Prednicarb® [Urea, Prednisolone]

Pharmacological properties

Prednicarb-darnitsa is a combined preparation for local use, which has anti-inflammatory, antiexudative, anti-allergic, keratolytic, keratoplastic, antimicrobial and antipruritic effects.

Prednisolone is a dehydrogenated analogue of hydrocortisone. When applied externally, it has anti-inflammatory, anti-allergic, antipruritic and antiexudative effects. Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, prostaglandins, lysosomal enzymes). Inhibits the migration of cells to the site of inflammation; reduces vasodilation and increased vascular permeability in the focus of inflammation. Reduces exudation due to vasoconstrictor effect. It has an immunosuppressive effect of the type III – IV hypersensitivity reaction, inhibiting the effect of antigen – antibody complexes that accumulate on the walls of blood vessels and cause allergic vasculitis. Reduces the severity of the action of macrophages, target cells, cytokines involved in the development of the reaction in the form of allergic contact dermatitis. Prevents access of sensitized T-lymphocytes and macrophages to target cells.

Urea (urea) regulates the water balance of the skin and provides its turgor. Interacting with keratin in skin cells, enhances its hydration and desquamation of the keratinized layer, has keratoplastic (softens the keratinized epithelium) and keratolytic effects. Urea at a concentration of 10% when applied topically has a bacteriostatic and fungistatic effect. It has a slight superficial local anesthetic effect, due to which it has an antipruritic effect, which is additively enhanced by the similar action of prednisolone.

Pharmacokinetics When applied topically, prednisolone is absorbed.

Prednisolone crosses the placental barrier and in small amounts into breast milk. Excipients that make up the ointment hold urea at the site of application, and prevent its absorption into the systemic circulation.

Indications

Psoriasis, atopic dermatitis, various forms of eczema (including lichenization), dyshidrosis, seborrheic dermatitis, ichthyosis, ichthyosiform dermatoses, accompanied by dryness and hyperkeratosis.

Application

Adults and children over 1 year old. apply externally. ointment apply a thin layer on the affected skin 1-3 times a day. in limited areas, occlusion dressings may be used to enhance the effect. the duration of the course of treatment is determined by the doctor depending on the nature of the disease and the effectiveness of therapy, usually the course of treatment is 6-14 days.

When prescribing, children should limit the total duration of treatment to 5-7 days and exclude measures leading to increased absorption of GCS (warming, fixing and occlusive dressings).

Contraindications

Individual hypersensitivity to the components of the drug; cushing syndrome; chickenpox; vaccination period; herpes simplex, wounds and ulcers; bacterial, viral, fungal skin lesions, skin tuberculosis; skin manifestations of syphilis; skin tumors; common acne, rosacea; dermatoses, accompanied by severe exudation.

Side effects

From the immune system: allergic reactions may develop.

On the part of the skin and subcutaneous tissue: when using the medicine, itching, hyperemia, edema, skin rash, dermatitis, urticaria, dry skin, burning sensation, tingling, skin irritation, steroid acne, purpura, telangiectasia can occur.

With prolonged use or application on large areas of the skin, systemic adverse reactions may occur, in particular the development of secondary infectious skin lesions, atrophic changes, hypertrichosis, hypercorticism.

General disorders and reactions at the site of application: skin cracks at the site of application are possible, side effects (frequency not determined), such as thinning of the skin (skin atrophy), the appearance of striae, inflammation of the hair follicles (folliculitis), discoloration of the skin, and bacterial cellulitis are possible .

special instructions

It is necessary to prescribe the drug in the minimum dose and for the shortest possible time necessary to achieve the necessary therapeutic effect.

In order to avoid exposure to healthy tissues, it is desirable that the area of ​​the skin on which the ointment is applied does not exceed the size of the affected area.

Treatment should be carried out under the supervision of a physician. In the process of treatment, oculist monitoring and blood pressure monitoring are necessary.

In order to reduce the severity of side effects, alternate corticosteroids and non-steroidal drugs.

The maximum allowable area of ​​the skin treated with the drug should not exceed 20% of the body surface.

GCS should be used in short courses and only for the treatment of exacerbation, but not for prevention.

When prescribing the drug, the daily secretory rhythm of GCS should be taken into account: high doses are prescribed in the morning, medium doses in the afternoon, and minimal doses in the evening.

Sudden withdrawal of the drug is dangerous, since an exacerbation of the disease and a deterioration in the general condition of the patient are possible. It is necessary to cancel a drug gradually.

During the treatment period, vaccination against smallpox or other types of immunization should not be carried out due to the immunosuppressive effect of GCS. Avoid contact with eyes, mucous membranes and scalp. If there is a history of indications of psychosis, high doses are prescribed under the strict supervision of a physician.

Use with caution in immunodeficiency conditions (including AIDS or HIV infection).

If skin irritation or signs of hypersensitivity appear in connection with the use of the ointment, treatment should be discontinued and the patient should be given adequate therapy.

In the case of prolonged use of the drug when used on a large surface of the body, especially in children, systemic side effects from the endocrine system are possible. These adverse reactions develop extremely rarely, are reversible and disappear immediately after the cessation of the use of the drug. For such patients, during the period of use of the drug, regular monitoring of the function of the hypothalamic-pituitary-adrenal system is necessary. When symptoms of inhibition of the function of the hypothalamic-pituitary-adrenal system appear, it is necessary to cancel the drug or increase the intervals between applications of the ointment. The use of local steroids for the treatment of psoriasis can in some cases lead to relapse of the disease, the development of tolerance, increase the risk of generalized pustular psoriasis and the development of local or systemic (reversible inhibition of the hypothalamic-pituitary-adrenal system) toxicity due to reduced skin barrier function. Therefore, in the treatment of psoriasis with the drug, it is important to constantly monitor the patients condition.

In the case of the development of fungal or bacterial superinfection of the skin, additional use of an antifungal or antibacterial agent is necessary.

Use during pregnancy and lactation. Contraindicated.

Children. In children over the age of 1 year, the drug is used in limited areas of the skin with a short course (5-7 days). The use of the drug in children aged 1-3 years is possible if the expected effect of therapy exceeds the potential risk to the child.In such cases, it is necessary to limit the total duration of treatment and exclude measures that increase the resorption and absorption of the steroid (warming, fixing, and occlusive dressings). Diapers can have an occlusive effect. Avoid prolonged use in children, regardless of age. With prolonged use for the prevention of local infectious complications, it is possible to use in combination with antimicrobial drugs. It is not recommended to apply on large surfaces. It should be remembered that the larger the area of ​​application of the drug, the higher the likelihood of adverse reactions. When using the drug in children, it is necessary to take into account the possibility of signs of inhibition of the hypothalamic-pituitary-adrenal system, which occur in children more often than in adult patients, which is associated with greater absorption of the drug in children due to the greater ratio of skin area to body weight.

In children receiving topical corticosteroids, inhibition of adrenal function, Cushings syndrome, growth retardation, insufficient weight gain, increased intracranial pressure were noted.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Does not affect.

Interactions

Glucocorticosteroid drugs of systemic and local action enhance the effects of the drug.

The combined use with antimicrobial and antifungal drugs helps to prevent secondary infection with prolonged use of the drug.

Overdose

Depending on the amount of corticosteroid that has been ingested, the development of both local and systemic adverse reactions is possible. with an overdose of the drug, treatment should not be abruptly stopped - this is done by gradually reducing the dose of the drug. with the development of symptoms of adrenal insufficiency, the administration of hydrocortisone may be required.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° c. do not freeze.