Translation of the instruction Mose

Instruction

On medical use of medicine

Ingredients:

Active ingredient:

1 g of ointment: Prednisolonum (in terms of 100% substance) – 5 mg;

excipients: glycerin, paraffin yellow soft, water the purified, stearic acid, emulsifier No. 1, methylparahydroxybenzoate (E 218), propilparagidroksibenzoat (E 216).

Dosage form.

Ointment.

Pharmacotherapeutic group.

Corticosteroids for application in dermatology. Prednisolonum.

Pharmacological properties.

Pharmacodynamics.

anti-inflammatory, epidermostatichesky, antiallergenic, immunodepressive and mestnoanesteziruyushchy effect.

Anti-inflammatory action is followed by vasoconstriction, reduction of an itch and pain in the place of applique, violation of migration of lymphocytes and macrophages in the inflammation center. GKS render antimitotic and anti-proliferative effect. Important aspect of anti-inflammatory action of GKS is stimulation of formation of the lipokortin reducing formation of arachidonic acid and by that the inflammation reducing formation of mediators and an allergy. Stabilization of cellular membranes plays an essential role in the mechanism of action of GKS. At skin application practically does not render system glucocorticoid and mineralokortikoidny effects.

Pharmacokinetics.

After insignificant absorption from the surface of skin contacts proteins of blood plasma, it is metabolized in a liver, allocated through kidneys. Disturbance of integrity of integuments or an occlusive bandage can increase absorbability of Prednisolonum through skin. Prednisolonum gets through a placental barrier and in small amounts gets into breast milk.

Indications.

as a part of complex therapy of inflammatory and allergic diseases of skin of not microbic etiology: eczema, seborrheal dermatitis, lupus erythematosus, erythroses.

Contraindication.

Wound or cankers, bacterial, viral and fungus diseases of skin, Cushing's syndrome, chicken pox, a herpes simplex, the vaccination period, skin manifestations of syphilis, a tuberculosis cutis, skin tumors, ordinary eels, pink eels (exacerbation of a disease is possible), hypersensitivity to medicine components, shingles, perioral dermatitis, atrophic dermatitis, skin reactions after an inoculation in the field of putting medicine.

Special security measures.

in the smallest dosages and minimum long time necessary for achievement of the necessary therapeutic effect. in the presence in the anamnesis of the instruction to psychosis the high doses are appointed under stringent control of the doctor. at long administration of medicament its sudden cancellation is dangerous! there can be an exacerbation of a disease and deterioration in the general condition of the patient. therefore it is necessary to cancel medicine gradually. at bacterial infectious processes of skin and/or a case of a fungal infection the additional special treatment using antibacterial and/or anti-mycotic medicines is necessary. it is necessary to avoid hit of medicine in eyes and on deep open wounds, on mucous membranes. for the purpose of increase in efficiency of therapy use of occlusive bandages is possible. when drawing corticosteroids for topical administration on big parts of the body or during the long period, especially under an occlusive bandage, the risk of emergence of side effects considerably increases. the maximum allowed area of the integument processed ks should not exceed 20% of a body surface. treatment should be carried out under control of the doctor. in the course of treatment the observation of the oculist, control of arterial blood pressure is necessary. as well as in case of system application of corticosteroids, in case of their topical administration the developing of glaucoma is possible (for example, after application in high doses or on a big surface during the long period, use of occlusive bandages or drawing on skin around eyes). administration of medicaments intended for topical administration during the long period can cause a sensitization. in that case it is necessary to stop therapy and to carry out the corresponding treatment. for the purpose of reduction of side effect it is necessary to alternate corticosteroids (ks) and nonsteroid medicines. it is necessary to use ks short courses and only for aggravation treatment, but not for prevention. when prescribing Prednisolonum it is necessary to consider a day-night secretory rhythm of glucocorticosteroids (gks) – a rhythm of discharge of adrenal hormones: appoint high doses, in the afternoon in the morning – averages, in the evening – small. with care to apply at immunodeficiency (including AIDS or vich-infection). it is not necessary to apply more than 14 days.

Interaction with other medicines and other types of interactions.

For prevention of infectious damages of skin Prednisolonum is recommended to appoint in a combination with antibacterial and antifungal agents. during medicament treatment it is not recommended to carry out vaccination against smallpox or other types of immunization because of immunodepressive effect of glucocorticosteroids. in connection with absorption the processing of big sites of skin or treatment during the long period can cause the interaction similar to that which is observed during system therapy. nevertheless, till this time any of such types of interactions was not registered. in case of need simultaneous use of any other medicines it is necessary to consult with the doctor.

Special cautions.

Use during pregnancy or feeding by a breast.

pregnant. the feeding women are recommended to stop either breastfeeding, or use of medicine, especially in high doses.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

does not influence.

Route of administration and doses.

is Applied outwardly, to apply ointment 1-3 times a day with a uniform thin layer on an affected area, slightly rubbing in skin. on limited sites of inflammation for strengthening of effect use of occlusive bandages is possible. duration of a course of treatment – 6-14 days. it is not necessary to use medicament longer than 14 days. when assigning children should limit to age of 1 year the general duration of treatment up to 5-7 days and to exclude the actions leading to increase in a resorption and absorption of steroid (warming, fixing and occlusive bandages).

Children.

on limited sites of skin a short course (5-7 days) only under observation of the doctor. use of medicine to children aged from 1 up to 3 years perhaps if the expected effect of therapy exceeds potential risk for the child. in such cases it is necessary to limit the general duration of treatment and to exclude the actions leading to strengthening of a resorption and absorption of steroid (warming, fixing and occlusive bandages). it is not necessary to use medicament on face skin. at children's age the oppression of function of adrenal glands can quicker develop. besides, decrease in excretion of growth hormone can be observed. at use of medicine it is necessary to watch the body weight, growth, cortisol level in blood plasma for a long time.

Overdose.

. at prolonged use of medicine in high doses the emergence of symptoms of a hypercorticoidism is possible.

Symptoms: headache, heart failure, small tortoiseshell, rash, severe itch.

Treatment: symptomatic. Drug withdrawal and the request for consultation to the doctor. In hard cases the emergency medical care is necessary. In the cases of developing of a skin atrophodermia connected with overdose at topical administration of medicine, treatment should be stopped. As a rule, symptoms regress within 10-14 days.

Side reactions.

At use of medicine, especially sick with individual sensitivity to medicine components, hyperaemia, hypostasis, an itch, urticaria, rash, steroid eels, purple, telangiectasias, burning sensation, irritation, xeroderma in sites of application of medicine, a pustule, vesicle, pain, papules in sites of application, skin cracks can arise; as well as in case of external use of other corticosteroids, such side effects (frequency is not determined) as skin thinning (skin atrophy), emergence of striya, inflammation of hair follicles (folliculitis) in the site of application, perioral dermatitis, skin discoloration, bacterial cellulitis, contact dermatitis and allergic skin reactions to any of medicine components can be observed. at long-term treatment also development of secondary infectious damages of skin, atrophic changes, a hypertrichosis is possible. at prolonged use of ointment, especially on big affected areas of skin, development of a hypercorticoidism as manifestation of resorptive action of a hydrocortisone is possible. in such cases medicine should be cancelled.

Expiration date.

2 years. it is not necessary to apply after the expiration date specified on packing.

Storage conditions.

in original packing at a temperature not above 25 °C. to store out of children's reach.

Packing.

On 10 or 15 g in tubas No. 1, in a pack from cardboard.

Category of a holiday.

According to the prescription.