Celestoderm-V^® (Ointment, Cream) Instructions for Use

ATC Code

D07AC01 (Betamethasone)

Active Substance

Betamethasone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids; high-potency corticosteroids (group III)

Pharmacological Action

Betamethasone exerts anti-inflammatory and anti-allergic effects by inhibiting the release of cytokines and inflammatory mediators, reducing arachidonic acid metabolism, inducing the formation of lipocortins with anti-edema activity, and reducing vascular permeability.

The microdispersion of this glucocorticosteroid in a non-greasy, odorless, non-staining, easily washed-off cream base ensures effective penetration into the skin and rapid onset of action.

Indications

Inflammatory skin diseases amenable to glucocorticoid (GCS) therapy

• Eczema (atopic, infantile, nummular);
• Contact dermatitis;
• Seborrheic dermatitis;
• Neurodermatitis;
• Solar dermatitis;
• Exfoliative dermatitis;
• Radiation dermatitis;
• Intertriginous dermatitis;
• Psoriasis;
• Anogenital and senile pruritus.

ICD codes

Dosage Regimen

Cream

For external use.

Celestoderm-V^® Cream should be applied in a thin layer to the affected areas 1-3 times/day, depending on the severity of the condition. In most cases, application 1-2 times/day is sufficient to achieve the effect.

Ointment

For external use.

Celestoderm-V^® should be applied in a thin layer to the affected areas 1-3 times/day, depending on the severity of the condition. In most cases, application 1-2 times/day is sufficient to achieve the effect.

Adverse Reactions

The following adverse events have been observed with the use of topical GCS: burning, irritation and dryness of the skin, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae, miliaria, systemic side effects (blurred vision).

If the side effects mentioned in the instructions occur, or they worsen, or any other side effects not mentioned in the instructions are noted, the patient should inform the doctor.

Contraindications

• Hypersensitivity to any of the components of the drug;
• Pregnancy (use of high doses, long-term treatment);
• Breastfeeding period;
• Children under 6 months of age.

Use in Pregnancy and Lactation

Since the safety of topical GCS use 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 potential harm to the fetus. Drugs of this group should not be used in pregnant women in large doses or for a long time.

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

Pediatric Use

Contraindicated for use in children under 6 months of age.

Special Precautions

If there is no effect from treatment within 2 weeks, it is recommended to consult the attending physician for possible clarification of the diagnosis. If irritation or hypersensitivity reaction is noted when using the drug, treatment should be discontinued and a doctor should be consulted. In case of secondary fungal or bacterial infection, a doctor should be consulted to select appropriate medications. If there is no rapid positive effect in this case, the use of GCS should be discontinued until all signs of infection are eliminated.

Any side effects of systemic GCS, including suppression of adrenal cortex function, can also be observed with the use of topical GCS, especially in children.

Systemic absorption of topical GCS is increased with their long-term use, when treating extensive body surfaces, or when using occlusive dressings, as well as in children.

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

With systemic and topical use of corticosteroids, visual disturbances may occur. If the patient complains of blurred vision or other visual disturbances, an ophthalmologist should be consulted to assess possible causes, which may include cataract, glaucoma, serous chorioretinopathy.

Use in pediatrics

Celestoderm-V^® Cream can be used to treat children aged 6 months and older.

Children may be more susceptible than older patients to the use of topical GCS causing suppression of the hypothalamic-pituitary-adrenal (HPA) system due to increased absorption of the drug associated with their larger surface area to body weight ratio.

The following side effects have been observed in children treated with topical GCS: suppression of HPA system function, Cushing’s syndrome, linear growth retardation, delayed weight gain, increased intracranial pressure. Symptoms of adrenal cortex suppression in children include reduced plasma cortisol levels and lack of response to ACTH stimulation. Increased intracranial pressure is manifested by bulging fontanelle, headache, bilateral papilledema.

Effect on ability to drive vehicles and operate machinery

No effect of Celestoderm-V^® on the ability to drive vehicles and operate machinery has been registered.

Overdose

Symptoms: excessive or prolonged use of topical GCS can cause suppression of the pituitary-adrenal system function, which can lead to the development of secondary adrenal cortex insufficiency and the appearance of symptoms of hypercortisolism, including Cushing’s syndrome.

Treatment: symptomatic therapy. 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.

Drug Interactions

No interaction of Celestoderm-V^® with other medicinal products has been registered.

Storage Conditions

Keep out of reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.