Celestoderm-B - instructions for use, dose, side effects, contraindications

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

Description:Homogeneous cream, white, soft consistency, free of visible particles.

Pharmacotherapeutic group:glucocorticosteroid for topical application

ATX: & nbsp

H.02.A.B.01 Betamethasone

Pharmacodynamics:

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, not leaving traces on clothing, easily washed off cream base provides effective penetration into the skin and rapid onset of action.

Indications:

Inflammatory skin diseases, amenable to glucocorticosteroid (GCS) therapy, eczema (atopic, childish, coin-like), contact dermatitis, seborrheic dermatitis, neurodermatitis, sun dermatitis, exfoliative dermatitis, radiation dermatitis, intertriginous dermatitis, psoriasis,anogenital and senile itching.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- pregnancy (high doses, long-term treatment);

- lactation period;

- children's age - up 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.

Dosing and Administration:

Outwardly.

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

Side effects:

The following undesirable effects were observed in the application of local SCS: burning, irritation and dryness of the skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae and sweating.

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.

Interaction:

No interaction of Celestoderm-B with other drugs has been reported.

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 SCS, including suppression of adrenal cortex function, 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

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

Children who took local SCS experienced the following side effects: suppression of the function of the systemic GGN, Cushing 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.

Effect on the ability to drive transp. cf. and fur:

There is no evidence of any effect of Celestoderm-B on the ability to drive vehicles and work with machinery.

Form release / dosage:Cream for external use, 0,1%.

Packaging:

For 15 g or 30 g in aluminum tubes, covered with epoxy varnish and closed with a membrane and a screw cap.

One tube with instructions for use in a cardboard pack.

Storage conditions:

In a place inaccessible to children.

Store at a temperature not exceeding 25 ° C.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N012745 / 02

Date of registration:14.06.2011

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. Belgium

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp16.11.2015

Illustrated instructions

Instructions

Celestoderm-B (Celestoderm-V)