Celestoderm B, ointment 0.1%, 15g

Composition

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of 1 g of ointment contains:

betamethasone 17-valerate (equivalent to 1 mg of betamethasone),

gentamicin sulfate (equivalent to 1 mg of gentamicin base).

Auxiliary substances:

white soft paraffin,

liquid paraffin.

Pharmacological action

Pharmaceutical group:

glucocorticosteroid for topical use.

Pharmaceutical action:

Celestoderm-B-corticosteroids for external use; has local anti-inflammatory, anti-allergic, anti-edematous and antiproliferative effects.

Betamethasone has an anti-inflammatory and anti-allergic effect by inhibiting the release of cytokines and inflammatory mediators, reducing arachidonic acid metabolism, inducing the formation of lipocortins with anti-edematous activity, and reducing vascular permeability.

Microdispersion of this glucocorticosteroid (corticosteroid) in a non-greasy, odorless, clothing-free, easy-to-wash ointment or cream base ensures effective skin penetration and rapid onset of action.

Indications

Inflammatory skin diseases that respond to glucocorticosteroid (corticosteroid) therapy: – eczema (atonic, children’s, coin-shaped);- contact dermatitis;- seborrheic dermatitis;- neurodermatitis— – sun dermatitis;- exfoliative dermatitis;- radiation dermatitis;- intertriginal dermatitis;- psoriasis;— anogenital and senile itching.

Use during pregnancy and lactation

Due to the fact that the safety of using topical corticosteroids in pregnant women has not been established, the appointment of drugs of this class during pregnancy is justified only if the benefit to the mother clearly exceeds the possible harm to the fetus.

CORTICOSTEROIDS should not be used during pregnancy for a long time or in large doses.

Since it has not yet been established whether corticosteroids can enter breast milk with topical application and systemic absorption, a decision should be made to stop breastfeeding or to discontinue the drug, taking into account how necessary its use is for the mother.

Contraindications

-Hypersensitivity to any of the components of the drug. – Tuberculosis of the skin. – Skin manifestations of syphilis. “Chicken pox. ” – Herpes simplex. – Fungal diseases of the skin. – Vaccination period and skin post-vaccination reactions. – Lactation period. – Pregnancy (long-term treatment of large areas of the skin). – Children under 6 months of age. With caution:  – Pregnancy (in the absence of criteria for contraindication), especially in the 1st trimester. – Long-term treatment of large areas of the skin, especially in children. – If there are cracks in the skin or if occlusive dressings are used.

Side effects

Local reactions:  skin irritation (pruritus, erythema), burning sensation, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis.

When using occlusal dressings:  maceration of the skin, secondary infection, skin atrophy, striae, sweating. For long-term treatment or application on a large surface:  it is possible to develop systemic side effects characteristic of corticosteroids: weight gain, osteoporosis, increased blood pressure, edema, ulceration of the gastrointestinal mucosa, exacerbation of hidden foci of infection, hyperglycemia, agitation, insomnia, menstrual disorders.

Children receiving topical corticosteroids may experience the following side effects: :  suppression of the hypothalamic-pituitary-adrenal system, Cushing’s syndrome, growth retardation, lag in weight gain, increased intracranial pressure. Symptoms of adrenal cortical depression in children include decreased plasma cortisol levels and a lack of response to ACTH stimulation. An increase in intracranial pressure is manifested by a bulging fontanel, headache, and bilateral edema of the optic nerve disc.

How to take, course of use and dosage

Externally. Apply a thin layer on the affected areas of the skin 2 times a day-in the morning and in the evening.

The frequency of use that differs from the recommended one can be determined by the doctor, based on the severity of the disease.

In mild cases, once-daily use is usually sufficient; in more severe cases, more frequent use may also be required.

Overdose

Symptoms:  excessive or prolonged use of topical corticosteroids can cause suppression of the pituitary-adrenal system, which can lead to the development of secondary adrenal insufficiency and the appearance of symptoms of hypercorticism, including Cushing’s syndrome. A single gentamicin overdose does not cause any symptoms. Long-term use in doses exceeding the recommended ones can lead to a significant increase in insensitive flora, including fungal ones, in the lesion site.

Treatment:  appropriate symptomatic treatment is indicated. Acute symptoms of hypercorticism are usually reversible. If necessary, correction of the electrolyte imbalance is indicated. In case of chronic toxic effects, gradual withdrawal of corticosteroids is recommended. In case of uncontrolled growth of microorganisms, appropriate antibacterial or antifungal treatment should be selected.

Special instructions

If there is no effect from treatment within 2 weeks, it is recommended to consult your doctor to clarify the diagnosis and treatment. If irritation or hypersensitivity is noted during the use of the drug, treatment should be discontinued and another therapy should be selected for the patient. Any side effects of systemic corticosteroids, including suppression of the adrenal cortex, may also occur with the use of topical corticosteroids, especially in children. Systemic absorption of topical corticosteroids may increase with prolonged use, treatment of large body surfaces, or the use of occlusive dressings, especially in children.

Systemic absorption of gentamicin with topical application may increase if applied to large areas of the skin, especially with prolonged treatment or in the presence of skin cracks. In such cases, the development of adverse events characteristic of gentamicin with its systemic use, especially in children, is possible. With topical application of antibiotics, the growth of insensitive microflora, including fungal, is occasionally observed. In this case, treatment should be stopped and appropriate therapy should be prescribed. Celestoderm-B with Garamycin is indicated only for external use and is not intended for use in ophthalmology.

Celestoderm-B with Garamycin can be used to treat children aged from 6 months. Children may be more susceptible to local corticosteroids that cause hypothalamic-pituitary-adrenal depression than older patients. This is due to the higher absorption of the drug in children due to the higher ratio of surface area and body weight.

Form of production

Ointment.

Storage conditions

Store at a temperature not exceeding 25°C.

Active ingredient

Betamethasone

Dosage form

ointment

Description

For adults, Children over 6 months of age

Indications

Dermatitis, Urticaria, Dermatosis, Neurodermatitis, Allergies, Eczema, Psoriasis