topical administration of glucocorticosteroids.
However it is necessary to remember that it is impossible to carry out vaccination of patients against smallpox and other sort immunization, especially at chronic use on the extensive surface of skin, considering a possibility of lack of the adequate immunological answer in the form of emergence of the corresponding antibodies.
Флуцинар® can strengthen effect of immunosuppressive medicines and weaken effect of immunoexcitants.
Special instructions
not to apply without interruption more than 2 weeks. At long use on an extensive body surface the frequency of manifestation of side effects and a possibility of development of hypostases, arterial hypertension, hyperglycemia, decrease in resilience to infections increases.
At topical administration of a fluotsinolon of acetonide there can occur reduction of products of AKTG owing to oppression of a system a hypophysis adrenal glands, reduction of level of cortisol in blood and development of an iatrogenic syndrome of Cushing who passes after the treatment termination. Periodic control of function of bark of adrenal glands by definition of cortisol in blood and in urine after stimulation of adrenal glands of AKTG is shown.
In case of development of an infection in the place of use of ointment, it is necessary to carry out the corresponding antibacterial or antifungal treatment. If symptoms of an infection do not pass, it is necessary to stop use of ointment for treatment of an infection.
It is necessary to avoid use of drug 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 also on skin inguinal and an underarm to apply only in cases of special need, taking in attention the increased absorption and high risk of development of side effects (teleangiectasias, dermatitis perioralis), even after short use.
It is careful to apply at already available conditions of an atrophy of hypodermic cellulose, especially at elderly people.
Pregnancy
of Flutsinar® can be applied at women in II and III trimesters of pregnancy only when the advantage of use for mother exceeds potential risk for a fruit.
Feature of influence on ability to run the vehicle and potentially dangerous mechanisms
Medicine does not limit psychomotor activity,
ability to control of vehicles and service
of moving mechanisms.

Overdose
Symptoms: after long use on the extensive surface of skin the following symptoms can take place: hypostases, arterial hypertension, a hyperglycemia, decrease in resilience to infections, and in hard cases, development of a syndrome of Cushing.
Treatment: it is necessary to cancel gradually medicine and to use therapy by slaboaktivny glucocorticosteroids.
A form of release and packing
On 15 g in aluminum tubas with the varnished internal surface.
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 25oC.
To store out of children's reach!

3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription


the Jelfa Pharmaceutical Plant A Producer. The lake
of 58-500 Jelenia Góra, ul.W.Pola 21, 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 Îffice.KZ@valeant.com