Universal reference book for medicines
Name of the preparation: CELESTODERM®-B (CELESTODERM®-V)

Active substance: betamethasone

Type: GCS for external use

Manufacturer: BAYER (Russia) manufactured by SCHERING-PLOUGH LABO (Belgium)
Composition, form of production and packaging
?
Cream for external use 0.1% white, soft consistency, homogeneous, does not contain visible particles.
1 g

betamethasone valerate 1.22 mg,

which corresponds to the content of betamethasone 1 mg

Auxiliary substances: paraffin soft white - 150 mg, cetostearyl alcohol - 72 mg, paraffin liquid - 60 mg, macrogol cetostearyl ether - 22.5 mg, phosphoric acid and sodium hydroxide - qs (in the form of 5% solutions in the amount necessary to establish the pH) , sodium dihydrogen phosphate dihydrate - 3.39 mg (corresponding to 3 mg of sodium dihydrogen phosphate monohydrate), chlorocresol - 1 mg, purified water - qs to 1 g.

15 g - aluminum tubes (1) - cardboard packs.

30 g - aluminum tubes (1) - cardboard packs.

?
Ointment for external use 0.1% from almost white to white, homogeneous, translucent, soft consistency, free of visible particles.
1 g

betamethasone valerate 1.22 mg,

which corresponds to the content of betamethasone 1 mg

Excipients: paraffin liquid - 100 mg, paraffin soft white - 898.78 mg.

15 g - aluminum tubes (1) - cardboard packs.

30 g - aluminum tubes (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

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, having anti-edematous activity, reducing vascular permeability.

The microdispersion of this glucocorticosteroid (GCS) in a low-fat, odorless, leaving no traces on clothing, easily washed off with an ointment or cream base, provides effective penetration into the skin and a rapid onset of action.

INDICATIONS

Inflammatory skin diseases susceptible to glucocorticosteroid (GCS) therapy:

- eczema (atonic, childish, coin-like);

contact dermatitis;

- seborrheic dermatitis;

- Neurodermatitis;

- sunny dermatitis;

- exfoliative dermatitis;

- radiation dermatitis;

- Intertriginous dermatitis;

- psoriasis;

anogenital and senile itching.

DOSING MODE

Outwardly.

Celestoderm-B should be applied a thin layer on the affected areas 1-3 times / day, depending on the severity of the condition.
In most cases, to achieve the effect, it is sufficient to apply 1-2 times / day.
SIDE EFFECT

The following adverse events were observed with the use of local SCS: burning, irritation and dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, neutral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae and sweating.

CONTRAINDICATIONS

- Hypersensitivity to any of the components of the drug;

- Pregnancy (use of high doses, long-term treatment);

- lactation period;

- Children's age to 6 months.

PREGNANCY AND LACTATION

Due to the fact that the safety of the use of local GCS in pregnant women is not established, the prescription of this class of drugs during pregnancy is justified only if the benefit to the mother clearly exceeds the possible harm to the fetus.
Preparations of this group should not be used in pregnant women in large doses or for a long time.
Since it has not been established to date whether SCS can be absorbed into breast milk by topical application and systemic absorption, breastfeeding or use of the drug should be stopped, given how much it is needed for the mother.

APPLICATION FOR CHILDREN

Celestoderm-B can be used to treat children aged 6 months.
Children may be more susceptible to the use of local SCS, which causes oppression of the hypothalamic-pituitary-adrenal (HHG) system than older patients, due to increased absorption of the drug, associated with a greater ratio of their surface area and body weight

SPECIAL INSTRUCTIONS

In the absence of the effect of treatment for 2 weeks, it is recommended to consult a doctor in order to clarify the diagnosis.
If there is irritation or a hypersensitivity reaction when using the drug, treatment should be discontinued and the patient should be adequately treated. With secondary fungal or bacterial infection, appropriate medications should be prescribed. If there is no immediate positive effect, the use of GCS should be discontinued until all signs of infection are eliminated.
Any side effects of systemic GCS, incl.
oppression of the function of the adrenal cortex, can also be noted when using local GCS, especially in children.
Systemic absorption of local GCS is increased with their long-term use, in the treatment of extensive body surfaces or in the use of cover bandages, as well as in children.

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

Application in pediatric practice

Celestoderm-B can be used to treat children aged 6 months.

Children may be more susceptible to the use of local SCS, which causes oppression of the hypothalamic-pituitary-adrenal system (GGN) than older patients, due to increased absorption of the drug, associated with a greater ratio of their surface area and body weight.

In children receiving local SCS, the following side effects were noted: suppression of the function of the GGN system, Cushing's syndrome, linear growth retardation, lag in weight gain, increased intracranial pressure.
Symptoms of suppression of adrenal cortex function in children include a decrease in the level of cortisol in the plasma and a lack of response to stimulation of ACTH. Increase in intracranial pressure is manifested by bulging fontanel, headache, bilateral edema of the optic disc.
OVERDOSE

Symptoms.
Excessive or prolonged use of local SCS can cause oppression of the pituitary-adrenal system, which can lead to secondary adrenal insufficiency and the emergence of symptoms of hypercortisy, including Cushing's syndrome.
Treatment.
The corresponding symptomatic treatment was shown. Acute symptoms of hypercorticoidism are usually reversible. If necessary, correction of electrolyte imbalance is shown. In the case of chronic toxic effects, gradual cancellation of GCS is recommended.
TERMS OF RELEASE FROM PHARMACY

Without recipe.

TERMS AND CONDITIONS OF STORAGE

Store in a place inaccessible to children, at a temperature not exceeding 25 ° C.

Shelf life 5 years.

Do not use after expiry date.

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