Indications:
Reduces the inflammatory manifestations of hyperkeratotic and dry corticosteroid-responsive dermatoses such as psoriasis, chronic atopic dermatitis, neurodermatitis, eczema etc.
Administration, dosage: Apply the ointment to affected areas twice daily (morning and evening).
Some special attention on the handling of the medicine before and after use:
There are no special requirements for handling this medicine after use.
Contraindications:
Hypersensitivity to any component of BESALICYD, skin diseases in children under 1 year of age, bacterial skin infection, viral infection (shingles, herpes, chickenpox) etc.
BESALICYD should not be used in open skin wounds, avoid contact with the eyes and mucous membranes.
Warnings and precautions for use:
Caution should be exercised when applying corticosteroids over a large area or under occlusion as it may have systemic effects.
BESALICYD should be used cautiously in pregnant women and breastfeeding mothers (do not apply BESALICYD to the areola of the breast during breastfeeding).
Pregnancy and lactation:
BESALICYD should be used cautiously during pregnancy and lactation.
Effects on ability to drive and use machines:
There is no evidence of the medicine effects on the ability to drive, operate machinery.
Interactions, incompatibilities of medicine:
Interaction with other medicinal products and other forms of interaction:
Interactions only occur when BESALICYD is used long-term, on large areas of skin absorption and systemic effects.
Incompatibilities:
Because there have been no studies of drug incompatibility, do not mix this drug with other drugs.
Undesirable effects:
There may be skin burning, itching, irritation, dryness, folliculitis, hypertrichosis, rash pustular, hypopigmentation, perioral dermatitis, allergic contact dermatitis, intertrigo, infection, skin atrophy, striae, miliaria. Adrenal insufficiency, especially in children.
Overdose and prolonged treatment may inhibit the function of the pituitary gland, adrenal glands leading to secondary renal insufficiency. Treatment of electrolyte imbalance is required if necessary and the dose should be reduced gradually.
Inform doctor about unwanted effects encountered when using this drug.
Overdose and management:
Upon the occurrence of overdose, BESALICYD should be discontinued and appropriate symptomatic treatment measures should be used.
Pharmacodynamic properties:
Pharmacotherapeutic group: Anti-inflammatory drug (combination with corticosteroids and salicylic acid)
ATC code: D07XC01, D01AE12
Betamethasone dipropionate is a synthetic corticosteroid with strong glucocorticoid effects, and negligible mineralocorticoid effects. Betamethasone has anti-inflammatory, anti-pruritic and vasoconstrictive effects.
Salicylic acid desquamates strongly horny layer of the skin and has slight antiseptic action when applied topically.
Pharmacokinetic properties:
Betamethasone is easily absorbed when used topically. An amount of betamethasone can be absorbed enough for systemic effect, especially, when the occlusive dressings are used or skin tear occurs. Betamethasone is rapidly distributed to all tissues in the body, bound to plasma proteins – mainly to globulin – the low binding affinity with slow metabolism resulting in stronger effect of betamethasone compared with natural corticosteroids. Betamethasone is metabolized primarily in the liver and the kidneys and excreted in urine.
Salicylic acid is easily absorbed through the skin and slowly excreted in the urine, so there have been cases of salicylate acute poisoning after applying excessive salicylic acid over large body surface areas.
Storage conditions, shelf life, quality specification of the medicine:
Storage conditions: Protect from humidity and light, below 300C.
Shelf life: 36 months from the manufacture date.
Specification: In house.
A1205000604
