Flucinar®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLUCINAR® (FLUCINAR®)

Composition:

Active substance: fluocinolone;

1 g of ointment contains 0.25 mg of fluocinolone acetonide;

Excipients: propylene glycol, citric acid, lanolin, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: a white or almost white, translucent, greasy ointment with a faint specific odor.

Pharmacotherapeutic group.

Corticosteroids for dermatological use. ATC code: D07AC04.

Pharmacological Properties.

Pharmacodynamics.

Fluocinolone acetonide is a potent synthetic glucocorticoid for topical use. When applied as an ointment at a concentration of 0.25 mg/g, it exerts a strong anti-inflammatory, antipruritic, anti-allergic, and vasoconstrictive effect. It has lipophilic properties and is readily absorbed through the skin. Even after application of 2 g of ointment, production of adrenocorticotropic hormone (ACTH) by the pituitary gland may be reduced due to suppression of the hypothalamic-pituitary-adrenal axis.

Pharmacokinetics.

Absorption. Absorption of fluocinolone acetonide through the skin is enhanced when applied to sensitive areas of skin, such as skin folds and facial areas, as well as to skin with impaired epidermis or inflammatory processes. Use of an occlusive dressing increases skin temperature and moisture, which also enhances absorption of fluocinolone acetonide. In addition, absorption is increased when the medicinal product is applied frequently and over large areas of skin. Skin absorption is higher in children than in adult patients.

Biotransformation and elimination. Fluocinolone acetonide readily penetrates the stratum corneum of the skin, where it gradually accumulates and can be detected even 15 days after application. It is not biotransformed in the skin. After systemic absorption, it is mainly metabolized in the liver. It is excreted in the urine and, to a lesser extent, in bile, primarily as conjugates with glucuronic acid, as well as in small amounts unchanged.

Preclinical safety data.

Single-dose toxicity. Fluocinolone acetonide is intended for topical (external) use only. The toxicity of this compound following oral or parenteral administration has not been studied. It can be assumed that the toxicity after single administration of fluocinolone acetonide does not significantly differ from the toxicity of other fluorinated glucocorticosteroids.

Genotoxicity. No mutagenic effects of fluocinolone acetonide have been studied; however, tests have been conducted to assess the mutagenic potential of other glucocorticosteroids with a similar chemical structure. Fluticasone propionate was not mutagenic in the Ames test performed on Escherichia coli bacteria, in a gene conversion test conducted on Saccharomyces cerevisiae yeast, and in a mutagenicity test performed on Chinese hamster ovary cells. Furthermore, no mutagenic effects of fluticasone were observed in tests conducted in vitro on human lymphocytes, nor clastogenic activity in the micronucleus test in mice.

Studies with hydrocortisone and prednisolone also showed no mutagenic effects.

Carcinogenicity. There are no data indicating that topical application of glucocorticoids promotes the development of skin cancer in humans.

Toxic effects on reproductive function and offspring development. The effect of fluocinolone acetonide on fertility has not yet been fully studied. However, effects of other glucocorticoids on fertility have been demonstrated.

Clinical Characteristics.

Indications.

Short-term treatment of acute and severe non-infectious inflammatory skin diseases (without exudation) accompanied by persistent pruritus or hyperkeratosis: seborrheic dermatitis, atopic dermatitis, nodular urticaria (papular urticaria), allergic contact dermatitis, erythema multiforme, lupus erythematosus, psoriasis, lichen planus.

Contraindications.

Children under 2 years of age. Skin manifestations of syphilis, cutaneous tuberculosis, pyoderma, varicella, herpes, actinomycosis, blastomycosis, sporotrichosis, diaper dermatitis, anogenital pruritus, nevus; atheroma, hemangioma, xanthoma, skin neoplasms, wounds and ulcerative skin lesions, wounds at application sites, numerous psoriatic plaques, trophic ulcers associated with varicose veins, erosive-ulcerative lesions of the gastrointestinal tract.

The ointment should not be used in bacterial, viral, and fungal skin infections, common and rosacea acne, perioral dermatitis (dermatitis perioralis), or in cases of confirmed hypersensitivity to fluocinolone acetonide or to other glucocorticosteroids and other components of the drug.

Interaction with other medicinal products and other types of interactions.

There is no information on interactions occurring during topical application of corticosteroids with other drugs.

The drug may be used concomitantly with antimicrobial agents of local and systemic action. Concurrent use with systemic-acting glucocorticosteroids enhances the drug's efficacy, but also increases the risk of adverse effects. Concurrent use with nonsteroidal anti-inflammatory agents increases the risk of developing systemic and local adverse effects. May potentiate the effects of antihypertensive, diuretic, antiarrhythmic drugs, and potassium preparations. Diuretic drugs (except potassium-sparing diuretics) increase the likelihood of hypokalemia.

The medicinal product may enhance the action of immunosuppressive agents and reduce the effect of immunostimulating drugs.

Special precautions for use.

The treatment must be carried out under medical supervision.

Before each repeated application of the drug, residues of ointment from the previous application should be washed off with soapy water or an antiseptic solution. During treatment, it is recommended to wear loose clothing. Do not apply to the skin of the mammary glands.

Do not use the cream simultaneously with other topical medicinal products.

If application of the ointment is accompanied by symptoms of irritation or allergic skin reaction (itching, burning, or redness of the skin), its use should be discontinued immediately.

Periodic monitoring of adrenal gland function by measuring cortisol levels in blood and urine after adrenal stimulation with ACTH is recommended during prolonged treatment.

Do not use the medicinal product for longer than 2 weeks without interruption. With prolonged use over large skin areas, the frequency of adverse effects increases, as well as the risk of developing edema, arterial hypertension, hyperglycemia, and reduced resistance of the body.

With topical application of the drug, the following may occur: decreased production of adrenocorticotropic hormone by the pituitary due to suppression of the hypothalamic-pituitary-adrenal axis, reduced blood cortisol levels, and development of iatrogenic Cushing's syndrome, which resolves after discontinuation of the drug.

In case of infection developing at the site of ointment application, appropriate antibacterial or antifungal treatment should be administered. If infection symptoms do not resolve, the use of the drug should be discontinued during the period of infection treatment.

Avoid applying the drug to the eyelids or skin around the eyes in patients with closed-angle or open-angle glaucoma, as well as in patients with cataract, due to possible worsening of disease symptoms.

Visual disturbances may occur during systemic and topical use of corticosteroids.

If symptoms such as blurred vision or other visual disturbances occur, patients should consult an ophthalmologist to evaluate possible causes, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported with systemic and topical corticosteroid use.

Avoid contact of the drug with the eyes. If skin irritation occurs at the site of ointment application, discontinue use.

In children, due to a higher body surface area to body weight ratio compared to adults, there is an increased risk of systemic adverse effects of corticosteroids caused by hypothalamic-pituitary-adrenal axis suppression and induction of Cushing's syndrome. Corticosteroid treatment may lead to impaired growth and development in children.

Use on the facial skin and in the axillary area only when strictly necessary, as increased absorption and a high risk of adverse effects (telangiectasia, dermatitis perioralis) are possible, even after short-term use. Uncontrolled topical use of steroids may also cause telangiectasia and perioral dermatitis. Symptoms usually resolve spontaneously after discontinuation of therapy.

Exercise caution when using the medicinal product in patients with subcutaneous atrophy, particularly in elderly individuals.

This medicinal product contains propylene glycol (50 mg per 1 g of ointment) and lanolin.

As the medicinal product contains propylene glycol, it may cause skin irritation upon application.

As the medicinal product contains lanolin, its use may cause local reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding.

Pregnancy.

Data on the use of fluocinolone in pregnant women are lacking or limited.

Flucinar ointment may be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus. Do not use the medicinal product during the first trimester of pregnancy.

Animal studies have shown that glucocorticosteroids have teratogenic effects even at low oral doses. Teratogenic effects have also been observed in animals after topical application of potent corticosteroids. No studies have been conducted on the teratogenic effects of topical fluocinolone acetonide use in pregnant women.

Animal studies with other glucocorticosteroids have shown reproductive toxicity (see section "Preclinical safety data").

Breastfeeding. A decision should be made whether to discontinue breastfeeding or to discontinue use of Flucinar ointment, taking into account the potential benefit of breastfeeding for the child and the benefit of treatment for the mother.

It is unknown to what extent fluocinolone acetonide/metabolites are excreted in breast milk following topical application. Risk to newborns/infants cannot be excluded.

Fertility. There are no data on the effect of fluocinolone on human fertility (see section "Preclinical safety data").

Ability to affect reaction rate while driving or operating machinery.

The medicinal product has no effect or has a negligible effect on the ability to drive or operate machinery.

Dosage and Administration

The product is intended for topical use. Apply a thin layer of the ointment to the affected skin area once or twice daily.

Do not use the ointment under occlusive dressings. However, in cases of psoriasis, a closed dressing may be used, which should be changed daily.

Treatment should not continue continuously for more than 2 weeks. Do not use on facial skin for longer than 1 week. It is recommended not to exceed 15 g of ointment (1 tube) per week.

Use with caution and under medical supervision in children aged 2 years and older, applying only once daily on a small skin area; do not apply to the facial skin.

Children. The medicinal product is contraindicated in children under 2 years of age.

Overdose.

Prolonged use over large skin areas may lead to symptoms of overdose, manifested by an increase in adverse reactions, including burning sensation at the application site, glucosuria, edema, arterial hypertension, and decreased resistance to infections. Pruritus, hyperglycemia, and Cushing's syndrome may also occur. Treatment is symptomatic, with gradual discontinuation of the drug or substitution with less potent glucocorticosteroids.

Adverse reactions.

The adverse reactions listed below are classified by organ systems according to MedDRA (Medical Dictionary for Regulatory Activities). Frequency is defined using the following categories: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

Due to the absorption of fluocinolone acetonide into the bloodstream, systemic adverse effects are also possible. These occur primarily with prolonged use of the medicinal product, application over a large body surface area, under occlusive dressing, or when used in children.

Systemic adverse effects of fluocinolone acetonide, typical for corticosteroids, include, among others, suppression of the hypothalamic-pituitary-adrenal axis function, Cushing's syndrome, growth and developmental suppression in children, hyperglycemia, glucosuria, hypertension, and decreased immunity.

Reporting of adverse reactions after medicinal product registration is of great importance. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Shelf life after first opening of the tube – 3 months.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 15 g in a tube; 1 tube in a cardboard box.

Prescription status. Prescription only.

Manufacturer. Elfa Plant A.T.

Manufacturer's address and place of business.
58-500 Jelenia Góra, ul. Wincentego Pola 21, Poland.