Celestoderm B, 0.1% ointment 30 g

A glucocorticosteroid for topical use.

Celestoderm-B is a GKS for external use; it has local anti-inflammatory, 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

Inflammatory skin diseases amenable to glucocorticosteroid (GCS) therapy:
– eczema (atonic, childhood, coin-shaped);
— contact dermatitis;
— seborrheic dermatitis;
— neurodermatitis;
– solar dermatitis;
— exfoliative dermatitis;
— radiation dermatitis;
— intertriginous dermatitis;
— psoriasis;
– anogenital and senile itching.

Pharmacological effect

Glucocorticosteroid for local use.

Celestoderm-V – GCS for external use; has local anti-inflammatory, anti-allergic, anti-edematous and anti-proliferative effects.

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

Microdispersion of this glucocorticosteroid (GCS) in a non-greasy, odorless, non-marking ointment or cream base that does not leave marks on clothing ensures effective penetration into the skin and a rapid onset of action.

Special instructions

Celestoderm B is not intended for use in ophthalmology.

When using the drug on large surfaces and/or with an occlusive dressing, it is necessary to keep in mind the possibility of systemic action of betamethasone, as well as the development of the following side effects: maceration of the skin, secondary infection, skin atrophy, stretch marks, prickly heat.

If drug-resistant bacterial and fungal microflora appears, use of the drug should be discontinued and appropriate therapy should be prescribed.

Use in pediatrics

The drug is prescribed to children only according to strict indications and under medical supervision, because it is possible to develop systemic side effects associated with betamethasone: suppression of the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercortisolism. In addition, there may be a decrease in the excretion of growth hormones, as well as an increase in intracranial pressure.

Active ingredient

Betamethasone

Composition

1 g of ointment contains:
active substance: betamethasone 17-valerate – 1.22 mg (equivalent to 1 mg betamethasone);
excipients: liquid paraffin – 100.0 mg, white soft paraffin – 898.78 mg.

Pregnancy

Due to the fact that the safety of the use of local corticosteroids in pregnant women has not been established, the prescription of drugs of this class during pregnancy is justified only if the benefit to the mother clearly outweighs the possible harm to the fetus. GCS should not be used during pregnancy for a long time or in large doses.

Since it has not yet been established whether GCS, when applied topically and systemically absorbed, can penetrate into breast milk, a decision should be made to stop breastfeeding or discontinue the drug, taking into account how necessary its use is for the mother.

Contraindications

– Hypersensitivity to any of the components of the drug.
– Skin tuberculosis.
– Skin manifestations of syphilis.
– Chicken pox.
– Simple herpes.
– Fungal skin diseases.
– Vaccination period and post-vaccination skin reactions.
– Lactation period.
– Pregnancy (long-term treatment of large areas of skin).
– Children up to 6 months.

With caution:

– Pregnancy (in the absence of criteria for contraindications), especially in the 1st trimester.
– Long-term treatment of large areas of skin, especially in children.
– If there are cracks in the skin or if occlusive dressings are used.

Side Effects

When using topical corticosteroids, the following undesirable effects were observed: burning, irritation and dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, neutral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, stretch marks and miliaria.

Overdose

Symptoms: excessive or prolonged use of local corticosteroids can cause inhibition of the function of the pituitary-adrenal system, which can cause the development of secondary adrenal insufficiency and the appearance of symptoms of hypercortisolism, including Cushing’s syndrome.

A single overdose of gentamicin is not accompanied by the appearance of any symptoms. Long-term use in doses exceeding the recommended ones can lead to a significant growth of insensitive flora, including fungal flora, in the affected area.

Treatment: Appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance is indicated.

In case of chronic toxic effects, gradual withdrawal of GCS is recommended. If the growth of microorganisms is uncontrolled, appropriate antibacterial or antifungal treatment should be selected.

Storage conditions

Store at a temperature not exceeding 25°C.

Shelf life

5 years. Do not use after expiration date.

Manufacturer

Schering-Plau Labeau N.V., Belgium