Expiration date: 07/2026

The composition and form of issue:

Ointment or cream for external use 1 g contains:

betamethasone (betamethasone 17-valerate) 1 mg

gentamicin base (gentamicin sulfate) 1 mg

excipients: cream white soft paraffin cetostearyl alcohol liquid paraffin macrogol-cetostearyl ether phosphoric acid sodium dihydrogen phosphate dihydrate chlorocresol sodium hydroxide phosphoric acid (to determine pH) purified water 

excipients: ointment — liquid paraffin white soft paraffin 

in tubes of 15 or 30 grams in a cardboard box 1 tuba.

Description pharmaceutical form:

Cream: smooth cream white color and soft consistency, does not contain extraneous inclusions.

Ointment: homogeneous ointment white soft consistency, does not contain extraneous inclusions.

Description pharmacological action:

Betamethasone valerate — a corticosteroids. Anti-inflammatory and anti-allergic effect, inhibits the release of cytokines and inflammatory mediators, reduce the metabolism of arachidonic acid, induces the formation lipokortinov with anti-edematous activity, reduces the permeability of blood vessels.

Gentamicin is a broad-spectrum antibiotic. The local application is effective against most common pathogens. Among the susceptible bacteria to gentamicin include sensitive strains of streptococci (beta hemolytic, alpha hemolytic), Staphylococcus aureus (coagulasepositive, coagulasenegative and some penicillinaseproducing strains), and gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.

Indications:

Local treatment of skin diseases in adults and children from 6 months, amenable to therapy GCS, in the presence of secondary infections caused by sensitive to gentamycin microorganisms, or if you suspect an infection:

• (atopica, children's, coin-like)
  
• psoriasis
  
• dermatitis (contact, seborainey, intertriginous, Sunny, exfoliativei, radiation)
  
• atopic dermatitis
  
• anogenital and senile pruritus
  
• diaper rash.
  

Ointment (optional)

Skin lesions on a background of eczema and psoriasis.

Cream (optional)

Of the disease wet and oily skin.

Contraindications:

• hypersensitivity to any component of the drug
  
• tuberculosis skin, skin manifestations of syphilis, varicella, herpes simplex, fungal diseases of the skin
  
• vaccination and post-vaccination skin reaction
  
• lactation
  
• pregnancy (long-term treatment of large skin areas)
  
• children up to age 6 months.
  

With caution:

• pregnancy (in the absence of criteria for contraindications, especially in the first trimester
  
• long-term treatment of extensive skin areas, especially in children, or if cracked skin or use occlusive dressings.
  

Application of pregnancy and breast-feeding:

Due to the fact that the safety of locally applied corticosteroids in pregnant women has not been established, the appointment of agents of this class in pregnancy is justified only if the benefit to the mother clearly outweighs the potential harm to the fetus. Should not be used during pregnancy for a long time or in high doses.

As not established, if GCS in the local application and systemic absorption to penetrate into breast milk, you should decide on the termination of breastfeeding or the cancellation of the drug, considering how necessary its application for mother.

Side effects:

Local reactions: skin irritation (itching, erythema), burning sensation, dryness, folliculitis, hypertrichosis, pustular rash, hypopigmentation, perioral dermatitis, allergic contact dermatitis.

When using occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

With prolonged treatment or drawing on a large surface may develop systemic side effects characteristic of corticosteroids: increased body mass, osteoporosis, increased blood pressure, edema, ulceration of the mucous membrane of the gastrointestinal tract, the exacerbation of latent foci of infection, hyperglycemia, agitation, insomnia, menstrual disorders.

In children receiving local corticosteroids, may experience the following side effects: suppression of the function of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, retarded weight gain, increased intracranial pressure. Symptoms of depression of adrenocortical function in children include lower levels of cortisol in plasma and the lack of response to ACTH stimulation. Increased intracranial pressure manifested by bulging fontanel, headache, bilateral edema of the optic disc.

Method of application and dose:

Externally, a thin layer on the affected skin 2 times a day (morning and evening).

In mild cases — 1 per day (is usually sufficient) in more severe lesions — and perhaps more frequent use.

The frequency of application other than those recommended, can install the doctor based on the severity of the disease.

Overdose:

Symptoms: excessive or prolonged use of local corticosteroids may cause inhibition of pituitary-adrenal system, which can be a cause of secondary insufficiency of the adrenal cortex and symptoms of hypercortisolism, including Cushing's syndrome.

A single overdose of gentamicin is not accompanied by the appearance of any symptoms. Long-term use in doses exceeding recommended, may lead to significant growth of insensitive flora, including fungal, in the lesion.

Treatment: symptomatic therapy. Acute symptoms of hypercortisolism are usually reversible. If necessary, shows the correction of electrolyte imbalance. In the case of chronic toxic effect the gradual elimination of the drug. The uncontrolled growth of microorganisms should be selected antibacterial or antifungal treatment.

Special instructions:

In the absence of effect from treatment for 2 weeks is recommended to consult your doctor for diagnosis and treatment.

If irritation or hypersensitivity of the skin treatment should be discontinued and the patient to choose another treatment.

Any side-effects of systemic corticosteroids, including the inhibition of the function of the adrenal cortex, can be observed also with the use of local corticosteroids, especially in children. Systemic absorption of local corticosteroids improves their long-term use in the treatment of extensive body surfaces, when using occlusive dressings, as well as in children.

The local application of antibiotics is rarely observed the growth of insensitive microorganisms, including fungal. In this case, the treatment should be stopped and assign appropriate therapy.

Intended for external use only and should be applied in ophthalmic practice.

Use in Pediatrics

Celestoderm In Garamizinom can be used for the treatment of children aged 6 months.

Children may be more receptive to the application of local corticosteroids causing inhibition of the hypothalamic-pituitary-adrenal system than older patients due to increased absorption of the drug associated with a higher ratio of their surface area and body mass.