Celestoderm B, cream 0.1% 30 g

Pharmgroup: Glucocorticosteroid for topical use.

Pharmacological 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 microdispersion of this glucocorticosteroid (GCS) in a non-greasy, odorless, non-marking, easy-to-wash ointment or cream base allows effective skin penetration and rapid onset of action.

Indications

Dermatitis, Dermatitis, Dermatosis, Urticaria, Eczema, Neurodermatitis, Allergy, Psoriasis

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

Active ingredient

Betamethasone

Composition

Active ingredient:
Betamethasone 17-valerate – 1.22 mg (equivalent to 1 mg of betamethasone)

Excipients: soft white paraffin – 150 mg; cetostearyl alcohol – 72 mg; liquid paraffin – 60 mg; macrogoal-cetostearyl ether – 22.5 mg; phosphoric acid and sodium hydroxide – q.s. (in the form of 5% solutions in the amount necessary to establish the pH); sodium dihydrophosphate dihydrate – 3.39 mg (equivalent to 3 mg of sodium dihydrophosphate monohydrate); chloracresol – 1 mg; 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, 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

Celestoderm B is not indicated for use in ophthalmology.

When using the drug on large surfaces and/or with an occlusive dressing, 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 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

The following adverse events have been reported with topical GKS: burning, irritation, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, neutral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, stretch marks, and sweat.

Overdose

Symptoms:Excessive or prolonged use of topical GCS may cause suppression of pituitary-adrenal function, which may result in secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing’s syndrome. A single overdose of gentamicin is not accompanied by the appearance of any symptoms.

Long-term use in doses greater than recommended can lead to 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 toxic effects, 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 benefits to the mother clearly outweigh the possible harm to the fetus. GCSs should not be used in pregnancy for long periods of time or in high doses.

As it has not yet been determined whether topical and systemic absorption of GCSs can penetrate into breast milk, a decision should be made to discontinue breastfeeding or to discontinue the drug, given the need for the mother.

Similarities

Beloderm, Akriderm, Beloderm Express