Name:
Flucinar ointment for nar. approx. 0.25mg/g in tubes 15g in pack №1
Description:
Light yellow translucent oily soft mass. The main active ingredient Neomycin + fluocinolone acetonide Release form Ointment Dosage Fluocinolone acetonide 0.25 mg Pharmacological action The properties of the drug are due to the combined action of fluocinolone acetonide and neomycin sulfate. Fluocinolone acetonide is a potent synthetic corticosteroid. Used in the form of an ointment, it has a strong anti-inflammatory, antipruritic and vasoconstrictive effect. Neomycin sulfate is a broad spectrum antibiotic. It acts on aerobic Gram-positive and certain Gram-negative bacteria. Indications for use Flucinar N in the form of an ointment is intended for the external treatment of dry inflammatory processes of the skin that can be treated with corticosteroids, especially in allergic reactions complicated by a secondary bacterial infection sensitive to neomycin, accompanied by persistent itching and hyperkeratosis. The drug is indicated for seborrheic dermatitis, atopic dermatitis, allergic contact dermatitis, erythema multiforme exudative, lupus erythematosus, psoriasis (see section “Special precautions and special warnings”), lichen planus. Method of application and doses External (local) application. The frequency and method of application should be prescribed by a doctor. Apply a small amount of ointment to the affected areas of the skin, no more than 1-2 times a day. The ointment should not be used under an occlusive dressing. Treatment should not be continued without interruption for longer than 2 weeks. On the skin of the face, the drug is not used for more than 1 week. For a week, you can not use more than one tube of ointment. Application in children For children older than 2 years, the drug is used with caution, only if necessary, 1 time per day and on a small area of the skin. Do not use on the skin of the face of children. Application during pregnancy and lactation Flucinar N ointment can be used in pregnant women only if the benefit to the mother outweighs the potential risk to the fetus. The use of the drug during the first trimester of pregnancy is absolutely contraindicated. Animal studies have shown that glycocorticosteroids are teratogenic even after oral administration of small doses. Teratogenic effects have also been found in animals following the application of potent glucocorticosteroids to the skin. Studies regarding the possibility of teratogenic effects after external use of fluocinolone acetonide in pregnant women have not been conducted. Neomycin can cross the placental barrier. It is necessary to carefully consider whether it is better to stop breastfeeding or use Flucinar N, taking into account the possibility of side effects in children compared with the benefits for the mother. It is not known how much fluocinolone acetonide can pass into the milk of breastfeeding women after topical application. Precautions If symptoms of irritation or allergic skin reactions (itching, burning or redness) appear after using the drug, you should immediately stop using it. The drug should not be used without interruption for more than 2 weeks. Long-term use on large areas of the skin increases the incidence of adverse reactions, as it contributes to the occurrence of edema, high blood pressure, hyperglycemia and reduces immunity. Since corticosteroids can be absorbed through the skin, long-term treatment, use on large areas of the skin, and use in children should be avoided. If the symptoms of infection in the area of application of the ointment increase, it is necessary to carry out appropriate antibacterial and antifungal treatment. If the symptoms of the infection do not improve, you should stop using the drug for the period of treatment of the infection. Avoid getting the drug in the eyes, open wounds and mucous membranes. If the drug gets into the eyes or mucous membranes, it is recommended to rinse them with plenty of water. As in the case of the use of systemic glucocorticosteroids, after external use of the drug, cataracts and glaucoma or such a rare disease as central serous chorioretinopathy (CSC) may develop. Consult your doctor if you experience blurred vision or other visual disturbances. Do not use the drug to treat the eyes and skin around the eyes due to the risk of cataracts or glaucoma. Particular caution should be used in patients with psoriasis, since topical use of glucocorticosteroids in psoriasis can cause a relapse of the disease due to the development of addiction, the risk of generalized pustular psoriasis and systemic toxicity caused by skin dysfunction. Apply the ointment to the skin of the face, groin and armpits only in case of urgent need, due to increased absorption and a high risk of side effects of the drug (telangioctasia, perioral dermatitis). Use this drug with caution in pre-existing skin atrophy, especially in elderly patients. Cross-allergy to aminoglycoside antibiotics may occur. Due to the ototoxic and nephrotoxic effects of neomycin, the use of the drug on large areas of the skin or for a long time can cause hearing impairment, including hearing loss, as well as kidney damage. Particular care must be taken in patients with impaired renal function and hearing impairment. The risk of ototoxic and nephrotoxic effects is increased in patients with impaired renal function. The drug may enhance the effect of concomitantly used drugs with ototoxic and nephrotoxic effects. Long-term treatment can lead to the multiplication of neomycin-resistant strains of bacteria and to allergies. Use in children under 2 years of age only if absolutely necessary, due to the risk of unwanted systemic effects of neomycin and the steroid component of the drug – fluocinolone acetonide. For children, who have a higher body surface area to body weight ratio than adults, there is an increased risk of unwanted systemic effects of glucocorticosteroids, including dysfunction of the hypothalamus, pituitary gland, adrenal glands and Itsenko-Cushing’s syndrome. Treatment with corticosteroids can adversely affect the growth and development of children. Contains propylene glycol and lanolin which may cause local skin reactions (eg contact dermatitis) or irritation. Interaction with other drugs There are no known cases of interaction after external use of glucocorticosteroids. However, it must be remembered that patients cannot be vaccinated against chickenpox. Also, other types of immunization should not be carried out, especially in the case of long-term use on large areas of the skin, since there is a risk that an immune response due to antibodies may not occur. Flucinar N can both enhance the effect of immunosuppressive drugs and reduce their effect. Do not use together with nephrotoxic and ototoxic drugs such as furosemide and ethacrynic acid, as these drugs can increase the blood concentration of the aminoglycoside antibiotic, which increases the risk of hearing loss. Contraindications Flucinar N ointment should not be used in the following cases: with known hypersensitivity to corticosteroids, gentamicin or excipient components; with a viral infection (for example, chicken pox), fungal skin infection; with tuberculous skin diseases and other bacterial infections of the skin; skin neoplasm; rosacea (rosacea); perioral dermatitis (dermatitis perioralis); after vaccination; with thrombophlebitis and the formation of trophic ulcers; with extensive skin lesions, especially long-term non-healing lesions, such as deep burns; with diaper dermatitis; in children under two years of age. Composition 1 g of ointment contains: Fluocinolone acetonide 0.25 mg Neomycin sulfate 5 mg (680 IU / mg, which corresponds to 3400 IU neomycin) areas of the skin can lead to the appearance of overdose symptoms, in the form of an increase in undesirable effects such as edema, high blood pressure, hyperglycemia, decreased immunity and, in severe cases, Itsenko-Cushing’s syndrome. In this case, treatment with the drug should be gradually discontinued or a low-acting glucocorticosteroid should be prescribed. Due to the content of neomycin in the composition, excessive or prolonged use of the drug may lead to the emergence of resistant strains or damage to the kidneys and hearing. Side effects May occur: acne, post-steroid purpura, epidermal growth inhibition, burning sensation, itching, irritation, subcutaneous tissue atrophy, dry skin, hypertrichosis or alopecia, skin depigmentation or pigmentation, skin atrophy and stretching, telangioctasia, perioral dermatitis, furunculosis, secondary infection , local skin reactions (eg contact dermatitis). Occasionally, urticaria or a maculopapular rash or exacerbation of existing changes may occur. Blurred vision – the frequency of development of the reaction is unknown. After external use on the skin of the eyelids, the symptoms of glaucoma or accelerate the development of cataracts can sometimes increase. Due to the absorption of fluocinolone acetonide through the skin, systemic adverse reactions may occur, especially with prolonged use, use on large areas of the skin, under an occlusive dressing and in children. The following undesirable systemic reactions are characteristic of fluocinolone acetonide: dysfunction of the hypothalamus, pituitary gland, adrenal glands, Itsenko-Cushing’s syndrome, suppression of the growth and development of children, edema, high blood pressure, hyperglycemia, glucosuria, decreased immunity. Neomycin may cause local skin irritation and allergic reactions. The use of the drug on large areas of the skin, especially damaged, or under an occlusive dressing, can lead to an ototoxic reaction, including hearing loss, or cause damage to the kidneys. If any of the side effects indicated in the instructions worsen, or you notice any other side effects not listed in the instructions, tell your doctor about it. Storage conditions Store at a temperature not exceeding 25 ° C, out of the reach of children g 15g №1 Price for Flucinar ointment 0.25mg/g 15g №1
INN | FLUOCINOLONE ACETONIDE |
---|---|
The code | 650 |
Barcode | 5 904 398 410 098 |
Dosage | 0.25mg/g |
Active substance | fluocinolone acetonide |
Manufacturer | Elfa SA Pharmaceutical Plant, Poland |
Importer | Closed Joint Stock Company "BAUSH HEALTH", 220073, Minsk, st. Olshevsky, 22, room 22 |
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