Composition, form of production and packaging
? Ointment for external use is almost white, translucent, homogeneous.
100 g
betamethasone dipropionate 64 mg,
which corresponds to the content of betamethasone 50 mg
salicylic acid 3 g
[PRING] paraffin liquid (vaseline oil) - 40 g, Vaseline (white petrolatum, soft white paraffin) - up to 100 g.
15 g - aluminum tubes (1) - cardboard packs.
30 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Combination drug for external use, the effect of which is due to its constituent components.
The drug has anti-inflammatory, anti-allergic, antipruritic, keratolytic action.
Betamethasone inhibits the release of inflammatory mediators, prevents the accumulation of neutrophils, reduces inflammatory exudates and production of cytokines, reduces the migration of macrophages, leading to a reduction in infiltration and granulation.
The presence of salicylic acid softens the skin, eliminates horny layers and promotes deeper penetration of betamethasone.
PHARMACOKINETICS
Data on the pharmacokinetics of the drug Rederm В® are not available.
INDICATIONS
Treatment of subacute and chronic dermatoses accompanied by hyperkeratosis and desquamation:
- psoriasis;
- dyshidrotic dermatitis;
- eczema;
- Neurodermatitis;
- Red flat lichen;
ichthyosis and ichthyosis skin lesions;
- atopic dermatitis;
- diffuse neurodermatitis;
- simple and allergic dermatitis;
- hives;
- multiforme exudative erythema;
- simple chronic lichen (limited neurodermatitis);
- dermatoses that are not amenable to treatment by other SCS (especially red warty lichen);
skin dyshidrosis.
DOSING MODE
Apply externally. Apply to the affected areas of the skin at the rate of: a column of ointment 0.5 cm long on a skin area of ​​about 7 cm? 7 cm, slightly rubbed, a thin layer 2 times / day. Another frequency of use can be determined by the doctor, based on the severity of the disease.
In light cases, the ointment is sufficient to apply, as a rule, 1 time / day; with more severe lesions may need more frequent use.
If necessary, impose occlusive dressings, which are changed every 24 hours.
The duration of treatment depends on the effectiveness and tolerability of therapy and is 2-4 weeks.
If clinical improvement does not occur, it is necessary to clarify the diagnosis.
SIDE EFFECT
Dermatological reactions: burning, irritation, dryness, hypopigmentation, skin itching, folliculitis, hypertrichosis, dermatitis, acne-like rashes.
When using occlusive dressings: skin maceration, striae, skin atrophy, secondary infection, sweating.
With prolonged use: skin atrophy, local hirsutism, telangiectasia, purpura, hypopigmentation, hypertrichosis.
When applied to large areas : systemic manifestations of side effects of SCS (growth retardation, Itenko-Cushing syndrome, increased intracranial pressure after treatment, hyperglycemia, glucosuria, hypokalemia, increased blood pressure) or salicylates (pallor, fatigue, drowsiness, hyperventilation against tachypnea , nausea, vomiting, hearing loss, confusion).
CONTRAINDICATIONS
- open wounds;
- bacterial, viral and fungal skin diseases (pyoderma, syphilis, skin tuberculosis, chicken pox, herpes, actinomycosis, blastomycosis, sporotrichosis);
- postvaccinal skin reactions;
- perioral dermatitis;
- rosacea;
- trophic ulcers on the background of chronic venous insufficiency;
- skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma);
- Children under 2 years;
- lactation period;
- Hypersensitivity to the components of the drug.
With caution should be used in patients with hepatic insufficiency, in children older than 2 years, for prolonged therapy, especially with the use of occlusive dressings.
PREGNANCY AND LACTATION
The safety of the use of GCS for external use in pregnant women is not established. The purpose of this group of drugs during pregnancy is justified only if the potential benefit to the mother exceeds the potential risk to the fetus. When pregnancy, drugs of this group should not be used in high doses or for a long time.
It is not established whether external application of GCS can cause them to appear in the mother's milk, therefore, the question of stopping breastfeeding should be resolved.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Carefully should be used in case of liver failure.
APPLICATION FOR CHILDREN
Children from 2 years of age, the drug is prescribed only by strict indications under medical supervision, since it is possible to develop systemic side effects associated with betamethasone. The duration of treatment should be as short as possible. When using the drug on extensive surfaces and / or under occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism, a decrease in the excretion of growth hormone, an increase in intracranial pressure can be observed.
SPECIAL INSTRUCTIONS
Avoid contact with the eye, do not apply to the skin near the eyes and mucous membranes. The drug is not intended for use in ophthalmology.
With prolonged treatment, when applying the drug on the vast surface of the skin, with the use of occlusive dressings, systemic absorption of GCS is possible.
It is not recommended for long-term use on the skin of a person - it is possible to develop dermatitis by the type of rosacea, perioral dermatitis, atrophy of the skin and acne; avoid application in the anogenital area.
Ointment is most suitable for the treatment of patients with dry and fragile skin.
If there are signs of increased sensitivity or skin irritation associated with the use of the drug, the treatment should be discontinued and the patient should be treated adequately.
With prolonged use of the drug, it should be canceled gradually.
Use in Pediatrics
Children from 2 years of age, the drug is prescribed only according to strict indications and under medical supervision, tk. possible development of systemic side effects associated with betamethasone. The duration of treatment should be as short as possible. When using the drug on extensive surfaces and / or under occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism, a decrease in the excretion of growth hormone, an increase in intracranial pressure can be observed.
OVERDOSE
Acute overdose is unlikely, however, with excessive or prolonged use of the drug, chronic overdose is possible, accompanied by signs of hypercorticism: hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing's syndrome.
Treatment: the appropriate symptomatic treatment is indicated. In the case of chronic toxic effects, a gradual withdrawal of the drug is recommended.
DRUG INTERACTION
Interactions of the drug with other drugs have not been identified.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
