INSTRUCTIONS
for medical use of the drug
FLUCINAR®
(FLUCINAR®)
Storage:
active substance: fluocinolone;
1 g of ointment contains fluocinolone acetonide 0.25 mg;
Excipients: propylene glycol, citric acid, lanolin, white soft paraffin.
Dosage form. Ointment.
Main physical and chemical properties: white or almost white, oily, translucent soft mass with a specific faint odor.
Pharmacotherapeutic group.
Corticosteroids for use in dermatology. ATX code D07A C04.
Pharmacological properties.
Pharmacodynamics.
Fluocinolone acetonide is an effective synthetic glucocorticosteroid for external use. When used as an ointment at a concentration of 0.25 mg / g has a strong anti-inflammatory, antipruritic, anti-allergic and vasoconstrictive effect. It has lipophilic properties and is easily absorbed through the skin. Already after application of 2 g of ointment the production of adrenocorticotropic hormone (ACTH) by the pituitary gland may decrease as a result of suppression of the adrenal system pituitary gland.
Pharmacokinetics.
Fluocinolone acetonide easily penetrates the stratum corneum, where it gradually accumulates and is determined even 15 days after application. Not biotransformed in the skin. After absorption, it is systemically biotransformed, mainly in the liver. Excreted in the urine and in smaller quantities кіль with bile, mainly as a compound with glucuronic acid, as well as in small quantities unchanged.
Absorption of fluocinolone acetonide through the skin is enhanced by applying to sensitive skin areas of anatomical folds of the body and face, as well as on skin with damaged epidermis or inflammation. The use of an occlusive dressing causes an increase in the temperature and humidity of the skin, which also leads to increased absorption of fluocinolone acetonide. In addition, absorption is enhanced by the use of the drug often on large areas of skin. Absorption through the skin is higher in adolescents than in adult patients.
Clinical characteristics.
Indication.
Short-term treatment of acute and severe non-infectious inflammatory skin diseases (without exudation), accompanied by persistent itching or hyperkeratosis: seborrheic dermatitis, atopic dermatitis, nodular urticaria (papular urticaria), allergic contact dermatitis, erythema multiforme, erythema multiforme. herpes zoster.
Contraindication.
Skin manifestations of syphilis, tuberculosis of the skin, pyoderma, chickenpox, herpes, actinomycosis, blastomycosis, sporotrichosis, diaper dermatitis, anogenital itching, nevus; atheroma, hemangioma, xanthoma, skin neoplasms, wounds and ulcers of the skin, wounds at the sites of application, numerous psoriatic plaques, trophic ulcers associated with varicose veins, erosive-ulcerative lesions of the digestive tract.
The ointment should not be used for bacterial, viral and fungal skin infections, common and pink acne, perioral dermatitis (dermatitis perioralis), after prophylactic vaccinations, as well as in case of confirmed hypersensitivity to fluocinolone acetonide or other glucocorticosteroid steroids and other components.
Interaction with other drugs and other types of interactions.
The drug can be used with antimicrobial agents of local and systemic action. Concomitant use with systemic glucocorticosteroids increases the effectiveness of the drug, but at the same time increases the likelihood of side effects. Concomitant use of the drug with nonsteroidal anti-inflammatory drugs increases the risk of systemic and local side effects. May increase the effect of antihypertensive, diuretic, antiarrhythmic drugs, potassium supplements. Diuretic drugs (except potassium-sparing) increase the likelihood of hypokalemia. During treatment with the drug is not recommended to vaccinate against smallpox, as well as other types of immunization (especially with prolonged use on large areas of skin) due to the possible lack of adequate immunological response in the form of production of appropriate antibodies.
The drug may increase the effect of immunosuppressive and weaken the effect of immunostimulatory drugs.
Features of application.
Treatment should be performed under the supervision of a physician.
Before each re-application of the drug ointment residues after pre-application should be washed off with a soap solution or antiseptic solution. It is recommended to wear loose clothing during treatment. Do not apply to the skin of the mammary glands.
Do not use the cream at the same time as other drugs for external use.
Periodic monitoring of adrenal function by determining the level of cortisol in the blood and urine after stimulation of the adrenal glands ACTH with long-term use is shown.
The ointment should be used under special control in patients with psoriasis, as topical application of glucocorticoids in areas affected by psoriasis may lead to the spread of a pathological process or recurrence caused by the development of tolerance, as well as generalized pustular psoriasis and systemic toxicity caused by skin.
Do not use the drug for more than 2 weeks without a break. With long-term use on large areas of skin increases the frequency of side effects and the possibility of edema, hypertension, hyperglycemia, decreased body resistance.
With external use of the drug are possible: decreased production of adrenocorticotropic hormone by the pituitary gland due to suppression of the adrenal glands, pituitary gland, decreased cortisol levels in the blood and the development of iatrogenic Cushing's syndrome, which disappears after discontinuation of the drug.
In case of infection at the site of application of the ointment should be appropriate antibacterial or antifungal treatment. If the symptoms of the infection do not disappear, it is necessary to stop using the drug for the period of treatment of the infection.
Patients with angle-closure and open-angle glaucoma, as well as patients with cataracts, should avoid applying the product to the eyelids or the skin around the eyes due to the possible worsening of symptoms.
When using systemic and topical corticosteroids, visual impairment is possible.
If symptoms such as blurred vision or other visual disturbances occur, an ophthalmologist should be consulted to assess possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy reported with systemic and topical corticosteroids.
Avoid contact with eyes. If the skin at the site of application of the ointment is irritated, it should be canceled.
On the skin of the face, as well as in the axillary area, apply only in case of special need, as there may be increased absorption and a high risk of side effects (telangiectasia, dermatitis perioralis), even after short-term use.
The drug should be used with caution in the presence of atrophy of the subcutaneous tissue, mainly in the elderly.
Because the medicine contains propylene glycol, it may cause skin irritation when used.
Because the medicine contains lanolin, its use may cause a local reaction (eg contact dermatitis).
Use during pregnancy or breastfeeding.
The drug is contraindicated during pregnancy. Breast-feeding should be discontinued during treatment.
Ability to influence the speed of reaction when driving a car or other machinery.
The drug does not limit mental and motor ability, as well as the ability to drive vehicles and machinery.
Method of application and dosage.
The drug is intended for topical use. The ointment should be applied in a thin layer on the affected skin 1-2 times a day.
Occlusion dressings should not be used. Only in the case of psoriasis is it allowed to use a closed bandage, which should be changed every day.
Treatment should not be continued continuously for more than 2 weeks. Do not apply on the skin for more than 1 week. It is recommended to use no more than 15 g of ointment (1 tube) during the week.
The drug should be used with caution under the supervision of a physician in children over 2 years of age, only once a day, on a small area of skin; do not apply to the skin.
Children. Do not use in children under 2 years of age.
Overdose.
Prolonged use on large areas of skin may cause symptoms of overdose, manifested by increased side effects, including burning of the skin at the application site, glucosuria, edema, hypertension, decreased resistance to infections. Possible itching, hyperglycemia, Itsenko Cushing's syndrome. Treatment is symptomatic against the background of gradual withdrawal of the drug.
Adverse reactions.
From the skin and subcutaneous tissue
Acne, post-steroid purpura, epidermal growth inhibition, burning, itching, irritation, rash, subcutaneous tissue atrophy, dry skin, excessive hair growth or alopecia, skin depigmentation or hyperpigmentation, skin atrophy, teleangulation and , secondary infections, local skin reactions (including perioral, contact, allergic dermatitis). In some cases, urticaria or maculopapular rash may occur, as well as possible exacerbation of pre-existing lesions.
From the eyes
External application to the skin of the eyelids can sometimes develop cataracts or glaucoma.
Blurred vision is possible.
Systemic disorders
The use of ointment under the occlusive dressing, given the increased absorption, can cause a strong systemic effect, manifested in the form of edema, hypertension, decreased resistance to infection.
Systemic side effects
Secondary immunodeficiency (exacerbation of chronic infectious diseases, generalization of the infectious process, development of opportunistic infections), gastritis, steroid gastric ulcer, hyperglycemia, glucosuria, slowing of reparative processes, adrenal insufficiency, inhibition of growth and development in children, syndrome.
From the immune system
Allergic or hypersensitivity reactions are possible.
Expiration date. 3 years.
Storage conditions. Store at a temperature not exceeding 25 ºC. Keep out of reach of children.
Packaging. 15 g in a tube; 1 tube in a cardboard box.
Vacation category. According to the recipe.
Producer. Elf Pharmacy AT
Location of the manufacturer and his address of the place of business.
58-500 Yelenya Gura, street Vincentego Paula, 21, Poland.
