BETADERM cream 15 g.

cream
Ingredients:

Drugs Betamethasone 0.5 mg / g (as Betamethasone dipropionate) Gentamicin 1.0 mg / g (as Gentamicin sulphate) Excipient chlorocresol, cetostearyl alcohol, white soft paraffin, liquid paraffin, macrogol cetostearyl ether (Cremophor A 25), disodium phosphate, potassium dihydrogen phosphate , propylene glycol, disodium edetate, hemoderm 841, purified water.

Properties and action

Medicinal product for use on the skin. The ingredients of Betaderm Betamethasone dipropionate cream and Gentamicin sulfate exhibit a combined activity in the treatment of inflammatory thickened skin lesions from allergic origin, exacerbated by bacterial infection.

Betamethasone dipropionate is a synthetic fluorinated derivative of hydrocortisone. It easily penetrates the cream into the skin and has a strong local anti-inflammatory, antiallergic effect. Tentamitsin sulfate is a broad spectrum antibiotic with antibacterial activity against Gram (-) against some Gram (+) bacteria.

indications

Betaderm cream applied topically in wetting skin inflammations, in particular those of allergic origin, complicated by secondary bacterial infection and associated with thickening of the horny layer of the skin, itching or allergic reaction intensity. Betaderm cream was applied to atopic dermatitis, seborrheic dermatitis, lichen simplex hronikus, hyperkeratotic eczema, allergic contact dermatitis, erythema multiforme.

Contraindications

• Hypersensitivity to corticosteroids or gentamicin to constituents.

• Viral, fungal or tubercular skin diseases, skin malignancies, acne rosacea and youthful acne, chicken pox, stasis dermatitis, and varicose ulcers.

• Do not use the drug on extensively damaged skin surface, especially related to the skin defect, eg. burns.

• Do not apply on the face.

• Do not use in children under 12 years.

Undesirable effects

• You may experience acne steroidnoprichinena purpura, suppressing the growth of the epidermis, thymic tissue infections skin dryness, discoloration or discoloration of the skin, skin atrophy and striae, expansion of small blood vessels, folliculitis.

• Sometimes it may appear urticaria or maculopapular rash.

• After prolonged use are possible systemic effects edema, increased blood pressure and weakening of immunity.

• For topical application to the eyelids is possible amplification symptoms of glaucoma and accelerate the development of cataracts. Consult doctor in case of adverse reactions or disturbing symptoms in administration.

Interactions

During treatment with glucocorticoids, patients should not be vaccinated against smallpox. Should not be made and other immunizations.

Dosage and method of administration

Application on the skin.

Apply carefully small amount of cream to the affected skin area 1-2 times a day. If required the placement of a bandage, it should not restrict the access of oxygen. Continuous treatment should not last longer than two weeks. Do not use more than 45 g cream week.

overdose

May occur after prolonged use on large skin surfaces and results in a weakening of the immune system, high blood pressure and swelling. Symptoms resolve after stopping the application of the cream.

Special warnings and special precautions for use

• Apply only on prescription.

• Do not use bandage, increasing temperature and humidity.

• Do not apply to other diseases unless specified by your doctor.

• The patient immediately inform your doctor about any side effects that occur during treatment.

• Do not use for longer than prescribed by the doctor due to increased absorption of the medicine and the incidence of adverse drug reactions.

• In case of infection of the area to be treated, your doctor may appoint and antibacterial or antifungal therapy.

• Do not apply to face, even for a short time because of the risk of permanent enlargement of small blood vessels and atrophy of the subcutaneous tissue around the lips.

• Use with caution in existing atrophy of the subcutaneous tissue, especially in elderly patients.

• After topical administration of betamethasone dipropionate in combination with gentamicin, could lead to a decrease in the secretion of adrenocorticotropic hormone (ACTH), due to the suppression of the pituitary-adrenal axis, and the reduction in the level of cortisol in the blood and iatrogenic syndrome Cushing, that after discontinuation of therapy subside

• After application of the product on large areas of skin or after systemic use, it is recommended that periodic monitoring of adrenal function, including cortisol levels in the blood and urine test after stimulation of the adrenal gland to ACTH.

Pregnancy and lactation

Not recommended for use in pregnant and nursing mothers.

Effects on ability to drive and use machines

Not limited psychomotor skills, the ability to drive and use

 
Shelf life

3 years.

Do not use after the expiry date stated on the packaging.

Special precautions for storage

Do not store above 25 ° C. Do not freeze. Keep out of the reach and sight of children

packing

Aluminum tube containing 15g of cream. The tubes are packed in individual cardboard boxes with all necessary signage and information leaflet.