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

active substance:
prednisolone	0.5 g
Excipients:
glycerin distilled	18.5 g
Vaseline medical	14.0 grams
stearic acid	5.0 grams
emulsifier # 1	7.0 g
nipagin	0.08 g
nip	0.02 g
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:

Prednisolone has anti-inflammatory, anti-allergic, antipruritic and anti-exsudative action.

Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, 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.

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:

When applied externally, Prednisolone is absorbed and the active substance enters the bloodstream. In plasma, 90% of prednisolone is in a bound form (with transcortin and albumin). Biotransformed by oxidation mainly in the liver; oxidized forms are glucuronized or sulphated.

It is excreted by the kidneys and with bile in the form of metabolites, in part - in an unchanged form.It penetrates through the placental barrier and in small amounts is found in breast milk.

Indications:

The drug is used in the complex therapy of inflammatory and allergic skin diseases of non-microbial etiology: urticaria, atopic dermatitis, simple chronic lichen (limited neurodermatitis), eczema, seborrheic dermatitis, discoid lupus erythematosus, simple and allergic dermatitis, toxicermy, erythroderma, psoriasis, alopecia.

Contraindications:

Hypersensitivity to prednisolone or any of the components of the drug, wound, ulcerative, bacterial, viral, fungal skin lesions, open wounds, trophic ulcers, skin post-vaccination reactions, tuberculosis, syphilis, skin tumors, acne, rosacea (possibly exacerbation) pregnancy, the period of breastfeeding, children under 1 year.

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

Pregnancy and lactation:

Glucocorticosteroids penetrate the placenta. During pregnancy, the drug is contraindicated.

Glucocorticosteroids are excreted in breast milk, so for the period of treatment during lactation breastfeeding should be discontinued.

Dosing and Administration:

Outwardly.

Ointment is applied a thin layer on the affected skin areas 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. During the period of aftercare, it is possible to apply the drug once a day.

On sites with more dense skin (for example, elbows, palms, feet), and also places from which the preparation is easily erased, ointment can be applied more often.

On limited foci, occlusal dressings can be used to enhance the effect.

Side effects:

When using the drug, especially in patients with individual intolerance, there may be hyperemia, swelling, itching within the site of application, steroid acne, telangiectasia, irritation, dry skin.

With prolonged use of the drug, it is also possible to develop secondary infectious skin lesions, atrophic changes in it, hypertrichosis.

To prevent infectious skin lesions, the drug is recommended to be prescribed in combination with antibacterial and antifungal agents.

With prolonged use of the drug, especially in large areas of damage, it is possible to develop hypercorticism, as a manifestation of the resorptive effect of prednisolone. In these cases, the drug is canceled.

If any adverse reaction occurs, consult a doctor as soon as possible. If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose:

Symptoms: oppression of hypothalamic-pituitary-adrenal system function, hyperglycemia, glucosuria, Itzenko-Cushing syndrome, Symptoms disappear after discontinuation of the drug.

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

Interaction:

Prednisolone enhances the anticoagulant effect of anticoagulants. Increases the likelihood of bleeding against the background of salicylates.

Increases the possibility of violations of electrolyte metabolism while taking diuretics.

Increases the risk of cardiac glycoside intoxication.

Reduces the hypoglycemic effect of antidiabetic drugs and reduces the antibacterial activity of rifampicin.

It is not recommended to combine with antacids.

Special instructions:

The duration of the drug should not exceed 14 days.

Do not apply to the skin in the eye area (due to the possible development of glaucoma and cataracts).

In cases of application of the drug on the face or under occlusive dressings, as well as in children from 1 year and older, the duration of the course of treatment should be reduced.

In childhood, suppression of the function of the adrenal cortex can develop faster. In addition, there may be a decrease in the excretion of growth hormone. When using the drug for a long time, it is necessary to observe the body weight, growth, plasma cortisol level.

Pediatric Use

When using the drug in children from 1 year and older, the total duration of treatment should be limited and the measures leading to increased resorption of steroid absorption (warming, fixing and occlusive dressings) should be excluded.

It should be borne in mind that in young children skin folds, diapers and diapers can have an effect,similar to the action of the occlusive dressing, and to increase the systemic resorption of the active substance of the preparation. Due to the fact that the ratio of surface area and body weight is greater in children than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and the development of the Itenko-Cushing syndrome with any glucocorticosteroids for external use. Long-term treatment with glucocorticosteroid can lead to disruption in the growth and development of the child. Therefore, children should receive the minimum dose of the drug to achieve the effect and the drug should be administered under the supervision of a doctor.

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

The drug in this dosage form does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Ointment for external use, 0,5%.

Packaging:

For 10 grams, 15 grams in tubes of aluminum.

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

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002593 / 01-2003

Date of registration:28.04.2008

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

Prednisolone (Prednisolon )