Betamethasone, Cetylpyridinium Chloride

Pharmacological properties

Betamethasone valerate, which is part of the drug, has a local anti-inflammatory, anti-allergic, antipruritic and antiexudative effect.

Cetylpyridinium chloride has a bacteriostatic and fungistatic effect, as a result of which the drug prevents the development of a secondary infection.

Indications

Reducing the severity of inflammatory manifestations of dermatoses sensitive to corticosteroids, such as eczema (atopic, numular), neurodermatitis, dermatitis (contact, solar, seborrheic, exfoliative, radiation, intertriginous, stasis-dermatitis), psoriasis (except for common psoriasis), anogenital and senile itching.

Application

The drug is used externally. apply the cream in a thin layer on the affected skin surface 1-3 times a day, depending on the severity of the disease. the frequency of application depends on the degree of damage: with a mild degree, the drug can be applied 1 time per day, in case of more severe lesions, the frequency of application of the drug must be increased. in most cases, to achieve the effect, it is enough to apply the drug 1-2 times a day.

The drug should not be used under occlusive dressings, since the side effect of the drug may increase.

Continuous use of the drug should not exceed 4 weeks. If the condition does not improve or worsens within 2–4 weeks of therapy, a second examination should be performed and treatment reviewed.

Contraindications

Hypersensitivity to active substances or other components of the drug; bacterial, viral, fungal infections of the skin (including herpes simplex and herpes zoster, chickenpox, tuberculosis and syphilis of the skin), post-vaccination skin reactions, rosacea, rosacea-like (perioral) dermatitis.

The drug is not intended for use in ophthalmology.

Side effects

From the immune system, skin and subcutaneous tissue: hypersensitivity reactions, burning sensation and / or tingling of the skin, sensation of heat, itching, irritation, dryness, cracking, lamellar and / or focal peeling of the skin, erythema, telangiectasia, folliculitis, follicular rash, acne-like rash, hypertrichosis, prickly heat, hypopigmentation, rosacea-like (perioral) dermatitis, allergic contact dermatitis, skin tightening, maceration of the skin, skin atrophy, striae, secondary infection.

On the part of the endocrine system: suppression of the hypothalamic-pituitary-adrenal system (GGNS) with the development of secondary adrenal insufficiency, symptoms of hypercorticism, Itsenko-Cushings syndrome.

Any adverse reactions detected during the systemic use of corticosteroids, including inhibition of the function of the adrenal cortex, can also occur with their local use, especially in high doses, for a long time, under occlusive dressings and in children.

In children receiving local corticosteroids, there were cases of inhibition of adrenal cortex function, Itsenko-Cushings syndrome, growth retardation, insufficient weight gain and intracranial hypertension. Symptoms of adrenal suppression in children include low levels of cortisol in blood plasma and urine and a lack of response to ACTH stimulation. Manifestations of intracranial hypertension include fontanel swelling, headache, and bilateral optic nerve edema.

special instructions

The drug is not intended for use in ophthalmology (on the mucous membrane of the eye, around the eyes).

Avoid prolonged use of the drug on the skin of the face.

Caution should be exercised when using the drug near the face and avoid contact with the drug in the eyes and mucous membranes.

The drug is not recommended for use under occlusive dressings and / or on large areas of the skin (high doses) and / or for a long time (more than 3-4 weeks) due to systemic absorption of betamethasone.

Systemic absorption of local corticosteroids increases with their dose. GCS with high activity in large areas of the skin should be used under the supervision of a physician and periodically monitoring the patients condition, since they can cause inhibition of GNSS. The function of GNSS is usually restored when the drug is discontinued. In some cases, withdrawal symptoms may develop that require the addition of systemic corticosteroids. In the case of development of inhibition of HHF, it is necessary to reduce the frequency of application or stop using the drug and transfer the patient to a weaker corticosteroids

In case of skin irritation or signs of hypersensitivity, the use of the drug should be discontinued and consult a doctor.

In the case of the development of fungal or bacterial superinfection of the skin, additional use of an antifungal or antibacterial agent is necessary. If at the same time the desired effect does not occur quickly, the use of GCS should be discontinued until the signs of infection are eliminated.

Use during pregnancy and lactation. Do not use the drug in the first trimester of pregnancy.

The appointment of the drug is possible only at a later stage of pregnancy and in the case when the expected benefit to the mother clearly exceeds the potential threat to the fetus. Drugs of this group should not be used in pregnant women at high doses, for a long time or under occlusive dressings.

It has not yet been established whether topical application of GCS due to systemic absorption can lead to their penetration into breast milk, therefore, when deciding whether to stop breastfeeding or stop taking the drug, it is necessary to take into account the importance of treatment for the mother.

Children. The safety of the drug in children has not been established, therefore, the drug is not intended for use in this category of patients.

The ability to influence the reaction rate when driving vehicles or other mechanisms. Typically, the drug does not affect the patients reaction rate when driving vehicles or other mechanisms.

Interactions

There is no data on interactions with other drugs and other types of interactions.

However, the drug is not recommended to be used simultaneously with local forms of drugs, in particular those containing anionic surfactants that inactivate the action of cetylpyridinium chloride.

Due to the presence of mineral oil in the excipients, the use of the drug in the anogenital area can damage the structure of latex condoms and reduce their safety during use.

In cases where systemic absorption of betamethasone can be assumed, numerous interactions with other drugs should be remembered.

Overdose

Symptoms excessive or prolonged use of corticosteroids for topical use can cause inhibition of pituitary-adrenal function, which leads to secondary adrenal insufficiency and the appearance of hypercorticism symptoms, including itsenko-cushings syndrome. acute symptoms of hypercorticism are usually reversible.

Treatment: symptomatic therapy; if necessary, electrolyte balance correction should be performed. In case of chronic toxic effects, gradual discontinuation of the drug is recommended.

Storage conditions

At a temperature not exceeding 25 ° c.