Fluorocort ointment 0.1%, 15 g
Expiration Date: 05/2027
Russian Pharmacy name:
Фторокорт мазь 0.1%, 15 г
Skin diseases sensitive to GCS:
acute and chronic eczema;
neurodermatitis;
contact dermatitis;
lichen planus;
psoriasis;
exfoliative erythroderma;
otitis externa, not complicated by infection;
insect bites.
For external use only.
Adults
A thin layer of ointment should be applied to the affected area of ??the skin 2 or 3 times / day (maximum 15 g of ointment per day) or under an occlusive dressing (maximum 10 g of ointment per day).
Children and adolescents
The drug Ftorocort should not be used in children under 2 years of age .
For children over 2 years old , to reduce the risk of undesirable effects, the ointment can be applied to the affected area a maximum of 2 times / day. The duration of treatment is no more than 5 days. Application under an occlusive dressing is not recommended.
Elderly patients (over 65 years old)
GCS should be used with caution and for a short period of time, since the elderly have a natural thinning of the skin.
triamcinolone acetonide - 1 mg
Excipients: methyl parahydroxybenzoate, stearic acid, polysorbate 60, cetyl alcohol, liquid paraffin, glycerol 85%, purified water.
hypersensitivity to the active substance or to any of the excipients;
fungal or bacterial skin infection without concomitant appropriate antibiotic therapy;
tuberculous and viral skin lesions, especially with herpes simplex and chickenpox;
skin infections caused by parasites (such as scabies);
I trimester of pregnancy;
children under 2 years of age.
The drug should not be used to treat the following diseases: trophic ulcers of the lower extremities, pink acne on the face (rosacea), acne, perioral and diaper dermatitis, dry, flaky skin; also should not be applied to the breast area before breastfeeding.
With care: pregnancy, elderly patients (over 65 years old).
Clinical and pharmacological group: GCS for external use
Pharmaco-therapeutic group: Topical glucocorticosteroid
pharmachologic effect
GCS for external use. When applied topically, it has anti-inflammatory, anti-allergic, decongestant and antiproliferative effects. When exposed to the skin, the marginal accumulation of neutrophils is prevented, which leads to a decrease in exudation, production of cytokines, inhibition of the migration of macrophages, which ultimately leads to a decrease in the processes of infiltration and granulation.
Pharmacokinetics
Absorption and distribution
When applied to the skin, glucocorticoids are well absorbed. When applied under occlusive dressings or in violation of the integrity of the skin, or when used in the form of an enema, a sufficient amount of corticosteroids can be absorbed, providing systemic effects.
GCS are rapidly distributed in body tissues.
Metabolism and excretion
The main metabolite of triamcinolone is 6-beta-hydroxytriamcinolone. Triamcinolone is metabolized mainly in the liver and kidneys and is excreted in equal proportions by the kidneys and through the intestines. T1 / 2 from plasma is about 5 hours, T1 / 2 from tissues within 18-36 hours.
The slower metabolism of synthetic GCS with their lower ability to bind to blood proteins may explain their higher activity in comparison with natural GCS.
Indications
Skin diseases sensitive to GCS:
acute and chronic eczema;
neurodermatitis;
contact dermatitis;
lichen planus;
psoriasis;
exfoliative erythroderma;
otitis externa, not complicated by infection;
insect bites.
Dosage regimen
For external use only.
Adults
A thin layer of ointment should be applied to the affected area of ??the skin 2 or 3 times / day (maximum 15 g of ointment per day) or under an occlusive dressing (maximum 10 g of ointment per day).
Children and adolescents
The drug Ftorocort should not be used in children under 2 years of age .
For children over 2 years old , to reduce the risk of undesirable effects, the ointment can be applied to the affected area a maximum of 2 times / day. The duration of treatment is no more than 5 days. Application under an occlusive dressing is not recommended.
Elderly patients (over 65 years old)
GCS should be used with caution and for a short period of time, since the elderly have a natural thinning of the skin.
Side effect
Topical steroid treatment is potentially associated with the development of local adverse reactions. Systemic effects are also to be expected, depending on the amount of steroid penetrating the skin.
Suppression of adrenal function can occur with prolonged local use of GCS on large areas of the skin. This can happen when treating children, as well as when applying Ftorocort under occlusive dressings. Protein catabolism can lead to negative nitrogen balance.
There are no data on the incidence of adverse effects, so their frequency cannot be determined based on the available data.
Infectious and parasitic diseases: infection, masked infection, opportunistic infection.
From the immune system: hypersensitivity reactions.
From the side of metabolism and nutrition: secondary insufficiency of the adrenal cortex (suppression of the function of the adrenal cortex), hypokalemic alkalosis, fluid retention, hypokalemia, sodium retention.
Mental disorders: insomnia.
From the nervous system: mental disorders, convulsions, dizziness, headache, increased intracranial pressure.
From the side of the organ of vision: cataract (the likelihood of cataract formation is higher in pediatric patients), subcapsular cataract, exophthalmos, glaucoma, papillary edema, ulcerative keratitis, choreoretinopathy, blurred vision.
From the side of the cardiovascular system: heart failure, increased blood pressure.
From the digestive system: gastric bleeding, gastrointestinal bleeding, gastrointestinal perforation, esophagitis, pancreatitis, peptic ulcer.
Skin and subcutaneous tissue disorders: dermatitis, burning sensation of the skin, folliculitis at the site of application, acne-like dermatitis, contact dermatitis, dryness and thinning of the skin, erythema, hirsutism, hyperhidrosis, diaper rash, itching, skin atrophy, skin hypopigmentation, skin irritation, striae, telangiectasia.
From the musculoskeletal system: growth retardation (in children), steroid myopathy, osteonecrosis, osteoporosis.
General disorders and disorders at the injection site: impaired wound healing.
Laboratory and instrumental data: increased intraocular pressure, negative nitrogen balance, negative skin test.
Contraindications for use
hypersensitivity to the active substance or to any of the excipients;
fungal or bacterial skin infection without concomitant appropriate antibiotic therapy;
tuberculous and viral skin lesions, especially with herpes simplex and chickenpox;
skin infections caused by parasites (such as scabies);
I trimester of pregnancy;
children under 2 years of age.
The drug should not be used to treat the following diseases: trophic ulcers of the lower extremities, pink acne on the face (rosacea), acne, perioral and diaper dermatitis, dry, flaky skin; also should not be applied to the breast area before breastfeeding.
With care: pregnancy, elderly patients (over 65 years old).
Application during pregnancy and lactation
Pregnancy
The drug Ftorocort should not be used in the first trimester of pregnancy, further use is possible only in cases where the expected benefit definitely justifies the potential risk to the fetus.
The safety of external use of corticosteroids in pregnant women has not been established.
There is insufficient data on safe use in human pregnancy regarding teratogenicity and embryotoxicity.
According to the results of preclinical studies, topical application of GCS can cause pathologies of fetal development, including cleft palate and intrauterine growth retardation. Therefore, there is a very small risk of developing such disorders in the human fetus.
T1 / 2 GCS increases during pregnancy, and clearance from blood plasma in newborns is lower than in children and adults.
Breastfeeding period
Systemic corticosteroids pass into breast milk and can adversely affect the function of the adrenal cortex in newborns and cause unwanted effects such as growth suppression. It is necessary to stop breastfeeding.
Application for violations of liver function
There is no data.
Application for impaired renal function
There is no data.
Application in children
Use is contraindicated in children under 2 years of age.
Use in elderly patients
The drug should be prescribed with caution in elderly patients (over 65 years).
special instructions
With prolonged treatment, application to large areas of the body surface, as well as in the armpits and groin folds, when using occlusive dressings and diapers, systemic absorption of GCS is possible. In case of side effects, therapy should be canceled and a doctor should be consulted.
Avoid contact of the drug with the eyes and / or the periorbital area. In case of accidental contact with the eyes, rinse with copious amounts of water.
In psoriasis, local treatment of GCS may be accompanied by several risk factors (for example, 'withdrawal' effect, steroid dependence, the risk of developing generalized pustular psoriasis and local / systemic toxicity due to impaired skin barrier function). Thus, in psoriasis, local treatment of corticosteroids should be carried out under strict medical supervision.
With prolonged therapy with GCS, a sudden cessation of therapy can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after a long course of treatment, the drug should be withdrawn gradually, for example, by switching to an intermittent treatment regimen before completely stopping it. If there are signs of hypersensitivity or skin irritation associated with the use of the drug, you should stop treatment and consult a doctor.
Visual impairment
With systemic and local use of GCS, the development of visual impairment is possible. If patients develop symptoms such as blurred vision or other disorders, an ophthalmologist should be consulted to rule out diseases such as cataracts, glaucoma, or such a rare disease as central serous chorioretinopathy, which can develop after systemic or local use of GCS.
Excipients
Fluorocort contains methyl parahydroxybenzoate, which can cause allergic reactions (possibly delayed), and cetyl alcohol, which can cause a local skin reaction (for example, contact dermatitis).
Application in pediatrics
Application in children aged 2 years and older is possible only under medical supervision. Children are more at risk of suppression of the function of the hypothalamic-pituitary-adrenal system due to the use of GCS for external use than adults, due to their higher ratio of surface area and body weight and, accordingly, increased absorption of the drug. In children, this is accompanied by low plasma cortisol levels and a lack of response to ACTH stimulation. It is possible the occurrence of Itsenko-Cushing's syndrome, impaired growth and development, a slowdown in weight gain, an increase in intracranial pressure, manifested by protruding fontanelle, headaches, bilateral edema of the optic nerve. Long-term use of the drug in children should be carried out according to strict indications and under the supervision of a physician. Children more often than adultsthere are atrophic changes in the skin with external use of GCS. The course of treatment should be limited to 5 days. Occlusive dressings should not be applied.
Influence on the ability to drive vehicles and mechanisms
There are no data on the effect of the drug on the ability to drive vehicles.
Overdose
Symptoms: Although no cases of overdose have been reported, overdose can cause local and systemic effects depending on the amount of steroids ingested.
Treatment: in case of an overdose, you cannot abruptly stop treatment, it must be canceled gradually. With the development of adrenal cortex insufficiency, intravenous administration of hydrocortisone may be required.
Drug interactions
Interaction studies of the drug Ftorocort have not been conducted.
When steroids are used topically, interactions with other drugs are unknown.
Storage conditions
The drug should be stored out of the reach of children at a temperature not lower than 8 ? C.
Shelf life
Shelf life is 2 years. Do not use after the expiration date printed on the package.
Terms of sale
The drug is available with a prescription.
Contacts for inquiries
GEDEON RICHTER JSC (Hungary)