Фуцикорт®

General characteristics. Structure:

Active ingredients: Betamethasone valerate (it is equivalent to betamethasone – 1 mg) – 1,214 mg, Fuzidovy acid гемигидрат (it is equivalent to fuzidovy acid anhydrous – 20 mg) – 20,4 mg
Excipients: a macrogoal цетостеарат 18 mg, cetostearyl alcohol [cetyl alcohol of 60%, stearyl alcohol of 40%] of 72 mg, chlorocresol of 1 mg, dihydrophosphate sodium a dihydrate of 3 mg, liquid paraffin (contains about 10 ррт alpha tocopherol) 60 mg, white soft paraffin (contains about 10 ррт alpha tocopherol) 150 mg, sodium q.s hydroxide., the water purified to 1 g.

Description
Homogeneous cream of white color.

Pharmacological properties:

Фуцикорт® – the combined drug containing a glucocorticosteroid betamethasone and the fuzidovy acid having antibacterial effect. Betamethasone concerns to group of strong glucocorticosteroids (group III) and has the pharmacological effect, suppressing local immune responses, including a vazodilatation, puffiness and painful feelings.
Fuzidovy acid – an antibiotic with preferential activity against gram-positive bacteria. In particular, fuzidovy acid has activity against bacteria of Staphylococcus aureus, Propionibacterium acnes and korinebakteriya, and also suppresses synthesis of protein at bacteria. After 30 years of use fuzidovy acid resistance of bacteria is noted seldom (1-3%). Most often the bacteria steady against penicillin and other antibiotics are sensitive to fuzidovy acid.

Pharmacokinetics. When drawing on skin absorption of betamethasone can result in system effects, in particular, when drawing on extensive sites of the inflamed skin or under occlusive bandages. At outside putting the drug Futsikort® absorption of betamethasone through the unimpaired skin makes less than 2%. The amount of the soaked-up betamethasone is metabolized in a liver and removed through kidneys.
System absorption of fuzidovy acid is insignificant.

Indications to use:

The dermatitis, allergic eczema and toxidermia infected with microorganisms sensitive to fuzidovy acid.

Route of administration and doses:

For external use.
Adults and children: to apply cream with a thin layer 2-3 times a day.
Course of treatment: no more than 2 weeks.

Features of use:

The bacterial resistance connected using fuzidovy acid is noted.
As well as in a case with all antibiotics, excessive or numerous use can increase risk of development of resistance to antibiotics.
It is necessary to take with caution drug at a perianal or genital itch.
Futsikort it is necessary to apply with care on extensive sites of skin, under occlusive bandages, the person, sites of intertriginous skin. Not to apply drug on open wounds and mucous membranes. It is necessary to use with care drug in periorbital area as at the same time development of glaucoma is possible.
If use of Futsikort® cream causes irritation or excessive sensitivity of skin, it is necessary to stop its use and to begin other corresponding treatment.
In case of the treatment termination, emergence of the withdrawal which is shown in the form of reddening, a burning sensation or a pricking of skin or an exacerbation of psoriasis is possible.
These phenomena can be prevented at gradual drug withdrawal.
Because children have a size of a ratio of surface area and body weight it is more, than at adults, children are subject to bigger risk of suppression of function гипоталамо - pituitary and adrenal system and development of a syndrome of Cushing at use of any glucocorticosteroids of local action. Prolonged treatment of children of GKS can lead to disturbances of their growth and development.
Children have to receive the minimum dose of drug sufficient for achievement of effect.
After prolonged outside treatment by strong corticosteroids atrophic changes most often meet on a face, external genitals, the interior of upper and lower extremities, in comparison with other sites.
Drug contains chlorocresol which can cause allergic reactions, and also cetostearyl alcohol which can cause local skin rashes (for example, contact dermatitis).

Influence on ability to manage vehicles and mechanisms
Does not influence.

Side effects:

Side effects are classified depending on occurrence frequency:
the most frequent> 1/10
frequent> 1/100 and <1/10
infrequent> 1/1000 and <1/100
rare> 1/10000 and <1/1000
very rare <1/10000
Disturbances from immune system:
Frequency is unknown: allergic reactions
From integuments and appendages of skin:
Infrequent: rash, exacerbation of eczema, irritation of skin, skin itch, burning sensation or prickings of skin.
Frequency is unknown: skin atrophy, contact dermatitis, small tortoiseshell, erythema, xeroderma.
Though these reactions were not noted in clinical trials of the drug Futsikort®, external use глкжокортико steroids can lead to teleangiectasias and striya, especially at prolonged use.
As well as in a case with other glucocorticosteroids, development of a folliculitis (steroid eels), a hypertrichosis, perioral dermatitis, a depigmentation, gemmoragichesky rash, pink eels, a heat rash, maceration of skin and system effects of glucocorticosteroids is possible.

Interaction with other medicines:

It is not known.

Contraindications:

• Hypersensitivity to drug components.

Considering existence in composition of the drug Futsikort® of a glucocorticosteroid, drug is contraindicated at:

• Rozatsy
• Perioral dermatitis
• Youthful eels
• Primary bacterial, viral and fungus skin diseases
• Tuberculosis cutis, syphilis (skin manifestations)
• Children's age up to one year

Use at pregnancy and a lactation
At pregnancy:
Clinical data concerning use of a preperat Futsikort at pregnancy and a lactation are absent. Experiments on animals do not show teratogenic effect of fuzidovy acid, but show such effect at use of glucocorticosteroids.
Safety of use of outside corticosteroid therapy during pregnancy was not established, this group of medicines should be used only if the advantage of their use for mother exceeds any potential risks for a fruit. Pregnant women should not apply this group of medicines in high doses or for a long time.
At a lactation:
Use of the drug Futsikort® in the period of a lactation is possible. Women in the period of a lactation should use Futsikort® only according to the recommendation of the doctor.
Glucocorticosteroids are removed with breast milk, but the probability of their impact on the raised child is very small at outside drawing on the limited site of skin. If prolonged treatment or use of high doses of drug is shown, it is necessary to stop breastfeeding. In the period of a lactation it is not necessary to apply cream on mammary glands.

Overdose:

Excessive prolonged outside treatment by glucocorticosteroids can suppress function of a hypophysis and adrenal glands that can result in secondary (usually reversible) insufficiency of adrenal glands. Symptomatic therapy can be in that case shown.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after expiry date.

Issue conditions:

According to the recipe

Packaging:

External use cream.
On 15, 30 60 g of cream in a tuba aluminum, sealed by a membrane from aluminum foil and corked by the screw-on polyethylene cover; on 1 tuba together with the application instruction in a cardboard pack.