Celestoderm-B with garamycin cream, 30 g

Local treatment of skin disease responsive to GCS 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;

• solar dermatitis;

• exfoliative dermatitis;

• radiation dermatitis;

• intertrigo;

• psoriasis;

• anogenital and senile itching.

The ointment is used for skin lesions against the background of eczema or psoriasis, and the cream is used for diseases of wet or oily skin.

betamethasone valerate (equivalent to 1 mg betamethasone) - 1.22 mg

gentamicin (in the form of sulfate) - 1 mg (1000 IU)

Excipients: white soft paraffin, cetostearyl alcohol, liquid paraffin, macrogol cetostearate, phosphoric acid, sodium dihydrogen phosphate dihydrate, chlorocresol, sodium hydroxide or phosphoric acid (to create the required pH level), purified water.

• hypersensitivity to any of the components of the drug;

• tuberculosis of the skin, skin manifestations of syphilis, chickenpox, herpes simplex, fungal skin diseases;

• period of vaccination and post-vaccination skin reactions;

• lactation period;

• pregnancy (long-term treatment of large areas of the skin);

• children's age - up to 6 months.

With care: pregnancy (in the absence of criteria for contraindications), especially in the first trimester; long-term treatment of large areas of skin, especially in children, or with skin cracks or using occlusive dressings;

Composition:

Active ingredients:

betamethasone valerate (equivalent to 1 mg betamethasone) - 1.22 mg

gentamicin (in the form of sulfate) - 1 mg (1000 IU)

Excipients: white soft paraffin, cetostearyl alcohol, liquid paraffin, macrogol cetostearate, phosphoric acid, sodium dihydrogen phosphate dihydrate, chlorocresol, sodium hydroxide or phosphoric acid (to create the required pH level), purified water.

Clinical and pharmacological group: Drug with antibacterial and anti-inflammatory action for external use

Pharmaco-therapeutic group: Topical glucocorticosteroid + aminoglycoside antibiotic

pharmachologic effect

Betamethasone valerate - GCS - has an anti-inflammatory and antiallergic effect, inhibits the release of cytokines and inflammatory mediators, reduces the metabolism of arachidonic acid, induces the formation of lipocortins, which have anti-edematous activity, and reduces vascular permeability.

Gentamicin is a broad-spectrum antibiotic that, when applied topically, is effective against most common pathogens. Bacteria susceptible to gentamicin include susceptible strains of streptococcus (beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative, and some penicillinase-producing strains), as well as gram-negative col- lens, Escherobacus aererobacus, Proteinseudomonas and Klebsiella pneumoniae.

Indications

Local treatment of skin disease responsive to GCS 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;

• solar dermatitis;

• exfoliative dermatitis;

• radiation dermatitis;

• intertrigo;

• psoriasis;

• anogenital and senile itching.

The ointment is used for skin lesions against the background of eczema or psoriasis, and the cream is used for diseases of wet or oily skin.

Dosage regimen

Outwardly. Apply a thin layer to the affected skin 2 times / day - in the morning and in the evening.

The frequency of use, which is different from the recommended one, can be determined by the doctor, focusing on the severity of the disease. In mild cases, application once a day is usually sufficient, with more severe lesions, more frequent use may be required.

Side effect

Local reactions: skin irritation (itching, erythema), burning sensation, dry skin, folliculitis, hypertrichosis, acne-like eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. When using occlusive dressings: skin maceration, secondary infection, skin atrophy, stretch marks, prickly heat.

With prolonged treatment or application to a large surface: the development of systemic side effects characteristic of GCS is possible: increased body weight, osteoporosis, increased blood pressure, edema, ulceration of the gastrointestinal mucosa, exacerbation of hidden foci of infection, hyperglycemia, agitation, insomnia, menstrual irregularities ...

Children receiving local GCS may experience the following side effects: suppression of the function of the hypothalamic-pituitary-adrenal system, Cushing's syndrome, growth retardation, lag in weight gain, increased intracranial pressure. Symptoms of adrenal cortex suppression in children include decreased plasma cortisol levels and lack of response to ACTH stimulation. Increased intracranial pressure is manifested by bulging fontanelle, headache, bilateral edema of the optic nerve head.

Contraindications for use

• hypersensitivity to any of the components of the drug;

• tuberculosis of the skin, skin manifestations of syphilis, chickenpox, herpes simplex, fungal skin diseases;

• period of vaccination and post-vaccination skin reactions;

• lactation period;

• pregnancy (long-term treatment of large areas of the skin);

• children's age - up to 6 months.

With care: pregnancy (in the absence of criteria for contraindications), especially in the first trimester; long-term treatment of large areas of skin, especially in children, or with skin cracks or using occlusive dressings;

Application during pregnancy and lactation

Due to the fact that the safety of using local GCS in pregnant women has not been established, the appointment of drugs of this class during pregnancy is justified only if the benefits to the mother clearly outweigh the possible harm to the fetus. GCS should not be used during pregnancy for a long time or in high doses.

Since it has not yet been established whether GCS, when applied topically and systemically absorbed, can penetrate into breast milk, a decision should be made to stop breastfeeding or to discontinue the drug, taking into account how necessary its use for the mother.

Application in children

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

special instructions

If there is no effect of treatment within 2 weeks, it is recommended to contact your doctor to clarify the diagnosis and treatment.

If irritation or increased sensitivity is noted during the use of the drug, the treatment should be discontinued and the patient should be selected for another therapy.

Any side effects of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed when using local corticosteroids, especially in children. Systemic absorption of local corticosteroids may increase with prolonged use, treatment of large body surfaces or the use of occlusive dressings, especially in children.

Systemic absorption of gentamicin when applied topically can be increased when applied to large areas of the skin, especially with prolonged treatment or in the presence of skin cracks. In such cases, the development of undesirable phenomena characteristic of gentamicin with its systemic use, especially in children, is possible.

With local application of antibiotics, the growth of insensitive microflora, including fungal, is occasionally observed. In this case, treatment must be discontinued and appropriate therapy prescribed.

Celestoderm-B with Garamycin is indicated for external use only and is not intended for use in ophthalmology.

Application in pediatrics

Celestoderm-B with Garamycin can be used to treat children aged 6 months.

Children may be more susceptible to local GCS. causing depression of the hypothalamic-pituitary-adrenal system than older patients. This is due to the higher absorption of the drug in children due to the higher ratio of surface area to body weight.

Overdose

Symptoms Excessive or prolonged use of local GCS can cause inhibition of the function of the pituitary-adrenal system, which can lead to the development of secondary adrenal cortex insufficiency and the appearance of symptoms of hypercortisolism, including Cushing's syndrome.

A single overdose of gemtamycin is not accompanied by the appearance of any symptoms. Long-term use in doses exceeding the recommended ones can lead to a significant growth of insensitive flora, incl. fungal, in the lesion focus.

Treatment. Appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. Correction of electrolyte imbalance is indicated if necessary. In the case of chronic toxic effects, a gradual abolition of GCS is recommended. In case of uncontrolled growth of microorganisms, an appropriate antibacterial or antifungal treatment should be selected.

Storage conditions

Keep out of the reach of children, at a temperature not exceeding 25 ? C.

Shelf life

The shelf life of the cream is 3 years, the ointment is 5 years.

Do not use the drug after the expiration date.

Terms of sale

On prescription.