Celestoderm B with Garamycin, 0.1% ointment 15 g

Celestoderm-B with Garamycin is a combination drug, the action of which is due to the components in its composition.

Betamethasone valerate – GKS – has 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, which have anti-edema activity, reduces vascular permeability.

Gentamicin is a broad-spectrum antibiotic and when applied topically it is effective against the majority of common pathogens. Susceptible to gentamicin bacteria include sensitive strains of Streptococcus (beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase-positive, coagulaseonegative and some penicillinase-producing strains) and Gram-negative bacteria: Pseudomonas aeruginosa, Aeobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.

Indications

Neurodermitis, Dermatosis, Eczema, Urticaria, Psoriasis, Skin infections, Chapping, Allergy, Dermatitis

Topical treatment of skin diseases amenable to GCS therapy in the presence of secondary infection caused by gentamicin-susceptible microorganisms or when such infection is suspected:

• eczema (atonic, pediatric, montomatous);
• contact dermatitis;
• seborrheic dermatitis;
• neurodermatitis;
• Sun dermatitis;
• exfoliative dermatitis;
• radiation dermatitis;
• opecia;
• psoriasis;
• anogenital and senile itching.

The Celestoderm-B ointment with garamycin is used for skin lesions with a background of eczema or psoriasis, while the cream is used for diseases of moist or oily skin.

Active ingredient

Betamethasone, Gentamicin

Composition

Active ingredients:
betamethasone 17-valerate – 1.22 mg (equivalent to 1 mg of betamethasone)
gentamycin sulfate (in gentamycin equivalent) 1 mg (1000 ME).

Excipients: liquid paraffin – 100 mg; white soft paraffin – 898.78 mg.

How to take, the dosage

Externally. Apply a thin layer on the affected areas of the skin twice a day – in the morning and in the evening.

The frequency of application, other than recommended, can be determined by a physician based on the severity of the disease.

In mild cases, once-daily dosing is usually adequate; more frequent dosing may be needed for more severe lesions.

Special Instructions

If there is no effect of treatment within 2 weeks, it is recommended to see the attending physician for clarification of the diagnosis and treatment. If irritation or hypersensitivity is noted when using the drug, treatment should be discontinued and the patient should find another therapy.

Any adverse effects of systemic GKS, including inhibition of adrenal function, may also be noted with topical GKS, especially in children. Systemic absorption of topical GCS may be increased with prolonged use, treatment of large body surfaces or use of occlusive dressings, especially in children. Systemic absorption of gentamicin when applied topically may be increased in case of application to large areas of skin, especially during long-term treatment or in the presence of skin fissures.

In these cases adverse events typical for gentamicin in its systemic use may develop, especially in children. During local application of antibiotics the growth of insensitive microflora, including fungal microflora, is occasionally observed. In this case the treatment should be discontinued and appropriate therapy should be prescribed. Celestoderm-B with Garamycin is indicated for external use only and is not intended for use in ophthalmology.

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

Contraindications

• High sensitivity to any of the ingredients of the drug.
• Tuberculosis of the skin.
• Dermal manifestations of syphilis.
• Chicken pox.
• Herpes simplex.
• Fungal skin diseases.
• Vaccination period and skin post-vaccination reactions.
• Lactation period.
• Pregnancy (prolonged treatment of large areas of skin).
• Children under 6 months of age.

With caution:

• Pregnancy (in the absence of contraindication criteria), especially in the 1st trimester.
• Long-term treatment of extensive areas of skin, especially in children.
• In the presence of skin fissures or the use of occlusive dressings.

Overdose

Symptoms: Excessive or prolonged use of topical GCS may cause suppression of pituitary-adrenal function, which may cause development of secondary adrenal cortical insufficiency and symptoms of hypercorticism, including Cushing’s syndrome.

A single overdose of gentamicin is not accompanied by the appearance of any symptoms. Prolonged use in doses higher than recommended may result in a significant growth of insensitive flora, including fungal flora, in the lesion.

Treatment: Appropriate symptomatic treatment is indicated. Acute symptoms of hypercorticism are usually reversible. Correction of electrolyte imbalance is indicated if necessary. In the case of chronic toxicity, gradual withdrawal of GCS is recommended. In case of uncontrolled microbial growth, appropriate antibacterial or antifungal treatment should be selected.

Pregnancy use

Because the safety of topical GCS in pregnant women has not been established, the use of this class of drugs during pregnancy is justified only if the benefit to the mother clearly outweighs the possible harm to the fetus.

The GKS should not be used for long periods or in high doses during pregnancy.

As it has not yet been determined whether GCS can penetrate into breast milk with topical use and systemic absorption, a decision should be made to discontinue breastfeeding or to discontinue the drug, considering how necessary it is for the mother.

Similarities

Celestoderm B, Celestoderm B with Garamycin, Belogent, Acriderm GentA, Betaderm