CELESTODERM-IN CREAM 30G

Trade name of the drug

Celestoderm-V®

International non-proprietary name

Betamethasone (betamethasone).

Dosage Form

Cream for external use.

Composition

1 g of cream contains:

active substance: betamethasone 17-valerate - 1.22 mg (in the equivalent of 1 mg betamethasone);

excipients: white soft paraffin - 150.0 mg, cetostearyl alcohol - 72.0 mg, liquid paraffin - 60.0 mg, macrogol-cetostearyl ether - 22.5 mg, phosphoric acid and sodium hydroxide - q.s. (in the form of 5% solutions in an amount necessary to establish a pH), sodium dihydrogen phosphate dihydrate — 3.39 mg (corresponding to 3.0 mg sodium dihydrogen phosphate monohydrate), chlorocresol — 1.0 mg, purified water — q.s. up to 1.0 g

Description

Uniform cream of white color of a soft consistence, not containing visible particles.

Pharmacotherapeutic group

Glucocorticosteroid for topical use.

Pharmacological properties

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

The microdispersion of this glucocorticosteroid (GCS) in a non-greasy, odorless, non-marking on clothes, easily washable cream base provides effective penetration into the skin and a quick onset of action.

Indications for use

Inflammatory diseases of the skin, susceptible to glucocorticosteroid (GCS) therapy, eczema (atopic, pediatric, coin-like), contact dermatitis, seborrheic dermatitis, neurodermatitis, solar dermatitis, exfoliative dermatitis, radiation dermatitis, intertriginous dermatitis, psoriasis, an anogeous anatomy, an anomatitis, an anohytenitis

Contraindications

Hypersensitivity to any of the components of the drug.

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

Lactation period.

Childhood - up to 6 months.

Dosage and administration

Outwardly.

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

Side effect

When using GCS of local action, the following undesirable phenomena were observed: burning, irritation and dry skin, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, stria and strepitis.

Special instructions and precautionary measures

In the absence of the effect of treatment within 2 weeks, it is recommended to contact your doctor for possible clarification of the diagnosis.

If the use of the drug marked irritation or hypersensitivity reaction, treatment should be discontinued and the patient should be treated with adequate therapy.For secondary fungal or bacterial infection, appropriate medications should be prescribed. In the absence of a quick positive effect, the use of corticosteroids should be discontinued until all signs of infection have been eliminated.

Any side effects of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed when using local corticosteroids, especially in children.

Systemic absorption of local corticosteroids is enhanced with their long-term use, with the treatment of large areas of the body or with the use of covering dressings, 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 cream can be used to treat children from the age of 6 months.

Children may be more susceptible to the use of local corticosteroids, which cause inhibition of the hypothalamic-pituitary-adrenal system (HGN) than older patients, due to increased absorption of the drug, associated with a higher ratio of surface area and body weight.

In children who took local GCS, the following side effects were noted: suppression of the HGN system function, Cushing syndrome, linear growth retardation, lag in weight gain, increased intracranial pressure. Symptoms of inhibition of adrenal cortex function in children include a decrease in plasma cortisol and a lack of response to stimulation of ACTH.Increased intracranial pressure is manifested by bulging of the fontanel, headache, bilateral swelling of the optic nerve head.

Use during pregnancy and lactation

Due to the fact that the safety of using 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 exceeds the possible harm to the fetus. Drugs in 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 penetrate into breast milk, breastfeeding or use of the drug should be discontinued, considering how much its use is necessary for the mother.

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 insufficiency of the adrenal cortex and the appearance of symptoms of hypercorticism, including Cushing syndrome.

Treatment. Corresponding symptomatic treatment is indicated. The acute symptoms of hypercorticism are usually reversible. If necessary, correction of electrolyte imbalance is shown. In the case of chronic toxic effects, the gradual abolition of corticosteroids is recommended.

Interaction with other drugs

No interaction of the drug Celestoderm-B with other drugs is not registered.

Influence on ability to drive vehicles and work with mechanisms

No effect of Celestoderm-B on the ability to drive vehicles and work with mechanisms was detected.

Release form

Cream for external use of 0.1%. 15 g or 30 g in aluminum tubes, coated with epoxy varnish and closed with a membrane and a screw cap. On one tuba together with the application instruction in a cardboard pack.

Shelf life

3 years. Do not use after expiration date.

Storage conditions

In the reach of children.

Store at a temperature not higher than 25 ° С.

Vacation conditions

Over the counter.