Prednisolone - instructions for use, dose, side effects, contraindications

Active substance:
Prednisolone	0.5 g
Excipients:
Glycerol (glycerin distilled)	18.5 g
Petrolatum	14.0 grams
Stearic acid	5.0 grams
Emulsifier № 1	7.0 g
Methylparahydroxybenzoate	0.08 g
Propyl parahydroxybenzoate	1-0.02g
Purified water	54.9 grams

Description:Ointment of white color.

Pharmacotherapeutic group:glucocorticosteroid for topical application

ATX: & nbsp

H.02.A.B.06 Prednisolone

Pharmacodynamics:

With external application it has anti-inflammatory, anti-allergic, antipruritic and antiexudative action.

Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, Pg, lysosomal enzymes). Suppresses 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 action.

It has an immunosuppressive effect on the type III-IV hypersensitivity reactions, inhibiting the effect of antigen-antibody complexes accumulating on the walls of blood vessels and causing allergic vasculitis.

Suppresses the effect of macrophages, target cells, cytokines, which are involved in the development of the reaction in the form of allergic contact dermatitis. Prevents the access of sensitized T-lymphocytes and macrophages to target cells.

Pharmacokinetics:

Suction

With topical application prednisolone is subjected to systemic absorption.

Distribution

In plasma, 90% of prednisolone is in a bound form (with transcortin and albumin).It penetrates through the placental barrier and in small amounts is found in breast milk.

Metabolism

Biotransformed by oxidation mainly in the liver; oxidized forms are glucuronized or sulphated.

Excretion

It is excreted through the intestines and kidneys in the form of metabolites, in part - in unchanged form.

Indications:

Ointment Prednisolone are used in the complex therapy of inflammatory and allergic skin diseases of non-microbial etiology: eczema, allergic, seborrheic and contact dermatitis, neurodermatitis, psoriasis, discoid lupus erythematosus, erythroderma.

Contraindications:

Hypersensitivity to the components of the drug, tuberculosis, syphilis, skin tumors, acne vulgaris, rosacea (possibly exacerbation of the disease), wound, ulcerative lesions, bacterial, viral and fungal skin diseases, childhood (up to 1 year).

If you have any of the listed diseases, always consult a doctor before using the drug.

Carefully:BVariability, lactation period.

Pregnancy and lactation:

Glucocorticoids penetrate the placenta.Effects on the fetus can be particularly pronounced when applying the drug on large surfaces. It is recommended to observe special care when prescribing the drug during pregnancy and lactation. External use of prednisolone in pregnant women is allowed in cases where, according to the attending physician, the potential benefit for the pregnant woman prevails over the possible risk to the fetus. In these cases, the application should be short and limited to small areas of the skin.

Glucocorticosteroids are excreted in breast milk. Precautions should be observed when using prednisolone in nursing mothers, in particular, the drug should not be applied to the skin of the breast before feeding. If you need to use the drug in large doses and / or for a long time, you should stop breastfeeding.

Dosing and Administration:

Outwardly.

Ointment is applied a thin layer on the affected skin 1-3 times a day. The duration of treatment depends on the nature of the disease and the effectiveness of therapy, usually 6-14 days; when the disease persists, it can be prolonged to 20 days.On limited foci, occlusal dressings can be used to enhance the effect. When using ointment in children from 1 year and older, the total duration of treatment should be limited and the measures leading to increased absorption of the drug (warming and occlusive dressings) should be excluded.

Side effects:

Local reactions: hyperemia, puffiness, itching and burning within the plot of the drug, steroid acne, telangiectasia (dilatation of the skin capillaries), irritation, dry skin.

With prolonged use of ointment Prednisolone it is also possible to develop secondary infectious skin lesions, atrophic changes in it, hypertrichosis (excess hair growth on skin areas).

To prevent infectious skin lesions prednisolone ointment is recommended to be prescribed in combination with antibacterial antifungal agents.

With prolonged use of the ointment, especially in large areas of damage, it is possible to develop hypercorticism (a rise in blood levels of cortisol above the norm) as a manifestation of the resorptive effect of prednisolone.

In case of adverse reactions, it is necessary to cancel the drug and consult a doctor.

If any of the side effects indicated in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

With prolonged use of the drug in large doses, the appearance of symptoms hypercortisy (elevated blood levels of cortisol above the norm).

Treatment: gradual withdrawal of the drug, symptomatic treatment, if necessary - correction of electrolyte imbalance.

Interaction:

No data available.

Special instructions:

Use in Pediatrics

The drug in children should be used with caution, limit the total duration of treatment. Due to the fact that in children the magnitude / ratio of surface area and body weight is greater than that of adults, suppression of the function of the adrenal cortex can develop more rapidly. In addition, there may be a decrease in growth hormone. The use of the drug for a long time should be carried out under the supervision of a doctor, it is necessary to observe the body weight, growth, plasma cortisol level.

It should be borne in mind that in young children, skin folds, diapers and diapers can have an effect similar to the effect of an occlusive dressing and increase the systemic resorption of the active substance of the drug.

In cases of application of the drug to the face or under occlusive dressings, the duration of the course of treatment should be reduced.

The duration of the drug should not exceed 14 days.

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

Data on the effect of ointment Prednisolone there is no ability to control vehicles and mechanisms.

Form release / dosage:

Ointment, 5 mg / g.

Packaging:

In tubes of aluminum for 10 g.

Each tube together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 15 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001289

Date of registration:16.09.2011

The owner of the registration certificate:ALTAYVITAMINS, CJSC ALTAYVITAMINS, CJSC Russia

Manufacturer: & nbsp

ALTAYVITAMINS, CJSC Russia

Representation: & nbspALTAYVITAMINS, CJSCALTAYVITAMINS, CJSC

Information update date: & nbsp28.08.2015

Illustrated instructions

Instructions

Prednisolone (Prednisolon )