The instruction for medical use
of FLUTSINAR® medicine N
the Trade name
of Flutsinar® N
International unlicensed name
Is not present
the Dosage form
1 g of ointment contains
active agents: fluotsinolona acetonide of 0.25 mg, Neomycinum sulfate of 5.0 mg
excipients: propylene glycol, anhydrous lanolin, liquid paraffin, vaseline white
Homogeneous, the fat soft, translucent mass of light yellow color
Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids active in a combination with antibiotics. Fluotsinolona acetonide in a combination with antibiotics.
ATH D07CC02 code
Pharmacokinetics Later properties of putting Flutsinar® ointment N on skin, active components collect in epidermis.
Fluotsinolona 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 biotranformirutsya 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.
Neomycinum sulfate can get into deep skin layers. At prolonged use on extensive sites of the skin which is especially injured by disease process, active ingredient can get into a vascular bed. Substance does not biotransformirutsya in an organism and is removed generally with urine in an invariable look that can lead to nephrotoxic action.
of Flutsinar® of N – the combined drug which effect is caused by the components which are its part. As a result of total action of a fluotsinolon of acetonide and Neomycinum of sulfate, drug renders anti-inflammatory, antiallergic, antipruritic, antiedematous actions. Fluotsinolon acetonide is a highly active synthetic glucocorticosteroid for external use on skin. Applied in the form of ointment of 0.025%, drug shows anti-inflammatory, antipruritic, antiallergic and vasopressor action. Has lipophilic properties and easily 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 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 slows down proliferative processes.
Neomycinum sulfate – an antibiotic of group of aminoglycosides which because of the toxicity is intended generally for external use. Has bactericidal effect in the relation of aerobic gram-negative (Staphylococcus aureus) and some gram-positive bacteria (Eschrichia coli, Proteus spp.).
– the allergic diseases of skin complicated by the bacterial infection which is followed by dry eczema
– seborrheal dermatitis
– atopic dermatitis
– papular urticaria
– allergic contact eczema
– a polymorphic erythema
– a lupus erythematosus
– the started psoriasis form
– red flat deprive
the Route of administration and doses
Ointment apply a thin layer on affected areas of skin of 1 – 2 time within a day. It is not necessary to apply ointment under an occlusive bandage. The usual duration of treatment is 1 – 2 weeks. On face skin not to apply longer than 1 week. Not to use more than one tube a week.
Ointment at long use can cause side effects:
– the atrophy of hypodermic cellulose
– inflammation of sebaceous glands
– decolouration or discoloration of skin
– the increased growth of hair or their loss
– consecutive infection
– a skin atrophy
– urticaria, makulopapulezny skin rash
– exacerbation of the existing disease
– contact dermatitis
– akneformny damages
– oppression of growth of an epithelium
– an itching, irritation
– atrophic dermatitis, striya
– a steroid purpura
– perioral dermatitis
– a folliculitis
can give Topical administration on skin in the field of a century to:
– to glaucoma
– a cataract
Systemic side effects:
– from – and nephrotoxicity
– dysfunction gipotalamo –
– arterial hypertension
– decrease in immunity
– Cushing’s syndrome
– oppression of growth and development of children
– a hyperglycemia,
the Contraindication glucosuria
– virus (chicken pox, herpes) and fungal infections of skin
– the bacterial dermatosis caused by microorganisms, sensitive to Neomycinum,
– perioral dermatitis
– vulgar and pink eels
– varicose inflammation or an ulcer of skin
– hypersensitivity to drug components
– a tuberculosis cutis, precancerous conditions and new growths of skin
– children’s age up to 2 years
– after vaccination
– a diaper dermatitis
– not to apply a hypophysial and adrenal system on the extensive and becoming wet sites of skin
– the first trimester of pregnancy
Prolonged use along with gentamycin, Acidum etacrynicum and colistin increase risk of injury of kidneys and an organ of hearing. 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® N can increase influence of immunosuppressive medicines and reduce effect of immunoexcitants.
Not to use ointment in parallel with other medicines of topical administration.
If putting drug is followed by irritation or allergic reactions of skin (itching, burning or reddening), it is necessary to stop its use immediately.
Continuous use for more than 2 weeks is not recommended. As corticosteroids can be soaked up through skin, it is necessary to avoid prolonged use on big sites of skin and at children.
At prolonged use on big sites of skin the frequency of emergence of undesirable effects increases, and there is a risk of developing hypostases, hypertensia, a hyperglycemia and easing of immunity, bacterial resistance to Neomycinum to sulfate can develop.
Under the influence of topical administration of a fluotsinolon of acetonide, decrease in secretion of AKTG of a hypophysis by means of inhibition of an adrenal 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 recommended to check periodically concentration of cortisol in blood.
In case of exacerbation of an infection at any kinds of use, perform additional antibacterial or antifungal therapy. If symptoms of an infection remain, it is necessary to suspend use of ointment until treatment of an infection.
It is necessary to avoid hit of drug in eyes and on skin in the field of a century. At patients with a closed-angle and open angle glaucoma and also at patients with a cataract, when putting drug on an eyelid skin, strengthening of symptoms of a disease is possible.
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 (teleangiectasias, dermatitis perioralis), it is necessary to avoid hit of drug on mucous membranes.
To apply carefully at patients with psoriasis as patients with psoriasis can have a dangerous external use of glucocorticosteroids owing to the probability of emergence of a recurrence of a disease, and it is also careful apply at already available conditions of an atrophy of hypodermic cellulose, especially at elderly people.
Considering presence at structure of an aminoglikozidny antibiotic, especially carefully use drug in cases of a renal failure as Neomycinums can collect in kidneys. The cross allergy to aminoglikozidny antibiotics is possible. Due to the ototoksichesky and nephrotoxic action of Neomycinum, use of Flucinarum N on big sites of skin, on the injured skin or during the long span can lead to a hearing disorder, including to a hearing loss and a renal failure. Flucinarum N should be applied with care at patients with a renal failure and deterioration in hearing. The risk of nephrotoxic and ototoksichesky action is higher at patients with dysfunction of kidneys. At combined use of Flucinarum N with other ototoksichesky and nephrotoxic drugs their action can amplify.
Prolonged use of Flucinarum N can lead to emergence Neomycinum – resistant strains of bacteria and to allergic reactions.
Drug contains propylene glycol and lanolin which can cause local skin reactions (for example, contact dermatitis) or irritation.
Use for children
For children perhaps more frequent emergence of signs of oppression gipotalamo – a hypophysial and adrenal system and Cushing’s syndrome at use of glucocorticosteroids of local action, than at adults. It is connected with bigger absorption of drug because of a bigger ratio of surface area of skin to body weight. Corticosteroid therapy can cause a growth disorder and development of children. In this regard children should limit use of local corticosteroids to the minimum effective quantity of drug. The course of treatment should not exceed 5 days.
Pregnancy and the period of a lactation
It is established that glucocorticosteroids have teratogenic effect even at use inside in small doses. The teratogenic effect was also found at an external primeniye on skin of strong glucocorticosteroids. Neomycinum gets through a placental barrier and has nephrotoxic and ototoksichesky effect on a fruit.
Флуцинар® it is possible to apply N ointment in II and III trimesters of pregnancy only if the expected advantage of use for mother exceeds potential risk for a fruit. Флуцинар® N should not be applied in the I trimester of pregnancy.
During pregnancy of Flutsinar® of N it is not necessary to apply in high doses and it is long.
The termination of breastfeeding at use of Flutsinar® ointment N for the feeding women is recommended.
Feature of influence of medicine on ability to driving and potentially dangerous mechanisms
Medicine does not limit psychomotor activity and does not affect ability to control of vehicles and service of moving mechanisms.
At long or excessive use of a fluotsinalon of acetonide on the extensive surface of skin can take place development of undesirable effects, such as hypostasis, hypertensia, hyperglycemia, decrease in immunity and, in difficult cases, a giperadrenokortitsizm. In such cases it is necessary to cancel gradually intake of medicine or to apply less strong corticosteroids.
Owing to existence of Neomycinum the excessive or prolonged topical administration of medicine can lead to development of resistant bacterial strains, a hearing loss and damage of kidneys.
The form of release and packing
On 15 g of drug place in aluminum tubas, with the internal lithographed varnished surface. Each tuba together with the instruction for medical use in the state and Russian languages is put in a cardboard pack.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
A period of storage
the use Period after the first opening of 30 days.
Not to use medicine after an expiration date.
According to the prescription
the Jelfa Pharmaceutical Plant A Producer. Lake
58-500, Jelenia Gora, V. Paul St., 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, Block 4B, office 1104 Phone number + 7 727 311 1516 Fax + 7 727 311 1517 Eletronnaya Develop mail Office.KZ@valeant.com