Description
Release form
Ointment
Pharmacological action
Betaderm – a combined preparation for the treatment of inflammatory skin lesions of allergic etiology, complicated by bacterial infection or hyperkeratosis.
Betamethasone dipropionate is a synthetic fluorinated derivative of hydrocortisone. It easily penetrates the skin, exerting a pronounced local anti-inflammatory, antipruritic and anti-allergic effect. Due to the local vasoconstrictor effect, it reduces the severity of exudative reactions.
Gentamicin sulfate is a broad-spectrum antibiotic. Active against gram-negative and some gram-positive bacteria.
Indications
Dry inflammatory conditions of the skin (dermatosis), complicated by a secondary bacterial infection and with hyperkeratosis, itching:
– atopic dermatitis
– seborrheic dermatitis
– chronic chronic lichen srdlpkrd ecz – ecd lupus erythematosus (skin manifestations)
– polymorphic erythema.
Contraindications
Hypersensitivity to the components of the drug. Viral, fungal or tuberculous skin lesions, skin neoplasms, rosacea, open-angle glaucoma, chickenpox, HIV infection, herpes zoster, phlebitis, trophic ulcer, pregnancy and lactation, up to 2 years of age. The drug is not recommended to be applied to the skin of the face or applied to large areas of the skin (especially in case of violation of its integrity, for example, with burns). With caution, the drug should be used for atrophy of the subcutaneous tissue in the elderly.
Use during pregnancy and lactation
The use of the drug during pregnancy and lactation is contraindicated. At the time of treatment, it is recommended to stop breastfeeding.
Special instructions
Avoid prolonged use, as at the same time, the incidence of side effects increases and bacterial resistance to gentamicin may develop.
Do not use the drug on the skin of the face due to the possibility of telangiectasia even after a short application.
Avoid contact with Betaderm ® in the eyes and periorbital region.
Some parts of the body (inguinal folds, axillary hollows, and perianal region) are more at risk for striae. Therefore, the duration of the drug in these areas should be limited.
With prolonged use of Betaderm ® on large surfaces of the skin with impaired integrity, there is the potential for absorption of gentamicin and, consequently, the development of symptoms of ototoxicity.
Do not use the drug under an occlusive dressing.
If there is an urgent need for a dressing, an air-tight dressing should be applied and no sealing, oilcloth dressing should be used.
In cases of fungal superinfection, additional use of the antifungal drug is necessary.
Use in pediatrics
Children are allowed to prescribe the drug from 2 years old only under strict indications and under the supervision of a doctor.
Due to the fact that in children the area of ² ¹ ² ¹skin in relation to body weight is larger and the epidermis is not well developed, with external use of the drug, it is possible to absorb a proportionally larger number of active substances and, therefore, there is a greater risk of developing systemic side effects.
Use the drug in children as soon as possible and with all precautions.
Composition of
1 g of ointment for external use contains: active ingredients: betamethasone (in the form of dipropionate) 500 mcg, gentamicin (in the form of sulfate) 1 mg,
excipients: liquid paraffin, lanolin alcohol, cetostearyl alcohol, butyl butyol butyl butyol butyl butyol petroleum jelly white.
Dosage and administration
A small amount of the drug is applied to the affected surface of the skin 1-2 times a day. Do not apply the drug under an occlusive dressing. If necessary, gauze (air permeable) should be used, not an oilcloth dressing. A continuous course of treatment should not exceed 2-4 weeks. Within 1 week, you can not use more than 45 g of ointment.
Side effects
Dermatological reactions: acne, steroid purpura, atrophy of the subcutaneous tissue, dry skin, depigmentation or hyperpigmentation of the skin, atrophy of the skin, expansion of small blood vessels, folliculitis, growth inhibition.
With prolonged use, the drug can have a pronounced general effect, characterized by the appearance of edema, hypertension, and a decrease in body resistance. Application on the skin of the face can cause perioral dermatitis, and after application on the skin of the eyelids, the course of glaucoma sometimes worsens or the development of cataracts accelerates.
Drug Interactions
Prophylactic vaccinations should not be given during treatment with corticosteroids. The simultaneous use of Betaderm ® can enhance the effect of immunosuppressive drugs and weaken the effect of immunostimulating drugs.
Overdose
Overdose can be noted after prolonged use in extensive areas of the skin and manifest as suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Itzenko-Cushing’s syndrome. Gentamicin overdose can lead to an increased insensitive flora.
Treatment: symptomatic. If necessary, adjust the electrolyte balance.
Storage Conditions
Store at 25 ° C. Do not freeze.
Shelf life
3 years.
Active ingredient
Betamethasone, Gentamicin
Terms and conditions
without prescription
Dosage form
ointment
Possible product names
BETADERM 0.05% + 0.1% 15.0 Ointment
Betaderm ointment 0.05% + 0.1%, 15 g
Bet .p 0, 05% + 0.1% 15g tube
Elf Farmzavod, Poland
