Celestoderm B, ointment 0.1% 15 g

Pharmgroup:

Glucocorticosteroid for topical use.

Pharmic action:

Celestoderm-B is a GKS for topical use; it has anti-inflammatory local, anti-allergic, anti-edema and anti-proliferative effects.

Betamethasone has anti-inflammatory and antiallergic effect by inhibition of release of cytokines and inflammatory mediators, reduction of arachidonic acid metabolism, induction of formation of lipocortins which have anti-edema activity, reduction of vascular permeability.

The micro dispersion of this glucocorticosteroid (GCS) in a non-greasy, odorless, non-marking ointment or cream base that is easy to wash off ensures effective penetration into the skin and rapid onset of action.

Indications

Inflammatory skin diseases amenable to glucocorticosteroid (GCS) therapy:
– eczema (atonic, pediatric, montiform);
– contact dermatitis;
– seborrheic dermatitis;
– neurodermitis;
– sun dermatitis;
– exfoliative dermatitis;
– radiation dermatitis;
– intertriginous dermatitis;
– psoriasis;
– anogenital and senile itching.

Active ingredient

Composition

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 use other than recommended can be determined by a physician based on the severity of the condition.

In mild cases, once-daily dosing is usually sufficient; 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 be offered another therapy.

Any adverse effects of systemic GCS, including inhibition of adrenal function, may also be seen with topical GCS, especially in children. Systemic absorption of topical GCS may increase with prolonged use, treatment of large body surfaces or use of occlusive dressings, especially in children.

The systemic absorption of gentamicin when applied topically may be increased if applied to large areas of skin, especially with prolonged treatment or in the presence of skin fissures. In these cases the adverse effects typical for gentamicin in systemic administration may develop, especially in children.

In local use of antibiotics the growth of insensitive microflora, including fungal microflora, is occasionally observed. In this case, treatment should be discontinued and appropriate therapy should be prescribed. Celestoderm-B with Garamycin is indicated for external use only and is not indicated for use in ophthalmology.

Celestoderm-B with Garamycin may be used for the treatment of children from 6 months of age. Children may be more susceptible to the action of topical 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

– 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 postvaccination reactions.
– The period of lactation.
– Pregnancy (long-term treatment of large skin areas).
– Childhood up to 6 months.

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.
When prolonged treatment or application over a large surface area: systemic side effects typical for GKS may develop: weight gain, osteoporosis, increase in blood pressure, edema, gastrointestinal mucosa ulceration, exacerbation of latent infections, hyperglycemia, agitation, insomnia, menstrual disorders.

In children treated with local 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. Symptoms of suppressed adrenal cortical function in children include decreased plasma cortisol levels and no response to ACTH stimulation. Increased intracranial pressure is manifested by a swollen fontanelle, headache, and bilateral swelling of the optic disc.

Overdose

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

A single overdose of gentamicin does not result in 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 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 GCSs should not be used for long periods or in high doses during pregnancy.

As it has not yet been determined whether GCS can penetrate the breast milk with topical administration 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