Dermatology / Hormonal, Anti-Inflammatory Drugs / Psoriasis and keratosis

Ftorokort 0.1% 15g ointment tube

Brands: Gedeon Richter (Hungary)

$10.80

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Ftorokort 0.1% 15g ointment tube quantity

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Brands:: Gedeon Richter (Hungary)

Description

The instruction for medical use

of FTOROKORT® medicine

the Trade name
of Ftorokort®

the International unlicensed

name Triamcinolonum Dosage Form Ointment, 0.1%, 15 g

Structure
of 15 g of ointment contain
active agent – Triamcinolonum acetonide of 0.015 g,
excipients: methylparahydroxybenzoate, stearic acid, polysorbate 60, cetyl alcohol, liquid paraffin, glycerin (85%), water purified.

Description
Uniform ointment of white or almost white color, almost flavourless.

Pharmacotherapeutic group
Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids. Glucocorticosteroids with moderate activity (group II). Triamcinolonum
the ATX D07A B09 Code

the Pharmacological

Pharmacokinetics At properties drawing on skin the glucocorticosteroids are well absorbed. At use of an occlusive bandage on the struck integuments and at rectal use are soaked up in the quantity sufficient for rendering system effect.
Glucocorticosteroids are quickly distributed in body tissues. The main metabolite of Triamcinolonum – 6-β-гидрокситриамцинолон. Are metabolized in a liver and also in kidneys, and it is removed with a stake and urine in equal ratios. Time of semi-removal from plasma is about 5 hours, half-decay time 18-36 hour.
Metabolism of synthetic glucocorticosteroids is carried out more slowly because of weak communication of the last with proteins therefore they render stronger, than their endogenous analogs, action on an organism.

The pharmacodynamics
Triamcinolonum is a fluorinated glucocorticosteroid with anti-inflammatory, antiallergic and antipruritic properties.
Pharmacological action of Ftorokorta® is based on regulation of synthesis of specific proteins of an organism and ensuring adaptability of an organism to stressful situations due to decrease in utilization of glucose and strengthening of a gluconeogenesis (hyperglycemia). They promote adjournment of a glycogen, first of all in a liver, due to strengthening of secretion of insulin in the conditions of a hyperglycemia (anabolism). Reduce synthesis and strengthen catabolism of proteins of muscular, skin and bone fabrics (osteoporosis), promote a lipolysis. Narrow vessels, reduce their permeability and puffiness of fabrics.
Numerous receptors of glucocorticosteroids are also in tissues of a brain and heart. Glucocorticosteroids strengthen β-adrenergic reactions in lungs, expand bronchial tubes and reduce vascular resistance in lungs.
In high doses slows down corticotropin secretion, strengthens glomerular filtration and a diuresis, causes an ulceration of mucous membranes. In high doses show antiallergic and anti-inflammatory properties.
Esterification of a molecule of glucocorticosteroids fatty acids significantly strengthens its impact on skin fabrics. Cyclic acetonide strengthens local anti-inflammatory action, without affecting system effect of glucocorticosteroids. Fluorine promotes further increase in local activity of drug.

Indications
– topical treatment of the skin diseases sensitive to corticosteroids (eczema, vulgar psoriasis, allergic dermatitis).

A route of administration and doses
For external use.
Adult:
2-3 times a day to apply with a thin layer on the damaged body surface (maximum daily dose of 15 g), or to use under an occlusive bandage at likhenifitsirovanny manifestations (maximum daily dose of 10 g). A course of treatment – 5-10 days, at a persistent course – up to 25 days, but no more than 4 weeks.
To children:
To children, aged up to one year, it is impossible to use drug.
To children, is more senior than one year, for reduction of risk of emergence of side effects, it is possible to use ointment no more than two times a day, a thin layer (the maximum daily dose – 2 g). Duration of therapy should not exceed five days. Use of drug under an occlusive bandage is not recommended.

Patient of advanced age:
The course of treatment glucocorticosteroids has to be shorter because of age thinning of integuments.

Side effects
Topical treatment by steroids is potentially connected with development of local side reactions. Also it is necessary to expect system effects, depending on amount of the steroids getting through skin.
Suppression of function of adrenal glands can arise at long drawing topical corticosteroids on the extensive surfaces of skin. It can occur especially at treatment of pediatric patients and also when putting Ftorokort® ointment under occlusive bandages. Catabolism of proteins can result in negative nitrogenous balance.

– hypersensitivity reactions
– activization of latent infections, the erased course of infections, opportunistic infections
– suppression of function of bark of adrenal glands (secondary insufficiency of bark of adrenal glands), a gipokaliyemichesky alkalosis, a hypopotassemia
– a liquid delay, a sodium delay is possible at long-term treatment of big surface area of a body or at use of occlusive bandages
– insomnia, dizziness, a headache, increase in intracranial
pressure, mental disturbances, spasms
– increase in intraocular pressure, a keratohelcosis, an exophthalmos,
the Cataract (especially at children), a subkapsulyarny cataract, glaucoma, a papilledema, a horioretinopatiya
– an arterial hypertension, heart failure
– a peptic ulcer, an esophagitis, pancreatitis, gastrointestinal bleeding or perforation
– burning sensation of skin, dryness and thinning of skin, the increased
sweating, an intertrigo, an itching, hypopigmentation, dermatitis, contact dermatitis, a folliculitis in the site of application, akneformny rashes, an erythema, a hirsutism, striya, telangiectasias, a skin atrophy, irritation of skin
– delay of growth at children
– a steroid myopathy
– osteoporosis
– an osteonecrosis
– delay of healing of wounds
– negative nitrogenous balance,
– delay of reactions at skin tests

of the Contraindication
– hypersensitivity to active ingredients or to any of
drug excipients
– pregnancy and the period of a lactation
– children’s age till 1 year
– use in eyes and around eyes
– not treated infected surface of skin of a fungal and
bacterial etiology
– mikobakterialny (tubercular) infection of skin, virus
damage of skin (especially in herpes or chicken pox) and parasitic
infections. including a mange
– atrophic ulcers of a shin, an acne and perioral dermatitis, rozatseya
– diaper dermatitis, dry peeling of skin and greasing of a breast
just before feeding

the Medicinal interactions
With the drug Ftorokort®, ointment were not carried out tests on interaction with other drugs.
At local use of steroids the interaction with other medicines is unknown. It is not necessary to apply along with other local corticosteroids because of the increased risk of undesirable effects.

Special instructions
At emergence of the phenomena of irritation of skin it is necessary to stop use of Ftorokort® ointment and to continue treatment by other drug.
At use of occlusive bandages and treatment of big body surfaces perhaps systemic action of drug – in such cases is required extra care, especially at treatment of children. At long use of drug the risk of its penetration into blood increases what can lead to suppression of function of adrenal glands.
With softening of a corneal layer the danger of free penetration deep into of skin of the microorganisms especially piogenic with the subsequent development of various pyodermas which well respond to treatment by the disinfecting washing-away means increases. Fungal infections are possible, sometimes under the closed bandage there are bruises. On the place of long applique of drug the skin atrophy, especially at persons of young age is possible.
Prescribing of drug to children is possible only in exceptional cases. It is not recommended to apply on big surfaces, to avoid prolonged use at children irrespective of age. Use of an occlusive bandage is not recommended to children. Duration of treatment should not exceed 5 days.
Treatment of psoriasis local glucocorticosteroids can have the risk (for example: resuming of symptoms, development of steroid dependence, development of generalized pustular psoriasis and development of local or system toxicity because of disturbance of barrier function of skin). Because of it, treatment of patients with psoriasis local corticosteroids can be carried out only under stringent control of the doctor.
There are messages about sporadic cases of the central serous horioretinopatiya at use of corticosteroids regardless of a way of introduction (system, local or external) with stage of latency from several days to several years. Corticosteroids have to be applied with extra care at patients with existence of the central serous horioretinopatiya in the anamnesis.
Methylparahydroxybenzoate which is contained in composition of drug (it is known as paraben) can cause allergic reactions in predisposed people.
The cetyl alcohol which is contained in composition of drug can cause local skin reactions (for example, contact dermatitis).

Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to run vehicles and other mechanisms.

Overdose
In spite of the fact that there are no messages about drug overdose, depending on amount of the steroids which came to an organism the development of both local, and system side reactions is possible. At overdose of drug it is impossible to stop treatment sharply.
Symptoms: strengthening of local and system side reactions, signs of insufficiency of bark of adrenal glands. Treatment: the gradual dose decline of drug before full cancellation, at development of symptoms of insufficiency of bark of adrenal glands can be required intravenous administration of a hydrocortisone.

A form of release and packing
On 15 g in tubas the aluminum bushonam varnished with control of the first opening, corked polyethylene.
On 1 tuba together with the instruction for medical use in the state and Russian languages put in a cardboard pack.

To Store storage conditions at a temperature not higher than 250 Pages.
Not to freeze!
To store out of children’s reach!

2 years
not to use a period of storage after expiry date.

Prescription status
According to the prescription

the Name and the country
of the JSC Gideon Richter manufacturing organization,
1103 Budapest, Dyomryoi St., 19-21, Hungary

the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: Representative office of JSC Gideon Richter in RK E-mail: info@richter.kztelefon: 8 (727)258-26-22, 8 (727)258-26-23
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