Instructions Betaderm ointment tube 15 g
Composition
active ingredients: betamethasone, gentamicin;
1 g of ointment contains betamethasone (in the form of betamethasone dipropionate) 0.5 mg; gentamicin (in the form of gentamicin sulfate) 1 mg;
excipients: mineral oil, lanolin alcohol, cetostearyl alcohol, butylhydroxyanisole (E 320), butylhydroxytoluene (E 321), white soft paraffin.
Dosage form
Ointment.
Main physicochemical properties: white or almost white, oily, soft, translucent mass.
Pharmacotherapeutic group
Corticosteroids for use in dermatology. Corticosteroids, combinations with antibiotics. Betamethasone and antibiotics.
ATX code D07C C01.
Pharmacological properties
Pharmacodynamics
Betaderm® combines the long-lasting anti-inflammatory, antipruritic and vasoconstrictive effects of betamethasone dipropionate with the broad spectrum antibacterial activity of gentamicin sulfate. It is active against Staphylococcus aureus (coagulase-positive, coagulase-negative and some strains that produce penicillinase) and gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
Pharmacokinetics
There are no data on the pharmacokinetics of Betaderm®.
Indication
Dermatoses that are amenable to treatment with glucocorticosteroids, when complicated or suspected of being complicated by a secondary infection caused by microorganisms sensitive to gentamicin: eczema (atopic, infantile, coin-like), anogenital and senile pruritus, contact dermatitis, seborrheic dermatitis, neurodermatitis, intertriginous dermatitis, solar dermatitis, exfoliative dermatitis, stasis dermatitis and psoriasis.
Contraindication
The drug is contraindicated in patients with hypersensitivity to corticosteroids, gentamicin or any other component of the drug. As well as in skin tuberculosis, skin manifestations of syphilis, skin reactions after vaccination, widespread plaque psoriasis, varicose veins, perioral dermatitis, viral skin lesions (e.g., chickenpox, herpes), skin neoplasms, rosacea, juvenile (common) acne, other bacterial and fungal skin infections without appropriate antibacterial and antifungal therapy. Do not use on large areas of skin, especially in cases of impaired skin integrity, for example, burns.
Interaction with other medicinal products and other types of interactions
During treatment with the drug, it is not recommended to be 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.
The drug may enhance the effect of immunosuppressive and weaken the effect of immunostimulating drugs.
Due to the presence of white soft paraffin and mineral oil, the application of Betaderm® ointment to the anogenital area may damage the structure of latex condoms and reduce their safety when used during treatment.
Application features
The drug is not intended for use in ophthalmology.
Since Betaderm® contains a potent glucocorticosteroid, it is recommended to use the drug on small areas of skin.
With long-term use of the drug on large areas of skin, the frequency of side effects and the possibility of developing bacterial resistance to gentamicin sulfate increase.
Do not use continuously for longer than 2 weeks.
In the event of skin irritation, allergic reactions, or hypersensitivity reactions during treatment with Bataderm® ointment, the use of the drug should be discontinued and adequate therapy should be selected for the patient.
The ointment should not be applied under an occlusive dressing, as this may lead to epidermal atrophy, the appearance of striae, and superinfection.
Any side effects that occur with the use of systemic corticosteroids, including suppression of the function of the adrenal cortex, may also be observed with the local use of glucocorticosteroids, especially in children.
Visual impairment is possible with the use of systemic and topical corticosteroids.
If symptoms such as blurred vision or other visual disturbances occur, an ophthalmologist should be consulted to evaluate possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which has been reported with the use of systemic and topical corticosteroids.
Avoid contact with eyes and mucous membranes. Do not apply to eyelids as this may cause glaucoma or cataracts.
Do not use the drug on the skin of the face due to the risk of side effects (telangiectasia, perioral dermatitis) even after short-term use.
Since corticosteroids and gentamicin can be absorbed through the skin, there is a risk of systemic side effects from glucocorticosteroids (including suppression of adrenal cortex function) and gentamicin (ototoxicity, nephrotoxicity, especially in patients with renal insufficiency).
The drug should be used with caution in patients with psoriasis, since 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 a decrease in the protective function of the skin.
Corticosteroids with high potency should be used on large areas of skin under close regular supervision, as they may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis. If suppression develops, the drug should be discontinued, the frequency of application reduced, or the patient transferred to a less potent corticosteroid.
The function of the GHNS is usually restored after discontinuation of the drug.
In rare cases, withdrawal symptoms may develop, requiring the addition of a systemic corticosteroid.
It should be remembered that prolonged topical therapy with gentamicin may cause the development of microorganisms resistant to aminoglycosides.
Use on the skin of the groin, as well as in the inguinal area, only if absolutely necessary, as there is a possibility of increased absorption and a high risk of side effects even after short-term use.
The drug should be used with caution in cases of pre-existing atrophic conditions of the subcutaneous tissue, especially in the elderly.
The drug should be avoided on large areas of skin, on damaged skin, in large doses, in patients with renal and hepatic insufficiency, and in children.
Ability to influence reaction speed when driving vehicles or other mechanisms
Usually the drug does not affect the reaction speed when driving or working with other mechanisms.
Use during pregnancy or breastfeeding
Since the safety of topical corticosteroids in pregnant women has not been established, the drug should not be used in the first trimester of pregnancy. The drug should only be prescribed in later stages of pregnancy if the expected benefit to the expectant mother outweighs the potential risk to the fetus. Drugs of this group should not be used in pregnant women in high doses, for a long time, and under occlusive dressings.
It is currently unknown whether topical corticosteroids can be excreted in breast milk due to systemic absorption, therefore a decision should be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Method of administration and doses
Apply the ointment in a thin layer to the affected area of the skin 2 times a day - in the morning and in the evening.
The frequency of application of the drug is determined by the doctor individually, depending on the severity of the disease. In mild cases, apply once a day, in severe lesions, more frequent application may be necessary.
The duration of treatment depends on the size and location of the disease, as well as the patient's response to treatment. However, if clinical improvement is not observed within 3-4 weeks, the doctor should reconsider the diagnosis.
Children
There are no clinical data on the use of the drug in children, so it is undesirable to use it in patients of this age category.
Because children have a greater surface area to body weight ratio than adults, they are more likely to absorb the drug. Therefore, children are more susceptible to the development of hypothalamic-pituitary-adrenal (HPA) axis suppression due to corticosteroid use and to the development of exogenous corticosteroid effects.
In children receiving topical corticosteroids, adrenal suppression, Cushing's syndrome, growth retardation, insufficient weight gain, and increased intracranial pressure have been reported.
Manifestations of adrenal cortex suppression: low plasma cortisol levels and no response to the adrenal stimulation test with adrenocorticotropic hormone (ACTH) drugs. Increased intracranial pressure is manifested by fontanelle protrusion, headache, and bilateral optic disc edema.
Overdose
With long-term use on large areas of skin, in large doses, when using an occlusive dressing, symptoms of overdose may appear, manifested by increased systemic side effects characteristic of corticosteroids (hyperglycemia, glucosuria, suppression of pituitary-adrenal function with the development of secondary adrenal insufficiency and the appearance of symptoms of hypercorticism, including Cushing's disease).
With a single application of about 7 g of ointment, a reversible decrease in ACTH was observed.
Treatment. Provide appropriate symptomatic therapy. Symptoms of acute hypercorticism are usually reversible. If necessary, correct electrolyte balance. In case of chronic toxicity, gradual withdrawal of corticosteroids is recommended. In case of overgrowth of resistant microorganisms, it is recommended to discontinue treatment with the drug and prescribe the necessary therapy.
Adverse reactions
Skin and subcutaneous tissue disorders: acne, steroid purpura, epidermal growth inhibition, skin tingling, skin thickening, skin cracking, feeling of warmth, flaky skin peeling, focal skin peeling, subcutaneous tissue atrophy, dry skin, skin hyperpigmentation, skin discoloration, skin atrophy and striae, telangiectasia, folliculitis, allergic contact dermatitis, urticaria or maculopapular rash, sweating, itching, burning sensation, erythema, hypertrichosis, secondary infection, irritation or exacerbation of existing changes.
Application to the facial skin may cause perioral dermatitis.
On the part of the vascular system: when using the drug for a longer period than recommended, dilation of small blood vessels (telangiectasia) may occur.
On the part of the hearing organs: use on mucous membranes or on large areas of skin, especially damaged ones, or under an occlusive dressing, may cause ototoxic effects due to the presence of gentamicin sulfate in the ointment.
On the part of the endocrine system: signs of hypercortisolism. Prolonged use of the ointment on large areas of the skin or under an occlusive dressing, or in children, given the increased absorption of betamethasone dipropionate, can cause a strong systemic effect characteristic of corticosteroids, which manifests itself in the form of edema, arterial hypertension, decreased immunity, growth and development inhibition in children, hyperglycemia, glycosuria, and the development of Cushing's syndrome.
On the part of the organs of vision: when applied topically to the skin of the eyelids, the drug can sometimes lead to the development of glaucoma or accelerated cataract development.
Blurred vision is possible.
On the part of the immune system: hypersensitivity to corticosteroids may occur, in which case the use of the drug should be discontinued immediately.
On the part of the kidneys and urinary system: application to large areas of skin, especially damaged ones, or under an occlusive dressing, may cause nephrotoxic effects due to the presence of gentamicin sulfate in the ointment.
The product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
The product contains butylhydroxytoluene and butylhydroxyanisole, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
15 g of ointment in a tube.
Vacation category
According to the recipe.
Producer
Pharmaceutical factory Elfa A.T.
Location of the manufacturer and its business address
58-500 m. Jelenia Góra, 21 Vincentiego Pola Street, Poland.
