Celestoderm B, cream 0.1% 15 g

Pharmacodynamics
Betamethasone has anti-inflammatory and anti-allergic effect by inhibiting the release of cytokines and inflammatory mediators, reducing the metabolism of arachidonic acid, inducing the formation of lipocortins, which have anti-edema activity, reducing vascular permeability.

Micro dispersion of this GKS in a non-greasy, odorless, leaving no residue on clothes and easily washed off ointment or cream base ensures effective penetration into the skin and quick start of action.

Indications

Urticaria, Dermatosis, Insect bites, Dermatitis, Allergies, Eczema, Neurodermitis, Skin itching, Psoriasis

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

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

Outwardly. It should be applied by thin layer on the affected skin areas 1-3 times a day depending on the disease severity.

In most cases 1-2 times a day is enough to achieve the effect.

Application in pediatric practice:

Celestoderm®-B can be used for children from 6 month old. Children may be more susceptible to local GCS causing suppression of hypothalamic-pituitary-adrenal (HPA) system than older patients due to increased absorption of the drug associated with higher surface area to body weight ratio. The following side effects have been reported in children taking topical GCS: suppression of GGN system function, Cushing’s syndrome, linear growth retardation, delayed weight gain, increased IOP. Symptoms of suppression of adrenal cortical function in children include decreased plasma cortisol levels and no response to ACTH stimulation. Increased IOP is manifested by a swollen fontanelle, headache, and bilateral oedema of the optic disc.

Special Instructions

If there is no effect from the treatment within 2 weeks it is recommended to consult a doctor for possible clarification of the diagnosis.

If irritation or hypersensitivity reactions occur, treatment should be discontinued and the patient should be given adequate therapy. Secondary fungal or bacterial skin infection requires appropriate antimicrobial or antifungal therapy (if there is no rapid positive effect, the use of GCS should be discontinued until all signs of infection are eliminated).

Any side effects of systemic GCS, including

Systemic absorption of topical GCS is increased with prolonged use, treatment of larger body surfaces or use of occlusive dressings, and in children.

Celestoderm®-B is indicated for external use only and is not intended for use in ophthalmology.

Contraindications

Hypersensitivity to any of the drug components;

pregnancy (high doses, long-term treatment);

lactation;

children under 6 months.

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 system function, which may cause development of secondary adrenal insufficiency and occurrence of hypercorticism symptoms, including Cushing’s syndrome.

Treatment: symptomatic. Acute symptoms of hypercorticism are usually reversible. If necessary, correction of electrolyte imbalance is indicated. In case of chronic toxicity, gradual withdrawal of GCS is recommended.

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 may penetrate into breast milk with topical administration and systemic absorption, a decision should be made to discontinue breastfeeding or to discontinue the drug, given the need for its use in the mother.

Similarities

Beloderm, Akriderm, Beloderm Express