Fluorocort®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FTOROCORT® (FTOROCORT®)

Composition:

Active substance: triamcinolone;

1 g of ointment contains triamcinolone acetonide 1 mg;

Excipients: methylparahydroxybenzoate (E 218), stearic acid, polysorbate 60, cetyl alcohol, liquid paraffin, glycerol (85%), purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: white or almost white homogeneous ointment, practically odorless.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Moderately potent corticosteroids (group II). Triamcinolone. ATC code D07A B09.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the ointment is triamcinolone acetonide – a fluorinated glucocorticosteroid that, when applied topically, exhibits anti-inflammatory, anti-allergic, and antipruritic effects.

The pharmacological action of glucocorticosteroids is based on the regulation of synthesis of specific proteins in the body and ensuring the body's adaptation to stress conditions by reducing glucose utilization and enhancing gluconeogenesis (hyperglycemia). They promote glycogen deposition, primarily in the liver, by enhancing insulin secretion under conditions of hyperglycemia. They reduce protein synthesis and enhance catabolism of proteins in muscle, skin, and bone tissues; promote lipolysis. They constrict blood vessels, reduce their permeability, and decrease tissue edema.

Numerous glucocorticosteroid receptors are also present in brain and heart tissues. Glucocorticosteroids enhance β-adrenergic responses in the lungs, dilate bronchi, and reduce pulmonary vascular resistance.

In high doses, they inhibit corticotropin secretion; in adrenal corticosteroid insufficiency, they enhance glomerular filtration and diuresis; may cause ulcerative lesions of mucous membranes. At higher doses, they exhibit anti-allergic and anti-inflammatory properties.

Esterification of the glucocorticosteroid molecule with fatty acids at the 17 and 21 positions significantly enhances its effect on the skin. The presence of a cyclic acetonide group at positions 16 and 17 enhances local anti-inflammatory activity without affecting the systemic effects of glucocorticosteroids. Fluorine further increases the local activity of the drug.

Pharmacokinetics.

Triamcinolone penetrates well into deep layers of the skin and is partially absorbed into the bloodstream. When an occlusive dressing is applied to affected skin areas, it is absorbed in amounts sufficient to produce systemic effects. Glucocorticosteroids are rapidly distributed throughout body tissues. The main metabolite of triamcinolone – 6-β-hydroxytriamcinolone – is excreted by the liver, kidneys, feces, and urine in equal proportions. The plasma half-life is approximately 5 hours; the terminal half-life is 18–36 hours.

Clinical characteristics.

Indications.

Skin disorders sensitive to corticosteroids (eczema, vulgar psoriasis, allergic dermatitis).

Contraindications.

Hypersensitivity to triamcinolone acetonide or to any of the excipients of the medication.

The drug must not be applied into the eyes or onto skin areas near the eyes.

Do not use the medicinal product as monotherapy without specific treatment for fungal and bacterial skin infections.

Tuberculosis; viral skin infections, particularly herpes simplex and varicella; parasitic skin infections (scabies); skin manifestations of syphilis; skin reactions following vaccination; perianal and genital pruritus; leg ulcers; varicose veins; widespread plaque psoriasis; facial skin lesions (rosacea, acne vulgaris, perioral dermatitis); skin maceration caused by wet diapers; dry desquamation of the skin.

Do not apply the ointment directly to the breasts immediately before breastfeeding.

Do not use in children under 1 year of age.

Interaction with other medicinal products and other forms of interaction.

With topical application of corticosteroids, interactions with other medicinal products are unknown.

Special precautions for use.

If skin irritation occurs, discontinue use of Fluocort® ointment and continue treatment with another medication.

When using occlusive dressings or treating large areas of the body, systemic effects of the drug are possible; in such cases, special caution is required, particularly in children.

During treatment with the ointment, microorganisms present on the skin (primarily pyogenic microorganisms, and occasionally budding yeasts) may penetrate through the loosened stratum corneum and cause various pyodermas, which are treated with washable disinfectants. Fungal infections may occur, and rarely, bruising may appear under occlusive dressings. Prolonged use of the ointment on the same area of skin, especially in younger patients, may lead to atrophy of that skin area.

Certain areas of the body, such as axillae and inguinal folds (where natural occlusion occurs and the skin is more delicate and thinner), are more prone to the development of striae and easily noticeable, irreversible skin atrophy. Therefore, application of the ointment to these areas should be short-term.

If fungal or bacterial skin infection develops, additional local or systemic therapy is required.

The ointment should not be used on the scalp.

Prolonged application of the drug to the facial skin is not recommended due to the risk of skin atrophy. Avoid contact with the eyes. In case of accidental eye exposure, rinse thoroughly with copious amounts of running water and seek medical advice.

In psoriasis treatment, withdrawal syndrome, steroid dependence, generalized pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function may occur. Treatment of patients with psoriasis using topical corticosteroids should only be performed under strict medical supervision.

The use of the ointment in children aged 1 year and older is possible only in exceptional cases. The duration of treatment in children should not exceed 5 days. The use of occlusive dressings in children is contraindicated.

When used in children, one must consider the possibility of developing signs of hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome, which occur more frequently in children than in adults due to a higher skin surface area-to-body weight ratio, making children more susceptible to systemic toxicity. In children treated with topical corticosteroids, acute adrenal insufficiency, Cushing's syndrome, and increased intracranial pressure have been reported.

Visual disturbances

Visual disturbances may occur with both systemic and topical use of corticosteroids. If a patient experiences symptoms such as decreased vision or other visual disturbances, they should be referred to an ophthalmologist to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported with systemic and topical corticosteroid use.

Topical steroid withdrawal syndrome

Prolonged continuous or inappropriate use of topical corticosteroids may lead to recurrent flare-ups after discontinuation of treatment (topical steroid withdrawal syndrome). A severe rebound flare may develop, presenting as dermatitis with intense redness, stinging, and burning sensations, which may extend beyond the original treatment area. Rebound flares are more likely when treating sensitive skin areas such as the face and skin folds. If recurrence occurs within days or weeks after successful treatment, withdrawal reaction should be suspected. Re-initiating treatment requires caution—consultation with a specialist or consideration of alternative treatments is recommended.

Excipients

This medicinal product contains methylparaben (E 218), which may cause allergic reactions (possibly delayed), and stearic acid, which may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding.

Pregnancy. Use of the ointment during the first trimester of pregnancy is contraindicated. There is insufficient data to confirm the safety of the drug during the second and third trimesters of pregnancy. The decision on using the drug during the second and third trimesters of pregnancy and during breastfeeding must be made by a physician on an individual basis, carefully weighing the expected benefits of treatment against the potential risks to the fetus.

Breastfeeding. Systemic absorption of glucocorticoids is associated with their passage into breast milk and potential effects on the adrenal cortex and growth of the infant.

Topical use of triamcinolone during breastfeeding is not recommended. Application of the cream directly to the breasts immediately before breastfeeding is contraindicated (see section "Contraindications").

Ability to affect reaction speed while driving or operating machinery.

Currently, no reports are available. However, when driving or operating machinery, special caution is advised, considering the potential for adverse reactions affecting the nervous system.

Method of Administration and Dosage

For external use only.

Adults: Apply a thin layer of the ointment 2–3 times daily to the affected area of skin (maximum dose for adults – no more than 15 g of ointment per day), or apply the preparation under occlusive dressing (maximum dose for adults – no more than 10 g of ointment per day).

Children: For children aged 1 year and older, apply a thin layer of the ointment up to 2 times daily to the affected area of skin. The duration of treatment in children should not exceed 5 days. Use under occlusive dressing is contraindicated in children.

Elderly patients: The preparation should be used with caution and for a short duration, bearing in mind that skin in this patient group is typically thinner.

Children.

The ointment is contraindicated in children under 1 year of age.

Overdose.

Depending on the amount of steroid absorbed into the body, local and systemic adverse reactions may occur. In case of overdose, treatment should not be discontinued abruptly – it should be tapered gradually by reducing the dose. If symptoms of adrenal insufficiency develop, intravenous administration of hydrocortisone may be required.

Adverse Reactions

Local adverse reactions are typical for glucocorticosteroid preparations when applied topically; however, systemic effects may occur depending on the amount of substance absorbed into systemic circulation.

Prolonged use over large body surface areas may lead to suppression of adrenal cortex function, especially in children, as well as when occlusive dressings are used; negative nitrogen balance due to enhanced protein catabolism is also possible.

Excipients with known effect:
Cetyl alcohol – may cause local skin reactions (e.g., contact dermatitis);
Methylparahydroxybenzoate (E 218) – may cause allergic reactions (possibly delayed).

The frequency of the adverse reactions listed below is unknown, as adequate data are not available (cannot be estimated from the available data).

Infections and parasitic diseases: infection, masking of infection symptoms, opportunistic infections.

Immune system disorders: hypersensitivity.

Endocrine disorders: suppression of adrenal cortex function (secondary adrenal insufficiency).

Metabolism and nutrition disorders: hypokalemic alkalosis, fluid and sodium retention, hypokalemia.

Psychiatric disorders: insomnia, psychiatric disturbances.

Nervous system disorders: seizures, dizziness, headache, increased intracranial pressure.

Eye disorders: cataract, subcapsular cataract, exophthalmos, glaucoma, optic disc edema, ulcerative keratitis, chorioretinopathy, blurred vision (see section "Special Warnings and Precautions for Use").

Cardiac disorders: heart failure.

Vascular disorders: arterial hypertension.

Gastrointestinal disorders: gastric bleeding, gastrointestinal bleeding, gastrointestinal perforation, esophagitis, pancreatitis, peptic ulcer.

Skin and subcutaneous tissue disorders: dermatitis, skin burning sensation, folliculitis, acneiform eruptions, contact dermatitis, dryness and thinning of the skin, erythema, hirsutism, increased sweating, intertrigo, pruritus, skin atrophy, hypopigmentation, irritation, striae, telangiectasia.
Withdrawal reactions: skin redness that may spread beyond the initial affected area, burning or prickling sensation, pruritus, desquamation, oozing pustules (see section "Special Warnings and Precautions for Use").

Musculoskeletal and connective tissue disorders: steroid myopathy, osteoporosis, osteonecrosis, aseptic necrosis.

General disorders and administration site conditions: delayed wound healing.

Investigations: increased intraocular pressure, negative nitrogen balance, negative skin tests.

Children

Eye disorders: higher likelihood of cataract development in children.

Musculoskeletal and connective tissue disorders: growth retardation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicine authorization is important. It allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy via the Automated Information System of Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store at temperatures not exceeding 25 °C in the original packaging.

Keep the medicine out of the reach of children.

Packaging. 15 g of ointment in a closed aluminum tube with a polyethylene cap and perforated tip. One tube per cardboard box.

Prescription status. Prescription only.

Manufacturer. JSC "Gedeon Richter".

Manufacturer's address and location of its business activities.
H-1103 Budapest, Demre utca 19-21, Hungary.