Celestoderm B with Garamycin, cream 0.1% 30 g

Pharmgroup: antibiotic aminoglycoside + glucocorticosteroid.

Pharmacological action: Celestoderm-B with Garamycin is a combination drug whose action 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, a broad-spectrum antibiotic, is effective against the majority of common pathogens when applied topically.

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

Indications

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

Topical treatment of skin diseases amenable to GCS therapy in the presence of secondary infection caused by microorganisms susceptible to gentamicin, or with suspicion of such an infection:

– eczema (atonic, pediatric, montiform);
– contact dermatitis;
– seborrheic dermatitis;
– neurodermitis;
– Sun dermatitis;
– exfoliative dermatitis;
– radiation dermatitis;
– diaper rash;
– psoriasis;
– anogenital and senile itching.

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

Active ingredient

Betamethasone, Gentamicin

Composition

Active ingredients:

– betamethasone 17-valerate – 1.22 mg (equivalent to 1 mg of betamethasone)

– gentamicin sulfate (in gentamicin equivalent) 1 mg (1000 ME).

Excipients: White soft paraffin, 150 mg; cetostearyl alcohol, 72 mg; liquid paraffin, 60 mg; macrogoal-cetostearyl ether, 22.5 mg; phosphoric acid, 0.02 mg; Sodium dihydrophosphate dihydrate – 3.39 mg (equivalent to 3 mg of sodium dihydrophosphate monohydrate); chlorcresol – 1 mg; sodium hydroxide and phosphoric acid – until pH is adjusted; purified water – q.s. to 1 g.

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 may be determined by a physician based on the severity of the condition.

In mild cases, once a day is usually sufficient; more frequent use may be needed for more severe lesions.

Special Instructions

Celestoderm B is not indicated for use in ophthalmology.

When using the drug on large surfaces and/or with an occlusive dressing one should be aware of the possibility of systemic action of betamethasone as well as the development of the following side effects: skin maceration, accession of secondary infection, skin atrophy, stretch marks, sweating.

If bacterial or fungal flora resistant to the drug appear, discontinue use and initiate appropriate therapy.

Pediatric use

The drug should only be used in children under strict indications and medical supervision because of the possible systemic side effects associated with betamethasone: suppression of hypothalamic-pituitary-adrenal function and development of hypercorticism symptoms. In addition, there may be a decrease in growth hormone excretion as well as an increase in intracranial pressure.

Contraindications

– Hypersensitivity to any of the ingredients of the drug.

– Tuberculosis of the skin.

– Skin 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).

– Childhood under 6 months of age.

With caution:

– Pregnancy (in the absence of contraindication criteria), especially in the 1st trimester.

– Prolonged treatment of extensive areas of skin, especially in children. – In the presence of skin fissures or the use of occlusive dressings.

Side effects

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

In case of long-term treatment or application over a large surface area: development of systemic side effects typical of GKS is possible: weight gain, osteoporosis, increase in blood pressure, edema, ulceration of mucous membranes of the gastrointestinal tract, exacerbation of latent foci of infection, hyperglycemia, agitation, insomnia, menstrual cycle disorder.

In children who receive topical GCS the following side effects may be observed: suppression of hypothalamic-pituitary-adrenal system function, Cushing’s syndrome, stunting, delayed weight gain, increased intracranial pressure.

The symptoms of depression of adrenal cortical function in children include decreased plasma cortisol levels and lack of response to ACTH stimulation. Increased intracranial pressure is manifested by a swollen fontanelle, headache, and bilateral swelling of the optic disc.

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 greater 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 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