Celestoderm B with Garamycin, cream 0.1%, 30g

Composition

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of 1 g contains:

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

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

Pharmacological action

Pharmaceutical group: antibiotic-aminoglycoside+glucocorticosteroid.

Pharmaceutical action: Celestoderm-B with garamycin is a combined drug, the action of which is due to the components that make up its composition. Betamethasone valerate-GCS-has an anti-inflammatory and anti-allergic effect, inhibits the release of cytokines and inflammatory mediators, reduces the metabolism of arachidonic acid, induces the formation of lipocortins with anti-edematous activity, reduces vascular permeability.

Gentamicin, a broad-spectrum antibiotic, is effective against most common pathogens when applied topically.

The number of bacteria susceptible to gentamicin includes sensitive strains of streptococcus (beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative and some penicillinase-producing strains), as well as gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.

Indications

Topical treatment of skin diseases that respond to corticosteroid therapy, in the presence of a secondary infection caused by microorganisms susceptible to gentamicin, or if such an infection is suspected:

– eczema (atonic, children’s, coin-shaped);- contact dermatitis;- seborrheic dermatitis;- neurodermatitis— – sun dermatitis;- exfoliative dermatitis;- radiation dermatitis;- diaper rash;- psoriasis;— anogenital and senile itching.

Celestoderm-B ointment with garamycin is used for skin lesions on the background of eczema or psoriasis, and cream-for diseases of wet or oily skin.

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 occlusive 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.

In children receiving local corticosteroids, the following side effects may occur: 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

Celestoderm B is not intended for use in ophthalmology.

When using the drug on large surfaces and/or with an occlusive dressing, it is necessary to keep in mind the possibility of systemic action of betamethasone, as well as the development of the following side effects: maceration of the skin, secondary infection, skin atrophy, striae, sweating.

If bacterial and fungal microflora resistant to the drug appears, the drug should be discontinued and appropriate therapy should be prescribed.

Use in pediatrics

Children are prescribed the drug only for strict indications and under medical supervision, because it is possible to develop systemic side effects associated with betamethasone: suppression of the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism. In addition, there may be a decrease in the excretion of growth hormones, as well as an increase in intracranial pressure.

Storage conditions

Store at a temperature not exceeding 25°C.

Active ingredient

Betamethasone, Gentamicin

Conditions of release from pharmacies

By prescription

Dosage form

cream

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children over 6 months of age

Indications

Dermatitis, Neurodermatitis, Skin Infections, Psoriasis, Urticaria, Dermatosis, Eczema, Diaper Rash, Allergies