Instructions Flucinar gel 0.25 mg/g tube 15 g
Composition
active ingredient: fluocinolone;
1 g of gel contains fluocinolone acetonide 0.25 mg;
Excipients: propylene glycol, ethanol 96%, disodium edetate, citric acid monohydrate, methylparaben (E 218), propylparaben (E 216), triethanolamine, carbomer, purified water.
Dosage form
Gel.
Main physicochemical properties: colorless transparent gel with a faint opalescence and the smell of ethyl alcohol.
Pharmacotherapeutic group
Corticosteroids for use in dermatology.
ATX code D07A C04.
Pharmacological properties
Pharmacodynamics.
Fluocinolone acetonide is a highly active synthetic glucocorticosteroid for external use. When used in the form of a gel at a concentration of 0.025%, it has a strong anti-inflammatory, antipruritic, antiallergic and vasoconstrictor effect. It has lipophilic properties and is easily absorbed through the skin. After applying 2 g of gel, the production of adrenocorticotropic hormone (ACTH) by the pituitary gland may decrease as a result of suppression of the adrenal-pituitary system.
The mechanism of anti-inflammatory action of fluocinolone acetonide has not been fully studied, and it is believed that this agent reduces inflammatory processes by inhibiting the production of prostaglandins and leukotrienes as a result of a decrease in the activity of phospholipase A2 and the release of arachidonic acid from the phospholipids of the cell membrane. It has an anti-allergic effect by inhibiting the development of local hypersensitivity reactions. As a result of the local vasoconstrictor effect, it reduces the risk of exudative reactions. Reduces protein synthesis and collagen deposition. Accelerates the breakdown of proteins in the skin and weakens proliferative processes.
Pharmacokinetics.
Fluocinolone acetonide easily penetrates the stratum corneum of the skin, where it gradually accumulates and is detected even 15 days after application. It is not biotransformed in the skin. After absorption, it is systemically biotransformed mainly in the liver. It is excreted in the urine and in smaller quantities in the bile, mainly as a compound with glucuronic acid, and also in a small amount in an unchanged state.
Absorption of fluocinolone acetonide through the skin is increased when applied to sensitive skin in the area of anatomical folds of the body and face, as well as to skin with damaged epidermis or an existing inflammatory process. The use of an occlusive dressing causes an increase in skin temperature and humidity, which also leads to increased absorption of fluocinolone acetonide. In addition, absorption is increased with frequent use of the drug and on large areas of skin. Absorption through the skin is higher in adolescents than in adults.
Indication
Short-term local treatment of acute and severe non-infectious inflammatory skin diseases (dry forms), which are accompanied by persistent itching or hyperkeratosis and respond to treatment with glucocorticosteroids: seborrheic dermatitis, lichen urticarial, atopic dermatitis, allergic contact eczema, erythema multiforme, lupus erythematosus, psoriasis of the hairy areas of the skin, advanced psoriasis, lichen planus.
Contraindication
Pyoderma, chickenpox, herpes, actinomycosis, blastomycosis, sporotrichosis, multiple psoriatic plaques, skin manifestations of syphilis, skin tuberculosis, erosive-ulcerative lesions of the gastrointestinal tract, wounds in the application areas, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma, skin tumors, skin cancer, rosacea and vulgar acne, perianal and genital itching, perioral dermatitis, diaper dermatitis, thrombophlebitis and trophic ulcers on the background of varicose veins. Do not use after vaccination. The drug should not be used on large areas of the skin, especially on wounds that do not heal for a long time, for example, deep burn wounds. The drug should not be used in ophthalmology.
It is not recommended to use Flucinar® gel for bacterial, viral and fungal skin infections, acne vulgaris and rosacea, diaper dermatitis, perioral dermatitis, after prophylactic vaccinations, perianal and genital itching, as well as in case of confirmed hypersensitivity to fluocinolone acetonide or to other glucocorticosteroids and to other components of the drug.
Interaction with other drugs and other types of interactions
No interactions have been observed with topical glucocorticosteroids. However, it should be noted that during treatment with the drug, it is not recommended to get vaccinated against smallpox, as well as to carry out other types of immunization (especially with prolonged use on large areas of skin) due to the possible lack of an adequate immunological response in the form of the production of appropriate antibodies.
Systemic glucocorticosteroid preparations increase the effectiveness of the drug, but at the same time increase the likelihood of side effects. Concomitant use with
Flucinar® gel may enhance the effect of immunosuppressive and weaken the effect of immunostimulating drugs.
Application features
The gel is particularly suitable for the treatment of hairy skin and in patients who do not tolerate ointments and creams. The gel form allows it to be applied in small quantities, and thus to apply smaller doses of the drug to large areas of skin, as well as to apply to the skin of hairy parts of the body.
Do not use with other medicines for external use.
Patients who develop symptoms of irritation, allergy (itching, burning, or redness), or superinfection should discontinue the drug.
Do not use the drug continuously for more than 2 weeks. With long-term use on large areas of the skin, the frequency of side effects increases and the possibility of developing edema, arterial hypertension, hyperglycemia, and a decrease in the body's resistance increases.
Contact of the drug with mucous membranes, application of the drug to large areas of skin, under an occlusive dressing should be avoided, and use of the drug by children should also be avoided.
Children may absorb proportionally larger amounts of topical corticosteroids than adults and are therefore more susceptible to systemic side effects. This is because children have an underdeveloped skin barrier and a larger skin surface area relative to body weight than adults.
When using the drug externally, the following are possible: a decrease in the production of adrenocorticotropic hormone by the pituitary gland due to suppression of the adrenal-pituitary system, a decrease in the level of cortisol in the blood and the development of iatrogenic Cushing's syndrome, which disappears after discontinuation of the drug. Periodic monitoring of the function of the adrenal cortex is indicated by determining cortisol in the blood and urine after stimulation of the adrenal glands with ACTH during prolonged use.
In case of infection at the site of application of the gel, appropriate antibacterial or antifungal treatment should be carried out. If the symptoms of infection persist, the use of the drug should be discontinued for the period of treatment of the infection.
Application of the drug to the eyelids or skin around the eyes should be avoided in patients with angle-closure and open-angle glaucoma, as well as in patients with cataracts due to possible exacerbation of disease symptoms.
The drug should be used with caution in patients with psoriasis, as topical use of glucocorticosteroids on areas affected by psoriasis may lead to the spread of relapse caused by the development of tolerance, the risk of generalized pustular psoriasis, and systemic toxicity caused by skin dysfunction.
Use on the skin of the face, groin, and in the inguinal area only if absolutely necessary, as increased absorption and a high risk of side effects (telangiectasia, perioral dermatitis) are possible, even after short-term use.
The drug should be used with caution in the presence of subcutaneous tissue atrophy, especially in the elderly.
It is recommended to wear loose clothing during treatment. For the treatment of skin diseases accompanied by infection, it is recommended to prescribe the drug together with antimicrobial agents.
Do not use on the skin of the mammary glands.
The drug contains parahydroxybenzoates, which may cause allergic reactions (possibly delayed).
The product contains propylene glycol, which may cause skin irritation.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy or breastfeeding.
Pregnancy.
Animal studies have shown that glucocorticosteroids are teratogenic even at low doses. Teratogenic effects in animals have also been confirmed with topical application of potent corticosteroids to the skin. Controlled studies to assess the potential teratogenic effects in pregnant women when applied topically to the skin have not been conducted, therefore data on the effects of the drug on pregnancy and/or embryonic development, fetal development, childbirth, and postnatal development are insufficient. The potential risk to humans is unknown.
Breastfeeding period.
It is not known whether fluocinolone acetonide can pass into breast milk after topical application. Significant concentrations in breast milk have not been determined after oral administration of glucocorticosteroids, which can potentially cause side effects in the newborn infant.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not limit mental and motor activity, as well as the ability to drive vehicles and mechanisms.
Method of administration and doses
If deep penetration of the active substance is required, the gel can be gently rubbed into the skin at the application site. The gel should not be applied under an occlusive dressing. It is recommended to wear loose clothing during treatment.
The drug should be used with caution, under the supervision of a doctor, in children over 2 years of age only once a day on a small area of skin; do not apply to the child's face.
Children.
The drug should not be used in children under 2 years of age.
Overdose
With prolonged use on large areas of the skin, symptoms of overdose may appear, manifested by increased local side effects (edema, arterial hypertension, hyperglycemia, decreased immunity, glucosuria), and in severe cases - the development of Cushing's syndrome. In case of overdose, the drug should be discontinued or corticosteroids of lower potency should be used.
Adverse reactions
Adverse reactions occurring with the use of Flucinar® gel are listed below by frequency: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), isolated
(≥ 1/10,000, < 1/1,000), rare (< 1/10,000).
On the part of the organs of vision: frequency unknown - when applied externally to the skin of the eyelids, cataracts or glaucoma may sometimes develop.
Skin and subcutaneous tissue disorders: uncommon - atrophy of subcutaneous tissue and impaired skin integrity, atrophic striae, epidermal growth inhibition, telangiectasia; rare - hypertrichosis; frequency unknown - skin discoloration or hyperpigmentation, steroid acne, dry skin, excessive body hair growth or alopecia, itching, burning sensation, skin irritation, contact dermatitis; rare - urticaria, urticaria or maculopapular rash or exacerbation of existing changes.
On the part of the immune system: allergic reactions or hypersensitivity reactions are possible.
Systemic disorders: prolonged use of the gel on large areas of skin or under an occlusive dressing, or in children, given the increased absorption of fluocinolone acetonide, can cause a strong systemic effect, manifested in the form of edema, arterial hypertension, decreased immunity, growth and development inhibition in children, hyperglycemia, glucosuria, development of Cushing's syndrome, displacement of the hypothalamic-pituitary-adrenal axis.
Infections and infestations: uncommon – secondary infections.
With external use of corticosteroids, local adverse reactions were observed, which can also occur with the use of fluocinolone acetonide: folliculitis, skin maceration, steroid purpura, perioral dermatitis, worsening of eczema (ricochet phenomenon). Hyperkeratosis, furunculosis, exacerbation of existing pathological lesions, hirsutism are also possible, when applied to large areas of the skin, gastritis, steroid gastric ulcer, steroid diabetes mellitus, adrenal insufficiency are possible. With prolonged use, the following are possible: secondary immunodeficiency (exacerbation of chronic infectious diseases, generalization of the infectious process, development of opportunistic infections), slowing down of reparative processes.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not freeze.
Packaging: 15 g in a tube; 1 tube in a box.
Release category: By prescription.
Producer
Pharmaceutical factory Elfa A.T.
Location of the manufacturer and its business address
58-500 m. Jelenia Góra, 21 Vincentiego Pola Street, Poland.
